Pub Date : 2024-11-07eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102904
Fredrik Hieronymus, Alexander Lisinski, Elias Eriksson
<p><strong>Background: </strong>In an influential network meta-analysis, the tricyclic antidepressant (TCA) amitriptyline was found to be the most efficacious of 21 antidepressants, hence outranking selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). The alpha<sub>2</sub>/5HT<sub>2A</sub>/<sub>2C</sub>/<sub>3</sub>/H<sub>1</sub> antagonist mirtazapine was ranked as the second most effective and appeared at least as effective as the SSRIs and SNRIs that followed next. Since the most common effect parameter in depression trials-the sum score of the Hamilton Depression Rating Scale (HDRS-17-sum)-includes three items measuring sleep and two measuring appetite and weight, this outcome could be the result of amitriptyline and mirtazapine being more sedative and orexigenic. The main aim of this study was to compare mirtazapine with SSRIs or amitriptyline with respect to impact on core depression symptoms.</p><p><strong>Methods: </strong>Access to patient-level data from all company-sponsored, acute-phase, HDRS-based, and randomized trials of mirtazapine in adult major depression available to Merck was granted. Thirty-two studies compared mirtazapine to placebo and/or amitriptyline or an SSRI whereas five compared mirtazapine to another TCA or an SNRI, venlafaxine. Data were divided into subgroups for direct comparisons of mirtazapine vs placebo or different subgroups of antidepressants. Indirect comparisons of SSRIs vs amitriptyline were also undertaken. Mixed models for repeated measures were used to assess efficacy as reflected by i) HDRS-17-sum, ii) six core depression symptoms (HDRS-6-sum), and iii) all individual items.</p><p><strong>Findings: </strong>The dataset consisted of 5974 participants. Mirtazapine (n = 1362) outperformed SSRIs (n = 1369) on HDRS-17-sum, but this was due to differences regarding items reflecting sleep, appetite, and gastrointestinal dysfunction-with respect to reducing depressed mood, suicidality, and psychic anxiety, SSRIs and/or venlafaxine were more effective. Amitriptyline (n = 622) was superior to mirtazapine (n = 606) in reducing depressed mood, and the combined group of all TCAs (n = 831) outperformed mirtazapine (n = 824) also with respect to other core depression symptoms. Since there were no head-to-head comparisons of amitriptyline vs SSRIs, no firm conclusion may be drawn with respect to relative efficacy of the two, but indirect comparisons support the notion that amitriptyline and other tricyclics may be superior also to SSRIs.</p><p><strong>Interpretation: </strong>While the apparent superiority of mirtazapine over SSRIs is explained by its sedative and orexigenic properties, and by its absence of gastrointestinal side effects, amitriptyline appeared more effective in reducing core symptoms of depression than mirtazapine and possibly also than SSRIs; given the indirect nature of the latter comparison, this outcome should however be interpreted with cau
{"title":"Impact of sedative and appetite-increasing properties on the apparent antidepressant efficacy of mirtazapine, selective serotonin reuptake inhibitors and amitriptyline: an item-based, patient-level meta-analysis.","authors":"Fredrik Hieronymus, Alexander Lisinski, Elias Eriksson","doi":"10.1016/j.eclinm.2024.102904","DOIUrl":"10.1016/j.eclinm.2024.102904","url":null,"abstract":"<p><strong>Background: </strong>In an influential network meta-analysis, the tricyclic antidepressant (TCA) amitriptyline was found to be the most efficacious of 21 antidepressants, hence outranking selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). The alpha<sub>2</sub>/5HT<sub>2A</sub>/<sub>2C</sub>/<sub>3</sub>/H<sub>1</sub> antagonist mirtazapine was ranked as the second most effective and appeared at least as effective as the SSRIs and SNRIs that followed next. Since the most common effect parameter in depression trials-the sum score of the Hamilton Depression Rating Scale (HDRS-17-sum)-includes three items measuring sleep and two measuring appetite and weight, this outcome could be the result of amitriptyline and mirtazapine being more sedative and orexigenic. The main aim of this study was to compare mirtazapine with SSRIs or amitriptyline with respect to impact on core depression symptoms.