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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 (ppFEV1) 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 ppFEV1 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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). 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. 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. 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. [ABSTRACT FROM AUTHOR]

Anna Trier Heiberg Brix,1,2 Tanja Gram Petersen,3 Tine Nymark,1,2 Hagen Schmal,1,4 Martin Lindberg-Larsen,1,2 Katrine Hass Rubin2,3 1Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark; 2Department of Clinical Research, University of Southern Denmark, Odense, Denmark; 3Research Unit OPEN, Odense University Hospital and University of Southern Denmark, Odense, Denmark; 4Department of Orthopedics and Traumatology, University Medical Center Freiburg, Freiburg, GermanyCorrespondence: Anna Trier Heiberg Brix, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, J. B. Windsløws vej 4, Odense, 5000, Denmark, Tel +45 3027 2862, Email anna.trier.heiberg.brix@rsyd.dkObjective: 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.Keywords: major lower extremity amputation, registry study, mediator analysis, mortality, nationwide

OBJECTIVES: Physicians have been shown to have lower mortality compared to the general population, particularly regarding lifestyle-associated causes of death. Prior literature is divided on whether this is due to higher socioeconomic position (SEP), healthier lifestyle, or other specific occupational characteristics. This study analyzed the mortality of Austrian physicians compared to the general population and other (health) professionals with a similar SEP, and investigated patterns of lifestyle-associated mortality among physicians. METHODS: Data from professional associations and cause-of-death statistics were collated to determine causes of death for all occupational groups. Gender-specific age-standardized mortality rates (ASMR) and standardized rate ratios (SRR) were calculated to compare main causes of death [cancer, cardiovascular disease (CVD), external causes] among physicians to other (health) professionals and the general population. Standardized mortality ratios (SMR) were calculated for more detailed causes of death in physicians compared to the general population. RESULTS: Physicians had lower all-cause mortality than the general population [SRR 0.45, 95% confidence interval (CI) 0.41–0.49 for males and SRR 0.60, 95% CI 0.54–0.66 for females] and health professionals (SRR 0.72, 95% CI 0.60–0.88 for males and SRR 0.77, 95% CI 0.63–0.93 for females), mostly due to low CVD and cancer mortality. SMR for detailed causes of death among physicians exhibited a pattern of particularly low mortality in lifestyle-associated causes of death and an increased SMR for suicide among female physicians (SMR 1.58, 95% CI 1.22–2.02). CONCLUSIONS: This study confirmed lower mortality among physicians compared to the general population and compared to other (health) professionals. Low physician mortality can be primarily explained by lifestyle-associated causes of death.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

ABSTRACT 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.

Background and purpose: Major lower extremity amputation (MLEA) is associated with complications that may prolong length of hospital stay (LOS) and increase the risk of readmission. We primarily aimed to examine the LOS and risk of readmissions after MLEA in Denmark. Secondarily we investigated the time trends. Methods: Using Danish National Patient Registry data, this observational study analyzed 11,205 first-time MLEAs (35% transtibial amputations, 65% transfemoral amputations) performed between January 1, 2010 and December 31, 2021. Total LOS included pre- and postoperative nights. The first readmission within 30 days and 90 days post-discharge was analyzed. Results: The median total LOS after a transtibial amputation was 19 days (interquartile range [IQR] 11–30), and decreased from 28 days (IQR 17–41) in 2010 to 14 days (IQR 9–23) in 2021. The median total LOS after a transfemoral amputation was 13 days (IQR 8–22) and decreased from 16 days (IQR 9–27) in 2010 to 11 days (IQR 7–18) in 2021. Post-discharge readmission risks within 30 days were 27% (95% confidence interval [CI] 24–28) for transtibial amputations and 23% (CI 22–24) for transfemoral amputations, with corresponding 90-day risks of 40% (CI 39–42) and 35% (CI 34–36), respectively. The 30-day risk of readmission increased in both groups. Conclusion: We observed that MLEA patients’ hospital admissions lasted 2–3 weeks and decreased over the study period. A readmission risk of 23–27% within 30 days and 35–40 % within 90 days post-discharge was observed. Readmissions risk increased for both initial transtibial and transfemoral amputations over the study period.

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.

Abstract 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.

