Search

Background: Patients with a history of coronary revascularization are at a higher risk for subsequent cardiovascular events and all-cause mortality. Lowering LDL-cholesterol (LDL-C) levels post-revascularization significantly reduces these risks., Methods: This analysis compared LDL-C-lowering therapies at baseline and over time among patients with and without prior coronary revascularization in the GOULD registry (a prospective multicenter cohort study). Baseline- and 24-month follow-up characteristics-including LDL-C levels and strategies for lipid-lowering therapy (LLT)-were evaluated., Results: Out of 5006 patients, 2195 (43.8%) had prior coronary revascularization. At baseline, these patients had lower LDL-C (99.2 mg/dL vs. 102.5 mg/dL; p < 0.001) and were more likely to be on intensive LLT (52.8% vs. 42.7%; p < 0.001). At 24 months, they had small reductions in LDL-C (-15.6% vs. -13.7%; p = 0.145) and were more likely to be on intensive LLT (61.9% vs. 51.5%; p < 0.001). Similar LDL-C reductions were observed in the PCSK9i group regardless of revascularization status., Conclusions: Despite slightly better baseline LLT among patients with prior revascularization, few patients met the <70 mg/dL goal and LLT was rarely escalated during 24 months of follow-up. Improved systems-based strategies and personalized treatment approaches are urgently needed to enhance LDL-C lowering and reduce cardiovascular events, especially in patients with a history of coronary revascularization., Competing Interests: Declaration of competing interest Dr Bhatt reported receiving research funding paid to Brigham and Women’s Hospital from Amgen Research and serving on the Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Steering Committee during the conduct of the study and discloses the following relationships - Advisory Board: Angiowave, Bayer, Boehringer Ingelheim, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, E-Star Biotech, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Stasys; Tourmaline Bio; Board of Directors: American Heart Association New York City, Angiowave (stock options), Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock); Consultant: Broadview Ventures, GlaxoSmithKline, Hims, SFJ, Youngene; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic, Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical; for ALLAY-HF, funded by Alleviant Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (AHA lecture), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women’s Hospital who assigned to Lexicon; neither I nor Brigham and Women’s Hospital receive any income from this patent); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo. Dr Ballantyne reported receiving grants from Amgen and personal fees from Amgen during the conduct of the study and grants from Akcea, Arrowhead, Esperion, Ionis, Merck, Novartis, and Regeneron and personal fees from Alnylam Pharmaceuticals, Althera, Amarin, Arrowhead, Astra Zeneca, Esperion, Illumina, Matinas BioPharma Inc, Merck, New Amsterdam, Novartis, Pfizer, and Regeneron outside the submitted work. Dr de Lemos reported receiving personal fees from the Amgen Steering Committee during the conduct of the study and personal fees from Johnson and Johnson Data Monitoring Committee, Astra Zeneca Data Monitoring Committee, Verve Therapeutics Data Monitoring Committee, Novo Nordisc Data Monitoring Committee, Eli Lilly Data Monitoring Committee, and from Regeneron Data Monitoring Committee outside the submitted work. Dr Rosenson reported receiving personal fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Novartis, Precision Biosciences and Regeneron during the conduct of the study and personal fees from the Amgen Steering Committee outside the submitted work. Dr Kosiborod reported research grants from Boehringer Ingelheim, Pfizer, and Astra Zeneca; consultant/advisory boards for 35Pharma, Alnylam, Amgen, Applied Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Imbria Pharmaceuticals, Janssen, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, scPharmaceuticals, Structure Therapeutics, Vifor Pharma, and Youngene Therapeutics; honoraria from Astra Zeneca, Boehringer Ingelheim, and Novo Nordisk; stock options from Artera health and Saghmos Therapeutics; and other research support from Astra Zeneca. Dr Cannon reported receiving grants and personal fees from Amgen during the conduct of the study and grants from Better Therapeutics, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Merck, Novo Nordisk, and Pfizer and personal fees from Aegerion/Amryt, Alnylam, Amarin, Applied Therapeutics, Ascendia, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Lexicon, Merck, Pfizer, Rhoshan, and Sanofi outside the submitted work. No other disclosures were reported., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The Oswestry Disability Index (ODI) is a well-validated and widely used patient-reported outcome instrument to evaluate lumbar spinal stenosis (LSS) patients' treatment outcomes. The objective of the present study was to determine long the average interval between 2 preoperative measurements can be before a clinically significant difference of 10 points or more might appear., Methods: This was a retrospective observational study utilizing prospectively collected data from a single university hospital database, which was compatible with the national registry. One hundred and four surgically treated LSS patients were included in this observational study using systematic sampling. The preoperative ODI score was obtained at 2 timepoints. The 2-month mark as a potential turning point was of special interest, as the registry in question excludes preoperative data as outdated if the data are older than 2 months. Possible time dependence of the change in ODI scores was explored using a linear mixed-effects model with ODI as the dependent variable and interval length, sex, age, body mass index (BMI), and the presence of a concomitant disease as fixed effects., Results: The mean ODI score was 41.7 points (SD = 16.0) at the first and 41.1 points (SD = 15.5) at the second measurement. Mean time between the ODI scores was 74 days (range 8-361). On average, ODI changed by 9.17 points (SD = 7.16) between the 2 measurements, increasing for 48 patients, remaining unchanged for 9 patients, and decreasing for 47 patients. The arithmetic mean of the changes was -0.60 points and the median was 0.00 points. The estimated change in the population mean was -0.0005 points/day (95% CI [-0.022, 0.022], P = 0.97), meaning that we have strong evidence that the change in the mean is not clinically significant for up to 15 months (95% CI between ±10 points). Furthermore, no evidence was found that age, sex, BMI, or concomitant diseases were associated with the change of ODI score over time. Furthermore, the probability to observe a clinically significant change in a patient did not depend on the number of days between the 2 measurements (OR 1.003, 95% CI [0.997, 1.010], P = 0.30). Variance in ODI change did not grow over time., Conclusions: The probability of observing a clinically significant differences does not depend on the length of the observation interval, and ODI scores can be considered equally reliable for a significantly longer time than 2 months, even up to 1 year., Clinical Relevance: Preoperative ODI scores do not lose reliability up to 1 year in patients undergoing operatively treatment for LSS., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2025 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.)

Objective: Patients who undergo major lower extremity amputation (MLEA) have the highest postoperative mortality among orthopedic patient groups. The comorbidity profile for MLEA patients is often extensive and associated with elevated postoperative mortality. This study primarily aimed to investigate the increased short- and long-term mortality following first and subsequent major lower extremity amputation. Secondarily, to examine the mediation role of post-amputation complications., Study Design and Setting: With data from the Danish National Patient Registry, 11,695 first-time MLEAs in patients aged ≥50 years were identified between January 1, 2010, and December 31, 2021, along with 58,466 unamputated persons matched 1:5 by year of birth, sex, and region of residence. Mediators were identified through diagnosis codes (ICD-10) present in 6 months following MLEA., Results: The increased mortality following MLEA was highest in the month following MLEA, hazard ratio (HR) 38.7 (95% confidence interval (CI) 30.5-48.9) in women and HR 55.7 (CI 44.3-70.2) in men compared to a matched unamputated cohort. Subsequent amputation resulted in an increased mortality the month after a subsequent amputation (overall HR 3.2 (CI 2.8-3.7) in women and HR 3.2 (CI 2.8-3.6) in men) and almost normalized after the first year. The proportion of the mortality risk that potentially could be reduced by preventing sepsis was 16% (CI 11.7-20.3) for women and 17% (CI 13.4-20.4) for men. For pneumonia, it was 10.5% (CI 7.1-13.9) in women and 14.9% (11.6-18.2) in men., Conclusion: We observed an increased mortality in the month following MLEA, which remained elevated for years compared to the matched unamputated cohort. A subsequent amputation results in increased mortality in the following year, but declined and normalized after the first year. Sepsis and pneumonia arising after the amputation appeared to be important factors that contributed to the increased postoperative mortality., Competing Interests: Dr Anna Brix reports grants from Odense University Hospital, grants from Region of Southern Denmark, grants from The Novo Nordic Foundation (grant number: NNF21OC0071854), during the conduct of the study. The authors have no competing interests to declare. All Authors agreed on the final manuscript., (© 2025 Brix et al.)

Introduction: The provision of treatment for epidermal growth factor receptor (EGFR)-mutated nonsmall cell lung cancer (NSCLC) patients has increased in Korea. However, multicenter studies on the clinicopathologic dataset and treatment outcomes, using a large-scale dataset, have not been conducted. The current study is a prospective and retrospective multicenter observational cohort study that registers all stages of EGFR-mutated NSCLC patients., Methods: The Korean EGFR Registry was designed to enroll 2000 patients with all stages of EGFR-mutated NSCLC from 40 university hospitals across Korea. This study, encompassing both retrospective and prospective cohorts, aims to analyze clinical characteristics, treatment modalities, and outcomes in these patients. Data collection will include patient demographics, smoking history, quality of life assessments, pathological data, and treatment outcomes, with follow-up until December 2026. The primary endpoint is disease-free survival in patients who have undergone radical therapy (surgery and radiotherapy) or progression-free survival in those receiving targeted therapy (first, second, and subsequent lines), chemotherapy (first and subsequent lines), combination therapy, and palliative/maintenance therapy according to stages of EGFR-mutated NSCLC. The study will explore the diagnostic methods for EGFR mutations, clinical outcomes based on treatment modalities, and metastatic patterns in EGFR-mutated NSCLC patients. Moreover, it will investigate various aspects, including the safety and efficacy of a new third-generation EGFR tyrosine kinase inhibitor (TKI), lazertinib, approved for both first- and second-line treatments., Discussion: This study is expected to provide valuable insights into the epidemiology, risk factors, progression, and treatment outcomes of EGFR-mutated NSCLC in Korea. The Korean EGFR Registry will contribute significantly to the understanding of the complex dynamics of EGFR-mutated NSCLC, aiding in the development of more effective and personalized treatment strategies., (© 2025 The Author(s). The Clinical Respiratory Journal published by John Wiley & Sons Ltd.)