</p><p><strong>Methods: </strong>Access to patient-level data from all company-sponsored, acute-phase, HDRS-based, and randomized trials of mirtazapine in adult major depression available to Merck was granted. Thirty-two studies compared mirtazapine to placebo and/or amitriptyline or an SSRI whereas five compared mirtazapine to another TCA or an SNRI, venlafaxine. Data were divided into subgroups for direct comparisons of mirtazapine vs placebo or different subgroups of antidepressants. Indirect comparisons of SSRIs vs amitriptyline were also undertaken. Mixed models for repeated measures were used to assess efficacy as reflected by i) HDRS-17-sum, ii) six core depression symptoms (HDRS-6-sum), and iii) all individual items.</p><p><strong>Findings: </strong>The dataset consisted of 5974 participants. Mirtazapine (n = 1362) outperformed SSRIs (n = 1369) on HDRS-17-sum, but this was due to differences regarding items reflecting sleep, appetite, and gastrointestinal dysfunction-with respect to reducing depressed mood, suicidality, and psychic anxiety, SSRIs and/or venlafaxine were more effective. Amitriptyline (n = 622) was superior to mirtazapine (n = 606) in reducing depressed mood, and the combined group of all TCAs (n = 831) outperformed mirtazapine (n = 824) also with respect to other core depression symptoms. Since there were no head-to-head comparisons of amitriptyline vs SSRIs, no firm conclusion may be drawn with respect to relative efficacy of the two, but indirect comparisons support the notion that amitriptyline and other tricyclics may be superior also to SSRIs.</p><p><strong>Interpretation: </strong>While the apparent superiority of mirtazapine over SSRIs is explained by its sedative and orexigenic properties, and by its absence of gastrointestinal side effects, amitriptyline appeared more effective in reducing core symptoms of depression than mirtazapine and possibly also than SSRIs; given the indirect nature of the latter comparison, this outcome should however be interpreted with cau","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102904"},"PeriodicalIF":9.6,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11576391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142680907","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}
Pub Date : 2024-11-07eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102911
Robert J Petrella, Dawn P Gill, Nárlon C Boa Sorte Silva, Brendan Riggin, Wendy M Blunt, Marisa Kfrerer, Melissa Majoni, Jacquelyn Marsh, Jennifer D Irwin, Saverio Stranges, Merrick Zwarenstein, Guangyong Zou
Background: Obesity disproportionately impacts men's health yet fewer men engage in preventive healthcare. We examined the effectiveness of Hockey Fans in Training (Hockey FIT), a gender-sensitised lifestyle intervention that engages men with overweight/obesity through their passion as fans of a local sports team, on weight change and other health indicators.
Methods: Pragmatic, cluster randomised trial (aged 35-65 years, body mass index ≥ 27 kg/m2) within 42 community-based sites in Canada and the United States, randomly assigned (1:1) to intervention (Hockey FIT) or control (wait-list) and stratified by region. Sites were selected based on partnerships with local major junior/professional hockey teams and community implementation partners. Intervention participants received exercise and education during a three-month active phase (once-weekly, 90-min sessions) followed by a nine-month minimally-supported phase; control participants continued with usual activities. Primary outcome was weight change at 12 months. Assessment teams were blinded to group assignment including photos of weight measurements on digital scales, to provide proof of values recorded (post COVID-19). Analyses followed intent-to-treat. Trial registration: ClinicalTrials.gov, NCT03636282.
Findings: Between November 13, 2018-November 12, 2021, 20 sites (n = 497) were allocated to intervention and 22 sites (n = 500) to control. Participants with baseline weight and weight at 3 or 12 months, were included in the primary analysis (20 intervention sites [n = 354]; 22 control sites [n = 425]). At 12 months, mean weight change was -2.02 kg (95% confidence interval [CI], -2.78 to -1.26) with intervention and -0.92 kg (CI, -1.58 to -0.26) with control (difference, -1.10 kg [CI, -2.11 to -0.09], p = 0.03). There were 22 non-study related serious adverse events (45.5% in intervention; 54.5% in control).