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. 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). 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). 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [Display omitted] • Registry-based case review demonstrated 33.0% epithelial, 46.2% germ cell, 18.1% sex cord stromal, and 2.7% other tumors. • There is a strong agreement between the review diagnosis and the original diagnosis. • Total 5-year survival was 88.4%, with a worse survival in the cohort 1970–79. • Malignant epithelial tumors contributed 24% of tumor-related mortality events in this cohort. • The greatest diagnostic difficulty was subtyping within the epithelial and sex cord stromal group. [ABSTRACT FROM AUTHOR]

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). 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background and purpose: There is conflicting evidence regarding treatment outcomes after minimally invasive sacroiliac joint fusion for long-lasting severe sacroiliac joint pain. The primary aim of our cohort study was to investigate change in patient-reported outcome measures (PROMs) after minimally invasive sacroiliac joint surgery in daily practice in the Swedish Spine Registry. Secondary aims were to explore the proportion of patients reaching a patient acceptable symptom score (PASS) and the minimal clinically important difference (MCID) for pain scores, physical function, and health-related quality of life outcomes; furthermore, to evaluate self-reported satisfaction, walking distance, and changes in proportions of patients on full sick leave/disability leave and report complications and reoperations. Methods: Data from the Swedish Spine Registry was collected for patients with first-time sacroiliac joint fusion, aged 21 to 70 years, with PROMs available preoperatively, at 1 or 2 years after last surgery. PROMs included Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for low back pain (LBP) and leg pain, and EQ-VAS, in addition to demographic variables. We calculated mean change from pre- to postoperative and the proportion of patients achieving MCID and PASS. Results: 68 patients had available pre- and postoperative data, with a mean age of 45 years (range 25–70) and 59 (87%) were female. At follow-up the mean reduction was 2.3 NRS points (95% confidence interval [CI] 1.6–2.9; P < 0.001) for LBP and 14.8 points (CI 10.6–18.9; P < 0.001) for ODI. EQ-VAS improved by 22 points (CI 15.4–30.3, P < 0.001) at follow-up. Approximately half of the patients achieved MCID and PASS for pain (MCID NRS LBP: 38/65 [59%] and PASS NRS LBP: 32/66 [49%]) and physical function (MCID ODI: 27/67 [40%] and PASS ODI: 24/67 [36%]). The odds for increasing the patient’s walking distance to over 1 km at follow-up were 3.5 (CI 1.8–7.0; P < 0.0001), and of getting off full sick leave or full disability leave was 0.57 (CI 0.4–0.8; P = 0.001). In the first 3 months after surgery 3 complications were reported, and in the follow-up period 2 reoperations. Conclusion: We found moderate treatment outcomes after minimally invasive sacroiliac joint fusion when applied in daily practice with moderate pain relief and small improvements in physical function.

Background and purpose: Mortality after major lower extremity amputations is high and may depend on amputation level. We aimed to examine the mortality risk in the first year after major lower extremity amputation divided into transtibial and transfemoral amputations. Methods: This observational cohort study used data from the Danish Nationwide Health registers. 11,205 first-time major lower extremity amputations were included from January 1, 2010, to December 31, 2021, comprising 3,921 transtibial amputations and 7,284 transfemoral amputations. Results: The 30-day mortality after transtibial amputation was overall 11%, 95% confidence interval (CI) 10–12 (440/3,921) during the study period, but declined from 10%, CI 7–13 (37/381) in 2010 to 7%, CI 4–11 (15/220) in 2021. The 1-year mortality was 29% overall, CI 28–30 (1,140 /3,921), with a decline from 31%, CI 21–36 (117/381) to 20%, CI 15–26 (45/220) during the study period. For initial transfemoral amputation, the 30-day mortality was overall 23%, CI 22–23 (1,673/7,284) and declined from 27%, CI 23–31 (138/509) to 22%, CI 19–25 (148/683) during the study period. The 1-year mortality was 48% overall, CI 46–49 (3,466/7,284) and declined from 55%, CI 50–59 (279/509) to 46%, CI 42–50 (315/638). Conclusion: The mortality after major lower extremity amputation declined in the 12-year study period; however, the 1-year mortality remained high after both transtibial and transfemoral amputations (20% and 46% in 2021). Hence, major lower extremity amputation patients constitute one of the most fragile orthopedic patient groups, emphasizing an increased need for attention in the pre-, peri-, and postoperative setting.

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

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 [ABSTRACT FROM AUTHOR]

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. 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. 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). 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. People of working age who experience post-stroke fatigue encounter difficulties with complex rather than basic activities. Post-stroke fatigue may be developed when reclaiming complex activities; thus, long term routine assessments after discharge are recommended. Interventions addressing post-stroke fatigue are warranted, as the absence of post-stroke fatigue increases the chance of returning to everyday life, including work. [ABSTRACT FROM AUTHOR]

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Abstract 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).