Background: The stemmed anatomic total shoulder arthroplasty is the gold standard in the treatment of glenohumeral osteoarthritis. However, the use of stemless total shoulder arthroplasties has increased in recent years. The number of revision procedures are relatively low, and therefore it has been recommended that national joint replacement registries should collaborate when comparing revision rates. Therefore, we aimed to compare the revision rates of stemmed and stemless TSA used for the diagnosis of glenohumeral osteoarthritis using data from both the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the Danish Shoulder Arthroplasty Registry (DSR)., Methods: We included all patients who were registered in the AOANJRR and the DSR from January 1, 2012, to December 2021 with an anatomic total shoulder arthroplasty used for osteoarthritis. Revision for any reason was used as the primary outcome. We used the Kaplan-Meier method to illustrate the cumulative revision rates and a multivariate cox regression model to calculate the hazard ratios. All analyses were performed separately for data from AOANJRR and DSR, and the results were then reported using a qualitative approach., Results: A total of 13,066 arthroplasties from AOANJRR and 2882 arthroplasties from DSR were included. The hazard ratio for revision of stemmed TSA with stemless TSA as reference, adjusted for age and gender, was 1.67 (95% confidence interval [CI] 1.34-2.09, P < .001) in AOANJRR and 0.57 (95% CI 0.36-0.89, P = .014) in DSR. When including glenoid type and fixation, surface bearing (only in AOANJRR), and hospital volume in the cox regression model, the hazard ratio for revision of stemmed TSA compared to stemless TSA was 1.22 (95% CI 0.85-1.75, P = .286) in AOANJRR and 1.50 (95% CI 0.91-2.45, P = .109) in DSR. The adjusted hazard ratio for revision of total shoulder arthroplasties with metal-backed glenoid components compared to all-polyethylene glenoid components was 2.54 (95% CI 1.70-3.79, P < .001) in AOANJRR and 4.1 (95% CI 1.92-8.58, P < .001) in DSR., Conclusion: Based on data from 2 national shoulder arthroplasty registries, we found no significant difference in risk of revision between stemmed and stemless total shoulder arthroplasties after adjusting for the type of glenoid component. We advocate that metal-backed glenoid components should be used with caution and not on a routine basis., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: Ivacaftor (IVA) has been shown to change the trajectory of cystic fibrosis (CF) disease progression by slowing the rate of lung function decline in clinical studies. Long-term real-world data help to confirm the durability of this response., Methods: This non-interventional, longitudinal study used data from the US CF Foundation Patient Registry to describe the annualized rate of change in lung function in people with CF receiving IVA. The IVA-treated cohort included people with CF aged ≥ 6 years who had ≥ 1 CF transmembrane conductance regulator (CFTR)-gating mutation and initiated IVA between 31 January 2012 and 31 December 2018. An age-matched comparator cohort included people with CF heterozygous for the F508del-CFTR mutation and a minimal function mutation (R117H excluded) and had not received CFTR modulator therapy. Baseline characteristics were balanced using standardized mortality ratio (SMR) weights computed from estimated propensity scores. The annualized rate of change in percent predicted forced expiratory volume in 1 s (ppFEV 1 ) was estimated over 5 years and used to calculate the relative annualized rate of change in lung function in the IVA-treated versus comparator cohorts., Results: In the 5-year follow-up period, 548 people were in the IVA-treated and 541 in the comparator cohorts after SMR weighting. The annualized rate of change in ppFEV 1 over 5 years was -1.23 (95% CI -1.45, -1.03) and -2.03 (-2.16, -1.90) percentage points in the IVA-treated and comparator cohorts, respectively. There was a 39% reduction (95% CI: 28, 50) in the rate of lung function decline in the IVA-treated versus comparator cohort over 5 years. Findings were generally consistent with those of shorter follow-up periods., Conclusion: IVA showed a durable clinical benefit by slowing the rate of lung function decline over 5 years. Results support a sustained and consistent impact of IVA on lung function trajectory in people with CF. Word count: 300 (limit: 300 words)., Competing Interests: Declarations Conflict of Interest All authors received nonfinancial support (assistance with manuscript preparation) from Nucleus Global, which received funding from Vertex Pharmaceuticals Incorporated. Additional disclosures are as follows: Christian Merlo reports funding from Vertex Pharmaceuticals. Maral DerSarkissian, Catherine Nguyen, Yuqian M. Gu, and Aruna Muthukumar are current or former employees of Analysis Group Inc., which received research funding/consultancy fees from Vertex Pharmaceuticals. Yuqian M. Gu is a current employee of Kaiser Permanente. M. Alan Brookhart has served as a scientific advisory committee member for Amgen, Atara Biotherapeutics, Brigham and Women’s Hospital, Kite, Gilead, Intercept, NIDDK, and Vertex; he also has consulting fees/equity from Target RWE and equity from VitriVax and Accompany Health. Christina V. Scirica, Teja Thorat, Lisa J. McGarry, Joe Healy, and Jaime L. Rubin are current or former employees of Vertex Pharmaceuticals Incorporated and may own stock or stock options in Vertex. Joe Healy is currently employed with Regeneron Pharmaceuticals. Ethics Approval The US CFFPR protocol review committee provided feedback and approved the protocol with revisions prior to study start. The Advarra Institutional Review Board, which operates in accordance with the Helsinki Declaration of 1964 and its later amendments, granted an exemption for this research project based on the scope of the research in July 2020. All the patients in the CF registry provide informed consent to include their data in the registry., (© 2024. The Author(s).)

Objectives: To describe characteristics and primary healthcare utilisation in Danish patients with low back pain (LBP) or neck/thoracic spine pain (NTP) 8 years before and 2 years after assessment in secondary care., Methods: In this cohort study, we included patients aged ≥ 18 who were assessed at an outpatient spine clinic from 2013 to 2021 and linked self-reported information with national registry data. We calculated the prevalence of all-cause healthcare utilisation in primary care. Then, we determined changes in the number of consultations from before to after assessment in secondary care using generalised estimating equations., Results: We included 56,949 LBP patients and 18,926 NTP patients. The baseline characteristics were similar overall. For both LBP and NTP, all-cause healthcare utilisation increased slightly over time, with a substantial increase in the quarter before the secondary care assessment and a decrease after. Before the assessment, almost all patients consulted general practitioners (95%), while some consulted physiotherapists or chiropractors (60%). Overall, consultations decreased by 19% and 17% for patients with LBP and NTP from 12 to 1 month before to 1-12 months after the assessment. In contrast, 13-24 months after assessment, we found a slight increase in consultations in both groups compared to the same period before., Conclusions: Patients with LBP and NTP were similar and used similar primary healthcare, which slightly increased over the 10 years. As physiotherapists and chiropractors are first-line providers of guideline-recommended spine pain treatment, the finding that 40% did not consult these professions the year before the secondary care assessment indicates that not all patients receive recommended care before referral., (© 2024 John Wiley & Sons Ltd.)

The objective of this study was to reveal the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for Japanese patients with treatment-resistant depression (TRD) in clinical practice, based on real-world data from a nationwide multicenter observational study in Japan. Clinical data of patients with TRD treated with rTMS (NeuroStar TMS treatment system) under public insurance coverage were retrospectively collected from 21 institutes nationwide between June 2019 and December 2023. Depression severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17). Response and remission were defined as ≥50 % reduction from baseline and ≤7 points on the HAMD-17, respectively. The primary outcome was the changes in the HAMD-17 score from baseline to the endpoint following rTMS. Data from 497 patients with TRD were candidates for this study. The HAMD-17 scores (mean (SD)) improved significantly from 18.9 (5.3) to 9.7 (6.6), respectively. The response and remission rates at the end of rTMS therapy as assessed by the HAMD-17 were 53.5 % and 42.8 %, respectively. The dropout rate due to adverse effects was 4.2 %, and the treatment was generally well tolerated. No convulsive seizures or manic changes were observed. These results indicate that conventional rTMS is effective and safe in Japanese patients with TRD., Competing Interests: Declaration of competing interest The authors declare that there are no conflicts of interest in relation to this study., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Currently, there are limited therapeutic options for patients with non-active secondary progressive multiple sclerosis. Therefore, real-world studies have investigated differences between patients with relapsing-remitting multiple sclerosis, non-active secondary progressive multiple sclerosis and active secondary progressive multiple sclerosis. Here, we explore patterns and predictors of transitioning between these phenotypes. We performed a cohort study using data from The Danish Multiple Sclerosis Registry. We included patients with a relapsing-remitting phenotype, registered changes to secondary progressive multiple sclerosis and subsequent transitions between relapsing and non-relapsing secondary progressive multiple sclerosis, which was defined by the presence of relapses in the previous 2 years. We analysed predictors of transitioning from relapsing-remitting multiple sclerosis to relapsing and non-relapsing secondary progressive multiple sclerosis, as well as between the secondary progressive states using a multi-state Markov model. We included 4413 patients with relapsing-remitting multiple sclerosis. Within a median follow-up of 16.2 years, 962 were diagnosed with secondary progressive multiple sclerosis by their treating physician. Of these, we classified 729 as non-relapsing and 233 as relapsing secondary progressive multiple sclerosis. The risk of transitioning from relapsing-remitting to non-relapsing secondary progressive multiple sclerosis included older age (hazard ratio per increase of 1 year in age: 1.044, 95% confidence interval: 1.035-1.053), male sex (hazard ratio for female: 0.735, 95% confidence interval: 0.619-0.874), fewer relapses (hazard ratio per each additional relapse: 0.863, 95% confidence interval: 0.823-0.906), higher expanded disability status scale (hazard ratio per each additional point: 1.522, 95% confidence interval: 1.458-1.590) and longer time on disease-modifying therapies (hazard ratio per increase of 1 year in treatment, high-efficacy disease-modifying therapy: 1.095, 95% confidence interval: 1.051-1.141; hazard ratio, moderate-efficacy disease-modifying therapy: 1.073, 95% confidence interval: 1.051-1.095). We did not find significant predictors associated with the transition from relapsing secondary progressive multiple sclerosis to non-relapsing secondary progressive multiple sclerosis, whereas older age (hazard ratio per increase of 1 year in age: 0.956, 95% confidence interval: 0.942-0.971) prevented the transition from non-relapsing secondary progressive multiple sclerosis to relapsing secondary progressive multiple sclerosis. Our study suggests that transitioning from relapsing-remitting multiple sclerosis to non-relapsing secondary progressive multiple sclerosis depends on well-known factors affecting diagnosing secondary progressive multiple sclerosis. Further transitions between non-relapsing and relapsing secondary progressive multiple sclerosis are only affected by age. These findings add to the knowledge of non-active secondary progressive multiple sclerosis, a patient group with unmet needs in terms of therapies., Competing Interests: N.G. and S.S.G. are employees of Sanofi and may hold shares and/or stock options in the company. M.F.W.-H. has served on the scientific advisory board for Sanofi and has received honoraria for lecturing for Novartis and Sanofi. H.B.J. has served as advisory board member for Merck and Roche and has received speaker honoraria from Biogen and Novartis. Z.I. has received speakers’ honoraria and/or research grants from Biogen, Roche, Sanofi, Novartis, Merck, Alexion, Bristol Myers Squibb, Lundbeckfonden, Jascha Fonden and Scleroseforeningen, has been member of advisory boards at Alexion, Biogen, Sanofi, Merck, Roche and Novartis, has been member of adjudication relapse (clinical endpoint) committees in Phase 3 trials and has been principal investigator in studies sponsored by Biogen, Merck and Sanofi. R.M.J. has served on scientific advisory boards for Novartis and Merck and has received conference travel support from Biogen. T.S. has served in scientific advisory board for Biogen, Merck, Novartis, Roche and Sanofi and has received honoraria for lecturing from Biogen, Merck, Novartis, Roche and Sanofi. A.W. has served on scientific advisory boards for Merck, Roche and Sanofi, has received conference travel support from Biogen, Merck, Roche, Sanofi and Novartis and speaker honoraria from Roche, Merck and Sanofi. M.R.M. has received support for participation in scientific meetings from Merck and Novartis, as well as travel grants from The Danish Multiple Sclerosis Society. M.B.P. has served on scientific advisory boards for Merck and support for conference participation from Novartis and Merck. S.P. received honoraria for contributing to making a magazine and support for congress participation from Merck. M.S. has served on scientific advisory boards for, received support for congress participation or received speaker honoraria from Biogen, Merck, Novartis, Roche and Sanofi Genzyme. P.V.R. has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi Genzyme. K.B.S. has served as consultant for Takeda, has received travel grants from TEVA, Biogen Merck and Novartis and has been principal investigator in studies sponsored by Alexion, Roche and Sanofi. F.S. has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, Lundbeck, Merck, Novartis, Roche and Sanofi Genzyme. His laboratory has received research support from Biogen, Merck, Novartis, Roche and Sanofi Genzyme. M.M. has served on scientific advisory boards, served as a consultant, received support for congress participation or received speaker honoraria from Roche, Sanofi, Biogen, Merck, Novartis, Bristol Myers Squibb, Medscape, Alexion and Moderna. Her research group has contracts with Biogen, Merck, Novartis, Roche, Sanofi and Bristol Myers Squibb. All other authors report no competing interests., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Guarantors of Brain.)

