EClinicalMedicine最新文献

{"title":"Associations of dietary choline intake and kidney function with hyperuricemia in Chinese children and adolescents: a cross-sectional study.","authors":"Chengping Li, Jing Li, Zhiquan Diao, Lianhong Chen, Siwen Yu, Lianlong Yu, Qianrang Zhu, Xiaomei Dong, Yiya Liu, Tao Liu, Dan Liu","doi":"10.1016/j.eclinm.2024.103012","DOIUrl":"10.1016/j.eclinm.2024.103012","url":null,"abstract":"<p><strong>Background: </strong>Limited studies have suggested an effect of dietary choline intake on uric acid levels. We aim to investigate the associations between choline intake and hyperuricemia (HUA), as well as the mediating role of kidney function in this relationship, among the Chinese population aged 6-17 years.</p><p><strong>Methods: </strong>Participants were divided into quartiles according to residual energy-adjusted dietary choline intake in our cross-sectional study. Dietary choline intake was assessed using the 24-h dietary recalls method over three consecutive days, including two weekdays and one weekend day. The primary outcome was the HUA prevalence. Based on recommendation in <i>Clinical Paediatric Nephrology (3rd ed)</i>, HUA is defined based on fasting serum uric acid levels, with cutoffs varying by age and sex. The associations between choline intake and HUA were analysed using weighted logistic regression models, restricted cubic spline models, and linear regression models. The mediated proportions of estimated glomerular filtration rate (eGFR) in the associations were estimated with mediation effect models. The data for this study were collected from the China National Nutrition and Health Surveillance of Children and Lactating Mothers (2016-2017) conducted between October 2016 and December 2018. Eligible participants were identified through a database search conducted from October to December 2023.</p><p><strong>Findings: </strong>Among the 10749 participants, 3398 (31.6%) individuals were found to have HUA. A negative dose-dependent relationship was found between dietary choline intake and HUA. Compared to participants in the lowest intake quartile of total choline, phosphatidylcholine, and betaine, those in the 4th quartile had lower odds of HUA, with odds ratio (OR) of 0.75 (95% confidence interval [95% CI], 0.63-0.90), 0.75 (95% CI, 0.64-0.89), and 0.75 (95% CI, 0.59-0.94), respectively. The eGFR mediated 10.60%-14.58% of the associations. Participants in the 4th quartile of lipid-soluble dietary choline exhibited 24.00% reduced odds of HUA compared to those in the lowest intake quartile, with an OR of 0.76 (95% CI, 0.64-0.90).</p><p><strong>Interpretation: </strong>Moderate to high intake of dietary choline (181.20-357.92 mg/d), particularly phosphatidylcholine (120.22-207.58 mg/d), and betaine (189.24-282.37 mg/d), may reduce the odds of HUA by improving glomerular filtration function. Further interventional studies are needed to establish causal relationships.</p><p><strong>Funding: </strong>This work was supported by the National Natural Science Foundation of China (82003443, 42375180), the Natural Science Foundation of Guangdong Province of China (2024A1515012088), and the Construction of High-level University of Guangdong (G624330422).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103012"},"PeriodicalIF":9.6,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11720878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trial.","authors":"Katrine Lundby Høyer, Simon Mark Dahl Baunwall, Ditte Smed Kornum, Mette Winther Klinge, Asbjørn Mohr Drewes, Knud Bonnet Yderstræde, Louise Bruun Thingholm, Martin Steen Mortensen, Susan Mikkelsen, Christian Erikstrup, Christian Lodberg Hvas, Klaus Krogh","doi":"10.1016/j.eclinm.2024.103000","DOIUrl":"10.1016/j.eclinm.2024.103000","url":null,"abstract":"<p><strong>Background: </strong>Diabetic gastroenteropathy is associated with nausea, vomiting, bloating, pain, constipation, and diarrhoea. Current therapies are scarce. We tested faecal microbiota transplantation (FMT) for patients with type 1 diabetes and gastroenteropathy.