Interpretation: Hockey FIT reduced weight in men with overweight or obesity. Hockey FIT is an innovative approach to engage men at increased risk of non-communicable disease in effective health behaviour change, through their passion as fans of their local hockey team.
Funding: Public Health Agency of Canada; Canadian Institutes of Health Research.
{"title":"The hockey fans in training intervention for men with overweight or obesity: a pragmatic cluster randomised trial.","authors":"Robert J Petrella, Dawn P Gill, Nárlon C Boa Sorte Silva, Brendan Riggin, Wendy M Blunt, Marisa Kfrerer, Melissa Majoni, Jacquelyn Marsh, Jennifer D Irwin, Saverio Stranges, Merrick Zwarenstein, Guangyong Zou","doi":"10.1016/j.eclinm.2024.102911","DOIUrl":"10.1016/j.eclinm.2024.102911","url":null,"abstract":"<p><strong>Background: </strong>Obesity disproportionately impacts men's health yet fewer men engage in preventive healthcare. We examined the effectiveness of Hockey Fans in Training (Hockey FIT), a gender-sensitised lifestyle intervention that engages men with overweight/obesity through their passion as fans of a local sports team, on weight change and other health indicators.</p><p><strong>Methods: </strong>Pragmatic, cluster randomised trial (aged 35-65 years, body mass index ≥ 27 kg/m<sup>2</sup>) within 42 community-based sites in Canada and the United States, randomly assigned (1:1) to intervention (Hockey FIT) or control (wait-list) and stratified by region. Sites were selected based on partnerships with local major junior/professional hockey teams and community implementation partners. Intervention participants received exercise and education during a three-month active phase (once-weekly, 90-min sessions) followed by a nine-month minimally-supported phase; control participants continued with usual activities. Primary outcome was weight change at 12 months. Assessment teams were blinded to group assignment including photos of weight measurements on digital scales, to provide proof of values recorded (post COVID-19). Analyses followed intent-to-treat. Trial registration: ClinicalTrials.gov, NCT03636282.</p><p><strong>Findings: </strong>Between November 13, 2018-November 12, 2021, 20 sites (n = 497) were allocated to intervention and 22 sites (n = 500) to control. Participants with baseline weight and weight at 3 or 12 months, were included in the primary analysis (20 intervention sites [n = 354]; 22 control sites [n = 425]). At 12 months, mean weight change was -2.02 kg (95% confidence interval [CI], -2.78 to -1.26) with intervention and -0.92 kg (CI, -1.58 to -0.26) with control (difference, -1.10 kg [CI, -2.11 to -0.09], p = 0.03). There were 22 non-study related serious adverse events (45.5% in intervention; 54.5% in control).</p><p><strong>Interpretation: </strong>Hockey FIT reduced weight in men with overweight or obesity. Hockey FIT is an innovative approach to engage men at increased risk of non-communicable disease in effective health behaviour change, through their passion as fans of their local hockey team.</p><p><strong>Funding: </strong>Public Health Agency of Canada; Canadian Institutes of Health Research.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102911"},"PeriodicalIF":9.6,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11576405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681077","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}
Pub Date : 2024-11-05eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102899
Vaidehi Nafade, Paulami Sen, Matthew Arentz, Rigveda Kadam, Jacob Bigio, Luke N Allen, Dian Maria Blandina, Stellah Bosire, Julia Ferreira, Saurabh Jha, Oommen John, S P Kalantri, Nkirote Mwirigi, Mamsallah Faal-Omisore, Cesar Ugarte-Gil, Shibu Vijayan, Marie-Claire Wangari, Madhukar Pai
{"title":"The value of diagnostic imaging for enhancing primary care in low- and middle-income countries.","authors":"Vaidehi Nafade, Paulami Sen, Matthew Arentz, Rigveda Kadam, Jacob Bigio, Luke N Allen, Dian Maria Blandina, Stellah Bosire, Julia Ferreira, Saurabh Jha, Oommen John, S P Kalantri, Nkirote Mwirigi, Mamsallah Faal-Omisore, Cesar Ugarte-Gil, Shibu Vijayan, Marie-Claire Wangari, Madhukar Pai","doi":"10.1016/j.eclinm.2024.102899","DOIUrl":"10.1016/j.eclinm.2024.102899","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102899"},"PeriodicalIF":9.6,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142666361","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}
Background: This study explores the potential of the deep learning-based convolutional neural network (CNN) to automatically recognize MMD using MRA images from atherosclerotic disease (ASD) and normal control (NC).