Objectives: RA patients have an increased risk for cardiovascular diseases, including atrial fibrillation (AF), but the impact of RA on ischaemic stroke risk in the context of AF remains unknown. We explored whether the risk of ischaemic stroke after diagnosis of AF is further increased among patients with RA compared with non-RA patients., Methods: In the nationwide Norwegian Cardio-Rheuma Register, we evaluated cumulative incidence and hazard rate of ischaemic stroke after the first AF diagnosis (2750 individuals with RA and 158 879 without RA between 2010 and 2017) by using a competing risk model with a 3-month delayed entry., Results: The 5-year unadjusted cumulative incidence of ischaemic stroke was 7.3% (95% CI: 5.9-8.7%) for patients with RA and 5.0% (95% CI: 4.9-5.2%) for patients without RA. Unadjusted univariate analyses indicated that AF patients with RA had a HR of 1.36 (95% CI: 1.13, 1.62) for ischaemic stroke compared with those without RA. Sex- and age-adjusted HR for ischaemic stroke in RA patients with AF was 1.25 (95% CI: 1.05, 1.50), and the effect size remained unchanged after adjustment for diabetes, hypertension, atherosclerotic cardiovascular disease and oral anticoagulant (OAC) treatment. RA patients were less likely to receive OAC treatment than non-RA patients (adjusted odds ratio 0.88, 95% CI: 0.80, 0.97)., Conclusion: RA patients diagnosed with AF are at a further increased risk for stroke compared with non-RA patients with AF, and less likely to receive OAC treatment, emphasizing the need to improve stroke prevention in AF patients with RA., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: This registry-based study aimed to describe cross-sectional dental and demographic data with focus on diagnosis and treatment of periodontal disease. A second aim was to analyse the extent and content of performed periodontal treatment in patients with varying degrees of periodontitis and if treatment was provided on equal terms. An additional aim was to identify if possible differences in treatments were related to type of dental insurance system., Methods: A study population, 225,913 individuals ≥ 20 years living in the Region of Västra Götaland, was identified by the Swedish Quality Registry for Caries and Periodontal Diseases (SKaPa). Registry data were retrieved for the period 2010-2012. Logistic regression models were used to predict the probability of receiving periodontal interventions and access to fixed annual fees., Results: Among the study population, 17% had periodontal disease (≥ 4 teeth with periodontal pockets ≥ 4 mm) and constituted the final study sample. The probability of periodontal intervention increased with severity of periodontitis, in moderate (OR = 2.3) and severe cases (OR = 5.2) compared to the group with minor disease (p < 0.001). Severe periodontitis was associated with male gender, increasing age and smoking. About 30% of the individuals remained untreated over the 3-year period. Individuals with fee-for-service were more likely to receive periodontal intervention than individuals with fixed annual fees (OR = 1.7; p < 0.001)., Conclusion: Severe periodontitis and being in the fee-for-service system were associated with more periodontal interventions. However, one-third of the study subjects remained untreated. These findings indicate the need for improved care on equal terms for patients with periodontal disease., (© 2024 The Author(s). International Journal of Dental Hygiene published by John Wiley & Sons Ltd.)

Background: The aim of this study was to evaluate the impact of hepatitis C virus (HCV) infection and treatment status on coronavirus disease 2019 (COVID-19)-related hospitalizations in Georgia., Methods: We analyzed 2020-2021 Georgian health registry data for COVID-19-positive individuals and categorized the data by HCV infection and treatment status. Logistic regression was used to assess the strengths of the associations., Results: Treated individuals with HCV had lower odds of COVID-19-related hospitalization compared to anti-HCV-negative individuals, while untreated HCV-viremic and anti-HCV-positive nonviremic individuals had higher odds., Conclusions: HCV treatment prior to COVID-19 infection was associated with lower odds of COVID-19-related hospitalization, highlighting the benefits of HCV management in the context of the pandemic., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Several treatment-related challenges exist for gambling disorder, in particular at-scale dissemination in health care settings., Objective: This study describes the introduction of a newly developed internet-delivered cognitive behavioral therapy (iCBT) program for gambling disorder (GD), provided with therapist support in routine addiction care, in a nationally recruited sample in Sweden. The study details the introduction of the iCBT program, evaluates its effectiveness and acceptability, and compares registry outcomes among iCBT patients with other patients with GD at the clinic who received face-to-face psychological treatment as usual., Methods: The study site was the Stockholm Addiction eClinic, which offers digital interventions for addictive disorders in routine care. The iCBT program was introduced nationally for treatment-seeking patients through the Swedish eHealth platform. After approximately 2 years of routine treatment provision, we conducted a registry study, including ordinary patients in routine digital care (n=218), and a reference sample receiving face-to-face psychological treatment for GD (n=216)., Results: A statistically significant reduction in the Gambling Symptom Assessment Scale scores during the treatment was observed (B=-1.33, SE=0.17, P<.001), corresponding to a large within-group Cohen d effect size of d=1.39. The iCBT program was rated high for satisfaction. A registry-based survival analysis, controlling for psychiatric comorbidity, showed that patients receiving iCBT exhibited posttreatment outcomes (re-engagement in outpatient addiction care, receiving new psychiatric prescriptions, enrollment in psychiatric inpatient care, and care events indicative of contact with social services) similar to comparable patients who underwent face-to-face treatment-as-usual., Conclusions: A lack of randomized allocation notwithstanding, the iCBT program for GD evaluated in this study was well-received by patients in routine addiction care, was associated with the expected symptom decrease during treatment, and appears to result in posttreatment registry outcomes similar to face-to-face treatment. Future studies on treatment mechanisms and moderators are warranted., International Registered Report Identifier (irrid): RR2-10.1186/s40814-020-00647-5., (©Olof Molander, Anne H Berman, Miriam Jakobson, Mikael Gajecki, Hanna Hällström, Jonas Ramnerö, Johan Bjureberg, Per Carlbring, Philip Lindner. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 18.09.2024.)

We reported the main results of the Japanese Registry of Neuroendovascular Therapy (JR-NET) 4, a nationwide surveillance of therapy (NET) in Japan from January 2015 to December 2019. JR-NET 4 registered consecutive patients who underwent NETs by Japan Society of Neuroendovascular Therapy (JSNET) -certified specialists. The primary endpoint was functional independence (mRS score of 0-2) at 30 days post-NET, with secondary endpoints focusing on technical success and major adverse events within 30 days.A total of 63,230 patients and 60,354 NET procedures from 166 participating centers were analyzed. During the study period, NET cases have consistently increased, with an increase in the proportion of elderly patients. A significant trend shift was observed in the distribution of NET procedures, with endovascular treatment for acute ischemic stroke that showed a dramatic increase in 5 years. This trend aligns with key randomized clinical trials from 2015 that presented the efficacy of this treatment. Clinical outcomes at 30 days posttreatment revealed that endovascular treatment for acute ischemic stroke and other NETs maintained safety and effectiveness despite varying prevalence of functional independence between target diseases. The study also observed a steady increase in emergency treatment cases, reflecting the increase in acute ischemic stroke, a time-sensitive medical condition.This comprehensive surveillance highlights the trend of NET practices in Japan, driven by clinical evidence and advancements in treatment devices. Although these findings were specific to Japan, they offer valuable insights into the broader trends in NETs and acute stroke care.

Aims: To estimate sick leave (SL) duration after first-time elective open-heart surgery and identify factors contributing to increased SL., Methods and Results: A retrospective nationwide cohort study combined data from the Norwegian Register for Cardiac Surgery and SL data from the Norwegian Labour and Welfare Administrations. All able-bodied adults who underwent first-time elective open-heart surgery in Norway between 2012 and 2021 were followed until 1 year after surgery. The impact of socio-demographic and clinical factors on SL after surgery was analysed using logistic regression and odds ratios. Of 5456 patients, 1643 (30.1%), 1798 (33.0%), 971 (17.8%), 1035 (18.9%), and 9 (0.2%) had SL of <3, 3-6, 6-9, and 9-12 months, and 1 year, respectively. SL >6 months was associated with female gender, primary education only, and average annual income. Post-operative stroke, post-operative renal failure, New York Heart Association Functional Classification system (NYHA) score >3, earlier myocardial infarction, and diabetes mellitus increased the odds of SL >6 months., Conclusion: This study demonstrates that socio-demographic and clinical factors impact SL after first-time elective open-heart surgery. Patients who experience a stroke or develop renal failure after surgery have the highest odds of SL >6 months. Females and patients with low education levels, earlier myocardial infarction, or NYHA scores III-IV have a two-fold chance of SL >6 months. The findings allow for future investigations of pre- and post-surgery interventions that can most effectively reduce SL and aid return to work., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: A recent rapid increase in cementless total knee arthroplasty (TKA) has been noted in the American Joint Replacement Registry (AJRR). The purpose of our study was to compare TKA survivorship based on the mode of fixation reported to the AJRR in the Medicare population., Methods: Primary TKAs from Medicare patients submitted to AJRR from 2012 to 2022 were analyzed. The Medicare and AJRR databases were merged. Cox regression stratified by sex compared revision outcomes (all-cause, infection, mechanical loosening, and fracture) for cemented, cementless, and hybrid fixation, controlling for age and the Charlson comorbidity index (CCI)., Results: A total of 634,470 primary TKAs were analyzed. Cementless TKAs were younger (71.8 versus 73.1 years, P < .001) than cemented TKAs and more frequently utilized in men (8.2 versus 5.8% women, P < .001). Regional differences were noted, with cementless fixation more common in the Northeast (10.5%) and South (9.2%) compared to the West (4.4%) and Midwest (4.3%) (P < .001). No significant differences were identified in all-cause revision rates in men or women ≥ 65 for cemented, cementless, or hybrid TKA after adjusting for age and CCI. Significantly lower revision for fracture was identified for cemented compared to cementless and hybrid fixation in women ≥ 65 after adjusting for age and CCI (P = .0169)., Conclusions: No survivorship advantage for all-cause revision was noted based on the mode of fixation in men or women ≥ 65 after adjusting for age and CCI. A significantly lower revision rate for fractures was noted in women ≥ 65 utilizing cemented fixation. Cementless fixation in primary TKA should be used with caution in elderly women., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Most gastrointestinal stromal tumors (GISTs) harbor c-KIT or PDGFRA mutations. Administration of tyrosine kinase inhibitors (TKIs) has significantly improved the survival of patients with GISTs. We aimed to evaluate the clinical outcome of advanced or recurrent GIST patients in Taiwan., Methods: Patients diagnosed between 2010 and 2020 were enrolled. The collected data included baseline characteristics, treatment pattern, treatment outcome, genetic aberrations and survival status. Progression-free survival (PFS) and overall survival (OS) were analyzed and plotted with the Kaplan-Meier method. Cox regression analysis was used to analyze the prognostic factors of survival., Results: A total of 224 patients with advanced or recurrent GISTs treated with TKIs were enrolled. All patients received imatinib treatment. Ninety-three and 42 patients received sunitinib and regorafenib treatment, respectively. The 48-month PFS and OS rates for patients treated with imatinib were 50.5% and 79.5%, respectively. c-KIT exon 9 and PDGFRA mutations were prognostic factors for a poor PFS and PDGFRA mutation was a prognostic factor for a poor OS in patients treated with imatinib in multivariate Cox regression analysis. The median PFS of patients who received sunitinib treatment was 12.76 months (95% confidence interval (CI), 11.01-14.52). Patients with c-KIT exon 9 mutations had a longer PFS than those with other genetic aberrations. The median PFS of patients treated with regorafenib was 7.14 months (95% CI, 3.39-10.89)., Conclusions: We present real-world clinical outcomes for advanced GIST patients treated with TKIs and identify mutational status as an independent prognostic factor for patient survival., (© 2024. The Author(s).)

