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1.	Abozid, Hazim, et al. (författare) Prevalence of chronic cough, its risk factors and population attributable risk in the Burden of Obstructive Lung Disease (BOLD) study : a multinational cross-sectional study 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 68 Tidskriftsartikel (refereegranskat)abstract Background Chronic cough is a common respiratory symptom with an impact on daily activities and quality of life. Global prevalence data are scarce and derive mainly from European and Asian countries and studies with outcomes other than chronic cough. In this study, we aimed to estimate the prevalence of chronic cough across a large number of study sites as well as to identify its main risk factors using a standardised protocol and definition. Methods We analysed cross-sectional data from 33,983 adults (>= 40 years), recruited between Jan 2, 2003 and Dec 26, 2016, in 41 sites (34 countries) from the Burden of Obstructive Lung Disease (BOLD) study. We estimated the prevalence of chronic cough for each site accounting for sampling design. To identify risk factors, we conducted multivariable logistic regression analysis within each site and then pooled estimates using random -effects metaanalysis. We also calculated the population attributable risk (PAR) associated with each of the identifed risk factors. Findings The prevalence of chronic cough varied from 3% in India (rural Pune) to 24% in the United States of America (Lexington,KY). Chronic cough was more common among females, both current and passive smokers, those working in a dusty job, those with a history of tuberculosis, those who were obese, those with a low level of education and those with hypertension or airflow limitation. The most influential risk factors were current smoking and working in a dusty job. Interpretation Our findings suggested that the prevalence of chronic cough varies widely across sites in different world regions. Cigarette smoking and exposure to dust in the workplace are its major risk factors.
2.	Alesi, Simon, et al. (författare) Efficacy and safety of anti-androgens in the management of polycystic ovary syndrome: a systematic review and meta-analysis of randomised controlled trials. 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 63 Tidskriftsartikel (refereegranskat)abstract Anti-androgens and combined oral contraceptive pills (COCPs) may mitigate hyperandrogenism-related symptoms of polycystic ovary syndrome (PCOS). However, their efficacy and safety in PCOS remain unclear as previous reviews have focused on non-PCOS populations. To inform the 2023 International Evidence-based Guideline in PCOS, we conducted the first systematic review and meta-analysis investigating the efficacy and safety of anti-androgens in the management of hormonal and clinical features of PCOS.We systematically searched MEDLINE, Embase, PsycInfo, All EBM reviews, and CINAHL up to 28th June 2023 for randomised controlled trials (RCTs) examining oral anti-androgen use, alone or in combination with metformin, COCPs, lifestyle, or other interventions, in women of any age, with PCOS diagnosed by Rotterdam, National Institutes of Health or Androgen Excess & PCOS Society criteria, and using a form of contraception. Non-English studies and studies of less than 6 months duration or which used the same anti-androgen regimen in both/all groups were excluded in order to establish efficacy for the clinical outcomes of interest. Three authors screened articles against selection criteria and assessed risk of bias and quality using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. Critical outcomes (prioritised during guideline development for GRADE purposes) included weight, body mass index (BMI), irregular cycles, hirsutism, liver function, and quality of life. Random effects meta-analyses were conducted where appropriate. This study is registered with PROSPERO, CRD42022345640.From 1660 studies identified in the search, 27 articles comprising 20 unique studies were included. Of these, 13 studies (n=961) were pooled in meta-analysis. Seven studies had a high risk of bias, nine moderate and four low. Anti-androgens included finasteride, flutamide, spironolactone, or bicalutamide. In meta-analysis, anti-androgens+lifestyle were superior to metformin+lifestyle for hirsutism (weighted mean difference [WMD] [95% CI]:-1.59 [-3.06,-0.12], p=0.03; I2=74%), SHBG (7.70nmol/l [0.75, 14.66], p=0.03; I2=0%), fasting insulin and fasting insulin: glucose ratio (-2.11 μU/ml [-3.97,-0.26], p=0.03; I2=0% and-1.12 [-1.44,-0.79], p<0.0001, I2=0%, respectively), but were not superior to placebo+lifestyle for hirsutism (-0.93, [-3.37, 1.51], p=0.45; I2=76%) or SHBG (9.72nmol/l [-0.71, 20.14], p=0.07; I2=31%). Daily use was more effective for hirsutism than use every three days (-3.48 [-4.58,-2.39], p<0.0001, I2=1%), and resulted in lower androstenedione levels (-0.30ng/ml [-0.50,-0.10], p=0.004; I2=0%). Combination treatment with anti-androgens+metformin+lifestyle resulted in lower testosterone compared with metformin+lifestyle (-0.29nmol/l [-0.52,-0.06], p=0.01; I2=61%), but there were no differences in hirsutism when anti-androgens+metformin+lifestyle were compared with either anti-androgens+lifestyle or metformin+lifestyle. In limited meta-analyses (n=2 trials), combining anti-androgens with COCP resulted in poorer lipid profiles compared with COCP±placebo, with no differences in other outcomes.Current evidence does not support the use of anti-androgens preferentially to COCPs to treat hyperandrogenism in PCOS. Anti-androgens could be considered to treat hirsutism in PCOS, where COCPs are contraindicated, poorly tolerated, or present a sub-optimal response after a minimum 6-month period, with consideration of clinical context and individual risk factors and characteristics.National Health and Medical Research Council (NHMRC) of Australia Monash University.
3.	Alimoradi, Zainab, et al. (författare) Sleep problems during COVID-19 pandemic and its’ association to psychological distress : A systematic review and meta-analysis 2021 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 36 Forskningsöversikt (refereegranskat)abstract Background: The emerging novel coronavirus disease 2019 (COVID-19) has become one of the leading cause of deaths worldwide in 2020. The present systematic review and meta-analysis estimated the magnitude of sleep problems during the COVID-19 pandemic and its relationship with psychological distress.Methods: Five academic databases (Scopus, PubMed Central, ProQuest, ISI Web of Knowledge, and Embase) were searched. Observational studies including case-control studies and cross-sectional studies were included if relevant data relationships were reported (i.e., sleep assessed utilizing the Pittsburgh Sleep Quality Index or Insomnia Severity Index). All the studies were English, peer-reviewed papers published between December 2019 and February 2021. PROSPERO registration number: CRD42020181644.Findings: 168 cross-sectional, four case-control, and five longitudinal design papers comprising 345,270 participants from 39 countries were identified. The corrected pooled estimated prevalence of sleep problems were 31% among healthcare professionals, 18% among the general population, and 57% among COVID-19 patients (all p-values < 0.05). Sleep problems were associated with depression among healthcare professionals, the general population, and COVID-19 patients, with Fisher's Z scores of -0.28, -0.30, and -0.36, respectively. Sleep problems were positively (and moderately) associated with anxiety among healthcare professionals, the general population, and COVID-19 patients, with Fisher's z scores of 0.55, 0.48, and 0.49, respectively.Interpretation: Sleep problems appear to have been common during the ongoing COVID-19 pandemic. Moreover, sleep problems were found to be associated with higher levels of psychological distress. With the use of effective programs treating sleep problems, psychological distress may be reduced. Vice versa, the use of effective programs treating psychological distress, sleep problems may be reduced.
4.	Andersson, B., et al. (författare) Surgical outcomes of gallbladder cancer: the OMEGA retrospective, multicentre, international cohort study 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 59 Tidskriftsartikel (refereegranskat)abstract Background: Gallbladder cancer (GBC) is rare but aggressive. The extent of surgical intervention for different GBC stages is non-uniform, ranging from cholecystectomy alone to extended resections including major hepatectomy, resection of adjacent organs and routine extrahepatic bile duct resection (EBDR). Robust evidence here is lacking, however, and survival benefit poorly defined. This study assesses factors associated with recurrence-free survival (RFS), overall survival (OS) and morbidity and mortality following GBC surgery in high income countries (HIC) and low and middle income countries (LMIC). Methods: The multicentre, retrospective Operative Management of Gallbladder Cancer (OMEGA) cohort study included all patients who underwent GBC resection across 133 centres between 1st January 2010 and 31st December 2020. Regression analyses assessed factors associated with OS, RFS and morbidity. Findings: On multivariable analysis of all 3676 patients, wedge resection and segment IVb/V resection failed to improve RFS (HR 1.04 [0.84–1.29], p = 0.711 and HR 1.18 [0.95–1.46], p = 0.13 respectively) or OS (HR 0.96 [0.79–1.17], p = 0.67 and HR 1.48 [1.16–1.88], p = 0.49 respectively), while major hepatectomy was associated with worse RFS (HR 1.33 [1.02–1.74], p = 0.037) and OS (HR 1.26 [1.03–1.53], p = 0.022). Furthermore, EBDR (OR 2.86 [2.3–3.52], p < 0.0010), resection of additional organs (OR 2.22 [1.62–3.02], p < 0.0010) and major hepatectomy (OR 3.81 [2.55–5.73], p < 0.0010) were all associated with increased morbidity and mortality. Compared to LMIC, patients in HIC were associated with poorer RFS (HR 1.18 [1.02–1.37], p = 0.031) but not OS (HR 1.05 [0.91–1.22], p = 0.48). Adjuvant and neoadjuvant treatments were infrequently used. Interpretation: In this large, multicentre analysis of GBC surgical outcomes, liver resection was not conclusively associated with improved survival, and extended resections were associated with greater morbidity and mortality without oncological benefit. Aggressive upfront resections do not benefit higher stage GBC, and international collaborations are needed to develop evidence-based neoadjuvant and adjuvant treatment strategies to minimise surgical morbidity and prioritise prognostic benefit. Funding:Cambridge Hepatopancreatobiliary Department Research Fund. © 2023 The Author(s)
5.	Andréasson, Karin, et al. (författare) Body mass index in adolescence, risk of type 2 diabetes and associated complications: A nationwide cohort study of men 2022 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 46 Tidskriftsartikel (refereegranskat)abstract Background Obesity is a predominant factor in development of type 2 diabetes but to which extent adolescent obesity influences adult diabetes is unclear. We investigated the association between body mass index (BMI) in young men and subsequent type 2 diabetes and how, in diagnosed diabetes, adolescent BMI relates to glycemic control and diabetes complications. Methods Baseline data from the Swedish Conscript Register for men drafted 1968-2005 was combined with data from the National Diabetes and Patient registries. Diabetes risk was estimated through Cox regression and Kaplan-Meier survival estimates. Relationships between BMI, glycemic control and diabetes complications were assessed through multiple linear and logistic regression. Findings Among 1,647,826 men, 63,957 (3.88%) developed type 2 diabetes over a median follow-up of 29.0 years (IQR[21.0-37.0]). The risk of diabetes within 40 years after conscription was nearly 40% in individuals with adolescent BMI >= 35 kg/m(2). Compared to BMI 18.5-<20 kg/m(2) (reference), diabetes risk increased in a linear fashion from HR 1.18(95%CI 1.15-1.21) for BMI 20-<22.5 kg/m(2) to HR 15.93(95%CI 14.88-17.05) for BMI >= 35 kg/m(2), and a difference in age at onset of 11.4 years was seen. Among men who developed diabetes, higher adolescent BMI was associated with higher HbA1c levels and albuminuria rates. Interpretation Rising adolescent BMI was associated with increased risk of type 2 diabetes diagnosed at a younger age, with poorer metabolic control, and a greater prevalence of albuminuria, all suggestive of worse prognosis. Copyright (C) 2022 The Authors. Published by Elsevier Ltd.