Methods: In this retrospective study in China, 600 participants (200 MMD, 200 ASD and 200 NC) were collected from one institution as an internal dataset for training and 60 from another institution were collected as external testing set for validation. All participants were divided into training (N = 450) and validation sets (N = 90), internal testing set (N = 60), and external testing set (N = 60). The input to the CNN models comprised preprocessed MRA images, while the output was a tripartite classification label that identified the patient's diagnostic group. The performances of 3D CNN models were evaluated using a comprehensive set of metrics such as area under the curve (AUC) and accuracy. Gradient-weighted Class Activation Mapping (Grad-CAM) was used to visualize the CNN's decision-making process in MMD diagnosis by highlighting key areas. Finally, the diagnostic performances of the CNN models were compared with those of two experienced radiologists.
Findings: DenseNet-121 exhibited superior discrimination capabilities, achieving a macro-average AUC of 0.977 (95% CI, 0.928-0.995) in the internal test sets and 0.880 (95% CI, 0.786-0.937) in the external validation sets, thus exhibiting comparable diagnostic capabilities to those of human radiologists. In the binary classification where ASD and NC were group together, with MMD as the separate group for targeted detection, DenseNet-121 achieved an accuracy of 0.967 (95% CI, 0.886-0.991). Additionally, the Grad-CAM results for the MMD, with areas of intense redness indicating critical areas identified by the model, reflected decision-making similar to human experts.
Interpretation: This study highlights the efficacy of CNN model in the automated diagnosis of MMD on MRA images, easing the workload on radiologists and promising integration into clinical workflows.
Funding: National Natural Science Foundation of China, Tianjin Science and Technology Project and Beijing Natural Science Foundation.
{"title":"Deep learning model for automated diagnosis of moyamoya disease based on magnetic resonance angiography.","authors":"Mingming Lu, Yijia Zheng, Shitong Liu, Xiaolan Zhang, Jiahui Lv, Yuan Liu, Baobao Li, Fei Yuan, Peng Peng, Cong Han, Chune Ma, Chao Zheng, Hongtao Zhang, Jianming Cai","doi":"10.1016/j.eclinm.2024.102888","DOIUrl":"10.1016/j.eclinm.2024.102888","url":null,"abstract":"<p><strong>Background: </strong>This study explores the potential of the deep learning-based convolutional neural network (CNN) to automatically recognize MMD using MRA images from atherosclerotic disease (ASD) and normal control (NC).</p><p><strong>Methods: </strong>In this retrospective study in China, 600 participants (200 MMD, 200 ASD and 200 NC) were collected from one institution as an internal dataset for training and 60 from another institution were collected as external testing set for validation. All participants were divided into training (N = 450) and validation sets (N = 90), internal testing set (N = 60), and external testing set (N = 60). The input to the CNN models comprised preprocessed MRA images, while the output was a tripartite classification label that identified the patient's diagnostic group. The performances of 3D CNN models were evaluated using a comprehensive set of metrics such as area under the curve (AUC) and accuracy. Gradient-weighted Class Activation Mapping (Grad-CAM) was used to visualize the CNN's decision-making process in MMD diagnosis by highlighting key areas. Finally, the diagnostic performances of the CNN models were compared with those of two experienced radiologists.