Childhood cancer survivors are at risk of various endocrine late effects affecting their quality of life. The aim of this study was to assess the prevalence and predictors of endocrine and reproductive outcomes in young adult survivors. A secondary aim was to assess possible associations between testosterone replacement therapy (TRT) and other endocrine, cardiovascular and psychosocial late effects. This nationwide study comprised 1212 male childhood cancer survivors aged 19-40 years, identified through the National Quality Registry for Childhood Cancer in Sweden. Median age at diagnosis during 1981-2017 was 7 (range 0-17) and at study 29 (19-40) years. The study combined self-report survey data with cancer treatment data from the national registry. Hormone-induced puberty was self-reported by 3.8% of the survivors and ongoing TRT by 6.0%. In separate logistic regression analyses, these treatments were associated with hematopoietic stem cell transplantation and cranial radiotherapy. Hormone-induced puberty was additionally associated with younger age at diagnosis. Men with TRT had a higher prevalence of other endocrine deficiencies, cholesterol medication, depressive symptoms and fatigue as well as a lower probability of living with a partner, having a biological child or current occupation. In the total male cohort, 28.2% reported having a biological child. Reassuring reproductive outcomes after less intensive therapies and low frequency of TRT were observed in young adult male childhood cancer survivors treated in the most recent treatment era. However, men with TRT suffered from several other endocrine, cardiovascular and psychosocial late effects, indicating a need for long-term monitoring of this high-risk group., (© 2024 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Background: This registry aims to allow for a prospective non-interventional observational study of ulcerative colitis. This will facilitate monitoring of the current state of ulcerative colitis in Japan and improving the long-term disease course and adverse events associated with current treatment options., Methods: Inclusion of patients from five centres in Japan is planned. The study is expected to take place from July 15, 2020, to November 30, 2024. Background, demographics, and medical history/information will be collected from electronic medical records at enrolment. Medical information including medications, laboratory data, and disease activity will be collected automatically from electronic medical records throughout the study. Patient-reported quality of life data will be collected directly from patients via smartphone. Efficacy endpoints (clinical remission rate, clinical improvement rate, and endoscopic healing rate) and safety endpoints (incidence of adverse events and specific ulcerative colitis-related events) will be collected according to treatment administered. Treatment categories include no treatment, 5-aminosalicylic acids, corticosteroids, immunomodulators, immunosuppressants, anti-tumour necrosis alpha agents, cytapheresis, Janus kinase inhibitors, anti-integrin antibodies, and anti-interleukin-12/23 antibodies., Conclusions: The dataset will include cross-sectional and longitudinal data and is expected to capture the state of ulcerative colitis in Japan. Patients will be included on a large scale, and the registry will be established automatically from electronic medical records and direct patient input, facilitating the accurate recording of medical information for patients with ulcerative colitis in Japan and minimizing limitations intrinsic to databases that require manual data entry, such as the burden on participating investigators and entry of data with errors/typos., Competing Interests: KM has received full support for the current study from Pfizer Japan Inc.; grants and honoraria from Mitsubishi Tanabe Pharma, AbbVie Inc., EA Pharma Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., ZERIA Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., and JIMRO Co., Ltd; and honoraria from Takeda Pharmaceutical Co., Ltd., Pfizer Inc, Janssen Pharmaceutical K.K., Gilead Sciences, and Eli Lilly Japan K.K. SH has received full support for the current study from Pfizer Japan Inc.; and honoraria from AbbVie GK, Mochida Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., Ltd., EA Pharma Co. Ltd., and Kissei Pharmaceutical Co., Ltd. KA has received full support for the current study from Pfizer Japan Inc.; and honoraria from Nippon Kayaku Co. Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., AbbVie GK., JIMRO Co., Ltd., EA Pharma Co. Ltd., AYUMI Pharmaceutical Corporation, Mochida Pharmaceutical Co., Ltd., Aspen Japan K.K., Pfizer Japan Inc., Eli Lilly Japan K.K., Alfresa Pharma Co. Ltd., Sandoz K.K., and KYORIN Pharmaceutical Co., Ltd. YT has received full support for the current study from Pfizer Japan Inc. TT has received full support for the current study from Pfizer Japan Inc.; and grants from Mitsubishi Tanabe Pharma Corporation, Zeria Pharmaceutical Co., Ltd., AbbVie Inc, Mochida Pharmaceutical Co., Ltd., and EA Pharma Co., Ltd. HO has received full support for the current study from Pfizer Japan Inc.; and honoraria from Miyarisan Pharmaceutical Co. Ltd., Fujifilm Medical Co., Ltd., Terumo Corporation, FANCL Corporation, Jansen Pharmaceutical, Mitsubishi-Tanabe Pharmaceutical, Takeda Pharmaceutical, EA Pharma, JIMRO, Pfizer Japan Inc., and Mochida Pharmaceutical. TY has received full support for the current study from Pfizer Japan Inc. AA has received full support for the current study from Pfizer Japan Inc., and honoraria from Takeda Pharmaceutical Company and Miyarisan Pharmaceutical Company. YS has received full support for the current study from Pfizer Japan Inc. TM has received full support for the current study from Pfizer Japan Inc.; honoraria from Jansen Pharmaceutical, Mitsubishi-Tanabe Pharmaceutical, Takeda Pharmaceutical, EA Pharma, JIMRO, Kyorin Pharmaceutical, Viatris, Pfizer Japan, Mochida Pharmaceutical, Kissei Pharmaceutical, and Nippon Kayaku; and participates on the Data Safety Monitoring Board or Advisory Board of Jansen Pharmaceutical and Takeda Pharmaceutical. YI has received full support for the current study from Pfizer Japan Inc. TS has received full support for the current study from Pfizer Japan Inc. TK has received full support for the current study from Pfizer Japan Inc.; grants from JMDC Inc., Gilead Sciences, Inc., Eli Lilly Japan K.K., Ferring Pharmaceuticals, Bristol-Myers Squibb, Google Asia Pacific Pte. Ltd; grants and honoraria from Zeria Pharmaceutical Co., Ltd., JIMRO Co., Ltd.; grants, honoraria, and payment for expert testimony from Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., Ltd., Activaid, Nippon Kayaku Co., Ltd., Alfresa Pharma Corporation, Kyorin Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Pfizer Japan Inc.; grants and payment for expert testimony from EA Pharma Co., Ltd., Mochida Pharmaceutical Co., Ltd.; payment for expert testimony from KISSEI Pharmaceutical Co., Ltd.; and honoraria from Thermo Fisher Diagnostics K.K., (© 2024 Society for Clinical Epidemiology.)

Purpose: The aims of the present study were (1) to evaluate the survival of patellofemoral joint (PFJ) arthroplasty in a large cohort of patients using data obtained from an Italian regional arthroplasty registry and (2) to collect clinical outcomes of a subgroup of patients, with a minimum follow-up of 4 years. The hypotheses were that PFJ arthroplasty is a procedure that had good survival and clinical outcomes, not inferior to those reported in the literature for primary total knee arthroplasty (TKA)., Methods: The Register of Orthopaedic Prosthetic Implants (RIPO) of Emilia-Romagna (ER) (Italy) database was searched for the inclusion of all PFJ arthroplasties implanted between 2003 and 2019. PFJ arthroplasties were excluded if they were implanted in patients who lived outside of the ER. The survival information was extrapolated from the RIPO considering the partial or total revision of the implant as failure; moreover, a subgroup of patients was contacted and interviewed by telephone to collect clinical outcomes. Descriptive statistics were used to summarise the data. The survival curve was calculated and plotted using the Kaplan-Meier method., Results: A total of 126 arthroplasties in 114 patients were included in the final analysis (mean age at surgery 60.1 ± 11.5 years old). The main causes of patellofemoral arthroplasty were primary osteoarthritis (88%) and posttraumatic arthritis (7%). The survival was 90.4 ± 30.6 and 78.8 ± 51.5 at 5 and 10 years of follow-up, respectively. At the latest follow-up, 23 implants failed (18.3%). The main cause of revision was osteoarthrosis progression (34.8%). A total of 44 patients were contacted by telephone to collect clinical outcomes: Western Ontario and McMaster Universities Osteoarthritis Index, functional Knee Society Score, Forgotten Joint Score and Oxford Knee Score. These patients reported good to excellent scores at a medium follow-up of 10.3 ± 4.7 years., Conclusions: The PFJ showed good survival and clinical outcomes and could be considered a valuable option for patients affected by isolated patellofemoral osteoarthritis., Level of Evidence: Level IV., (© 2024 The Authors. Knee Surgery, Sports Traumatology, Arthroscopy published by John Wiley & Sons Ltd on behalf of European Society of Sports Traumatology, Knee Surgery and Arthroscopy.)

Simultaneous pancreas-kidney (SPK) transplantation improves quality of life and limits progression of diabetic complications. There is reluctance to accept pancreata from donors with abnormal blood tests, due to concern of inferior outcomes. We investigated whether donor amylase and liver blood tests (markers of visceral ischaemic injury) predict pancreas graft outcome using the UK Transplant Registry (2016-2021). 857 SPK recipients were included (619 following brainstem death, 238 following circulatory death). Peak donor amylase ranged from 8 to 3300 U/L (median = 70), and this had no impact on pancreas graft survival when adjusting for multiple confounders (aHR = 0.944, 95% CI = 0.754-1.81). Peak alanine transaminases also did not influence pancreas graft survival in multivariable models (aHR = 0.967, 95% CI = 0.848-1.102). Restricted cubic splines were used to assess associations between donor blood tests and pancreas graft survival without assuming linear relationships; these confirmed neither amylase, nor transaminases, significantly impact pancreas transplant outcome. This is the largest, most statistically robust study evaluating donor blood tests and transplant outcome. Provided other factors are acceptable, pancreata from donors with mild or moderately raised amylase and transaminases can be accepted with confidence. The use of pancreas grafts from such donors is therefore a safe, immediate, and simple approach to expand the donor pool to reach increasing demands., Competing Interests: Author ST worked on this project during an MRC Clinical Research Training Fellowship (MR/Y000676/1) at Newcastle University. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ho, Tingle, Malik, Thompson, Kourounis, Amer, Pandanaboyana, Wilson and White.)

Objectives: Ovarian tumors in the pediatric population are rare. The incidence and frequency of subtypes differ between children and adults. Although not all tumors are aggressive, they may still lead to morbidity. The goal of this study was a comprehensive review of malignant ovarian tumors in children and adolescents diagnosed and registered in Sweden., Methods: Individuals were identified through a search in the National Cancer Register, limited for ages 0-19, years 1970-2014. Stored tumor diagnostic material from regional biobanks was retrieved and reviewed., Results: The study includes 345 individuals with ovarian tumors and 70.7% of them were between 15 and 19 years at time of diagnosis. No differences in incidence over time or geographic location were identified. The average follow-up time was 21.2 years and 5-year survival was 88.4%. Survival was similar in the different time periods, except for 1970-1979. Review was possible for 260 cases, resulting in 85 epithelial tumors, 121 GCTs, 47 SCSTs and 7 others. For age 0-4 years SCSTs dominated (85.7%), for 5-9- and 10-14-years GCTs dominated (70,8% and 75.0% respectively), and for age 15-19 years epithelial tumors dominated (43.8%). There was a strong agreement between review diagnosis and original diagnosis (Cohen's κ 0.944). Differentiating between entities within the sex cord-stromal group posed the biggest diagnostic challenge., Conclusions: Ovarian tumors in children and adolescents are rare and distinct from their adult counterparts regarding incidence and frequency. There was a strong concurrence between original and review diagnoses. The greatest diagnostic difficulty was subtyping of epithelial tumors and differentiating between tumors within the SCST group., Competing Interests: Conflict of interest statement Sandra Wessman has received funding to attend a meeting from The Swedish Childhood Cancer Fund and The Cancer Research Funds of Radiumhemmet. Monica Nistér has received grants from The Swedish Cancer Society and The Cancer Society in Stockholm. Giorgio Tettamanti has received grants from The Swedish Childhood Cancer Fund and The Swedish Research Council. Joseph Carlson has received funding for the present manuscript from The Swedish Childhood Cancer Fund, The Swedish Cancer Society and The Cancer Research Fund of Radiumhemmet., (Copyright © 2024. Published by Elsevier Inc.)