</p><p><strong>Methods: </strong>In a randomised, double-blinded, placebo-controlled pilot trial, adults with type 1 diabetes and moderate-to-severe gastrointestinal symptoms were randomised (1:1) to encapsulated FMT or placebo. Each patient received around 25 capsules containing 50 g of faeces, administered in a single dose. The placebo capsules contained glycerol, saline and food colouring. All patients received FMT as a second intervention. The primary endpoint was number of adverse events of severity grade 2 or more assessed by the Common Terminology Criteria for Adverse Events during the week following the first intervention. Secondary endpoints included gastrointestinal symptoms and quality of life assessed four weeks after treatment. Public trial registration, ClinicalTrials.govNCT04749030.</p><p><strong>Findings: </strong>We randomised 20 patients to FMT or placebo. Following this intervention, 26 adverse events of grade 2 or more occurred. Four patients in the FMT group reported seven adverse events, and five patients in the placebo group reported 19, with no differences between the groups. The most frequent adverse events were diarrhoea, bloating, and abdominal pain. No serious adverse events were related to the treatment. Patients who received FMT reduced their median Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome score from 58 (IQR 54-65) to 35 (32-48), whereas patients receiving placebo reduced their score from 64 (55-70) to 56 (50-77) (p = 0.01). The Irritable Bowel Syndrome Impact Scale score improved from 108 (101-123) to 140 (124-161) with FMT and 77 (53-129) to 92 (54-142) with placebo (p = 0.02). The Patient Assessment of Gastrointestinal Symptom Severity Index declined from a median of 42 (28-47) to 25 (14-31) after FMT and 47 (31-69) to 41 (36-64) after placebo (p = 0.03).</p><p><strong>Interpretation: </strong>FMT was safe and improved clinical outcomes for patients with type 1 diabetes suffering from bowel symptoms.</p><p><strong>Funding: </strong>Steno Collaborative Grant.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103000"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714726/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Contrasting results in sacroiliac joint fusion studies: the role of bilateral complaints.","authors":"Nick Kampkuiper, Femke Schröder, Marjolein Brusse-Keizer, Jorm Nellensteijn","doi":"10.1016/j.eclinm.2024.102978","DOIUrl":"10.1016/j.eclinm.2024.102978","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102978"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Noninvasive respiratory support following extubation in critically ill adults with obesity: a systematic review and network meta-analysis.","authors":"Joris Pensier, Arthur Naudet-Lasserre, Clément Monet, Mathieu Capdevila, Yassir Aarab, Inès Lakbar, Gérald Chanques, Nicolas Molinari, Audrey De Jong, Samir Jaber","doi":"10.1016/j.eclinm.2024.103002","DOIUrl":"10.1016/j.eclinm.2024.103002","url":null,"abstract":"<p><strong>Background: </strong>Patients with obesity are at high-risk of extubation failure. Discrepancies were found in the results of recent randomized controlled trials (RCTs) regarding the roles of noninvasive ventilation (NIV), high flow nasal cannula (HFNC) and conventional oxygen therapy (COT) to prevent extubation failure in critically ill patients with obesity.</p><p><strong>Methods: </strong>In this systematic review and network meta-analysis, we searched MEDLINE, Cochrane Center Register of Controlled Trials and Web of Science from 1 January 1998 to 1 July 2024 for RCTs evaluating noninvasive respiratory support therapies (NIV, HFNC, COT, NIV + HFNC) after extubation in critically ill adults with obesity. Primary outcome was reintubation at day 7. Secondary outcome was 28-day mortality. We generated pooled risk ratios (RR) and numbers needed to treat (NNT). We rated risk of bias using the Cochrane risk-of-bias 2.0 tool. The study was registered with PROSPERO (CRD 42022308995).</p><p><strong>Findings: </strong>In seven RCTs including 1933 patients, NIV + HFNC (RR 0.36 [95% confidence interval (CI) 0.16-0.82], NNT = 10 [95% CI 7-33]) and NIV (RR 0.45 [95% CI 0.23-0.88], NNT = 11 [95% CI 8-50]) but not HFNC (RR 0.79 [95% CI 0.40-1.59]) reduced reintubation at day 7, compared to COT. Compared to HFNC, NIV + HFNC (RR 0.46 [95% CI 0.23-0.90], NNT = 14 [95% CI 10-77]) but not NIV (RR 0.57 [95% CI 0.32-1.02]) reduced reintubation at day 7. Compared to HFNC, both NIV (RR 0.31 [95% CI 0.13-0.74], NNT = 15 [95% CI 12-40]) and NIV + HFNC (RR 0.30 [95% CI 0.10-0.89], NNT = 15 [95% CI 11-90]) reduced 28-day mortality.