</p><p><strong>Findings: </strong>DenseNet-121 exhibited superior discrimination capabilities, achieving a macro-average AUC of 0.977 (95% CI, 0.928-0.995) in the internal test sets and 0.880 (95% CI, 0.786-0.937) in the external validation sets, thus exhibiting comparable diagnostic capabilities to those of human radiologists. In the binary classification where ASD and NC were group together, with MMD as the separate group for targeted detection, DenseNet-121 achieved an accuracy of 0.967 (95% CI, 0.886-0.991). Additionally, the Grad-CAM results for the MMD, with areas of intense redness indicating critical areas identified by the model, reflected decision-making similar to human experts.</p><p><strong>Interpretation: </strong>This study highlights the efficacy of CNN model in the automated diagnosis of MMD on MRA images, easing the workload on radiologists and promising integration into clinical workflows.</p><p><strong>Funding: </strong>National Natural Science Foundation of China, Tianjin Science and Technology Project and Beijing Natural Science Foundation.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102888"},"PeriodicalIF":9.6,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142666345","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}
Pub Date : 2024-11-02eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102893
Gideon Zulu, Dominik Stelzle, Kabemba E Mwape, Inge Van Damme, Chiara Trevisan, Chishimba Mubanga, Veronika Schmidt, Isaac K Phiri, Richard Mambo, Mwelwa Chembensofu, Maxwell Masuku, Charlotte Ruether, John Noh, Sukwan Handali, Emmanuel Bottieau, Pascal Magnussen, Pierre Dorny, Agnes Fleury, Andrea S Winkler, Sarah Gabriël
Background: Neurocysticercosis (NCC) is the main cause of epilepsy in Taenia solium endemic rural communities. NCC diagnosis is difficult due to unavailability and unaffordability of serologic assays and neuroimaging. This study aimed to assess the performance of a cheap, novel T. solium lateral-flow point-of-care (TS POC) test for the diagnosis of NCC in a community setting.
Methods: A diagnostic accuracy study with prospective data collection, using a two-stage design was conducted in Sinda district of the Eastern province of Zambia between December 2017 and June 2019. Eligible participants were tested with the TS POC test. Thereafter, participants with a TS POC CC+ result and a subset of participants with a TS POC CC- result were subjected to serological testing for reference assays, and cerebral computed tomography (CT) for the reference diagnosis of NCC.
Findings: A total of 1249 participants were tested with the TS POC of which 177 (14%) were positive. Of the 151 TS POC CC+ and 82 TS POC CC- participants with cerebral CT examination, 35 TS POC CC+ and 10 TS POC CC-, respectively, had NCC. The sensitivity of the TS POC CC strip was 26% (uncertainty interval [UI] 15-41) for any type of NCC, which was similar to that estimated for the rT24H-EITB (23%, UI 8-48) and the serum antigen ELISA (30%, UI 11-58). The specificity was 88% (UI 85-90) for the TS POC, 89% (UI 79-94) for the rT24H-EITB, and 82% (UI 71-89) for the antigen ELISA. For NCC with active stage lesions, sensitivity was >99% (UI 58->99) for the TS POC, 76% (UI 40-94) for the rT24H-EITB and 76% (UI 39-94) for the antigen ELISA.
Interpretation: The TS POC CC had a promising sensitivity for diagnosis of participants with active NCC lesions within a community-based setting. Accuracy for NCC at any stage was limited for all tests (TS POC, rT24H-EITB and antigen ELISA). With further development the TS POC CC may enable a better detection and faster referral of NCC patients who may benefit from antiparasitic treatment.
Funding: European and Developing Countries Clinical Trials Partnership (EDCTP) and the German Federal Ministry of Education and Research (BMBF).