Objective: The Finnish national Traffic Safety Strategy 2022-2026 seeks to halve the number of road fatalities and serious injuries from 2020 to 2030. The strategy states that better information on bicycle crashes is needed for safety promotion. The aim of this study was to describe the demographics, injury characteristics, alcohol involvement, and helmet use of severely injured cyclists and to compare single bicycle crashes (falling alone or hitting a fixed object) to collisions., Material and Methods: We identified all bicycle crashes between 2006 and 2021 from the Helsinki Trauma Registry (HTR). Variables analysed were basic patient demographics, Abbreviated Injury Scale (AIS) codes, AIS 3+ injuries, injured body regions, patient Injury Severity Score (ISS) and New Injury Severity Score (NISS), 30-day in-hospital mortality, ICU length of stay, injury mechanism, alcohol use by the injured cyclists, and helmet use., Results: Of the 325 severe (NISS >15) cycling injury patients in the HTR, 53.5 % were injured in single crashes and 46.5 % in collisions with a moving object. Most (71.4 %) patients were men and mean age of all patients was 54.1 years (SD 16.7). Alcohol was detected in 23.1 % of cases and more often in single crashes (32.8 %) than in collisions (11.9 %). Less than a third (29.2 %) of all cyclists wore a helmet; those who wore a helmet had fewer serious (AIS 3+) head injuries than those who did not. Cyclists injured in collisions had higher ISS and NISS scores than those injured in single crashes. Serious (AIS 3+) injuries in extremities or in pelvic girdle were more common in collisions than in single crashes., Conclusions: Among severely injured cyclists, single bicycle crashes were more common; alcohol was more often detected in single bicycle crashes than in collisions. Overall injury severity was higher in collisions than in single crashes. Helmet users had less AIS 3+ head injuries than non-users. Attention should be focused on preventing alcohol-related cycling injuries, promoting use of bicycle helmets, and more precise and comprehensive documentation of bicycle crashes in health care units., Competing Interests: Declaration of Competing Interest The authors declare that there are no financial or personal relationships with other people or organizations that could cause conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: Comprehensive follow-up data from the largest hospital district in Finland was used to assess hospital-based healthcare resource utilization (HCRU) and expenses, incidence and prevalence, survival, and effect of comorbidities/complications on survival of adult patients with intestinal failure due to short bowel syndrome (SBS-IF)., Methods: This study utilized electronic healthcare data covering all ≥18-year-old patients with SBS-IF at the Hospital District of Helsinki and Uusimaa in Finland between 2010 and 2019. Patients were followed from SBS-IF onset until the end of 2020 or death and compared to birth year and sex-matched control patients without SBS-IF., Results: The study included 77 patients with SBS-IF (cases) and 363 controls. Cases had high HCRU; the cumulative expenses were about tenfold compared to the controls, at the end of the study (€123,000 vs. €14,000 per patient). The expenses were highest during the first year after SBS-IF onset (€53,000 per patient). Of the cases with a median age 62.5 years, 51.9% died during study time. The median survival was 4.4 years from SBS-IF onset and cases died 13.5 times more likely during the follow-up compared to controls. Mortality risk was lower in female cases (hazard ratio (HR) 0.46; 95% confidence intervals (CI) 0.24, 0.9) and higher with presence of comorbidities (Charlson comorbidity index HR 1.55; 95% CI 1.2, 2.0) and mesenteric infarction (HR 4.5; 95% CI 1.95, 10.36). The incidence of adult SBS-IF was 0.6 per 100,000 adults., Conclusion: Our study demonstrates a high demand for healthcare support and elevated mortality in adult SBS-IF-patients. Our results suggest that the presence of comorbidities is a key driver for mortality.

Background: The clinical profile of cluster headache may differ among different regions of the world, warranting interest in the data obtained from the initial Chinese Cluster Headache Register Individual Study (CHRIS) for better understanding., Methods: We conducted a multicenter, prospective, longitudinal cohort study on cluster headache across all 31 provinces of China, aiming to gather clinical characteristics, treatment approaches, imaging, electrophysiological and biological samples., Results: In total 816 patients were enrolled with a male-to-female ratio of 4.33:1. The mean age at consultation was 34.98 ± 9.91 years, and 24.89 ± 9.77 years at onset. Only 2.33% were diagnosed with chronic cluster headache, and 6.99% had a family history of the condition. The most common bout was one to two times per year (45.96%), lasting two weeks to one month (44.00%), and occurring frequently in spring (76.23%) and winter (73.04%). Of these, 68.50% experienced one to two attacks per day, with the majority lasting one to two hours (45.59%). The most common time for attacks was between 9 am and 12 pm (75.86%), followed by 1 am and 3 am (43.48%). Lacrimation (78.80%) was the most predominant autonomic symptom reported. Furthermore, 39.22% of patients experienced a delay of 10 years or more in receiving a correct diagnosis. Only 35.67% and 24.26% of patients received common acute and preventive treatments, respectively., Conclusion: Due to differences in ethnicity, genetics and lifestyle conditions, CHRIS has provided valuable baseline data from China. By establishing a dynamic cohort with comprehensive multidimensional data, it aims to advance the management system for cluster headache in China., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Children with univentricular heart (UVH) have a limited life expectancy without early treatment. Long-term survival in UVH, in an unselected nationwide cohort, is unclear., Objectives: To determine long-term survival in patients with UVH including non-operated patients compared with a control population in Sweden., Methods: Patients with UVH born between 1970 and 2017 were identified from the National Registers and were matched for birth year and sex with 10 individuals without congenital heart disease. Follow-up was from birth until death, transplantation, or the end of study. Mortality risk was estimated by Cox proportional regression models and Kaplan-Meier survival analysis., Results: We included 5075 patients with UVH including 758 (14.9%) patients with hypoplastic left heart syndrome (HLHS), and 50,620 matched controls. Median follow-up time was 13.6 (IQR 0.7; 26.8) years. The hazard ratio for death in patients with UVH was 53.0 (95% confidence interval, 48.0-58.6), and for HLHS, 163.5 (95% CI, 124.3-215.2). In patients with HLHS, 84% of those who were born between 1982 and 1993 died or had transplantation during the first year of life compared with 29% born between 2006 and 2017. In patients with UVH without HLHS, death/transplantation in the first year of life declined from 36% in those born between 1970 and 1981 to 8.7% in those born between 2006 and 2017., Conclusions: The risk of mortality was >50 times higher in patients with UVH than in controls. The survival rate increased with a later decade of birth but was still <75% in patients born with HLHS., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Background: Secondary central nervous system lymphoma (SCNSL) confers a dismal prognosis and treatment advances are constrained by the lack of prospective studies and real-world treatment evidence., Methods: Patients with SCNSL of all entities were included at first diagnosis and patient characteristics, treatment data, and outcomes were prospectively collected in the Secondary CNS Lymphoma Registry (SCNSL-R) (NCT05114330)., Findings: 279 patients from 47 institutions were enrolled from 2011 to 2022 and 243 patients (median age: 66 years; range: 23-86) were available for analysis. Of those, 49 (20 %) patients presented with synchronous (cohort I) and 194 (80 %) with metachronous SCNSL (cohort II). The predominant histology was diffuse large B-cell lymphoma (DLBCL, 68 %). Median overall survival (OS) from diagnosis of CNS involvement was 17·2 months (95 % CI 12-27·5), with longer OS in cohort I (60·6 months, 95 % CI 45·5-not estimable (NE)) than cohort II (11·4 months, 95 % CI 7·8-17·7, log-rank test p < 0.0001). Predominant induction regimens included R-CHOP/high-dose MTX (cohort I) and high-dose MTX/cytarabine (cohort II). Rituximab was used in 166 (68 %) of B-cell lymphoma. Undergoing consolidating high-dose therapy and autologous hematopoietic stem cell transplantation (HDT-ASCT) in partial response (PR) or better was associated with longer OS (HR adjusted 0·47 (95 % CI 0·25-0·89), p = 0·0197)., Interpretation: This study is the largest prospective cohort of SCNSL patients providing a comprehensive overview of an international real-world treatment landscape and outcomes. Prognosis was better in patients with SCNSL involvement at initial diagnosis (cohort I) and consolidating HDT-ASCT was associated with favorable outcome in patients with PR or better., Competing Interests: Declaration of Competing Interest U.Ke. served in an advisory role for BMS/ Celgene, Takeda, Janssen, Gilead/ Kite, Roche, Abbvie, AstraZeneca, Novartis, Lilly, Pentixapharm and received travel support from BMS/ Celgene, Takeda, Janssen, Roche, Abbvie, Gilead/ Kite, AstraZeneca, Novartis, Lilly, Pentixapharm. S.H. served in an advisory role for Pentixapharm. Ro.S. served in an advisory role for BMS/ Celgene, Janssen, Gilead/ Kite, and Novartis. M.S-H. has an advisory role for Celgene GmbH, Amgen GmbH, Gilead/ Kite, Sanofi-Aventis, Glaxo Smith Kline, Bristol Myers Squibb, Shionogi and received financial support from Janssen-Cilag, Takeda, Novartis, Pfizer, Roche, Vifor Pharma, Celgene. P.L.R. received payment from Novartis, MSD, Abbvie, Roche, Incyte, Janssen-Cilag and travel support from Abbvie, Novartis, BMS, Janssen-Cilag and Roche. K.J. received royalties from Elsevier and Wolters Kluwer, obtained consulting fees and honoraria from Amgen, art tempi, Astra Zeneca, BD Solutions, Helsinn, Hexal, Karyopharm med update GmbH, MSD, Mundipharma, onkowissen, Riemser, Roche, Shire (Takeda), Vifor Pharma and Voluntis, B.C. received research grants from Gilead, received honoraria from BMS, Astra Zeneca, Gilead, Roche, Sandoz, Incyte, Abbvie and received travel support from Roche and Gilead. St. S. received research grants from Protherics Medicines Development Ltd., served in an advisory role for AMGEN, Gilead Sciences, Pfizer, SERB SAS, received honoraria from Akademie für Infektionsmedizin e.V., AMGEN, AVIR Pharma, CSi Hamburg GmbH, Gilead Sciences, Labor28, Novartis, Persberg Group GmbH/DGIM e.V., Pfizer, Vivantes GmbH and received travel support from Gilead Sciences and Novartis. A.K. Received financial support from Riemser. All remaining authors have declared no conflicts of interest., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Contrary to the trend of decreasing traffic fatalities, the number of cyclists killed in Germany has been steadily increasing in recent years. With the increasing popularity of cycling in all age groups, the number of accidents with sometimes serious injuries is rising. In the course of this, the question arises what influence age has on the type and severity of injuries, the probability of survival and the length of hospital stay in seriously injured cyclists., Methods: A retrospective analysis of data from the TraumaRegister DGU® (TR-DGU) from 2010 to 2019 was performed. All severely injured cyclists with a maximum abbreviated injury scale (MAIS) of 3+ (n = 14,651) in the TR-DGU were included in this study and the available parameters were evaluated. A subdivision into three age groups (60-69, 70-79, and ≥ 80 years) and a control group (20-59 years) was carried out., Results: Injuries to the head were by far the most common, accounting for 64.2%. There was a marked increase in severe head injuries in the 60-plus years age group. Furthermore, with increasing age, the probability of prehospital intubation, catecholamine requirement, intensive care and hospital length of stay, and mortality increased., Conclusion: Head injuries represent the most common serious injury, especially among older cyclists. As helmet wearing was not recorded in the TraumaRegister DGU® during the evaluation period, no conclusion can be drawn about its effect. Furthermore, a higher age correlates with a longer hospital stay and a higher mortality, but does not represent an independent risk factor for death in severely injured patients., (© 2023. The Author(s).)

Background : The incidence of acetabular fractures in geriatric patients has increased. Although there are strong data supporting the early operative treatment of hip fractures in geriatric patients, the optimal timing for acetabular fractures remains unclear and for several reasons, delayed treatment after trauma is common. Methods : A retrospective analysis of the German Pelvis Registry between 2008 and 2017 was performed. Ultimately, 665 patients with fractures of the anterior column or anterior column and posterior hemitransverse were enrolled. Patients above and below 65 years of age with these fracture types were analyzed regarding surgery day (within 48 hours, between 2 and 4 days, after 4 days), complication rate, reduction quality, and hospital stay. Results : The complication rate of the geriatric group was twice as high as that of younger patients; however, this finding was independent of the timing of surgery. Reduction quality and hospital stay were independent of surgical timing. Conclusions : In contrast to other fracture types, such as proximal femur fractures, the timing of surgery for acetabular fractures does not have a significant impact on the patient's outcome. The optimal time for surgery cannot be determined using the current data. However, as expected, there is a significantly higher risk for postoperative complications in the geriatric population.

Background: Population-based studies have indicated an increase in bone turnover in hyperthyroidism with a subsequent decrease in bone mineral density and an increased risk of fractures, especially in postmenopausal women. However, heterogeneity between studies prevents a definitive conclusion. Graves' disease (GD) is an autoimmune disease, and it is the most common cause of hyperthyroidism. The aim of this study was to investigate fracture risk in patients with GD. Methods: A total of 2134 patients with incident GD and 21,261 age, sex- and county-matched controls were included 16-18 years after diagnosis in a retrospective cohort study. Drug and patient national registries in Sweden were used to assess the risk of developing skeletal complications. Up to 10 years of age, sex- and county-matched controls per patient were selected from databases from the National Board of Health and Welfare and Statistics Sweden. Cox proportional hazards models were fitted to estimate hazard ratios (HR) and confidence intervals [CI]. Results: There were no significant differences in fracture rates between GD and controls but after adjustment for comorbidities, the data showed higher vertebral fracture rates in male GD patients aged >52 years compared to male controls, HR = 2.83 [CI 1.05-7.64]. The rates of osteoporosis treatments as well as treatment with corticosteroids were higher in patients with GD. However, HR for the association between GD and fractures remained largely unchanged after adjustment for osteoporosis treatments and treatments with corticosteroids. Conclusions: There were no significant differences in total fracture rate between GD and the general population. However, men older than 52 years had a higher vertebral fracture rate. This study also shows that patients with treated GD receive more osteoporosis treatments compared to the general population.

