{"title":"Salpingectomy versus tubal occlusion in laparoscopic sterilisation (SALSTER): a national register-based randomised non-inferiority trial","authors":"","doi":"10.1016/j.lanepe.2024.101026","DOIUrl":"10.1016/j.lanepe.2024.101026","url":null,"abstract":"<div><h3>Background</h3><div>Opportunistic salpingectomy to reduce ovarian cancer incidence has become increasingly common despite the lack of randomised trials investigating its safety. In SALSTER, we tested whether salpingectomy for laparoscopic sterilisation is non-inferior to tubal occlusion regarding complications up to eight weeks postoperatively.</div></div><div><h3>Methods</h3><div>SALSTER is a register-based randomised non-inferiority trial in which 41 gynaecological departments in Sweden participated. After being reported to The Swedish National Quality Register of Gynaecological Surgery (GynOp) for laparoscopic sterilisation, women aged <50 years received study information and could consent to participation online. If eligible, randomisation was performed by the examining/operating gynaecologist before surgery, with stratification for centre, and allocation 1:1 to salpingectomy or tubal occlusion. Blinding was attempted for patients but was impossible for surgeons. The first primary outcome, any complication up to eight weeks postoperatively, was routinely reported in GynOp through physician assessment of patient questionnaires, medical records and personal contact. Complications up to eight weeks postoperatively, a primary safety outcome, were analysed in the per-protocol population. The non-inferiority margin for the difference in the absolute risk of complications was defined as ten percentage points. Missing data were handled using multiple imputation. SALSTER was registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT03860805</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>Between April 4, 2019, and March 31, 2023, 539 women were randomised to salpingectomy and 527 to tubal occlusion. In the salpingectomy and tubal occlusion arms, 40 and 18 women discontinued their participation in the trial and another 26 and 10 did not receive the allocated surgery, respectively. Calculated on imputed data, any complication up to eight weeks postoperatively occurred in 8.1% (38.5/473) of patients after salpingectomy and in 6.2% (31.0/499) of patients after tubal occlusion. The risk difference was 1.9 percentage points (95% confidence interval −1.4 to 5.3).</div></div><div><h3>Interpretation</h3><div>Laparoscopic salpingectomy is non-inferior to tubal occlusion regarding complication rates up to eight weeks postoperatively.</div></div><div><h3>Funding</h3><div>This research was funded by the <span>Swedish Cancer Society</span>, the <span>Lena Wäppling foundation</span>, the Swedish state under the <span>ALF-agreement</span>, <span>Umeå University</span>, <span>County of Värmland</span>, and <span>Gothenburg Society of Medicine</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Trends in avoidable mortality from cardiovascular diseases in the European Union, 1995–2020: a retrospective secondary data analysis","authors":"","doi":"10.1016/j.lanepe.2024.101079","DOIUrl":"10.1016/j.lanepe.2024.101079","url":null,"abstract":"<div><h3>Background</h3><div>Certain causes of death can be avoided with access to timely prevention and treatment. We quantified trends in avoidable deaths from cardiovascular diseases for European Union (EU) countries from 1995 to 2020 and examined variations by demographics, disease characteristics, and geography.</div></div><div><h3>Methods</h3><div>Retrospective secondary data analysis of avoidable cardiovascular mortality using the WHO Mortality Database. Avoidable causes of death were identified from the OECD and Eurostat list (which uses an age threshold of 75 years). Regression models were used to identify changes in the trends of age-standardized mortality rates and potential years of life lost.</div></div><div><h3>Findings</h3><div>From 1995 to 2020, 11.4 million deaths from cardiovascular diseases in Europe were avoidable, resulting in 213.1 million potential life years lost. Avoidable deaths were highest among males (7.5 million), adults 65–74 years (6.8 million), and with the leading cause of death being ischemic heart disease (6.1 million). From its peak in 1995 until 2020, avoidable mortality from cardiovascular diseases has decreased by 57% across the EU. The difference in avoidable cardiovascular diseases mortality between females and males, and between Eastern and Western Europe has reduced greatly, however gaps continue to persist.