6.	Anindya, Kanya, et al. (författare) Socioeconomic inequalities in effective service coverage for reproductive, maternal, newborn, and child health: a comparative analysis of 39 low-income and middle-income countries. 2021 Ingår i: EClinicalMedicine. - 2589-5370. ; 40 Tidskriftsartikel (refereegranskat)abstract Reducing socioeconomic inequalities in access to good quality health care is key for countries to achieve Universal Health Coverage. This study aims to assess socioeconomic inequalities in effective coverage of reproductive, maternal, newborn and child health (RMNCH) in low- and middle-income countries (LMICs).Using the most recent national health surveys from 39 LMICs (between 2014 and 2018), we calculated coverage indicators using effective coverage care cascade that consists of service contact, crude coverage, quality-adjusted coverage, and user-adherence-adjusted coverage. We quantified wealth-related and education-related inequality using the relative index of inequality, slope index of inequality, and concentration index.The quality-adjusted coverage of RMNCH services in 39 countries was substantially lower than service contact, in particular for postnatal care (64 percentage points [pp], p-value<0·0001), family planning (48·7 pp, p<0·0001), and antenatal care (43·6 pp, p<0·0001) outcomes. Upper-middle-income countries had higher effective coverage levels compared with low- and lower-middle-income countries in family planning, antenatal care, delivery care, and postnatal care. Socioeconomic inequalities tend to be wider when using effective coverage measurement compared with crude and service contact measurements. Our findings show that upper-middle-income countries had a lower magnitude of inequality compared with low- and lower-middle-income countries.Reliance on the average contact coverage tends to underestimate the levels of socioeconomic inequalities for RMNCH service use in LMICs. Hence, the effective coverage measurement using a care cascade approach should be applied. While RMNCH coverages vary considerably across countries, equitable improvement in quality of care is particularly needed for lower-middle-income and low-income countries.None.
7.	Arya, S, et al. (författare) Effect on neonatal sepsis following immediate kangaroo mother care in a newborn intensive care unit: a post-hoc analysis of a multicentre, open-label, randomised controlled trial 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 60, s. 102006- Tidskriftsartikel (refereegranskat)
8.	Baker, K, et al. (författare) More work needs to be done to ensure that better pneumonia diagnostics aids are developed and launched to better support frontline health workers-A response to "Are respiratory rate counters really so bad" by Ansermino et al 2019 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 16, s. 15-15 Tidskriftsartikel (refereegranskat)
9.	Baker, K., et al. (författare) Performance of five pulse oximeters to detect hypoxaemia as an indicator of severe illness in children under five by frontline health workers in low resource settings- A prospective, multicentre, single-blinded, trial in Cambodia, Ethiopia, South Sudan, and Uganda 2021 Ingår i: Eclinicalmedicine. - : Elsevier BV. - 2589-5370. ; 38 Tidskriftsartikel (refereegranskat)abstract Background: Low blood oxygen saturation (SpO2), or hypoxaemia, is an indicator of severe illness in children. Pulse oximetry is a globally accepted, non-invasive method to identify hypoxaemia, but rarely available outside higher-level facilities in resource-constrained countries. This study aims to evaluate the performance of different types of pulse oximeters amongst frontline health workers in Cambodia, Ethiopia, South Sudan, and Uganda. Methods: Five pulse oximeters (POx) which passed laboratory testing, out of an initial 32 potential pulse oximeters, were evaluated by frontline health workers for performance, defined as agreement between the SpO2 measurements of the test device and the reference standard. The study protocol is registered with the Australia New Zealand Clinical Trials Registry (Ref: ACTRrn12615000348550). Findings: Two finger-tip pulse oximeters (Contec and Devon), two handheld pulse oximeters (Lifebox and Utech), and one phone pulse oximeter (Masimo) passed the laboratory testing. They were evaluated for performance on 1,313 children under five years old by 207 frontline health workers between February and May 2015. Phone and handheld pulse oximeters had greater overall agreement with the reference standard (56%; 95% CI 0.52 - 0.60 to 68%; 95% CI 0.65 - 0.71) than the finger-tip POx (31%; 95% CI 0.26 to 0.36 and 47%; 95% CI 0.42 to 0.52). Fingertip POx performance was substantially lower in the 0-2 month olds; having just 17% and 25% agreement. The finger-tip devices more often underreported SpO2 readings (mean difference -7.9%; 95%CI -8.6,-7.2 and -3.9%; 95%CI -4.4,-3.4), and therefore over diagnosed hypoxaemia in the children assessed. Interpretation: While the Masimo phone pulse oximeter performed best, all handheld POx with age-specific probes performed well in the hands of frontline health workers, further highlighting their suitability as a screening tool of severe illness. The poor performance of the fingertip POx suggests they should not be used in children under five by frontline health workers. It is essential that POx are performance tested on children in routine settings (in vivo), not only in laboratories or controlled settings (in vitro), before being introduced at scale.
10.	Baker, K., et al. (författare) Performance of Four Respiratory Rate Counters to Support Community Health Workers to Detect the Symptoms of Pneumonia in Children in Low Resource Settings: A Prospective, Multicentre, Hospital-Based, Single-Blinded, Comparative Trial 2019 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. Tidskriftsartikel (refereegranskat)abstract Background: Pneumonia is one of the leading causes of death in children under-five globally. The current diagnostic criteria for pneumonia are based on increased respiratory rate (RR) or chest in-drawing in children with cough and/or difficulty breathing. Accurately counting RR is difficult for community health workers (CHWs). Current RR counting devices are frequently inadequate or unavailable. This study analysed the performance of improved RR timers for detection of pneumonia symptoms in low-resource settings. Methods: Four RR timers were evaluated on 454 children, aged from 0 to 59 months with cough and/or difficulty breathing, over three months, by CHWs in hospital settings in Cambodia, Ethiopia, South Sudan and Uganda. The devices were the Mark Two ARI timer (MK2 ARI), counting beads with ARI timer, Rrate Android phone and the Respirometer feature phone applications. Performance was evaluated for agreement with an automated RR reference standard (Masimo Root patient monitoring and connectivity platform with ISA CO2 capnography). This study is registered with ANZCTR [ACTRN12615000348550]. Findings: While most CHWs managed to achieve a RR count with the four devices, the agreement was low for all; the mean difference of RR measurements from the reference standard for the four devices ranged from 0.5 (95% C.I. − 2.2 to 1.2) for the respirometer to 5.5 (95% C.I. 3.2 to 7.8) for Rrate. Performance was consistently lower for young infants (0 to < 2 months) than for older children (2 to ≤ 59 months). Agreement of RR classification into fast and normal breathing was moderate across all four devices, with Cohen's Kappa statistics ranging from 0.41 (SE 0.04) to 0.49 (SE 0.05). Interpretation: None of the four devices evaluated performed well based on agreement with the reference standard. The ARI timer currently recommended for use by CHWs should only be replaced by more expensive, equally performing, automated RR devices when aspects such as usability and duration of the device significantly improve the patient-provider experience. Funding: Bill & Melinda Gates Foundation [ OPP1054367]. © 2019
11.	Bell, M, et al. (författare) Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance 2019 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 11, s. 18-26 Tidskriftsartikel (refereegranskat)
12.	Benjamin, L. A., et al. (författare) Antiphospholipid antibodies and neurological manifestations in acute COVID-19: A single-centre cross-sectional study 2021 Ingår i: Eclinicalmedicine. - : Elsevier BV. - 2589-5370. ; 39 Tidskriftsartikel (refereegranskat)abstract Background: A high prevalence of antiphospholipid antibodies has been reported in case series of patients with neurological manifestations and COVID-19; however, the pathogenicity of antiphospholipid antibodies in COVID-19 neurology remains unclear. Methods: This single-centre cross-sectional study included 106 adult patients: 30 hospitalised COVID-neurological cases, 47 non-neurological COVID-hospitalised controls, and 29 COVID-non-hospitalised controls, recruited between March and July 2020. We evaluated nine antiphospholipid antibodies: anticardiolipin antibodies [aCL] IgA, IgM, IgG; anti-beta-2 glycoprotein-1 [a beta(2)GPI] IgA, IgM, IgG; anti-phosphatidylserine/prothrombin [aPS/PT] IgM, IgG; and anti-domain I b2GPI (aD1 beta 2GPI) IgG. Findings: There was a high prevalence of antiphospholipid antibodies in the COVID-neurological (73.3%) and non-neurological COVID-hospitalised controls (76.6%) in contrast to the COVID-non-hospitalised controls (48.2%). aPS/PT IgG titres were significantly higher in the COVID-neurological group compared to both control groups (p < 0.001). Moderate-high titre of aPS/PT IgG was found in 2 out of 3 (67%) patients with acute disseminated encephalomyelitis [ADEM]. aPS/PT IgG titres negatively correlated with oxygen requirement (FiO(2) R=-0.15 p = 0.040) and was associated with venous thromboembolism (p = 0.043). In contrast, aCL IgA (p < 0.001) and IgG (p < 0.001) was associated with non-neurological COVID-hospitalised controls compared to the other groups and correlated positively with D-dimer and creatinine but negatively with FiO(2). Interpretation: Our findings show that aPS/PT IgG is associated with COVID-19-associated ADEM. In contrast, aCL IgA and IgG are seen much more frequently in non-neurological hospitalised patients with COVID-19. Characterisation of antiphospholipid antibody persistence and potential longitudinal clinical impact are required to guide appropriate management. (C) 2021 The Author(s). Published by Elsevier Ltd.