Aims: To evaluate the impact of the updated nationwide Meds75+ database and its linkage to the Finnish health portal on the use of potentially inappropriate medications (PIMs) among older persons. We also aimed to evaluate whether there is regional variation in trend changes of PIM use., Methods: Meds75+ was implemented at the population level in 2015, so randomization is unfeasible. We used a quasi-experimental interrupted time series analysis to evaluate the changes in levels and trends of PIM use. The data included all Finnish community-dwelling persons aged ≥75 years (N = 920 163) who had medication purchases in the Prescription Register during 2009-2020. Data were linked with the Care Registers for Health and Social Care and the cause of death register., Results: The prevalence of PIMs decreased from 20.2% in 2009 to 11.7% in 2020. The change of level of the monthly PIM users was negative (β -0.036, 95% confidence interval [CI] -0.202 to 0.131), but not statistically significant (P = .673) after the publication of the database. We found a small decrease (β -0.018, 95% CI -0.083 to 0.047, P = .593) in the slope of PIM users, but it was not statistically significant. The regional results were similar to the main findings., Conclusions: Publication of the updated Meds75+ database did not decrease the level or trend of PIM users. In addition, this study did not show any significant regional variation in PIM use trends. Further research should focus on determining barriers and facilitators to the utilization of PIM criteria in clinical practice., (© 2023 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Background: Being able to work during and after breast cancer treatments is important for patients to have a sense of normalcy, financial security, and improved quality of life, and for society due to the economic burden of sick leave. Factors influencing the length of sick leave can be sociodemographic factors, workplace adaptations, recurrences, symptoms, and type of treatment. The aim of this study is to analyse factors associated with prolonged sick leave after adjuvant breast cancer treatments., Methods: The population of this registry study consists of 1333 early breast cancer patients diagnosed and treated in Helsinki University Hospital between 2016 and 2018. Data on patient demographics, disease characteristics, treatment, and healthcare resource utilization were obtained from Helsinki University Hospital and data on income level and sick leave were obtained from Kela sickness benefits registry. Prolonged sick leave was determined as the patient accumulating 30 or more reimbursed sick leave days during a 60-day follow-up period after the end of active oncological treatment. Univariate analysis and multivariate analysis were conducted., Results: A total of 26% of the patients in this study were on sick leave for 30 or more days after the active treatments ended. Study findings show that chemotherapy, triple-negative breast cancer, reconstructive surgery, amount of outpatient visits, and income are associated with prolonged sick leave. Independent predictors of prolonged sick leave were treatment line, number of outpatient contacts, reconstruction, and triple-negative breast cancer., Conclusions: Our study shows that prolonged sick leave affects a substantial number of working-age women with early breast cancer. Independent predictors for prolonged sick leave were all treatment-related. Targeted support for treatment-related side-effects already during the treatment period could lead to better recovery and earlier return to work.

Background: While substantial progress has been made in the development of disease-modifying medications for multiple sclerosis (MS), a high percentage of treated patients still show progression and persistent inflammatory activity. Autologous haematopoietic stem cell transplantation (AHSCT) aims at eliminating a pathogenic immune repertoire through intense short-term immunosuppression that enables subsequent regeneration of a new and healthy immune system to re-establish immune tolerance for a long period of time. A number of mostly open-label, uncontrolled studies conducted over the past 20 years collected about 4000 cases. They uniformly reported high efficacy of AHSCT in controlling MS inflammatory disease activity, more markedly beneficial in relapsing-remitting MS. Immunological studies provided evidence for qualitative immune resetting following AHSCT. These data and improved safety profiles of transplantation procedures spurred interest in using AHSCT as a treatment option for MS., Objective: To develop expert consensus recommendations on AHSCT in Germany and outline a registry study project., Methods: An open call among MS neurologists as well as among experts in stem cell transplantation in Germany started in December 2021 to join a series of virtual meetings., Results: We provide a consensus-based opinion paper authored by 25 experts on the up-to-date optimal use of AHSCT in managing MS based on the Swiss criteria. Current data indicate that patients who are most likely to benefit from AHSCT have relapsing-remitting MS and are young, ambulatory and have high disease activity. Treatment data with AHSCT will be collected within the German REgistry Cohort of autologous haematopoietic stem CeLl trAnsplantation In MS (RECLAIM)., Conclusion: Further clinical trials, including registry-based analyses, are urgently needed to better define the patient characteristics, efficacy and safety profile of AHSCT compared with other high-efficacy therapies and to optimally position it as a treatment option in different MS disease stages., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s), 2023.)

Introduction: This registry study aims to assess the prevalence and demographic characteristics of patients with lumbar spine (LS) surgical procedures who undergo total hip arthroplasty (THA), to compare the long-term survival and causes of failure of THA in patients who previously underwent LS fusion and non-fusion surgical procedures, and to evaluate the risk of undergoing a revision LS surgery after THA., Materials and Methods: Patients who underwent LS surgery followed by THA were identified by cross-referencing data from the Orthopedic Prosthetic Implants Registry and the Regional Hospital Discharge Database. Three groups of THA patients were identified: patients who underwent previous lumbar surgery with fusion (LS fusion-THA), without fusion (LS non-fusion-THA), and a control group with only THA (No LS surgery-THA). Demographic data, THA survival, number and causes of failure, and data on revision procedures on THA and LS were collected., Results: Of the total of 79,984 THA, 2.2% of patients had a history of LS procedures. THA only patients showed better results, while patients in the LS fusion-THA group had worse implant survival at 5-year follow-up. In the LS fusion-THA and LS non-fusion-THA, mechanical THA failures were more frequent in the first two years after implantation. There were no differences between groups regarding the risk of undergoing LS revision surgery., Conclusions: LS surgery negatively affects THA survivorship. In patients who previously underwent LS fusion and non-fusion surgical procedures, most THA failure occurs in the first two years after implant. The study contributes to the understanding of the relationship between the hip and the LS and provides useful guidance for clinical practice., (© 2023. The Author(s).)

Background: Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO)., Aims: Endovascular Treatment for Acute Ischemic Stroke in China (DETECT2-China) aims to evaluate real-world outcomes and safety of EVT for LVO-AIS patients in China., Design: DETECT2-China is a prospective, national, multi-center study registered in ClinicalTrials.gov (NCT05092139). This study plans to enroll a total of 3,000 consecutive patients who received EVT for LVO. All eligible patients are adults aged 18 years or older with acute LVO who received EVT and standard medical treatment according to the Chinese stroke guidelines and local practice., Outcome: The primary outcome is functional independence (modified Rankin Scale score, mRS ≤ 2) at 90 days. The secondary outcomes include (1) the proportion of patients with mRS scores of 0-1 at 90 days, (2) distribution of mRS at 90 days, (3) changes in National Institutes of Health stroke scale (NIHSS) at 24 h, 48 h, and 12 days or discharge (whichever is earlier), (4) the proportion of symptomatic intracranial hemorrhage (sICH) within 48 h, and (5) the proportion of death within 7 days., Discussion: The DETECT2-China will provide real-world data about the effectiveness and safety of EVT for AIS-LVO patients in China., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Liu, Nguyen and Chen.)

Endocrine complications are a common late effect after childhood cancer. Our study assessed the prevalence and predictors of premature ovarian insufficiency (POI) and prospects of pregnancy in young female survivors. This nationwide study combined registry and survey data for female childhood cancer survivors aged 19 to 40 years, identified through the National Quality Registry for Childhood Cancer in Sweden. Of 1989 approached young women, 1333 (67%) participated by completing a survey. Median age at diagnosis 1981 to 2017 was 6 (range 0-17) and at study 28 (19-40) years. There were two indicators of POI, induced puberty reported in 5.3% and estrogen replacement therapy (ERT) in 9.3% at assessment. In separate logistic regression analyses (P < .001), induced puberty and ERT were significantly predicted by hematopoietic stem cell transplantation (HSCT), abdominal irradiation, central nervous system irradiation and chemotherapy. ERT was also associated with older age at diagnosis. Of the 626 women (48% of responders) who had tried to become pregnant, 25% had undergone fertility investigations and 72% reported having a biological child. Treatment with HSCT was associated with 5.4 times the odds of needing fertility investigations (P < .001). Having a biological child was associated with non-HSCT treatment, but also with ever having had a partner and older age at the time of study (all P < .001). In conclusion, the majority of those female childhood cancer survivors who had tried to conceive were able to successfully give birth. However, a small identifiable group of female survivors are at risk of subfertility and early menopause., (© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Background: In relapsing-remitting multiple sclerosis (RRMS) the most common treatment strategy has been to start with low-moderate efficacy disease modifying therapy (LE-DMT) and to escalate to more efficacious treatments in cases of breakthrough disease activity. However, recent evidence suggests a better outcome in patients commencing with moderate-high efficacy DMT (HE-DMT) immediately after clinical onset., Objective: The aim of this study is to compare disease activity and disability outcomes in patients treated with the two alternative strategies using the Swedish and Czech national multiple sclerosis registries, taking advantage of the fact that the relative frequency of each strategy differs markedly between these two countries., Methods: Adult RRMS patients who initiated their first-ever DMT between 2013 and 2016 and were included in the Swedish MS register were compared with a similar cohort from the MS register of the Czech Republic using propensity score overlap weighting as a balancing method. The main outcomes of interest were time to confirmed disability worsening (CDW), time to achieve an expanded disability status scale (EDSS) value of 4, time to relapse, and time to confirmed disability improvement (CDI). To support the results, a sensitivity analysis focusing solely on patients from Sweden starting with HE-DMT and patients from the Czech Republic starting with LE-DMT was performed., Results: In the Swedish cohort, 42% of patients received HE-DMT as initial therapy compared to 3.8% of patients in the Czech cohort. The time to CDW was not significantly different between the Swedish and Czech cohorts (p-value 0.2764), with hazard ratio (HR) of 0.89 and a 95% confidence interval (CI) of 0.77-1.03. Patients from the Swedish cohort exhibited better outcomes for all remaining variables. The risk of reaching EDSS 4 was reduced by 26% (HR 0.74, 95%CI 0.6-0.91, p-value 0.0327), the risk of relapse was reduced by 66% (HR 0.34, 95%CI 0.3-0.39, p-value <0.001), and the probability of CDI was three times higher (HR 3.04, 95%CI 2.37-3.9, p-value <0.001)., Conclusion: The analysis of the Czech and the Swedish RRMS cohorts confirmed a better prognosis for patients in Sweden, where a significant proportion of patients received HE-DMT as initial treatment., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: T. Hrnciarova has nothing to disclose. J. Drahota has nothing to disclose. T. Spelman received compensation from serving on scientific advisory boards and steering comittees from Biogen and consultancy fees from Hartmann and Abbvie. J. Hillert received honoraria for serving on advisory boards for Biogen, Bristol-Myers-Squibb/Celgene, Janssen, Merck KGaA, Sandoz and Sanofi-Genzyme and speaker...s fees from Biogen, Janssen, Novartis, Merck, Teva, Sandoz and Sanofi-Genzyme. He has served as P.I. for projects sponsored by, or received unrestricted research support from, Biogen, Bristol-MyersSquibb/Celgene, Janssen, Merck KGaA, Novartis, Roche, and Sanofi-Genzyme. His MS research is funded by the Swedish Research Council and the Swedish Brain foundation. J. Lycke has received travel support and/or lecture honoraria and has served on scientific advisory boards for Alexion, Almirall, Biogen, Bristol Myers Squibb, Celgene, Janssen, Merck, Novartis, Roche and Sanofi; and has received unconditional research grants from Biogen and Novartis, and financial support from Sanofi for an investigator-initiated study. E. Kubala Havrdova has received honoraria/research support from Biogen, Merck Serono, Novartis, Roche, and Teva; has served as a member of advisory boards for Actelion, Biogen, Celgene, Merck Serono, Novartis, and Sanofi Genzyme; has been supported by the Czech Ministry of Education project Cooperatio LF1, research area Neuroscience, and the project National Institute for Neurological Research (Programme EXCELES, ID project No LX22NPO5107) funded by the European Union-Next Generation EU. E. Recmanova has nothing to disclose. J. Adamkova has nothing to disclose. J. Mares has nothing to disclose. J. Libertinova reported receiving grants, personal fees and funding for travel from Merck, Roche, Novartis, Biogen Inc, Sanofi Genzyme. Z. Pavelek reports personal fees from Biogen, Eli Lilly, Genzyme, Merck Serono, Novartis, Pfizer, Roche, and Teva Pharma. P. Hradilek received speakers honoraria and travel compensations from Biogen, Merck, Teva, Sanofi, Roche, Novartis and Janssen Cilag. R. Ampapa received conference travel support from Roche, Sanofi, Biogen and Merck and has participated in clinical trials by Biogen, Novartis, Sanofi, Merck and Roche. I. Stetkarova received compensation for travel and speaker honoraria from Biogen Idec, Merck, and Roche. M. Peterka has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck, Novartis, Biogen, Sanofi-Genzyme, Jansse-Cilag, Teva, Roche. A. Martinkova has nothing to disclose. P. Stourac has nothing to disclose. M. Grunermelova has nothing to disclose. M. Vachova received compensation for travel, conference fees, consulting fees and speaker honoraria from Biogen, Lundbeck, Merck, Novartis, Roche, Sanofi, and Teva. M. Dufek has nothing to disclose. D. Horakova was supported by the Charles University: Cooperatio Program in Neuroscience, by the project National Institute for Neurological Research (Programme EXCELES, ID Project No. LX22NPO5107) - Funded by the European Union Next Generation EU, and by General University Hospital in Prague project MH CZ-DRO-VFN64165. She also received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck, Bayer, Sanofi Genzyme, Roche, and Teva, as well as support for research activities from Biogen Idec., (Copyright © 2023. Published by Elsevier B.V.)