</div></div><div><h3>Interpretation</h3><div>Avoidable mortality from cardiovascular diseases has decreased substantially among EU countries, although improvement has not been uniform across diseases, demographic groups or regions. These trends suggest additional policy interventions are needed to ensure that improvements in mortality are continued.</div></div><div><h3>Funding</h3><div><span>World Health Organization</span>, Regional Office for Europe.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Trends in the incidence of newly diagnosed cerebral cavernous malformations in Finland: a population-based retrospective cohort study","authors":"","doi":"10.1016/j.lanepe.2024.101072","DOIUrl":"10.1016/j.lanepe.2024.101072","url":null,"abstract":"<div><h3>Background</h3><div>The few previous studies that have estimated the incidence of cerebral cavernous malformations (cavernomas) have reported incidence rates of 0.2–1.9/100,000 for diagnosed cavernomas. Our aim was to describe incidence trends of cavernomas by clinical presentation.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study of cavernomas diagnosed at two university hospitals in Finland (Kuopio University Hospital, KUH and Tampere University Hospital, TAUH). Cavernoma diagnoses during 2004–2020 were identified from the KUH and TAUH Care registry databases and verified from medical records and diagnostic imaging studies. We calculated the age-standardized incidence rates using the European standard population and analysed incidence trend and changes in trend by sex, age group, and calendar year using Poisson regression.</div></div><div><h3>Findings</h3><div>A total of 669 cavernoma diagnoses were identified during 2004–2020 in the combined KUH and TAUH population. The age-standardized incidence rate was 2.01/100,000 (95% confidence interval (CI) 1.85–2.16) for all cavernoma diagnoses, 1.25/100,000 (1.13–1.37) for asymptomatic, 0.75/100,000 (0.66–0.85) for symptomatic, and 0.46/100,000 (0.39–0.53) for ruptured cavernomas. No significant difference in the incidence of cavernoma diagnoses was seen between the KUH and TAUH populations or between the sexes. Incidence of cavernomas was highest at ages 40–59 years and low in those under 20 or over 80 years of age. Incidence of diagnosed cavernomas, especially asymptomatic, increased during the study period.</div></div><div><h3>Interpretation</h3><div>In our population-based study, incidence of cavernomas was higher than previously reported and increased during the study period. The burden imposed by cavernomas on healthcare system is considerable and increasing.</div></div><div><h3>Funding</h3><div>The <span>Research Council of Finland</span>, <span>Kuopio University Hospital</span>, <span>Tampere University Hospital</span>, and <span>Wellbeing services county of Pirkanmaa</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142323672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Axillary clearance and chemotherapy rates in ER+HER2− breast cancer: secondary analysis of the SENOMAC trial","authors":"","doi":"10.1016/j.lanepe.2024.101083","DOIUrl":"10.1016/j.lanepe.2024.101083","url":null,"abstract":"<div><h3>Background</h3><div>Randomized trials have shown that axillary clearance (AC) can safely be omitted in patients with sentinel lymph node-positive breast cancer. At the same time, de-escalation of chemotherapy in postmenopausal patients with ER+HER2− breast cancer may depend on detailed axillary nodal stage. The aim of this pre-specified secondary analysis of the SENOMAC trial was to investigate whether the choice of axillary staging affected the proportion of patients receiving adjuvant chemotherapy, and recurrence-free survival (RFS).</div></div><div><h3>Methods</h3><div>Proportion receiving adjuvant chemotherapy was calculated according to AC or sentinel lymph node biopsy (SLNB) only, menopausal status, and region of inclusion, for 2168 patients with clinically node-negative ER+HER2− breast cancer and 1–2 sentinel lymph node macrometastases included in the SENOMAC trial.