13.	Boeras, Debi, et al. (författare) Evaluation of Zika rapid tests as aids for clinical diagnosis and epidemic preparedness 2022 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 49 Tidskriftsartikel (refereegranskat)abstract Background: Development and evaluation of diagnostics for diseases of epidemic potential are often funded during epidemics, but not afterwards, leaving countries unprepared for the next epidemic. United Nations Children's Emergency Fund (UNICEF) partnered with the United States Agency for International Development (USAID) to address this important gap by investing in an advance purchase commitment (APC) mechanism to accelerate the development and evaluation of Zika rapid diagnostic tests (RDTs) for case detection and surveillance. This paper describes the performance evaluation of five Zika RDTs eligible for procurement.Methods: A network of European Union-funded ZikaPLAN sites in Africa, Asia, Latin America with access to relevant serum specimens were selected to evaluate RDTs developed for the UNICEF APC mechanism. A standardised protocol and evaluation panels were developed and a call for specimens for the evaluation panels issued to different sites. Each site contributed specimens to the evaluation from their biobank. Data were collated, analysed and presented to the UNICEF Procurement Review Group for review.Findings: Three RDTs met the criteria for UNICEF procurement of sensitivity and specificity of 85% against a refence standard. The sensitivity/specificity of the ChemBio anti-Zika Virus (ZIKV) immunoglobulin M (IgM) test was 86.4 %/86.7% and the ChemBio ZCD system for anti-ZIKV IgM was 79.0%/97.1%, anti-dengue virus (DENV) IgM 90.0%/89.2%, anti-Chikungunya virus (CHIKV) IgM 90.6%/97.2%. The sensitivity/specificity of the SD Biosensor anti-ZIKV IgM was 96.8 %/90.8%, anti-DENV IgM 71.8%/83.5%, the DENV nonstructural protein 1 (NS1) glycoprotein 90.0%/90.2%, anti- yellow fever virus (YFV) IgM 84.6%/92.4%, anti-CHIKV IgM 86.3%/97.5%.Interpretation: Three RDTs fulfilled the performance thresholds set by WHO and were eligible for UNICEF procurement. These tests will improve the diagnosis of ZIKV and other arboviral infections as well as providing countries with better tools for surveillance and response to future epidemics.
14.	Brito-Zerón, Pilar, et al. (författare) Mortality risk factors in primary Sjögren syndrome : a real-world, retrospective, cohort study 2023 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 61 Tidskriftsartikel (refereegranskat)abstract BackgroundWhat baseline predictors would be involved in mortality in people with primary Sjögren syndrome (SjS) remains uncertain. This study aimed to investigate the baseline characteristics collected at the time of diagnosis of SjS associated with mortality and to identify mortality risk factors for all-cause death and deaths related to systemic SjS activity measured by the ESSDAI score.MethodsIn this international, real-world, retrospective, cohort study, we retrospectively collected data from 27 countries on mortality and causes of death from the Big Data Sjögren Registry. Inclusion criteria consisted of fulfilling 2002/2016 SjS classification criteria, and exclusion criteria included chronic HCV/HIV infections and associated systemic autoimmune diseases. A statistical approach based on a directed acyclic graph was used, with all-cause and Sjögren-related mortality as primary endpoints. The key determinants that defined the disease phenotype at diagnosis (glandular, systemic, and immunological) were analysed as independent variables.FindingsBetween January 1st, 2014 and December 31, 2023, data from 11,372 patients with primary SjS (93.5% women, 78.4% classified as White, mean age at diagnosis of 51.1 years) included in the Registry were analysed. 876 (7.7%) deaths were recorded after a mean follow-up of 8.6 years (SD 7.12). Univariate analysis of prognostic factors for all-cause death identified eight Sjögren-related variables (ocular and oral tests, salivary biopsy, ESSDAI, ANA, anti-Ro, anti-La, and cryoglobulins). The multivariate CPH model adjusted for these variables and the epidemiological features showed that DAS-ESSDAI (high vs no high: HR = 1.68; 95% CI, 1.27–2.22) and cryoglobulins (positive vs negative: HR = 1.72; 95% CI, 1.22–2.42) were independent predictors of all-cause death. Of the 640 deaths with available information detailing the specific cause of death, 14% were due to systemic SjS. Univariate analysis of prognostic factors for Sjögren-cause death identified five Sjögren-related variables (oral tests, clinESSDAI, DAS-ESSDAI, ANA, and cryoglobulins). The multivariate competing risks CPH model adjusted for these variables and the epidemiological features showed that oral tests (abnormal vs normal results: HR = 1.38; 95% CI, 1.01–1.87), DAS-ESSDAI (high vs no high: HR = 1.55; 95% CI, 1.22–1.96) and cryoglobulins (positive vs negative: HR = 1.52; 95% CI, 1.16–2) were independent predictors of SjS-related death.InterpretationThe key mortality risk factors at the time of SjS diagnosis were positive cryoglobulins and a high systemic activity scored using the ESSDAI, conferring a 2-times increased risk of all-cause and SjS-related death. ESSDAI measurement and cryoglobulin testing should be considered mandatory when an individual is diagnosed with SjS.
15.	Bruno, C, et al. (författare) Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study 2024 Ingår i: EClinicalMedicine. - 2589-5370. ; 70, s. 102531- Tidskriftsartikel (refereegranskat)
16.	Cao, Y, et al. (författare) Pregnancy and neonatal outcomes among women with early-onset colorectal cancer: a nationwide case-control study 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 59, s. 101963- Tidskriftsartikel (refereegranskat)
17.	Cao, Y, et al. (författare) Pregnancy and neonatal outcomes among women with early-onset colorectal cancer: a nationwide case-control study 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 59, s. 101963- Tidskriftsartikel (refereegranskat)
18.	Capeding, MR, et al. (författare) Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study 2020 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 27, s. 100540- Tidskriftsartikel (refereegranskat)
19.	Carli, V, et al. (författare) The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial 2022 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 48, s. 101423- Tidskriftsartikel (refereegranskat)
20.	Carton, C., et al. (författare) ERN GENTURIS tumour surveillance guidelines for individuals with neurofibromatosis type 1 2023 Ingår i: Eclinicalmedicine. - : Elsevier BV. - 2589-5370. ; 56 Tidskriftsartikel (refereegranskat)abstract Background Neurofibromatosis type 1 (NF1) is a multisystem genetic disorder, predisposing development of benign and malignant tumours. Given the oncogenic potential, long-term surveillance is important in patients with NF1. Proposals for NF1 care and its specific manifestations have been developed, but lack integration within routine care. This guideline aims to assimilate available information on NF1 associated tumours (based on evidence and/ or expert opinion) to assist healthcare professionals in undertaking tumour surveillance of NF1 individuals.Methods By comprehensive literature review, performed March 18th 2020, guidelines were developed by a NF1 expert group and patient representatives, conversant with clinical care of the wide NF1 disease spectrum. We used a modified Delphi procedure to overcome issues of variability in recommendations for specific (national) health care settings, and to deal with recommendations based on indirect (scarce) evidence.Findings We defined proposals for personalised and targeted tumour management in NF1, ensuring appropriate care for those in need, whilst reducing unnecessary intervention. We also incorporated the tumour-related psychosocial and quality of life impact of NF1. Interpretation The guideline reflects the current care for NF1 in Europe. They are not meant to be prescriptive and may be adjusted to local available resources at the treating centre, both within and outside EU countries.Funding This guideline has been supported by the European Reference Network on Genetic Tumour Risk Syndromes (ERN GENTURIS). ERN GENTURIS is funded by the European Union. DGE is supported by the Manchester NIHR Biomedical Research Centre (IS-BRC-1215-20007). 2023;56: Published January https://doi.org/10. 1016/j.eclinm.2022. 101818
21.	Cashin, Peter, 1984-, et al. (författare) Perioperative chemotherapy in colorectal cancer with peritoneal metastases : A global propensity score matched study 2023 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 55 Tidskriftsartikel (refereegranskat)abstract Background: There is a paucity of studies evaluating perioperative systemic chemotherapy in conjunction with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colorectal cancer peritoneal metastases (CRCPM). The aim was to evaluate neoadjuvant and/or adjuvant systemic therapy in CRCPM.Methods: Patients with CRCPM from 39 treatment centres globally from January 1, 1991, to December 31, 2018, who underwent CRS+HIPEC were identified and stratified according to neoadjuvant/adjuvant use. Crude data analysis, propensity score matching (PSM) and Cox-proportional hazard modelling was performed.Findings: Of 2093 patients, 1613 were included in neoadjuvant crude evaluation with 708 in the PSM cohort (354 patients/arm). In the adjuvant evaluation, 1176 patients were included in the crude cohort with 778 in the PSM cohort (389 patients/arm). The median overall survival (OS) in the PSM cohort receiving no neoadjuvant vs neoadjuvant therapy was 37.0 months (95% CI: 32.6-42.7) vs 34.7 months (95% CI: 31.2-38.8, HR 1.08 95% CI: 0.88-1.32, p = 0.46). The median OS in the PSM cohort receiving no adjuvant therapy vs adjuvant therapy was 37.0 months (95% CI: 32.9-41.8) vs 45.7 months (95% CI: 38.8-56.2, HR 0.79 95% CI: 0.64-0.97, p = 0.022). Recurrence-free survival did not differ in the neoadjuvant evaluation but differed in the adjuvant evaluation - HR 1.04 (95% CI: 0.87-1.25, p = 0.66) and 0.83 (95% CI: 0.70-0.98, p = 0.03), respectively. Multivariable Cox-proportional hazard modelling in the crude cohorts showed hazard ratio 1.08 (95% CI: 0.92-1.26, p = 0.37) for administering neoadjuvant therapy and 0.86 (95% CI: 0.72-1.03, p = 0.095) for administering adjuvant therapy.Interpretation: Neoadjuvant therapy did not confer a benefit to patients undergoing CRS+HIPEC for CRCPM, whereas adjuvant therapy was associated with a benefit in this retrospective setting.