Objectives: The Estonian National Mental Health Study (EMHS) was conducted in 2021-2022 to provide population-wide data on mental health in the context of COVID-19 pandemic. The main objective of this paper is to describe the rationale, design, and methods of the EMHS and to evaluate the survey response., Methods: Regionally representative stratified random sample of 20,000 persons aged 15 years and older was drawn from the Estonian Population Register for the study. Persons aged 18 years and older at the time of the sampling were enrolled into three survey waves where they were invited to complete an online or postal questionnaire about mental well-being and disorders, and behavioral, cognitive, and other risk factors. Persons younger than 18 years of age were invited to fill an anonymous online questionnaire starting from wave 2. To complement and validate survey data, data on socio-demographic, health-related, and environmental variables were collected from six national administrative databases and registries. Additionally, a subsample was enrolled into a validation study using ecological momentary assessment., Results: In total, 5636 adults participated in the survey wave 1, 3751 in wave 2, and 4744 in wave 3. Adjusted response rates were 30.6%, 21.1%, and 27.6%, respectively. Women and older age groups were more likely to respond. Throughout the three survey waves, a considerable share of adult respondents screened positive for depression (27.6%, 25.1%, and 25.6% in waves 1, 2, and 3, respectively). Women and young adults aged 18 to 29 years had the highest prevalence of depression symptoms., Conclusions: The registry-linked longitudinal EMHS dataset comprises a rich and trustworthy data source to allow in-depth analysis of mental health outcomes and their correlates among the Estonian population. The study serves as an evidence base for planning mental health policies and prevention measures for possible future crises., (© 2023 The Authors. Brain and Behavior published by Wiley Periodicals LLC.)

To clarify the natural courses, medical conditions, and problems in daily life and medical care of the patients with Charcot-Marie-Tooth disease (CMT) in Japan, we have developed a patient registration system (CMT Patient Registry (CMTPR)). We analyzed data of questionnaires from 303 patients (males: 162, females: 141, mean age: 45.9 years old) who registered for CMTPR. The age of onset was less than 15 years old in 45% and more than 60 years old in 5% of the patients. Genetic testing was performed in 65%, and about half of the patients with genetic testing had a duplication of the PMP22 gene. Seventy-six percent of the patients had regular visits to medical facilities. Five percent of patients had no history of hospital visits. Fifteen percent of all patients needed assistance with daily activities due to motor function impairment in the upper extremities, and 25% required assistance due to lower limb impairment. There were no significant differences in the need for assistance by gender or age. Of the 267 adult patients, 18% had difficulty working due to reasons related to the disease, although none of the junior patients reported any problem attending school. This was the first nationwide epidemiological study with healthcare and welfare information on patients with CMT in Japan. We hope the results of this study will lead to better welfare and medical care in CMT patients.

Background: The purpose of the Korean Hip Fracture Registry (KHFR) Study is to establish a nationwide, hospital-based prospective cohort study of adults with hip fracture to explore the incidence and risk factors of second osteoporotic fractures for a Fracture Liaison Service (FLS) model., Methods: The KHFR, a prospective multicenter longitudinal study, was launched in 2014. Sixteen centers recruited participants who were treated for hip fracture. The inclusion criteria were patients, who were treated for proximal femur fracture due to low-energy trauma and aged 50 or more at the time of injury. Until 2018, 5,841 patients were enrolled in this study. Follow-up surveys were conducted annually to determine occurrence of second osteoporotic fracture, and 4,803 participants completed at least one follow-up survey., Discussion: KHFR is a unique resource of individual level on osteoporotic hip fracture with radiological, medical, and laboratory information including DXA (dual energy x-ray absorptiometry), bone turnover marker, body composition, and hand grip strength for future analyses for FLS model. Modifiable factors for mortality after hip surgery is planned to be identified with nutritional assessment and multi-disciplinary interventions from hospitalization to follow-ups. The proportions of femoral neck, intertrochanteric, and subtrochanteric fractures were 517 (42.0%), 730 (53.6%), and 60 (4.4%), respectively, from 2014 to 2016, which was similar in other studies. Radiologic definition of atypical subtrochanteric fracture was adopted and 17 (1.2%) fractures among 1,361 proximal femoral fractures were identified. Internal fixation showed higher reoperation rate compared to arthroplasty in unstable intertrochanteric fractures (6.1% vs. 2.4%, p = 0.046) with no significant difference in mortality. The KHFR plans to identify outcomes and risk factors associated with second fracture by conducting a 10-year cohort study, with a follow-up every year, using 5,841 baseline participants., Trial Registration: Present study was registered on Internet-based Clinical Research and Trial management system (iCReaT) as multicenter prospective observational cohort study (Project number: C160022, Date of registration: 22th, Apr, 2016)., (© 2023. The Author(s).)

Introduction: The present study aimed to investigate differences in survivorship between medial and lateral unicompartmental knee arthroplasty (UKA) by analyzing the data of an Italian regional registry. The hypothesis was that, according to recent literature, lateral implants have comparable survivorship with regard to the medial implants., Materials and Methods: The Register of Orthopaedic Prosthetic Implants (RIPO) of Emilia-Romagna (Italy) database was searched for all UKAs between July 1, 2000, and December 31, 2019. For both cohorts, subject demographics and reasons for revision were presented as a percentage of the total cohort. Kaplan-Meier survivorship analysis was performed using revision of any component as the endpoint and survival times of unrevised UKAs taken as the last observation date (December 31, 2019, or date of death)., Results: Patients living outside the region and symmetrical implants (which do not allow the compartment operated to be traced) were excluded. 5571 UKAs implanted on 5172 patients (5215 medial UKAs and 356 lateral UKAs) were included in the study. The survivorship analysis revealed 13 failures out of 356 lateral UKAs (3.7%) at a mean follow-up of 6.3 years and 495 failures out of 5215 medial UKAs (9.5%) at a mean follow-up of 6.7 years. The medial UKAs had a significantly higher risk of failure, with a Hazard Ratio of 2.6 (CI 95% 1.6-4.8; p < 0.001), adjusted for age, gender, weight, and mobility of the insert. Both the groups revealed a good survival rate, with 95.2% of lateral implants and 87.5% of medial implants still in situ at 10 years of follow-up., Conclusions: Lateral UKA is a safe procedure showing longer survivorship than medial UKAs (95.2% and 87.5% at 10 years, respectively) in the present study., Level of Evidence: Level 3, therapeutic study., (© 2022. The Author(s).)

Allogeneic hematopoietic stem cell transplantation (aHSCT) represents a therapeutic choice for high-risk and relapsed leukemia at a young age. In this retrospective population-based study, we evaluated cardiovascular complications after aHSCT (N = 272) vs conventional therapy (N = 1098) among patients diagnosed with acute lymphoblastic or acute myeloid leukemia below 35 years between 1985 and 2004. Additionally, siblings from a prior comparison group served as population controls (N = 39 217). Childhood leukemia and aHSCT was associated with a 16-fold HR for developing arterial hypertension (HR 16.8, 95%CI 1.5-185.5) compared with conventional therapy. A 2-fold HR for any cardiovascular complication was observed after AYA leukemia and aHSCT vs conventional treatment (HR 2.7, 95% CI 1.4-5.1). After AYA leukemia and aHSCT, the HR of cardiac arrhythmia was significantly elevated vs conventional therapy (HR 14.4, 95% CI 1.5-125.2). Moreover, after aHSCT in childhood, elevated hazard ratios (HRs) were found for cardiomyopathy/ cardiac insufficiency (HR 105.0, 95% CI 10.0-1100.0), cardiac arrhythmia, and arterial hypertension (HR 20.1, 95%CI 2.5-159.7 and HR 20.0, 95%CI 4.1-97.4) compared with healthy controls. After adolescent and young adult (AYA) leukemia and aHSCT, markedly increased HRs were observed for cardiac arrhythmia (HR 29.2, 95%CI 6.6-129.2), brain vascular thrombosis/ atherosclerosis and cardiomyopathy/cardiac insufficiency (HR 23.4, 95%CI 7.1-77.4 and HR 19.2, 95%CI 1.5-245.2) compared with healthy controls. As the cumulative incidence for cardiovascular complications rose during the follow-up of childhood and AYA leukemia patients, long-term cardiovascular surveillance is warranted to optimize the quality of life after childhood and AYA leukemia following both conventional treatment and aHSCT., (© 2023 UICC.)