</div></div><div><h3>Findings</h3><div>In premenopausal patients, 514 out of 615 patients (83.6%) received adjuvant chemotherapy with no significant difference between randomization arms. In postmenopausal patients, the proportion receiving chemotherapy varied considerably by region and country (36.0–82.4%). In Denmark, where 194 out of 539 postmenopausal patients (36.0%) received adjuvant chemotherapy, rates differed significantly between the AC and the SLNB only arm (41.3% vs 31.4%, p = 0.019). After a median follow-up of 44.88 months for Danish postmenopausal patients, no significant difference was seen in 5-year RFS, which was 91% (85.6%–96.6%) for the SLNB only and 90.9% (86.3%–95.6%) for the AC arm (p = 0.42).</div></div><div><h3>Interpretation</h3><div>When omitting axillary clearance, and thus reducing the risk of long-term arm morbidity, potential under-treatment of postmenopausal patients with ER+HER2− breast cancer may require the development of new predictive and imaging tools.</div></div><div><h3>Funding</h3><div><span>Swedish Research Council</span>, <span>Swedish Cancer Society</span>, <span>Nordic Cancer Union</span>, Swedish <span>Breast Cancer Association</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142323298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Can we ensure a safe and effective integration of language models in oncology?","authors":"","doi":"10.1016/j.lanepe.2024.101081","DOIUrl":"10.1016/j.lanepe.2024.101081","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666776224002485/pdfft?md5=32603d3e5cd0df724a3ec3d021a5c146&pid=1-s2.0-S2666776224002485-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142310468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Long-term autonomy, professional activities, cognition, and overall survival after awake functional-based surgery in patients with IDH-mutant grade 2 gliomas: a retrospective cohort study","authors":"","doi":"10.1016/j.lanepe.2024.101078","DOIUrl":"10.1016/j.lanepe.2024.101078","url":null,"abstract":"<div><h3>Background</h3><div>In isocitrate dehydrogenase (IDH)-mutant low-grade gliomas (LGGs), awake functional-based resection (i.e., resection based on intraoperative functional responses rather than anatomical margins) has emerged as an efficient method to reduce tumour volume (TV) while minimizing postoperative deficits. Here, our goal was to assess the long-term onco-functional outcomes after awake functional-based resection in IDH-mutant LGGs, in conjunction with clinico-radiological and molecular factors.</div></div><div><h3>Methods</h3><div>We retrospectively studied a consecutive cohort (June 1997–January 2023) of 949 patients. Six hundred patients with IDH-mutant LGGs benefited from an awake functional-based resection with a median follow-up of 7.8 years (95% Confidence interval [CI]: 7.1–8.4 years). The main outcomes were the overall survival (OS), the OS with Karnofsky performance status ≥80% (OS<sub>KPS</sub><sub>≥</sub><sub>80%</sub>), cognition measures, and professional activities at 12 months post-surgery.</div></div><div><h3>Findings</h3><div>600 patients were included in the cohort (274 female [46.0%], median age: 36 years [Interquartile range, IQR: 30–44 years]). The rate of return to work was 93.7%. The impact of surgery on cognition was of limited magnitude. The median postsurgical TV of 2.5 mL (IQR: 0–8.0 mL). The median OS was over 20 years (median: NA, 95% CI: 17.0-NA years). The median OS<sub>KPS</sub><sub>≥</sub><sub>80%</sub> was 14.7 years (95% CI: 13.2–17.2 years). Factors associated with longer OS and OS<sub>KPS</sub><sub>≥</sub><sub>P80%</sub> were 1p19q codeletion (Hazard ratio [HR]<sub>OS</sub>: 0.27, 95% CI: 0.16–0.43, HR<sub>KPS</sub><sub>≥</sub><sub>80%</sub>:0.25, 95% CI: 0.17–0.36), supratotal resection (HR<sub>OS</sub>: 0.08, 95% CI: 0.005–0.40, HR<sub>KPS</sub><sub>≥</sub><sub>80%</sub>:0.12, 95% CI: 0.03–0.34) and total resection (HR<sub>OS</sub>: 0.31, 95% CI: 0.16–0.59, HR<sub>KPS</sub><sub>≥</sub><sub>80%</sub>:0.21, 95% CI: 0.12–0.36). Recursive partitioning analyses established three OS and OS<sub>KPS</sub><sub>≥</sub><sub>80%</sub> prognostic groups, highlighting the contributions of histomolecular status, extent of resection, postsurgical and presurgical TV. Further propensity-matching analyses confirmed the oncological benefits of supratotal resections.