22.	Ceric, Ameldina, et al. (författare) Effect of level of sedation on outcomes in critically ill adult patients : a systematic review of clinical trials with meta-analysis and trial sequential analysis 2024 Ingår i: EClinicalMedicine. - 2589-5370. ; 71 Tidskriftsartikel (refereegranskat)abstract Background: Sedation is routinely administered to critically ill patients to alleviate anxiety, discomfort, and patient-ventilator asynchrony. However, it must be balanced against risks such as delirium and prolonged intensive care stays. This study aimed to investigate the effects of different levels of sedation in critically ill adults. Methods: Systematic review with meta-analysis and trial sequential analysis (TSA) of randomised clinical trials including critically ill adults admitted to the intensive care unit. CENTRAL, MEDLINE, Embase, LILACS, and Web of Science were searched from their inception to 13 June 2023. Risks of bias were assessed using the Cochrane risk of bias tool. Primary outcome was all-cause mortality. Aggregate data were synthesised with meta-analyses and TSA, and the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO: CRD42023386960. Findings: Fifteen trials randomising 4352 patients were included, of which 13 were assessed high risk of bias. Meta-analyses comparing lighter to deeper sedation showed no evidence of a difference in all-cause mortality (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.83–1.06; p = 0.28; 15 trials; moderate certainty evidence), serious adverse events (RR 0.99, CI 0.92–1.06; p = 0.80; 15 trials; moderate certainty evidence), or delirium (RR 1.01, 95% CI 0.94–1.09; p = 0.78; 11 trials; moderate certainty evidence). TSA showed that when assessing mortality, a relative risk reduction of 16% or more between the compared interventions could be rejected. Interpretation: The level of sedation has not been shown to affect the risks of death, delirium, and other serious adverse events in critically ill adult patients. While TSA suggests that additional trials are unlikely to significantly change the conclusion of the meta-analyses, the certainty of evidence was moderate. This suggests a need for future high-quality studies with higher methodological rigor. Funding: None.
23.	Christiansen, CF, et al. (författare) Chronic immune thrombocytopenia in Denmark, Sweden and Norway: The Nordic Country Patient Registry for Romiplostim 2019 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 14, s. 80-87 Tidskriftsartikel (refereegranskat)
24.	Clemens, J, et al. (författare) Evaluation of protection by COVID-19 vaccines after deployment in low and lower-middle income countries 2022 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 43, s. 101253- Tidskriftsartikel (refereegranskat)
25.	Cornillet, M, et al. (författare) The Swedish initiative for the study of Primary sclerosing cholangitis (SUPRIM) 2024 Ingår i: EClinicalMedicine. - 2589-5370. ; 70, s. 102526- Tidskriftsartikel (refereegranskat)
26.	Cornillet, Martin, et al. (författare) The Swedish initiative for the study of Primary sclerosing cholangitis (SUPRIM) 2024 Ingår i: eClinicalMedicine. - : ELSEVIER. - 2589-5370. ; 70 Tidskriftsartikel (refereegranskat)abstract Background Despite more than 50 years of research and parallel improvements in hepatology and oncology, there is still today neither a treatment to prevent disease progression in primary sclerosing cholangitis (PSC), nor reliable early diagnostic tools for the associated hepatobiliary cancers. Importantly, the limited understanding of the underlying biological mechanisms in PSC and its natural history not only affects the identification of new drug targets but implies a lack of surrogate markers that hampers the design of clinical trials and the evaluation of drug efficacy. The lack of easy access to large representative well -characterised prospective resources is an important contributing factor to the current situation. Methods We here present the SUPRIM cohort, a national multicentre prospective longitudinal study of unselected PSC patients capturing the representative diversity of PSC phenotypes. We describe the 10 -year effort of inclusion and follow-up, an intermediate analysis report including original results, and the associated research resource. All included patients gave written informed consent (recruitment: November 2011-April 2016). Findings Out of 512 included patients, 452 patients completed the five-year follow-up without endpoint outcomes. Liver transplantation was performed in 54 patients (10%) and hepatobiliary malignancy was diagnosed in 15 patients (3%). We draw a comprehensive landscape of the multidimensional clinical and biological heterogeneity of PSC illustrating the diversity of PSC phenotypes. Performances of available predictive scores are compared and perspectives on the continuation of the SUPRIM cohort are provided. Interpretation We envision the SUPRIM cohort as an open -access collaborative resource to accelerate the generation of new knowledge and independent validations of promising ones with the aim to uncover reliable diagnostics, prognostic tools, surrogate markers, and new treatment targets by 2040. Funding This work was supported by the Swedish Cancer Society, Stockholm County Council, and the Cancer Research Funds of Radiumhemmet. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
27.	Cornillet, Martin, et al. (författare) The Swedish initiative for the study of Primary sclerosing cholangitis (SUPRIM) 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 70 Tidskriftsartikel (refereegranskat)abstract BackgroundDespite more than 50 years of research and parallel improvements in hepatology and oncology, there is still today neither a treatment to prevent disease progression in primary sclerosing cholangitis (PSC), nor reliable early diagnostic tools for the associated hepatobiliary cancers. Importantly, the limited understanding of the underlying biological mechanisms in PSC and its natural history not only affects the identification of new drug targets but implies a lack of surrogate markers that hampers the design of clinical trials and the evaluation of drug efficacy. The lack of easy access to large representative well-characterised prospective resources is an important contributing factor to the current situation.MethodsWe here present the SUPRIM cohort, a national multicentre prospective longitudinal study of unselected PSC patients capturing the representative diversity of PSC phenotypes. We describe the 10-year effort of inclusion and follow-up, an intermediate analysis report including original results, and the associated research resource. All included patients gave written informed consent (recruitment: November 2011–April 2016).FindingsOut of 512 included patients, 452 patients completed the five-year follow-up without endpoint outcomes. Liver transplantation was performed in 54 patients (10%) and hepatobiliary malignancy was diagnosed in 15 patients (3%). We draw a comprehensive landscape of the multidimensional clinical and biological heterogeneity of PSC illustrating the diversity of PSC phenotypes. Performances of available predictive scores are compared and perspectives on the continuation of the SUPRIM cohort are provided.InterpretationWe envision the SUPRIM cohort as an open-access collaborative resource to accelerate the generation of new knowledge and independent validations of promising ones with the aim to uncover reliable diagnostics, prognostic tools, surrogate markers, and new treatment targets by 2040.
28.	Darmstadt, GL, et al. (författare) New World Health Organization recommendations for care of preterm or low birth weight infants: health policy 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 63, s. 102155- Tidskriftsartikel (refereegranskat)
29.	Darmstadt, GL, et al. (författare) Research priorities for care of preterm or low birth weight infants: health policy 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 63, s. 102126- Tidskriftsartikel (refereegranskat)
30.	Divanoglou, Anestis, et al. (författare) Rehabilitation needs and mortality associated with the Covid-19 pandemic : a population-based study of all hospitalised and home-healthcare individuals in a Swedish healthcare region 2021 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 36 Tidskriftsartikel (refereegranskat)abstract Background: This first report of the Linkoping Covid-19 Study (LinCoS) aimed at determination of Covid-19-associated mortality, impairments, activity and participation limitations denoting rehabilitation needs four months after discharge from hospital. Methods: An ambidirectional population-based cohort study including all confirmed Covid-19 cases admitted to hospital during 1/03-31/05 and those living in home healthcare settings identified through a regional registry and evaluated through medical records, including WHO Clinical Progression Scale (CPS). All patients discharged from hospital were followed-up by structured telephone interview at 4 months post-discharge. Respondents indicated any new or aggravated persisting problems in any of 25 body functions and 12 activity/participation items and rated them for impact on daily life. Findings: Out of 734 hospitalised patients, 149 were excluded, 125 died, and 460 were alive at 4-month follow-up of whom 433 (94.1%) were interviewed. In total, 40% reported impairments and activity/participation limitations affecting daily life and warranted further multi-professional rehabilitation assessment, predominantly those with severe disease and a considerable proportion of those with moderate disease. Cognitive and affective impairments were equally common in all groups and were reported by 20-40% of cases. Limb weakness was reported by 31%, with CPS 7-9 being four times more likely to report this problem as compared to CPS 4-5. 26% of those working or studying reported difficulties returning to these activities, this being 3.5 times more likely in CPS 7-9 as compared to CPS 4-5. 25% reported problems walking >1 km, with CPS 7-9 over three times more likely to report this as compared to the other two sub-groups. 90-day mortality rate of Covid-19 associated deaths was 15.1%. Interpretation: Most rehabilitation needs after Covid-19 involved higher cerebral dysfunction both in patients with moderate and severe disease. This should be considered when designing services aiming at minimizing long-term disability. (C) 2021 The Author(s). Published by Elsevier Ltd.