Background and purpose: Re-amputation after lower extremity amputation is frequent. The primary aim of our study was to investigate cumulative re-amputation risk after transtibial amputation (TTA), knee disarticulation (KD), and transfemoral amputation (TFA) and secondarily to investigate time to re-amputation, and risk factors. Methods: This observational cohort study was based on data from the Danish Nationwide Health registers. The population included first-time major lower extremity amputations (MLEA) performed in patients ≥ 50 years between 2010 and 2021. Both left and right sided MLEA from the same patient were included as index procedures. Results: 11,743 index MLEAs on 10,052 patients were included. The overall cumulative risks for re-amputation were 29% (95% confidence interval [CI] 27–30), 30% (CI 26–35), and 11% (CI 10–12) for TTA, KD, and TFA, respectively. 58% of re-amputations were performed within 30 days after index MLEA. Risk factors for re-amputation within 30 days were dyslipidemia (hazard ratio [HR] 1.2, CI 1.0–1.3), renal insufficiency (HR 1.2, CI 1.1–1.4), and prior vascular surgery (HR 1.3, CI 1.2–1.5). Conclusion: The risk of re-amputation was more than twice as high after TTA (29%) and KD (30%) compared with TFA (11%). Most re-amputations were conducted within 30 days of the index MLEA. Dyslipidemia, renal insufficiency, and prior vascular surgery were associated with higher risk of re-amputation.

Background and purpose: While registry studies have suggested a higher risk of revision for posterior-stabilized (PS) compared with posterior cruciate-retaining (CR) total knee replacements (TKR) using cement, it is unknown whether this is also the case for uncemented TKR. We aimed to compare the revision rates of PS and CR designs in patients receiving primary uncemented TKR. Patients and methods: Data from the Dutch arthroplasty register (LROI) was analyzed, comprising 12,226 uncemented primary CR TKRs and 750 uncemented PS TKRs registered between 2007 and 2022. Competing risk and multivariable Cox regression analyses were used to compare revision rates, risks of revision, and reasons for revision between groups. Sensitivity analyses were performed to analyze the risk, concerning the 5 most commonly used implants and performing hospitals for each group. Results: Uncemented PS TKRs had higher 10-year revision rates for any reason and aseptic loosening (6.5%, 95% confidence interval [CI] 4.6–9.2 and 3.9%, CI 2.6–6.7) compared with uncemented CR TKRs (4.2%, CI 3.8–4.7 and 1.4%, CI 1.2–1.7). PS TKRs were 1.4 and 2.5 times more likely to be revised for any reason and aseptic loosening, respectively. These results remained consistent after adjustment for age, sex, BMI, previous surgeries, bearing mobility, and surface modification, with sensitivity analyses. Conclusion: We found that uncemented PS implants have a higher rate of revision than uncemented CR implants, mainly due to a higher risk of aseptic loosening.

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.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 < 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 treatmentrelated. Targeted support for treatment-related side-effects already during the treatment period could lead to better recovery and earlier return to work. Abbreviations: AUROC: areas under the receiver operating characteristic; BCS: Breast conserving surgery; CI: confidence interval; ED: Emergency department; ER: oestrogen; EMR: Electronic medical record; HCRU: health care resource utilization; HER2: human epidermal growth factor receptor 2; HUS: Helsinki University Hospital; IQR: interquartile range; Kela: Kansanel€akelaitos - The Social Insurance institution of Finland; M: month; n: number; NCSP: Nordic Classification of Surgical Procedures; OR: odds ratio; PR: progesterone; QoL: Quality of Life; SD: standard deviation; VIF: Variance inflation factor. [ABSTRACT FROM AUTHOR]

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. Plain language summary: Autologous haematopoietic stem cell transplantation for multiple sclerosis Substantial progress has been made in the development of disease-modifying medications for multiple sclerosis (MS) during the last 20 years. However, in a relevant percentage of patients, the disease cannot completely be contained. Autologous haematopoietic stem cell transplantation (AHSCT) enables rebuilding of a new and healthy immune system and to potentially stop the autoimmune disease process for a long time. A number of studies documenting 4000 cases cumulatively over the past 20 years reported high efficacy of AHSCT in controlling MS inflammatory disease activity. These data and improved safety profiles of the treatment procedures spurred interest in using AHSCT as a treatment option for MS. 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 video calls to develop recommendations and outline a registry study project. We provide a consensus-based opinion paper authored by 25 experts on the up-to-date optimal use of AHSCT in managing MS. Current data indicate that patients are most likely to benefit from AHSCT if they are young, ambulatory, with high disease activity, that is, relapses or new magnetic resonance imaging (MRI) lesions. Treatment data with AHSCT will be collected within the German REgistry Cohort of autoLogous haematopoietic stem cell transplantation MS (RECLAIM). Further clinical trials including registry-based analyses and systematic follow-up are urgently needed to better define the optimal patient characteristics as well as the efficacy and safety profile of AHSCT compared with other high-efficacy therapies. These will help to position AHSCT as a treatment option in different MS disease stages. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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.