</div></div><div><h3>Interpretation</h3><div>Awake functional-based resection surgery in newly diagnosed IDH-mutant grade 2 LGG, was an effective strategy associated with long survival (median OS over 20 years) and long-term preservation of autonomy. More complete tumor resections favored better onco-functional outcomes across all molecularly-defined subtypes. Short-term effects were of limited magnitude regarding postoperative cognitive and professional outcomes. Supratotal functional-based resections offered additional survival benefits.</div></div><div><h3>Funding</h3><div>None.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266677622400245X/pdfft?md5=3cc60a9f54c016f5c76446211986140d&pid=1-s2.0-S266677622400245X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142310469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Physical, cognitive, and social triggers of symptom fluctuations in people living with long COVID: an intensive longitudinal cohort study","authors":"","doi":"10.1016/j.lanepe.2024.101082","DOIUrl":"10.1016/j.lanepe.2024.101082","url":null,"abstract":"<div><h3>Background</h3><div>Symptom fluctuations within and between individuals with long COVID are widely reported, but the extent to which severity varies following different types of activity and levels of exertion, and the timing of symptoms and recovery, have not previously been quantified. We aimed to characterise timing, severity, and nature of symptom fluctuations in response to effortful physical, social and cognitive activities, using Ecological Momentary Assessments.</div></div><div><h3>Methods</h3><div>We recorded activity, effort, and severity of 8 core symptoms every 3 h for up to 24 days, in cohorts from both clinic and community settings. Symptom severities were jointly modelled using autoregressive and moving average processes.</div></div><div><h3>Findings</h3><div>Consent was received from 376 participants providing ≥1 week's measurements (273 clinic-based, 103 community-based). Severity of all symptoms was elevated 30 min after all categories of activity. Increased effort was associated with increased symptom severity. Fatigue severity scores increased by 1.8/10 (95% CI: 1.6–1.9) following the highest physical exertions and by 1.5 (1.4–1.7) following cognitive efforts. There was evidence of only mild delayed fatigue 3 h (0.3, 0.2–0.5) or one day later (0.2, 0.0– 0.5). Fatigue severity increased as the day progressed (1.4, 1.0–1.7), and cognitive dysfunction was 0.2 lower at weekends (0.1–0.3).</div></div><div><h3>Interpretation</h3><div>Cognitive, social, self-care and physical activities all triggered increased severity across every symptom, consistent with associated common pathways as potential therapeutic targets. Clear patterns of symptom fluctuations emerged that support more targeted self-management.</div></div><div><h3>Funding</h3><div><span>National Institute for Health and Care Research</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666776224002497/pdfft?md5=f0cd883b7cd68ba7fe4bea7d80506bba&pid=1-s2.0-S2666776224002497-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142310470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Emerging data on SGLT2 benefits in acute coronary syndromes","authors":"","doi":"10.1016/j.lanepe.2024.101085","DOIUrl":"10.1016/j.lanepe.2024.101085","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666776224002527/pdfft?md5=09e81064915a8c58a71ecd67b1d12d25&pid=1-s2.0-S2666776224002527-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Blood-based biomarkers in the oldest old: towards Alzheimer's disease detection in primary care","authors":"","doi":"10.1016/j.lanepe.2024.101077","DOIUrl":"10.1016/j.lanepe.2024.101077","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666776224002448/pdfft?md5=9366f8cb802717eb778cfbf2b1bd76c7&pid=1-s2.0-S2666776224002448-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Ultra-processed foods and type 2 diabetes: more fundamental research is needed","authors":"","doi":"10.1016/j.lanepe.2024.101084","DOIUrl":"10.1016/j.lanepe.2024.101084","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":null,"pages":null},"PeriodicalIF":13.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666776224002515/pdfft?md5=fb2c4817668d269938f48caab1370d8a&pid=1-s2.0-S2666776224002515-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142240007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}