</p><p><strong>Interpretation: </strong>The results suggest that compared to COT and HFNC, NIV alone or with HFNC reduces reintubation in critically ill patients with obesity after extubation. Compared to HFNC, NIV alone or with HFNC reduces mortality. The number needed to treat with NIV or NIV + HFNC to avoid one death was 15. These findings support the application of NIV to mitigate extubation failure in critically ill adults with obesity.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103002"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11715126/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a machine learning-based model to predict survival in patients with cirrhosis after transjugular intrahepatic portosystemic shunt.","authors":"Binlin Da, Huan Chen, Wei Wu, Wuhua Guo, Anru Zhou, Qin Yin, Jun Gao, Junhui Chen, Jiangqiang Xiao, Lei Wang, Ming Zhang, Yuzheng Zhuge, Feng Zhang","doi":"10.1016/j.eclinm.2024.103001","DOIUrl":"10.1016/j.eclinm.2024.103001","url":null,"abstract":"<p><strong>Background: </strong>Although numerous prognostic scores have been developed for patients with cirrhosis after Transjugular intrahepatic portosystemic shunt (TIPS) placement over years, an accurate machine learning (ML)-based model remains unavailable. The aim of this study was to develop and validate a ML-based prognostic model to predict survival in patients with cirrhosis after TIPS placement.</p><p><strong>Methods: </strong>In this retrospective study in China, patients diagnosed with cirrhosis after TIPS placement from 2014 to 2020 in our cohort were included to develop a ML-based model. Patients from the other two tertiary hospitals between 2016 and 2022 were as external validation cohort. The random forest (RF) model was built using 7 selected features via the least absolute shrinkage and selection operator (LASSO) regression, and subsequent 10-fold cross-validation was performed.</p><p><strong>Findings: </strong>A total of 400 patients in our cohort were included (median age and interquartile range, 59 (50, 66); 240 men). Two hundred and eighty patients made up the training set and 120 were in the testing set, and 346 patients were included in the external validation cohort. Seven attributes were selected: Na, ammonia (Amm), total bilirubin (Tb), albumin (Alb), age, creatinine (Cr), and ascites. These parameters were included in a new score named the RF model. The accuracy, precision, recall, and F1 Score of the RF model were 0.84 (95% CI: 0.76, 0.91), 0.84 (95% CI: 0.77, 0.91), 0.99 (95% CI: 0.95, 1.00), 0.91 (95% CI: 0.81, 0.10) in the testing set, and 0.88 (95% CI: 0.84, 0.91), 0.89 (95% CI: 0.85, 0.92), 0.99 (95% CI: 0.97, 1.00), 0.93 (95% CI: 0.85, 0.97) in the validation cohort, respectively. The calibration curve showed a slope of 0.875 in the testing set and a slope of 0.778 in the external validation cohort, suggesting well calibration performance. The RF model outperformed other scoring systems, such as the (Child-Turcotte-Pugh score) CTP, (model for end-stage liver disease) MELD, (sodium MELD) MELD-Na, (Freiburg index of post-TIPS survival) FIPS and (Albumin-Bilirubin) ALBI, showing the highest (area under the curve) AUC of 0.82 (95% CI: 0.72, 0.91) and 0.7 (95% CI: 0.60, 0.79) in predicting 1-year survival across the testing set and external validation cohort.</p><p><strong>Interpretation: </strong>This study developed a RF model that better predicted 1-year survival for patients with cirrhosis after TIPS placement than the other scores.</p><p><strong>Funding: </strong>National Natural Science Foundation of China (grant numbers 81900552 and 82370628).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103001"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11719861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concerns regarding sham-controlled trial of SI joint fusion procedure.","authors":"Winston T Capel","doi":"10.1016/j.eclinm.2024.102977","DOIUrl":"10.1016/j.eclinm.2024.102977","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102977"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Possible factors influencing on the effect of minimally invasive sacroiliac joint fusion - a call for further research and discussion.","authors":"Engelke Marie Randers, Paul Gerdhem, Britt Stuge, Elias Diarbakerli, Lars Nordsletten, Stephan M Röhrl, Thomas Johan Kibsgård","doi":"10.1016/j.eclinm.2024.102976","DOIUrl":"10.1016/j.eclinm.2024.102976","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102976"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prediction