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. [ABSTRACT FROM AUTHOR]

The new term essential tremor (ET) plus was proposed in the 2018 tremor consensus criteria. The National Survey of Essential Tremor Plus in China, a large multicenter registry study, aimed to evaluate the clinical features of pure ET and ET plus and explore possible factors related to ET plus. All patients with ET underwent neurological examination and neuropsychological assessment at 17 clinical sites. The diagnosis was made according to the 2018 consensus criteria. Clinicodemographic characteristics were analyzed. A total of 1160 patients were included, including 546 patients with pure ET and 614 patients with ET plus. The proportion of females was significantly higher in the ET plus than that in the pure ET (P = 0.001). The age at onset (AAO) of pure ET showed a bimodal distribution, with peaks in the 2nd and 5th decades. However, the AAO of the ET plus group demonstrated a skewed distribution, with a single peak in the 6th decade. Female sex (OR=1.645, P<0.001), older age (OR=1.023, P<0.001), lower educational level (OR=0.934, P<0.001), head tremor (OR=1.457, P<0.001), and higher the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS)-II scores (OR=1.134, P<0.001) were significantly associated with ET plus. Old age and female sex may contribute to ET plus development. Pure ET showed a bimodal distribution for AAO, whereas ET plus showed a unimodal distribution. It remains unclear whether pure ET and ET plus are merely different stages of a single disease or represent distinct disease entities. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives Patients with idiopathic inflammatory rheumatic diseases (IIRD) often have decreased working capacity resulting in indirect costs. However, data on patients' short-term sick leave has been limited. This retrospective cohort study evaluated the number and length of sick leave, including short-term leave, and occupational healthcare resource utilization (HCRU) of the working-aged patients with IIRD compared to controls. Methods The data on sick leave and occupational HCRU were gathered from the electronic medical records of the largest occupational healthcare provider in Finland from January 2012 to December 2019. Employed patients with an IIRD (including rheumatoid arthritis, spondyloarthritis, psoriatic and enteropathic arthritis, juvenile arthritis, and reactive arthritis) with at least a 12-months follow-up were identified and compared to age-, sex-, and follow-up matched controls without IIRD. Results Altogether 5405 patients with IIRD were identified and compared with an equal number of controls. The patients incurred approximately 2.5 times more sick leave than controls: 21.7 versus 8.5 days per patient year, respectively. Short-term sick leave was common: 83% of sickness absence periods of the patients lasted 1-9 days and represented 30% of the total absenteeism. Loss of productivity due to lost workdays was on average €4572 (95% confidence interval €4352-4804) per patient year. Occupational HCRU was approximately 1.8 times higher among IIRD patients than controls. Conclusions Workers with an IIRD incur considerably more sick leave and use more occupational healthcare services than controls. Short sick leave not registered in national insurance registers constitute a significant portion of days off work among patients with IIRD. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). Key messages: The KHFR study, which is a representative of the Korean hip fracture patients, showed that basic epidemiologic information of hip fracture including atypical hip fracture in Korea. Perioperative nutritional assessment and management by multi-disciplinary interventions could decrease malnutrition and mortality risk. Internal fixation in unstable intertrochanteric fracture was associated with higher reoperation rate, comparing with bipolar hemiarthroplasty, while mortality after surgery was not significantly differ according to the type of surgery. Prospective cohort and representative registry should be established to develop effective secondary prevention program such as Fracture Liaison Service. [ABSTRACT FROM AUTHOR]

• This is the first Neurostar TMS registry study in Japan using multisite data. • Efficacy of rTMS for treatment-resistant depression was confirmed by multisite data. • HAMD-17 showed 53.5 % response and 42.8 % remission rates after rTMS therapy. • Low dropout rate due to side effects and high tolerability of rTMS were confirmed. • Real-world data confirmed the efficacy and safety of standard Neurostar TMS therapy. 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. [ABSTRACT FROM AUTHOR]