Perioperative atrial fibrillation (AF) is associated with increased mortality, morbidity, and excess healthcare costs. The objective of our study was to assess if preoperative AF in patients undergoing coronary artery bypass grafting is a predictor of operative mortality, postoperative stroke, and need for postoperative dialysis by interrogating a large registry database. We included all isolated procedures performed between February 1996 and March 2019. We used a generalized linear mixed model to assess the effect of preoperative AF on mortality stroke and the need for postoperative dialysis after adjusting for the relevant confounders derived from EuroSCORE 2. Confounders considered included age, gender, neurological dysfunction, renal dysfunction, recent myocardial infarction, pulmonary disease, unstable angina, NYHA class, pulmonary hypertension, diabetes on insulin and peripheral vascular disease, and urgency of the operation. We treated the hospital and operating consultant as random effect variables. We also performed LV function subgroup analyses to assess the effect of preoperative AF on the outcomes of interest. The incidence of pre-existent AF in the cohort of patients we analyzed (N = 356,040 patients) was 3.5% (N = 12,664). In the unadjusted baseline characteristics, preoperative AF patients had more associated comorbidities. After adjustment, preoperative AF remained a significant predictor of increased mortality (odds ratio [OR]: 1.63, confidence interval [CI] 1.48-1.79, p < 0.001), stroke (OR: 1.33, CI 1.16-1.54, p = 0.001), and need for renal dialysis (OR:1.61, CI 1.46-1.78, p < 0.001). Preoperative AF was a significant predictor of adverse outcomes in patients with moderate and good LV function but not in patients with poor LV function (EF <30%). Our study suggests that preoperative AF is associated with an increased risk for perioperative mortality and stroke in patients undergoing coronary artery bypass grafting., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Because of the genetic transmission of Huntington's disease (HD), informal caregivers (ICs, i.e., non-professional caregivers) might experience consecutive and/or concurrent caregiving roles to support several symptomatic relatives with HD over their life. Additionally, some ICs might be HD carriers. However, whether family burden of care is associated with specific factors in HD remains poorly studied., Objective: To provide a quantitative view of the IC burden and identify associated factors., Methods: This was a cross-sectional assessment of home-dwelling symptomatic HD individuals (from REGISTRY and Bio-HD studies) and their primary adult ICs, including the HD individual's motor, cognitive, behavioral, functional Unified Huntington's Disease Rating Scale score; IC objective burden (quantification of IC time in activities of daily living, instrumental activities of daily living and supervision, using the Resource Utilization in Dementia instrument), IC subjective burden (Zarit Burden Inventory), and ICs' social economic functioning and use of professional home care., Results: We included 80 ICs (mean [SD] age 57 [12.9] years, 60% women) in charge of 80 individuals with early to advanced stage HD (mean age 56 [12.6] years, 51% men). The mean hours of informal care time was high: 7.3 (7.9) h/day (range 0-24); the mean professional home care was 2.8 (2.8) h/day (range 0.1-12.3). This objective burden increased with higher functional loss of the HD individual and with more severe cognitive-behavioral disorders. The mean subjective burden (35.4 [17.8], range 4-73) showed a high level since the earliest stage of HD; it was associated with HD duration (mean 9.2 [4.7] years) and with aggressive symptoms in individuals (44% of cases). The burden was partially related to the multiplex caregiving status (19%). Protective factors lowering the IC burden included the absence of financial hardship (57%), a strong social network (16%) and keeping active on the job market outside home (46%)., Conclusions: The objective-subjective burden of ICs related to changing patterns of neuro-psychiatric symptoms and mitigating environmental characteristics around the HD individual-caregiver dyads., (Copyright © 2022. Published by Elsevier Masson SAS.)

Curebest™ 95GC breast (95GC) is a multigene classifier we developed for the prognostic prediction of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and node-negative (ER+/HER2-/n0) invasive breast cancer treated with adjuvant endocrine therapy alone. The aim of the preset study was to evaluate the clinical utility of 95GC in a multiinstitutional registry study. Patients (n=215) with ER + /HER2 - /n0 invasive breast cancer who had undergone the 95GC assay in seven hospitals were consecutively recruited in the registry study at various postoperative times. At recruitment, no patients had disease recurrences and were prospectively followed up for a median of 62 (range, 6-91) postoperative months. Of the 124 patients classified as 95GC low risk, 118 received adjuvant endocrine therapy alone and six received adjuvant chemo-endocrine therapy. Only two patients developed distant recurrences, and the 5-year distant recurrence-free survival (DRFS) was as high as 98.0%. Of the 91 patients classified as 95GC high risk, 81 received adjuvant chemo-endocrine therapy and 10 received adjuvant endocrine therapy alone. A total of four of these patients developed distant recurrences (5-year DRFS=95.5%). Among the 95GC high-risk patients, prognosis was significantly improved for the 81 treated with adjuvant chemo-endocrine therapy compared with for the 77 (historical controls) treated with adjuvant endocrine therapy alone (P=0.0002; hazard ratio, 0.24). Compared with the St. Gallen 2013 guideline, a significant de-escalation from 73.1% (155/212) to 40.6% (86/212) in adjuvant chemotherapy was achieved. The excellent prognosis of patients with ER + /HER2 - /n0 invasive breast cancer classified as 95GC low risk could be validated in the present registry study, indicating that 95GC is useful for safe de-escalation of adjuvant chemotherapy in patients with ER + /HER2 - /n0 invasive breast cancer., Competing Interests: Yasuto Naoi has received research funding from Sysmex and AstraZeneca; he has received honoraria from AstraZeneca, Pfizer, Eli Lilly, and Chugai outside the submitted work; and he holds joint patents with Sysmex including CurebestTM 95GC Breast (JP.5725274.B2) and has received patent royalties outside the submitted work. Kenzo Shimazu has received honoraria from Sysmex and research funding to institution from Sysmex. Tomo Osako received honoraria from Diaceutics and Daiichi Sankyo, and consulting fee from Chiba Cytopathology Laboratory outside the submitted work. Seigo Nakamura/Showa University received a research grant from Sysmex Corporation. Hitoshi Tsuda received research grant from Roche Diagnostics, Goryo Chemical and Scholarship donation from Chugai Pharmaceutical. Kazuhiro Ishihara received lecture fees from Nippon Kayaku, Kyowa Kirin, Daiichi Sankyo and Eisai. Shinzaburo Noguchi has received consulting fees and research funding from Sysmex; he has received consulting fees from AstraZeneca and Nittobo outside the submitted work; he has received honoraria from AstraZeneca, Pfizer, Eli Lilly, and Chugai outside the submitted work; and he holds joint patents with Sysmex including Curebest™ 95GC Breast (JP.5725274.B2) and has received patent royalties outside the submitted work., (Copyright: © Naoi et al.)

Background: Infectious diseases are treated based on clinical guidelines, which usually require a large amount of data and time to formulate. Therefore, various treatments are tried and used in the early stages of epidemics of emerging and reemerging infectious diseases. In this study, we focused on two drugs for coronavirus disease 2019 (COVID-19) treatment, i.e., steroids and favipiravir, and analyzed the changes in treatment trends by region., Methods: This was a retrospective study of cases from the COVID-19 Registry Japan. The proportion of patients who received steroids and favipiravir was calculated on a monthly and pandemic wave basis, and the trend of drug administration by region was estimated using logistic curves., Results: The effect of wave on steroid administration was as high as 2.75 [2.60, 2.90], indicating a rapid increase in the proportion of steroid administration. The odds ratios for Hokuriku and Hokkaido were 0.49 [0.35, 0.68] and 0.55 [0.43, 0.71], respectively, indicating that steroids were less likely administered in these regions. For favipiravir, the effect of timing was 0.43 [0.41, 0.46], denoting a decreasing trend. On the other hand, the odds ratio was very high in some regions, such as Hokkaido (6.66 [5.24, 8.48]), indicating that the administration trend varied by region., Conclusions: The increase in the proportion of steroid use showed the same trend nationwide, although the rate of increase differed, confirming that the use of drugs with proven efficacy was spreading rapidly and that effective treatment was available nationwide. However, the results suggest that drugs such as favipiravir, which were initially expected to be effective, may continue to be administered. Registry studies include larger populations than clinical trials and enable real-time monitoring of medication status and trends. Further use of registry studies for treatment standardization is expected in the future., Competing Interests: Conflict of Interest All authors report no conflicts of interest relevant to this article., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Introduction: Life after stroke is a comprehensive area that involves engagement in meaningful everyday activities, including work, and can be adversely affected by post-stroke fatigue. This study investigates post-stroke fatigue, its development over time, and its impact on return to work and other everyday life activities. In addition, we investigated whether post-stroke fatigue could predict functioning in everyday life activities one year after stroke., Material and Methods: This prospective registry-based study includes 2850 working age (18 - 63 years) patients registered in the Swedish Stroke Register (Riksstroke) during year 2017 and 2018. Post-stroke fatigue and everyday activities were analyzed 3- and 12-months post-stroke., Results: The mean age of the included participants was 54 years and the majority, 65%, were men. Three months post-stroke, 43% self-reported fatigue, at 12-months the proportion increased to 48%. About 90% of the patients were independent in basic ADL at 3-month. Dependence in complex activities one year post-stroke was significantly associated with fatigue. Not experiencing fatigue one year after stroke could predict positive functioning in everyday activities, increasing the chance of returning to work (OR = 3.7) and pre-stroke life and everyday activities (OR = 5.7)., Conclusion: Post-stroke fatigue is a common persistent disability that negatively impacts complex activities; therefore, fatigue needs to be acknowledged and addressed long term after discharge.

Introduction: Although ischemic stroke incidence has decreased in Sweden over the past decade, trends in spontaneous intracerebral hemorrhage (ICH) incidence are less well delineated. In this time period, there has been a dramatic increase in use of oral anticoagulants (OAC). The aim of our study was to investigate incidence trends in spontaneous first-ever ICH in Sweden between 2010 and 2019, with a focus on non-OAC-associated and OAC-associated ICH., Methods: We included patients (≥18 years) with first-ever ICH registered in the hospital-based Swedish Stroke Register (Riksstroke) 2010-2019. Data were stratified by non-OAC and OAC ICH and analyzed for 2010-2012, 2013-2016, and 2017-2019. Incidence rates are shown as crude and age-specific per 100,000 person-years., Results: Between 2010 and 2019, 22,289 patients with first-ever ICH were registered; 18,325 (82.2%) patients with non-OAC ICH and 3,964 (17.8%) patients with OAC ICH. Annual crude incidence (per 100,000) of all first-ever ICH decreased by 10% from 29.5 (95% CI 28.8-30.3) to 26.7 (95% CI 26.0-27.3) between 2010-2012 and 2017-2019. The crude incidence rate of non-OAC ICH decreased by 20% from 25.7 (95% CI 25.0-26.3) to 20.7 (95% CI 20.1-21.2), whereas OAC ICH increased by 56% from 3.86 (95% CI 3.61-4.12) to 6.01 (95% CI 5.70-6.32). The proportion of OAC ICH of all first-ever ICH increased between 2010-2012 and 2017-2019 from 13.1% to 22.5% (p &lt; 0.001). Proportional changes were largest in the age group ≥85 years with a decrease in non-OAC ICH by 32% from 155 (95% CI 146-164) to 106 (95% CI 98.6-113) and an increase in OAC ICH by 155% from 25.7 (95% CI 22.1-29.4) to 65.5 (95% CI 59.9-71.2)., Conclusion: Incidence of first-ever ICH in Sweden decreased by 10% between 2010 and 2019. We found diverging trends with a 20% decrease in non-OAC-associated ICH and a 56% increase in OAC-associated ICH. Further research on ICH epidemiology, analyzing non-OAC and OAC-associated ICH separately, is needed to follow up these diverging trends including underlying risk factors., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Introduction: This planned multicenter observational study will evaluate the overall survival of those undergoing integrated Chinese and Western medicine for stage IIIb-IVb non-small cell lung cancer and analyze the factors related to the prognosis., Method and Analysis: The prospective cohort will enroll patients with stage IIIb-IVb NSCLC from March 1, 2019, to December 31, 2025, and follow them for 5 years. We plan to collect data on the patients' demographics, treatment, overall survival, and factors related to the prognosis., Ethics and Dissemination: The institutional review board and ethics committee reviewed the study protocol. All patients will provide informed consent before enrollment.Trial registration number: ChiCTR1900021430.

Background: Prosthetic valve endocarditis (PVE) is a feared complication after heart valve surgery. Studies on differences in bacteriology in various types of PVE are limited., Objectives: This study aimed to investigate the microbiology of PVE depending on the type of prosthetic valve and timing of diagnosis., Methods: A retrospective study based on the Swedish Registry on Infective Endocarditis focusing on PVE was conducted. The cohort was divided into mechanical and bioprosthetic valves; into endocarditis localization in the aortic, mitral, or tricuspid valve; and into early and late PVE. The microbiology in these groups was compared. Predictors of Staphylococcus aureus as the cause of PVE were examined by multivariable logistic regression., Results: A total of 780 episodes of PVE in 749 patients were compared regarding the distribution of causative microbiological agents. The most common agents included alpha-hemolytic streptococci (29%), S. aureus (22%), enterococci (14%), coagulase-negative staphylococci (CoNS) (12%), and Cutibacterium acnes (6%). S. aureus was more commonly found on mechanical valves compared to bioprosthetic ones (36% vs. 17%, p < 0.001) whereas alpha-hemolytic streptococci, enterococci, and CoNS were more common on bioprosthetic valves. There were no significant differences in the microbiology of PVE affecting mitral or aortic valves or in cases of early and late PVE. Predictors for S. aureus as the cause of PVE were end-stage renal disease, intravenous drug use, mechanical valve, and tricuspid localization of endocarditis., Conclusions: The type of prosthetic heart valve is associated with the causative pathogen. Patients with mechanical valves are more likely to have PVE caused by S. aureus., (© 2022 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.)