accuracy of discrete choice experiments in health-related research: a systematic review and meta-analysis.","authors":"Ying Zhang, Thi Quynh Anh Ho, Fern Terris-Prestholt, Matthew Quaife, Esther de Bekker-Grob, Peter Vickerman, Jason J Ong","doi":"10.1016/j.eclinm.2024.102965","DOIUrl":"10.1016/j.eclinm.2024.102965","url":null,"abstract":"<p><strong>Background: </strong>Discrete choice experiments (DCEs) are increasingly used to inform the design of health products and services. It is essential to understand the extent to which DCEs provide reliable predictions outside of experimental settings in real-world decision-making situations. We aimed to compare the prediction accuracy of stated preferences with real-world choices, as modelled from DCE data.</p><p><strong>Methods: </strong>We searched six databases for health-related studies that used DCE to assess external validity and reported on predicted versus real-world choices, up to July 2024. A generalised linear mixed model was used for a meta-analysis to jointly pool the sensitivity and specificity. Heterogeneity was assessed using the <i>I</i> ² statistic, and sources of heterogeneity using meta-regression. This study is registered with PROSPERO (CRD42023451545).</p><p><strong>Findings: </strong>We identified 14 relevant studies, of which 10 were included in the meta-analysis. Most studies were conducted in high-income countries (11/14, 79%) from the European region (9/14, 64%) and analysed using mixed logit models (5/14, 36%). Pooled sensitivity and specificity estimates were 89% (95% CI:77-95, <i>I</i> ² = 97%) and 52% (95% CI:32-72, <i>I</i> ² = 95%), respectively. The area under the SROC curve (AUC) was 0.81 (95% CI:0.77-0.84). Our meta-regression found that DCEs for prevention-related choices had higher sensitivity than treatment-related choices. DCEs conducted under clinical settings and analysed using the heteroskedastic multinomial logit model, incorporating systematic preference heterogeneity and random opt-out utility, had higher specificity than non-clinical settings and alternative models.</p><p><strong>Interpretation: </strong>DCEs are valuable for capturing health-related preferences and possess reasonable external validity to predict health-related behaviours, particularly for opt-in choices. Contextual factors (e.g., type of intervention, study setting, analysis method) influenced the predictive accuracy.</p><p><strong>Funding: </strong>JJO is supported by an Australian National Health and Medical Research Council Emerging Leadership Investigator Grant (GNT1193955). EBG is supported by the Dutch Research Council (NWO-Talent-Scheme-Vidi-Grant No, 09150171910002). YZ is supported by an Australian Government Research Training Program (RTP) scholarship.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102965"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Panitumumab plus 5-fluorouracil and folinic acid or 5-fluorouracil and folinic acid alone as maintenance therapy in RAS wild-type metastatic colorectal cancer (PanaMa, AIO KRK 0212): final efficacy analysis of a randomised, open-label, phase 2 trial.","authors":"Arndt Stahler, Meinolf Karthaus, Stefan Fruehauf, Ullrich Graeven, Lothar Müller, Ludwig Fischer von Weikersthal, Karel Caca, Eray Goekkurt, Alexej Ballhausen, Greta Sommerhäuser, Annabel H S Alig, Swantje Held, Armin Jarosch, David Horst, Anke Reinacher-Schick, Stefan Kasper, Volker Heinemann, Sebastian Stintzing, Tanja Trarbach, Dominik P Modest","doi":"10.1016/j.eclinm.2024.103004","DOIUrl":"10.1016/j.eclinm.2024.103004","url":null,"abstract":"<p><strong>Background: </strong>The PanaMa trial aimed to compare the efficacy of 5-fluorouracil and folinic acid (FU/FA) ± panitumumab maintenance in untreated <i>RAS</i> wild-type metastatic colorectal cancer (mCRC) patients.</p><p><strong>Methods: </strong>In this final phase 2 trial analysis, adult mCRC patients responding to six cycles of FU/FA, oxaliplatin and panitumumab were randomized (1:1, open-label) to maintenance of either FU/FA + panitumumab or FU/FA alone. The primary endpoint was superiority of progression-free survival of maintenance (PFS; time from random assignment to progression/death) in favour of FU/FA + panitumumab. Secondary endpoints included PFS of re-induction (PFS re-ind.), time to failure of strategy (TFS) and overall survival (OS). The trial is registered with ClinicalTrials.gov (NCT01991873).