31.	El-Khatib, Z, et al. (författare) The disproportionate effect of COVID-19 mortality on ethnic minorities: Genetics or health inequalities? 2020 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 23, s. 100430- Tidskriftsartikel (refereegranskat)
32.	Enlund, Mats, et al. (författare) Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane 2023 Ingår i: EClinicalMedicine. - : Elsevier. - 2589-5370. ; 60 Tidskriftsartikel (refereegranskat)abstract Background Anaesthesia may impact long-term cancer survival. In the Cancer and Anaesthesia study, we hypothesised that the hypnotic drug propofol will have an advantage of at least five percentage points in five-year survival over the inhalational anaesthetic sevoflurane for breast cancer surgery. Methods From 2118 eligible breast cancer patients scheduled for primary curable, invasive breast cancer surgery, 1764 were recruited after ethical approval and individual informed consent to this open label, single-blind, randomised trial at four county- and three university hospitals in Sweden and one Chinese university hospital. Of surveyed patients, 354 were excluded, mainly due to refusal to participate. Patients were randomised by computer at the monitoring organisation to general anaesthesia maintenance with either intravenous propofol or inhaled sevoflurane in a 1:1 ratio in permuted blocks. Data related to anaesthesia, surgery, oncology, and demographics were registered. The primary endpoint was five-year overall survival. Data are presented as Kaplan-Meier survival curves and Hazard Ratios based on Cox univariable regression analyses by both intention-to-treat and perprotocol. EudraCT, 2013-002380-25 and ClinicalTrials.gov, NCT01975064. Findings Of 1764 patients, included from December 3, 2013, to September 29, 2017, 1670 remained for analysis. The numbers who survived at least five years were 773/841 (91.9% (95% CI 90.1-93.8)) in the propofol group and 764/829 (92.2% (90.3-94.0)) in the sevoflurane group, (HR 1.03 (0.73-1.44); P = 0.875); the corresponding results in the per-protocol-analysis were: 733/798 (91.9% (90.0-93.8)) and 653/710 (92.0% (90.0-94.0)) (HR = 1.01 (0.71-1.44); P = 0.955). Survival after a median follow-up of 76.7 months did not indicate any difference between the groups (HR 0.97, 0.72-1.29; P = 0.829, log rank test). Interpretation No difference in overall survival was found between general anaesthesia with propofol or sevoflurane for breast cancer surgery. Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.
33.	Falconer, Henrik, et al. (författare) Oncologic outcomes after Total Mesometrial Resection (TMMR) or treatment according to current international guidelines in FIGO (2009) stages IB1-IIB cervical cancer : an observational cohort study. 2024 Ingår i: eClinicalMedicine. - 2589-5370. ; 73, s. 102696- Tidskriftsartikel (refereegranskat)abstract BACKGROUND: According to international guidelines, standard treatment (ST) with curative intent in cervical cancer (CC) comprises radical hysterectomy and pelvic lymphadenectomy in early stages (International Federation of Gynecology and Obstetrics (FIGO) 2009 IB1, IIA1), adjuvant chemoradiation is recommended based on risk factors upon final pathology. Definitive chemoradiation is recommended in locally advanced stages (FIGO 2009 IB2, IIA2, IIB). Total mesometrial resection (TMMR) with therapeutic lymph node dissection (tLND) without adjuvant radiation has emerged as a promising treatment. Here we compare oncologic outcome by TMMR + tLND or ST.METHODS: In this observational cohort study, women treated according to international guidelines were identified in the population-based registries from Sweden and women treated with TMMR were identified in the Leipzig Mesometrial Resection (MMR) Study Database (DRKS 0001517) 2011-2020. Relevant clinical and tumour related variables were extracted. Recurrence-free survival (RFS) and overall survival (OS) by ST or TMMR was analysed with log-rank test, cumulative incidence function and proportional hazard regression yielding hazard ratios (HR) with 95% confidence intervals (CI), adjusted for relevant confounders.FINDINGS: Between 2011 and 2020, 1007 women were included in the final analysis. 733 women were treated according to ST and 274 with TMMR. RFS at five years was 77.9% (95% CI 74.3-81.1) and 82.6% (95% CI 77.2-86.9) for the ST and TMMR cohorts respectively (p = 0.053). In early-stage CC, RFS was higher after TMMR as compared to ST, 91.2% vs 81.8% (p = 0.002). In the adjusted analysis, TMMR was associated with a lower hazard of recurrence (HR 0.39; 95% CI 0.22-0.69) and death (HR 0.42; 95% CI 0.21-0.86) compared to ST. The absolute difference in risk of recurrence at 5 years was 9.4% (95% CI 3.2-15.7) in favor of TMMR. In locally advanced CC, no significant differences in RFS or OS was observed.INTERPRETATION: Compared to ST, TMMR without radiation therapy was associated with superior oncologic outcomes in women with early-stage cervical cancer whereas no difference was observed in locally advanced disease. Our findings together with previous evidence suggest that TMMR may be considered the primary option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment.FUNDING: This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden).
34.	Fields, JC, et al. (författare) Risk of postpartum readmission for depression in relation to ischaemic placental disease: a population-based study 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 60, s. 102011- Tidskriftsartikel (refereegranskat)
35.	Files, DC (författare) Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial 2023 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 58, s. 101889- Tidskriftsartikel (refereegranskat)
36.	Greco, Raffaella, et al. (författare) Innovative cellular therapies for autoimmune diseases : expert-based position statement and clinical practice recommendations from the EBMT practice harmonization and guidelines committee 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 69 Tidskriftsartikel (refereegranskat)abstract Autoimmune diseases (ADs) are characterized by loss of immune tolerance, high chronicity, with substantial morbidity and mortality, despite conventional immunosuppression (IS) or targeted disease modifying therapies (DMTs), which usually require repeated administration. Recently, novel cellular therapies (CT), including mesenchymal stromal cells (MSC), Chimeric Antigen Receptors T cells (CART) and regulatory T cells (Tregs), have been successfully adopted in ADs. An international expert panel of the European Society for Blood and Marrow Transplantation and the International Society for the Cell and Gene Therapy, reviewed all available evidence, based on the current literature and expert practices, on use of MSC, CART and Tregs, in AD patients with rheumatological, neurological, and gastroenterological indications. Expert -based consensus and recommendations for best practice and quality of patient care were developed to support clinicians, scientists, and their multidisciplinary teams, as well as patients and care providers and will be regularly updated. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
37.	Gunst, Jesper D., et al. (författare) Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial 2021 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 35 Tidskriftsartikel (refereegranskat)abstract Background: The trans-membrane protease serine 2 (TMPRSS2) is essential for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cell entry and infection. Efficacy and safety of TMPRSS2 inhibitors in patients with coronavirus disease 2019 (Covid-19) have not been evaluated in randomized trials.Methods: We conducted an investigator-initiated, double-blind, randomized, placebo-controlled multicenter trial in patients hospitalized with confirmed SARS-CoV-2 infection from April 4, to December 31, 2020. Within 48 h of admission, participants were randomly assigned in a 2:1 ratio to receive the TMPRSS2 inhibitor camostat mesilate 200 mg three times daily for 5 days or placebo. The primary outcome was time to discharge or clinical improvement measured as ≥2 points improvement on a 7-point ordinal scale. Other outcomes included 30-day mortality, safety and change in oropharyngeal viral load. ClinicalTrials.gov Identifier: NCT04321096. EudraCT Number: 2020-001,200-42.Findings: 137 patients were assigned to receive camostat mesilate and 68 to placebo. Median time to clinical improvement was 5 days (interquartile range [IQR], 3 to 7) in the camostat group and 5 days (IQR, 2 to 10) in the placebo group (P = 0·31). The hazard ratio for 30-day mortality in the camostat compared with the placebo group was 0·82 (95% confidence interval [CI], 0·24 to 2·79; P = 0·75). The frequency of adverse events was similar in the two groups. Median change in viral load from baseline to day 5 in the camostat group was -0·22 log10 copies/mL (p <0·05) and -0·82 log10 in the placebo group (P <0·05).Interpretation: Under this protocol, camostat mesilate treatment was not associated with increased adverse events during hospitalization for Covid-19 and did not affect time to clinical improvement, progression to ICU admission or mortality.
38.	Gupta, S, et al. (författare) Following the path: Increasing trends of HIV-1 drug resistance in China 2020 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 18, s. 100251- Tidskriftsartikel (refereegranskat)
39.	Hahn, Jong Woo, et al. (författare) Global incidence and prevalence of autoimmune hepatitis, 1970-2022: a systematic review and meta-analysis 2023 Ingår i: eClinicalMedicine. - : ELSEVIER. - 2589-5370. ; 65 Forskningsöversikt (refereegranskat)abstract Background Autoimmune hepatitis (AIH) varies significantly in incidence and prevalence across countries and regions. We aimed to examine global, regional, and national trends in incidence and prevalence of AIH from 1970 to 2022.Methods We conducted a thorough search of the PubMed/MEDLINE, Embase, CINAHL, Google Scholar, and Cochrane databases from database inception to August 9, 2023, using the search term "autoimmune hepatitis" in combination with "incidence," "prevalence," or "trend." Only general population-based observational studies with larger samples sizes were considered for inclusion. Studies that recruited convenience samples, and those with fewer than 50 participants were excluded. Summary data were extracted from published reports. A random effects model was used and pooled estimates with 95% CI were used to calculate the incidence and prevalence of AIH. Heterogeneity was evaluated using the I-2 statistic. The study protocol was registered with PROSPERO, CRD42023430138. Findings A total of 37 eligible studies, encompassing more than 239 million participants and 55,839 patients with AIH from 18 countries across five continents, were included in the analysis. Global pooled incidence and prevalence of AIH were found to be 1.28 cases per 100,000 inhabitant-years (95% CI, 1.01-1.63, I-2 = 99<middle dot>51%; number of studies, 33; sample population, 220,673,674) and 15.65 cases per 100,000 inhabitants (95% CI, 13.42-18.24, I-2 = 99<middle dot>75%; number of studies, 26; sample population, 217,178,684), respectively. The incidence of AIH was greater in countries with high Human Development Index (>0.92), in North America and Oceania (compared with Asia), among females, adults (compared with children), and high latitude (>45 degrees). Similar patterns in AIH prevalence were observed. Pooled AIH prevalence increased gradually from 1970 to 2019 (1970-1999; 9.95 [4.77-15.13], I-2 = 95<middle dot>58% versus 2015-2022; 27.91 [24.86-30.96], I-2 = 99<middle dot>32%; cases per 100,000 inhabitants). The overall incidence and prevalence of AIH, as well as some subgroup analyses of the studies, displayed asymmetry in the funnel plots, suggesting potential evidence of publication bias.Interpretation AIH incidence and prevalence have increased significantly and exhibit substantial variation across regions worldwide. Further research is required to assess the incidence and prevalence of AIH, specifically in South America and Africa.