{"title":"The performance of a point-of-care test for the diagnosis of Neurocysticercosis in a resource-poor community setting in Zambia - a diagnostic accuracy study.","authors":"Gideon Zulu, Dominik Stelzle, Kabemba E Mwape, Inge Van Damme, Chiara Trevisan, Chishimba Mubanga, Veronika Schmidt, Isaac K Phiri, Richard Mambo, Mwelwa Chembensofu, Maxwell Masuku, Charlotte Ruether, John Noh, Sukwan Handali, Emmanuel Bottieau, Pascal Magnussen, Pierre Dorny, Agnes Fleury, Andrea S Winkler, Sarah Gabriël","doi":"10.1016/j.eclinm.2024.102893","DOIUrl":"10.1016/j.eclinm.2024.102893","url":null,"abstract":"<p><strong>Background: </strong>Neurocysticercosis (NCC) is the main cause of epilepsy in <i>Taenia solium</i> endemic rural communities. NCC diagnosis is difficult due to unavailability and unaffordability of serologic assays and neuroimaging. This study aimed to assess the performance of a cheap, novel <i>T. solium</i> lateral-flow point-of-care (TS POC) test for the diagnosis of NCC in a community setting.</p><p><strong>Methods: </strong>A diagnostic accuracy study with prospective data collection, using a two-stage design was conducted in Sinda district of the Eastern province of Zambia between December 2017 and June 2019. Eligible participants were tested with the TS POC test. Thereafter, participants with a TS POC CC+ result and a subset of participants with a TS POC CC- result were subjected to serological testing for reference assays, and cerebral computed tomography (CT) for the reference diagnosis of NCC.</p><p><strong>Findings: </strong>A total of 1249 participants were tested with the TS POC of which 177 (14%) were positive. Of the 151 TS POC CC+ and 82 TS POC CC- participants with cerebral CT examination, 35 TS POC CC+ and 10 TS POC CC-, respectively, had NCC. The sensitivity of the TS POC CC strip was 26% (uncertainty interval [UI] 15-41) for any type of NCC, which was similar to that estimated for the rT24H-EITB (23%, UI 8-48) and the serum antigen ELISA (30%, UI 11-58). The specificity was 88% (UI 85-90) for the TS POC, 89% (UI 79-94) for the rT24H-EITB, and 82% (UI 71-89) for the antigen ELISA. For NCC with active stage lesions, sensitivity was >99% (UI 58->99) for the TS POC, 76% (UI 40-94) for the rT24H-EITB and 76% (UI 39-94) for the antigen ELISA.</p><p><strong>Interpretation: </strong>The TS POC CC had a promising sensitivity for diagnosis of participants with active NCC lesions within a community-based setting. Accuracy for NCC at any stage was limited for all tests (TS POC, rT24H-EITB and antigen ELISA). With further development the TS POC CC may enable a better detection and faster referral of NCC patients who may benefit from antiparasitic treatment.</p><p><strong>Funding: </strong>European and Developing Countries Clinical Trials Partnership (EDCTP) and the German Federal Ministry of Education and Research (BMBF).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102893"},"PeriodicalIF":9.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11567943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647667","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}
Pub Date : 2024-10-30eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102894
Brian Hutchinson, Rory Watts, Mary Nyangasi, Benjamin O Anderson, Joyfrida Chepchumba, Elizabeth Wangia, Rose Jalang'o, Valerian Mwenda, Pooja Yerramilli, Toni Lee Kuguru, Kenneth Munge Kabubei, Amparo Gordillo-Tobar, Filip Meheus, Christina Meyer, Andre Ilbawi, Rachel Nugent
Background: Cancer is the third leading cause of death in Kenya. Breast cancer is responsible for 3100 deaths annually. Quantifying the economic and social impacts of breast cancer supports inclusion of cancer care within Kenya's universal healthcare plan.
Methods: Kenya's Ministry of Health led an economic cost-benefit analysis of expanding breast cancer prevention and treatment services. Three scenarios (early diagnosis only, screening with clinical breast exam (CBE-led), and screening with mammography (MG-led)) were modelled using an adapted version of a deterministic state-transition cohort simulation model jointly developed by the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) and maintained by Forecast Health. Real world evidence on the favorable stage-shift induced by each early detection scenario was used as model inputs. The model estimated the mortality benefits of favorable stage-shifting, and net financial costs and health and economic benefits in 2020 USD.