</p><p><strong>Findings: </strong>In 248 patients of the Full Analysis Set recruited between May 2014 and February 2021, with a median observation of 64.0 (range 12.5-86.3) months and 59.7 (range 3.7-97.3) months in the treatment arms, 230 events for PFS (92.7%) and 196 events for OS (79.0%) were recorded. Adding panitumumab to FU/FA resulted in significantly longer PFS (8.8 versus 5.8 months, HR = 0.73 (95% CI 0.56-0.94), <i>P</i> = 0.015), shorter PFS re-ind. (4.1 versus 7.4 months, HR = 1.93 (95% CI 1.33-2.82), <i>P</i> < 0.001), comparable TFS (17.1 versus 15.7 months, HR = 0.98 (95% CI 0.68-1.42), <i>P</i> = 0.92) and numerically longer OS (29.9 versus 24.7 months, HR = 0.85 (95% CI 0.64-1.12), <i>P</i> = 0.24). The most frequent adverse event (AE) grade ≥3 was rash (FU/FA + panitumumab: n = 15, 12.0%, FU/FA: n = 17, 6.9%). 141 patients (37.3%) experienced at least one serious AE One treatment-related death occurred (neutropenic sepsis, FU/FA).</p><p><strong>Interpretation: </strong>Panitumumab plus FU/FA might be considered a standard of care maintenance regimen since a potential re-induction therapy with panitumumab cannot be guaranteed at the time of maintenance treatment decision.</p><p><strong>Funding: </strong>Amgen.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103004"},"PeriodicalIF":9.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11719858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of war on people with type 2 diabetes in Ukraine: a survey study.","authors":"Oksana Sulaieva, Viktoriia Yerokhovych, Sergii Zemskov, Iuliia Komisarenko, Vitalii Gurianov, Volodymyr Pankiv, Oleksandr Tovkai, Tetyana Yuzvenko, Violetta Yuzvenko, Andrii Tovkai, Zlatoslava Shaienko, Tetyana Falalyeyeva, Nadiya Skrypnyk, Taras Romaniv, Nadiya Pasyechko, Taras Krytskyy, Solomiia Danyliuk, Andrii Klantsa, Dmytro Krasnienkov, Oleksandr Gurbych, Nazarii Kobyliak","doi":"10.1016/j.eclinm.2024.103008","DOIUrl":"10.1016/j.eclinm.2024.103008","url":null,"abstract":"<p><strong>Background: </strong>Although the number of studies reporting war-induced effects on the health of the Ukrainian population has been growing, there are still little data on assessing patients with type 2 diabetes (T2D) during the war. This study aimed to evaluate the impact of war on T2D patients' health to define key risk factors promoting disease progression.</p><p><strong>Methods: </strong>A survey covering various aspects of T2D patients' experience and glycemic control data was conducted from June 2022 to February 2024. Overall, 1193 patients from all regions of Ukraine were enrolled in the study. According to the difference between the initial and current levels of HbA1c, all the respondents were subdivided into two categories: progressors (with HbA1c levels greater than 5% of the initial value) and stable (patients with stable HbA1c levels). Next, the impact of intrinsic and war-related factors on T2D progression was assessed via logistic regression analysis and machine learning tools.</p><p><strong>Findings: </strong>Two years of war experience was associated with significant increase in the median HbA1c from 7.8% (7.0-8.93) to 8.4% (7.4-9.9; p < 0.001), with the highest value occurring in eastern and northern Ukraine. HbA1c levels demonstrated a time-dependent pattern of growth, reflecting the cumulative effect of war-related factors on T2D patients' health. Witnesses of armed attacks and occupation aggravated the T2D course. Experience with military actions (p = 0.002), occupation (p = 0.001), internal displacement (p = 0.018) and family member injury or death (p = 0.031) increased HbA1c. In addition, lack of regular glucose monitoring (p < 0.001), consultation by endocrinologists (p < 0.001), diet inconsistency (p = 0.017) and scarcity of physical activity (p = 0.047) affected the HbA1c parameters.</p><p><strong>Interpretation: </strong>This study demonstrated a dramatic cumulative effect of the war on T2D patients' health. Uncovered direct and indirect war-related risk factors can guide further adjustment of diabetic care in Ukraine to improve T2D patient support.</p><p><strong>Funding: </strong>National Research Foundation of Ukraine (grant number 2022.01/0089).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103008"},"PeriodicalIF":9.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}