40.	Haque, Mohammad M., et al. (författare) Cost-effectiveness of diagnosis and treatment of early gestational diabetes mellitus : economic evaluation of the TOBOGM study, an international multicenter randomized controlled trial 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 71 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: A recently undertaken multicenter randomized controlled trial (RCT) "Treatment Of BOoking Gestational diabetes Mellitus" (TOBOGM: 2017-2022) found that the diagnosis and treatment of pregnant women with early gestational diabetes mellitus (GDM) improved pregnancy outcomes. Based on data from the trial, this study aimed to assess the cost-effectiveness of diagnosis and treatment of early GDM (from <20 weeks') among women with risk factors for hyperglycemia in pregnancy compared with usual care (no treatment until 24-28 weeks') from a healthcare perspective.METHODS: Participants' healthcare resource utilization data were collected from their self-reported questionnaires and hospital records, and valued using the unit costs obtained from standard Australian national sources. Costs were reported in US dollars ($) using the purchasing power parity (PPP) estimates to facilitate comparison of costs across countries. Intention-to-treat (ITT) principle was followed. Missing cost data were replaced using multiple imputations. Bootstrapping method was used to estimate the uncertainty around mean cost difference and cost-effectiveness results. Bootstrapped cost-effect pairs were used to plot the cost-effectiveness (CE) plane and cost-effectiveness acceptability curve (CEAC).FINDINGS: Diagnosis and treatment of early GDM was more effective and tended to be less costly, i.e., dominant (cost-saving) [-5.6% composite adverse pregnancy outcome (95% CI: -10.1%, -1.2%), -$1373 (95% CI: -$3,749, $642)] compared with usual care. Our findings were confirmed by both the CE plane (88% of the bootstrapped cost-effect pairs fall in the south-west quadrant), and CEAC (the probability of the intervention being cost-effective ranged from 84% at a willingness-to-pay (WTP) threshold value of $10,000-99% at a WTP threshold value of $100,000 per composite adverse pregnancy outcome prevented). Sub-group analyses demonstrated that diagnosis and treatment of early GDM among women in the higher glycemic range (fasting blood glucose 95-109 mg/dl [5.3-6.0 mmol/L], 1-h blood glucose ≥191 mg/dl [10.6 mmol/L] and/or 2-h blood glucose 162-199 mg/dl [9.0-11.0 mmol/L]) was more effective and less costly (dominant) [-7.8% composite adverse pregnancy outcome (95% CI: -14.6%, -0.9%), -$2795 (95% CI: -$6,638, -$533)]; the intervention was more effective and tended to be less costly [-8.9% composite adverse pregnancy outcome (95% CI: -15.1%, -2.6%), -$5548 (95% CI: -$16,740, $1547)] among women diagnosed before 14 weeks' gestation as well. INTERPRETATION: Our findings highlight the potential health and economic benefits from the diagnosis and treatment of early GDM among women with risk factors for hyperglycemia in pregnancy and supports its implementation. Long-term follow-up studies are recommended as a key future area of research to assess the potential long-term health benefits and economic consequences of the intervention.
41.	Hintermeier, Maren, et al. (författare) COVID-19 among migrants, refugees, and internally displaced persons : systematic review, meta-analysis and qualitative synthesis of the global empirical literature 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. Tidskriftsartikel (refereegranskat)abstract Background: Evidence amounted early that migrants, who are often side-lined in pandemic response or preparedness plans, are disproportionately affected by the COVID-19 pandemic and its consequences. However, synthesised evidence that quantifies the magnitude of inequalities in infection risk, disease outcomes, consequences of pandemic measures or that explains the underlying mechanisms is lacking.Methods: We conducted a systematic review searching 25 databases and grey literature (12/2019 to 09/2023) and considered empirical articles covering migrants, refugees, asylum-seekers, and internally displaced persons reporting COVID-19 cases, hospitalisation, ICU admission, mortality, COVID-19 vaccination rates or health consequences of pandemic measures. Random-effects meta-analysis of observational studies and qualitative analysis were performed for evidence synthesis. A protocol was registered with PROSPERO (CRD42021296952).Findings: Out of 17,088 records, we included 370 reports in the review. For the quantitative studies (n = 65; mainly from high income countries), meta-analysis with over 53 million participants studied showed that, compared to non-migrants, migrants have an elevated risk of infection (RR = 1.84; 95%-CI: 1.44–2.35) but similar risk for hospitalisation (RR = 1.10; 0.91–1.33), while the probability of ICU admission was higher (RR = 1.23; 0.99–1.52). Among those hospitalised, migrants had a lower risk of mortality (RR = 0.56; 0.42–0.76), while their population-based mortality tended to be higher (RR = 1.46; 0.95–2.26). The qualitative synthesis (n = 75) highlighted the complex interplay of social and COVID-19-related factors at different levels. This involved increased exposure, risk, and impact of pandemic measures that compromised the health of migrants.Interpretation: Even in the advanced stages of the pandemic, migrants faced higher infection risks and disproportionately suffered from the consequences of COVID-19 disease, including deaths. Population-level interventions in future health emergencies must better consider socio-economic, structural and community-level exposures to mitigate risks among migrants. Enhancing health information systems is crucial, as the lack of migration variables makes it difficult to close coverage gaps, leaving migrants largely ‘invisible’ in official data.
42.	Hjern, Anders, et al. (författare) Increased risk of suicidal behaviour in non-European international adoptees decreases with age - A Swedish national cohort study 2020 Ingår i: eClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 29-30 Tidskriftsartikel (refereegranskat)abstract Background: Non-European international adoptees in Sweden were shown to have a three-to fourfold higher risk of suicidal behaviour in youth during 1986-1995 compared with the general population. The aim of this study was to investigate whether this high risk persists beyond youth and in later cohorts.Methods: A register study of Swedish national cohorts born 1972-86 including 20 625 non-European international adoptees, and comparison populations of 10 915 non-European immigrants and 1 435 167 Swedish born was performed. The study population was followed from age 18 between 1991 and 2016, with suicide and hospital admissions due to suicide attempt as outcomes. Poisson regression models of person time in the study, adjusted for gender and household income at age 17, were fitted to calculate relative risks (RR).Findings: Adjusted RR for suicide in non-European international adoptees was high at age 18-22, 2.74 (95% C. I. 1.95-3.86), but decreased gradually to age 33-43 when the risk was similar to Swedish-born. Adjusted RR for suicide attempts in international adoptees was 2.33 (2.15-2.52) at age 18-22, decreased slightly with older age, but remained higher than Swedish born in all age-classes. Risks for both outcomes were greatest, around three times higher compared with the Swedish-born in the oldest birth cohorts of non-European international adoptees, born 1972-76. Risks for both suicidal outcomes increased with higher age at adoption.Interpretation: The risk of suicidal behaviour in non-European international adoptees in Sweden decreases with age and is lower in later birth cohorts and in infant adoptions.
43.	Houssami, Nehmat, et al. (författare) Interval breast cancer rates for digital breast tomosynthesis versus digital mammography population screening : An individual participant data meta-analysis 2021 Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 34 Tidskriftsartikel (refereegranskat)abstract Background: Digital breast tomosynthesis (DBT) improves breast cancer (BC) detection compared to mammography, however, it is unknown whether this reduces interval cancer rate (ICR) at follow-up. Methods: Using individual participant data (IPD) from DBT screening studies (identified via periodic literature searches July 2016 to November 2019) we performed an IPD meta-analysis. We estimated ICR for DBT-screened participants and the difference in pooled ICR for DBT and mammography-only screening, and compared interval BC characteristics. Two-stage meta-analysis (study-specific estimation, pooled synthesis) of ICR included random-effects, adjusting for study and age, and was estimated in age and density subgroups. Comparative screening sensitivity was calculated using screen-detected and interval BC data. Findings: Four prospective DBT studies, from European population-based programs, contributed IPD for 66,451 DBT-screened participants: age-adjusted pooled ICR was 13.17/10,000 (95%CI: 8.25–21.02). Pooled ICR was higher in the high-density (21.08/10,000; 95%CI: 6.71–66.27) than the low-density (8.63/10,000; 95%CI: 5.25–14.192) groups (P = 0.03) however estimates did not differ across age-groups (P = 0.32). Based on two studies that also provided data for 153,800 mammography screens (age-adjusted ICR 17.69/10,000; 95%CI: 13.22–23.66), DBT's pooled ICR was 16.83/10,000 (95%CI: 11.89–23.82). Comparative meta-analysis showed a non-significant difference in ICR (-0.44/10,000; 95%CI: -11.00–10.11) and non-significant difference in screening sensitivity (6.79%; 95%CI: -0.73–14.87%) between DBT and DM but a significant pooled difference in cancer detection rate of 33.49/10,000 (95%CI: 23.88–43.10). Distribution of interval BC prognostic characteristics did not differ between screening modalities except that those occurring in DBT-screened participants were significantly more likely to be negative for axillary-node metastases (P = 0.005). Interpretation: Although heterogeneity in ICR estimates and few datasets limit recommendations, there was no difference between DBT and mammography in pooled ICR despite DBT increasing cancer detection.