Findings: Respectively, over 40 years, the cost to sustain early diagnosis programs only, CBE-led screening, or mammogram-led screening would require 1.4, 2.8, or 5.2 percent increases above current government health spending. All three strategies are economically efficient in the long run. Net economic benefits of expanded breast cancer care using clinical breast exam screening are $2.3 billion dollars (USD) over the next 40 years with 236,000 women's lives saved in Kenya. Mammographic screening provides net benefits of $1.9 billion (USD) with an additional 34,000 lives saved over 40 years compared to the CBE-led screening approach. Over 40 years, an early diagnosis-only strategy saves the fewest lives and has the lowest net benefit among the three strategies.
Interpretation: We offer a novel economic evaluation for breast cancer prevention and care expansion within Universal Health Coverage in Kenya. It demonstrates the economic viability of providing those services in a low-middle income (LMI) context.
Funding: The work was funded by the World Bank Group's Tackling Non-Communicable Diseases Challenges in Low- and Middle-Income Countries Trust Fund, supported by the Access Accelerated Partnership. This report was also partially financed by the Global Financing Facility for Women, Children and Adolescents (GFF). The GFF is a global multi-stakeholder partnership hosted at the World Bank that provides catalytic financing and technical support for safe and equitable delivery of essential health and nutrition services for women, children and adolescents, while helping countries to build more resilient health systems.
背景:癌症是肯尼亚的第三大死因。每年有 3100 人死于乳腺癌。量化乳腺癌的经济和社会影响有助于将癌症治疗纳入肯尼亚的全民医疗保健计划:肯尼亚卫生部牵头对扩大乳腺癌预防和治疗服务进行了经济成本效益分析。使用世界卫生组织(WHO)和国际癌症研究机构(IARC)联合开发的、由 Forecast Health 维护的确定性状态转换队列模拟模型的改编版,对三种方案(仅早期诊断、临床乳腺检查筛查(CBE 主导)和乳腺 X 射线照相筛查(MG 主导))进行了模拟。每个早期检测方案所引起的有利分期转移的现实证据被用作模型输入。该模型估算了有利的阶段转移所带来的死亡率收益,以及以 2020 年美元为单位的净财务成本、健康和经济收益:在 40 年内,仅维持早期诊断项目、CBE 主导的筛查或乳房 X 线照相主导的筛查所需的成本将分别比目前的政府医疗支出增加 1.4%、2.8% 或 5.2%。从长远来看,这三种策略都具有经济效益。在未来 40 年内,通过临床乳房检查筛查来扩大乳腺癌治疗范围的净经济效益为 23 亿美元(USD),可挽救肯尼亚 23.6 万名妇女的生命。与临床乳房检查为主导的筛查方法相比,乳腺 X 线照相筛查的净效益为 19 亿美元,40 年内可挽救 34,000 人的生命。在 40 年中,仅早期诊断策略挽救的生命最少,净效益也是三种策略中最低的:我们为肯尼亚在全民医保范围内扩大乳腺癌预防和治疗提供了一个新颖的经济评估。它证明了在中低收入国家提供这些服务的经济可行性:这项工作由世界银行集团 "应对中低收入国家非传染性疾病挑战信托基金 "资助,并得到了 "加速获取伙伴关系"(Access Accelerated Partnership)的支持。本报告还得到了全球妇女、儿童和青少年融资机制(GFF)的部分资助。全球妇女、儿童和青少年筹资机制是世界银行主持的一个全球多方利益相关者伙伴关系,为安全、公平地向妇女、儿童和青少年提供基本保健和营养服务提供催化资金和技术支持,同时帮助各国建立更具复原力的保健系统。
{"title":"An economic evaluation of breast cancer interventions in Kenya.","authors":"Brian Hutchinson, Rory Watts, Mary Nyangasi, Benjamin O Anderson, Joyfrida Chepchumba, Elizabeth Wangia, Rose Jalang'o, Valerian Mwenda, Pooja Yerramilli, Toni Lee Kuguru, Kenneth Munge Kabubei, Amparo Gordillo-Tobar, Filip Meheus, Christina Meyer, Andre Ilbawi, Rachel Nugent","doi":"10.1016/j.eclinm.2024.102894","DOIUrl":"10.1016/j.eclinm.2024.102894","url":null,"abstract":"<p><strong>Background: </strong>Cancer is the third leading cause of death in Kenya. Breast cancer is responsible for 3100 deaths annually. Quantifying the economic and social impacts of breast cancer supports inclusion of cancer care within Kenya's universal healthcare plan.</p><p><strong>Methods: </strong>Kenya's Ministry of Health led an economic cost-benefit analysis of expanding breast cancer prevention and treatment services. Three scenarios (early diagnosis only, screening with clinical breast exam (CBE-led), and screening with mammography (MG-led)) were modelled using an adapted version of a deterministic state-transition cohort simulation model jointly developed by the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) and maintained by Forecast Health. Real world evidence on the favorable stage-shift induced by each early detection scenario was used as model inputs. The model estimated the mortality benefits of favorable stage-shifting, and net financial costs and health and economic benefits in 2020 USD.