44.	Jayawickrama, Ravisha S, et al. (författare) Explicit and implicit weight bias among health care students : a cross-sectional study of 39 Australian universities. 2023 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 58 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Weight bias exhibited by health care students may continue into their future practice, compromising the provision of care that people living with overweight or obesity receive. This highlights the need to comprehensively examine the extent to which weight bias is present among health care students and the factors that may be associated with students' weight bias.METHODS: In this cross-sectional study, Australian university students enrolled in health care courses were invited via social media advertisements, snowball and convenience sampling, and by making direct contact with universities to complete an online survey. Students provided demographic information including discipline of study, perceived weight status, and state of residence. Students then completed several measures which assessed their explicit and implicit weight bias, and empathy. Descriptive statistics established the presence of explicit and implicit weight bias, and ANCOVAs, ANOVA, and multiple regression analyses were conducted to examine the potential factors associated with students' exhibited weight bias.FINDINGS: Between March 08, 2022, and March 15, 2022, 900 eligible health care students attending 39 Australian universities participated in the study. Students reported varying levels of explicit and implicit weight bias, with minimal differences between disciplines on most outcome measures. Students who identified as men (vs. women) exhibited higher of both explicit and implicit bias (Beliefs About Obese Persons (BAOP): p = 0.0002, Antifat Attitudes Questionnaire (AFA)-Dislike: p = 0.019, AFA Willpower p < 0.0001, Empathy for Obese Patients: p = 0.0011, Implicit Association Test: p = 0.022), and students who displayed greater (vs. less) empathic concern exhibited lower levels of explicit bias (BAOP, AFA Dislike and Willpower, and Empathy for Obese Patients: p < 0.0001). Having witnessed the enactment of weight stigma sporadically (vs. regularly) by role models was associated with greater attribution of the causes of obesity to willpower (a few times a month vs. daily: p = 0.020, a few times a year vs. daily: p = 0.022), and less time spent with people living with overweight or obesity outside of study was associated with more dislike (a few times a month vs. daily: p = 0.0048, once a month vs. daily: p = 0.0002) and less fear of fat (once a month vs. daily: p = 0.036, and once a month vs. a few times a week: p = 0.0028).INTERPRETATION: Results demonstrate the presence of both explicit and implicit weight bias among Australian health care students. Several characteristics and experiences of students were associated with their weight bias. Validity of the exhibited weight bias should be established in practical interactions with people living with overweight or obesity and novel interventions should be developed to ameliorate weight bias.FUNDING: Research Training Program (RTP) Scholarship, Australian Government, Department of Education.
45.	Jensen, Georg Bach, et al. (författare) Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk : a randomised controlled trial 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 68 Tidskriftsartikel (refereegranskat)abstract Background: Mortality and severe morbidity remain high in extremely preterm infants. Human milk-based nutrient fortifiers may prevent serious complications and death. We aimed to investigate whether supplementation with human milk-based fortifier (HMBF), as compared to bovine milk-based fortifier (BMBF), reduced the incidence of the composite outcome of necrotising enterocolitis (NEC), sepsis, and mortality in extremely preterm infants exclusively fed human milk.Methods: In this multicentre, randomised controlled trial at 24 neonatal units in Sweden, extremely preterm infants born between gestational week 22 + 0 and 27 + 6 fed exclusively human breast milk (mother's own and/or donor milk), were randomly assigned (1:1) to receive targeted fortification with either HMBF or BMBF. Randomisation was conducted before the enteral feeds reached 100 mL/kg/day, and was stratified by enrolment site, gestational age, singleton/twin, and sex. The allocation was concealed before inclusion, but after randomisation the study was not blinded for the clinical staff. For the NEC diagnosis, the study group was masked to an independent radiologist, and the final assessment of NEC and culture-proven sepsis was done by a blinded consensus panel review. The primary outcome was the composite of NEC stage II–III, culture-proven sepsis, and mortality from inclusion to discharge, no longer than postmenstrual week 44 + 0, in the intention-to-treat population (ClinicalTrials.gov, NCT03797157).Findings: Between February 21st, 2019, and May 21st, 2021, 229 neonates were randomly assigned (115 HMBF, 114 BMBF). After exclusion of one infant due to parents’ withdrawal of consent, 228 infants were included in the intention-to-treat analysis. Of the 115 infants assigned to HMBF, 41 (35.7%) fulfilled the criteria of either NEC, sepsis, or death, compared with 39 (34.5%) of 113 infants assigned to BMBF (OR 1.05, 95% CI 0.61–1.81, p = 0.86). Adverse events did not differ significantly between groups.Interpretation: Supplementation with HMBF, as compared with BMBF, did not reduce the incidence of the composite outcome of NEC, sepsis, or death. Our results do not support routine supplementation with HMBF as a nutritional strategy to prevent NEC, sepsis, or death in extremely preterm infants exclusively fed human milk. Funding: ALF grant, Prolacta Bioscience, Swedish Research Council, and Research Council for Southeast Sweden.
46.	Jensen, Georg Bach, et al. (författare) Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk : a randomised controlled trial 2024 Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 68 Tidskriftsartikel (refereegranskat)abstract BackgroundMortality and severe morbidity remain high in extremely preterm infants. Human milk-based nutrient fortifiers may prevent serious complications and death. We aimed to investigate whether supplementation with human milk-based fortifier (HMBF), as compared to bovine milk-based fortifier (BMBF), reduced the incidence of the composite outcome of necrotising enterocolitis (NEC), sepsis, and mortality in extremely preterm infants exclusively fed human milk.MethodsIn this multicentre, randomised controlled trial at 24 neonatal units in Sweden, extremely preterm infants born between gestational week 22 + 0 and 27 + 6 fed exclusively human breast milk (mother's own and/or donor milk), were randomly assigned (1:1) to receive targeted fortification with either HMBF or BMBF. Randomisation was conducted before the enteral feeds reached 100 mL/kg/day, and was stratified by enrolment site, gestational age, singleton/twin, and sex. The allocation was concealed before inclusion, but after randomisation the study was not blinded for the clinical staff. For the NEC diagnosis, the study group was masked to an independent radiologist, and the final assessment of NEC and culture-proven sepsis was done by a blinded consensus panel review. The primary outcome was the composite of NEC stage II–III, culture-proven sepsis, and mortality from inclusion to discharge, no longer than postmenstrual week 44 + 0, in the intention-to-treat population (ClinicalTrials.gov, NCT03797157).FindingsBetween February 21st, 2019, and May 21st, 2021, 229 neonates were randomly assigned (115 HMBF, 114 BMBF). After exclusion of one infant due to parents’ withdrawal of consent, 228 infants were included in the intention-to-treat analysis. Of the 115 infants assigned to HMBF, 41 (35.7%) fulfilled the criteria of either NEC, sepsis, or death, compared with 39 (34.5%) of 113 infants assigned to BMBF (OR 1.05, 95% CI 0.61–1.81, p = 0.86). Adverse events did not differ significantly between groups.InterpretationSupplementation with HMBF, as compared with BMBF, did not reduce the incidence of the composite outcome of NEC, sepsis, or death. Our results do not support routine supplementation with HMBF as a nutritional strategy to prevent NEC, sepsis, or death in extremely preterm infants exclusively fed human milk.
47.	Jensen, Georg Bach, et al. (författare) Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial 2024 Ingår i: ECLINICALMEDICINE. - : Elsevier. - 2589-5370. ; 68 Tidskriftsartikel (refereegranskat)abstract Background Mortality and severe morbidity remain high in extremely preterm infants. Human milk -based nutrient fortifiers may prevent serious complications and death. We aimed to investigate whether supplementation with human milk -based fortifier (HMBF), as compared to bovine milk -based fortifier (BMBF), reduced the incidence of the composite outcome of necrotising enterocolitis (NEC), sepsis, and mortality in extremely preterm infants exclusively fed human milk. Methods In this multicentre, randomised controlled trial at 24 neonatal units in Sweden, extremely preterm infants born between gestational week 22 + 0 and 27 + 6 fed exclusively human breast milk (mother's own and/or donor milk), were randomly assigned (1:1) to receive targeted fortification with either HMBF or BMBF. Randomisation was conducted before the enteral feeds reached 100 mL/kg/day, and was stratified by enrolment site, gestational age, singleton/twin, and sex. The allocation was concealed before inclusion, but after randomisation the study was not blinded for the clinical staff. For the NEC diagnosis, the study group was masked to an independent radiologist, and the final assessment of NEC and culture -proven sepsis was done by a blinded consensus panel review. The primary outcome was the composite of NEC stage II-III, culture -proven sepsis, and mortality from inclusion to discharge, no longer than postmenstrual week 44 + 0, in the intention -to -treat population (ClinicalTrials.gov, NCT03797157). Findings Between February 21st, 2019, and May 21st, 2021, 229 neonates were randomly assigned (115 HMBF, 114 BMBF). After exclusion of one infant due to parents' withdrawal of consent, 228 infants were included in the intention -to -treat analysis. Of the 115 infants assigned to HMBF, 41 (35.7%) fulfilled the criteria of either NEC, sepsis, or death, compared with 39 (34.5%) of 113 infants assigned to BMBF (OR 1.05, 95% CI 0.61-1.81, p = 0.86). Adverse events did not differ significantly between groups. Interpretation Supplementation with HMBF, as compared with BMBF, did not reduce the incidence of the composite outcome of NEC, sepsis, or death. Our results do not support routine supplementation with HMBF as a nutritional strategy to prevent NEC, sepsis, or death in extremely preterm infants exclusively fed human milk. Copyright (c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
48.	Järvholm, Kajsa, et al. (författare) Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial 2024 Ingår i: eClinicalMedicine. - : ELSEVIER. - 2589-5370. ; 70 Tidskriftsartikel (refereegranskat)abstract Background Severe obesity during childhood is associated with cognitive deficits. Studies in adults have suggested improvements in executive functioning and memory after bariatric surgery. Our aim was to explore changes in cognitive function in adolescents over two years after bariatric surgery or intensive non-surgical treatment. Methods The Adolescent Morbid Obesity Surgery 2 (AMOS2) is a multicentre, open-label, randomised controlled trial in which adolescents (aged 13-16 years) with severe obesity (defined as body mass index (BMI) >= 35 kg/m(2)) at three specialised obesity centres in Sweden, were randomly assigned to receive bariatric surgery or intensive non-surgical treatment. Herein we report the results of the prespecified exploratory endpoint of change in cognitive functioning. Inclusion in AMOS2 required Tanner pubertal stage >= 3, previous participation in lifestyle obesity treatment for at least one year, and passed assessment form a paediatrician and a paediatric psychologist. Adolescents with severe intellectual disability or other severe, pervasive developmental disorder were excluded. Participants underwent baseline assessment of general intellectual ability, executive functioning, and memory before randomisation. Tests were administrated by clinical psychologists and repeated at one- and two-year follow-up timepoints. Differences in means between groups during follow-up are provided with confidence intervals. The trial is registered at ClinicalTrials.gov, NCT02378259. Findings Between October 28 2015 and June 7 2017, 46 adolescents (74% girls), with a mean age of 15.8 (+/- 0.92) years and a mean BMI of 42.8 (+/- 5.4) kg/m(2), were included and randomised (23 to bariatric surgery and 23 to intensive non-surgical treatment). At baseline 23/46 (50%) of the adolescents had general intellectual functioning classified as borderline or below. For 15/18 (83%) aspects of cognitive functioning, no significant differences in change over two years were identified between groups; Immediate (average difference during follow-up 1.0 [95% CI: -2.6 to 4.6]) and Delayed (0.5 [95% CI: -0.6 to 1.6]) Verbal Recall, Category Fluency (1.1 [95% CI: -1.6 to 3.8]) and Switching (1.5 [95% CI: -0.0 to 2.9]), Number (-6.0 [95% CI: -12.3 to 0.3]) and Letter (0.1 [95% CI: -5.2 to 5.3]) Sequencing, Number-Letter Switching (-10.3 [95% CI: -26.4 to 5.8]), Motor Speed (-8.3 [95% CI: -17.5 to 0.9]), Colour Naming (-1.9 [95% CI: -4.2 to 0.3]), Inhibition (-3.6 [95% CI: -9.6 to 2.5]), Inhibition Switching (-6.7 [95% CI: -15.3 to 1.9]), Mazes (-0.5 [95% CI: -4.9 to 3.9]), Digit Span Forward (0.1 [95% CI: -0.6 to 0.9 ]) and Backward (0.6 [95% CI: -0.4 to 1.6 ]), and Estimated IQ (0.4 [95% CI: -3.9 to 4.8]; all p > 0.05). Three sub-tests assessing fundamental cognitive skills improved more over two years in operated adolescents than in intensive non-surgical treatment; Letter Fluency (average difference during follow-up 3.8 [95% CI: 0.1-7.5]; p = 0.046), Visual Scanning (-6.5 [95% CI: -11.6 to -1.5]; p = 0.011), and Word Reading (-1.9 [95% CI: -3.3 to -0.4]; p = 0.011). Interpretation In contrast to non-randomised studies in adults, we could not demonstrate an association of bariatric surgery and its accompanying significant weight loss with overall greater improvement in executive functions and memory in adolescents over two years compared with a non-surgical group without weight loss. However, lack of statistical power is a potential limitation. The clinical relevance of greater improvements in basic cognitive skills needs to be explored. Funding Sweden's innovation agency (VINNOVA), Swedish Research Council, Joanna Cocozza foundation for paediatric research, The Skane University Hospital Psychology Research and Development Grant, Tore Nilsson's Foundation, SUS Foundations and Donations, and Mary von Sydow's Foundation. (c) 2024 The Author(s). Published by Elsevier Ltd.
49.	Järvholm, Kajsa, et al. (författare) Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial 2024 Ingår i: ECLINICALMEDICINE. - : ELSEVIER. - 2589-5370. ; 70 Tidskriftsartikel (refereegranskat)abstract Background Severe obesity during childhood is associated with cognitive deficits. Studies in adults have suggested improvements in executive functioning and memory after bariatric surgery. Our aim was to explore changes in cognitive function in adolescents over two years after bariatric surgery or intensive non-surgical treatment. Methods The Adolescent Morbid Obesity Surgery 2 (AMOS2) is a multicentre, open-label, randomised controlled trial in which adolescents (aged 13-16 years) with severe obesity (defined as body mass index (BMI) >= 35 kg/m(2)) at three specialised obesity centres in Sweden, were randomly assigned to receive bariatric surgery or intensive non-surgical treatment. Herein we report the results of the prespecified exploratory endpoint of change in cognitive functioning. Inclusion in AMOS2 required Tanner pubertal stage >= 3, previous participation in lifestyle obesity treatment for at least one year, and passed assessment form a paediatrician and a paediatric psychologist. Adolescents with severe intellectual disability or other severe, pervasive developmental disorder were excluded. Participants underwent baseline assessment of general intellectual ability, executive functioning, and memory before randomisation. Tests were administrated by clinical psychologists and repeated at one- and two-year follow-up timepoints. Differences in means between groups during follow-up are provided with confidence intervals. The trial is registered at ClinicalTrials.gov, NCT02378259. Findings Between October 28 2015 and June 7 2017, 46 adolescents (74% girls), with a mean age of 15.8 (+/- 0.92) years and a mean BMI of 42.8 (+/- 5.4) kg/m(2), were included and randomised (23 to bariatric surgery and 23 to intensive non-surgical treatment). At baseline 23/46 (50%) of the adolescents had general intellectual functioning classified as borderline or below. For 15/18 (83%) aspects of cognitive functioning, no significant differences in change over two years were identified between groups; Immediate (average difference during follow-up 1.0 [95% CI: -2.6 to 4.6]) and Delayed (0.5 [95% CI: -0.6 to 1.6]) Verbal Recall, Category Fluency (1.1 [95% CI: -1.6 to 3.8]) and Switching (1.5 [95% CI: -0.0 to 2.9]), Number (-6.0 [95% CI: -12.3 to 0.3]) and Letter (0.1 [95% CI: -5.2 to 5.3]) Sequencing, Number-Letter Switching (-10.3 [95% CI: -26.4 to 5.8]), Motor Speed (-8.3 [95% CI: -17.5 to 0.9]), Colour Naming (-1.9 [95% CI: -4.2 to 0.3]), Inhibition (-3.6 [95% CI: -9.6 to 2.5]), Inhibition Switching (-6.7 [95% CI: -15.3 to 1.9]), Mazes (-0.5 [95% CI: -4.9 to 3.9]), Digit Span Forward (0.1 [95% CI: -0.6 to 0.9 ]) and Backward (0.6 [95% CI: -0.4 to 1.6 ]), and Estimated IQ (0.4 [95% CI: -3.9 to 4.8]; all p > 0.05). Three sub-tests assessing fundamental cognitive skills improved more over two years in operated adolescents than in intensive non-surgical treatment; Letter Fluency (average difference during follow-up 3.8 [95% CI: 0.1-7.5]; p = 0.046), Visual Scanning (-6.5 [95% CI: -11.6 to -1.5]; p = 0.011), and Word Reading (-1.9 [95% CI: -3.3 to -0.4]; p = 0.011). Interpretation In contrast to non-randomised studies in adults, we could not demonstrate an association of bariatric surgery and its accompanying significant weight loss with overall greater improvement in executive functions and memory in adolescents over two years compared with a non-surgical group without weight loss. However, lack of statistical power is a potential limitation. The clinical relevance of greater improvements in basic cognitive skills needs to be explored. Funding Sweden's innovation agency (VINNOVA), Swedish Research Council, Joanna Cocozza foundation for paediatric research, The Skane University Hospital Psychology Research and Development Grant, Tore Nilsson's Foundation, SUS Foundations and Donations, and Mary von Sydow's Foundation. (c) 2024 The Author(s). Published by Elsevier Ltd.
50.	Kaidar-Person, Orit, et al. (författare) The Lucerne Toolbox 2 to optimise axillary management for early breast cancer : a multidisciplinary expert consensus 2023 Ingår i: EClinicalMedicine. - 2589-5370. ; 61 Forskningsöversikt (refereegranskat)abstract Clinical axillary lymph node management in early breast cancer has evolved from being merely an aspect of surgical management and now includes the entire multidisciplinary team. The second edition of the “Lucerne Toolbox”, a multidisciplinary consortium of European cancer societies and patient representatives, addresses the challenges of clinical axillary lymph node management, from diagnosis to local therapy of the axilla. Five working packages were developed, following the patients’ journey and addressing specific clinical scenarios. Panellists voted on 72 statements, reaching consensus (agreement of 75% or more) in 52.8%, majority (51%–74% agreement) in 43.1%, and no decision in 4.2%. Based on the votes, targeted imaging and standardized pathology of lymph nodes should be a prerequisite to planning local and systemic therapy, axillary lymph node dissection can be replaced by sentinel lymph node biopsy ( ± targeted approaches) in a majority of scenarios; and positive patient outcomes should be driven by both low recurrence risks and low rates of lymphoedema.

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