</p><p><strong>Findings: </strong>Respectively, over 40 years, the cost to sustain early diagnosis programs only, CBE-led screening, or mammogram-led screening would require 1.4, 2.8, or 5.2 percent increases above current government health spending. All three strategies are economically efficient in the long run. Net economic benefits of expanded breast cancer care using clinical breast exam screening are $2.3 billion dollars (USD) over the next 40 years with 236,000 women's lives saved in Kenya. Mammographic screening provides net benefits of $1.9 billion (USD) with an additional 34,000 lives saved over 40 years compared to the CBE-led screening approach. Over 40 years, an early diagnosis-only strategy saves the fewest lives and has the lowest net benefit among the three strategies.</p><p><strong>Interpretation: </strong>We offer a novel economic evaluation for breast cancer prevention and care expansion within Universal Health Coverage in Kenya. It demonstrates the economic viability of providing those services in a low-middle income (LMI) context.</p><p><strong>Funding: </strong>The work was funded by the World Bank Group's Tackling Non-Communicable Diseases Challenges in Low- and Middle-Income Countries Trust Fund, supported by the Access Accelerated Partnership. This report was also partially financed by the Global Financing Facility for Women, Children and Adolescents (GFF). The GFF is a global multi-stakeholder partnership hosted at the World Bank that provides catalytic financing and technical support for safe and equitable delivery of essential health and nutrition services for women, children and adolescents, while helping countries to build more resilient health systems.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102894"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11563939/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647664","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}
Pub Date : 2024-10-30eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102903
Junqing Xie, Kim López-Güell, Daniel Dedman, Talita Duarte-Salles, Raivo Kolde, Raúl López-Blasco, Álvaro Martínez, Gregoire Mercier, Alicia Abellan, Johnmary T Arinze, Zara Cuccu, Antonella Delmestri, Dominique Delseny, Sara Khalid, Chungsoo Kim, Ji-Woo Kim, Kristin Kostka, Cora Loste, Lourdes Mateu, Miguel A Mayer, Jaime Meléndez-Cardiel, Núria Mercadé-Besora, Mees Mosseveld, Akihito Nishimura, Hedvig M E Nordeng, Jessie O Oyinlola, Laura Pérez-Crespo, Marta Pineda-Moncusí, Juan Manuel Ramírez-Anguita, Nhung T H Trinh, Anneli Uusküla, Bernardo Valdivieso, Theresa Burkard, Edward Burn, Martí Català, Daniel Prieto-Alhambra, Roger Paredes, Annika M Jödicke
<p><strong>Background: </strong>The World Health Organisation (WHO) has identified a range of symptomatic manifestations to aid in the clinical diagnosis of post-COVID conditions, herein referred to as post-acute COVID-19 symptoms. We conducted an international network cohort study to estimate the burden of these symptoms in North American, European, and Asian populations.</p><p><strong>Methods: </strong>A federated analysis was conducted including 10 databases from the United Kingdom, Netherlands, Norway, Estonia, Spain, France, South Korea, and the United States, between September 1st 2020 and latest data availability (which varied from December 31st 2021 to February 28th 2023), covering primary and secondary care, nationwide registries, and claims data, all mapped to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM). We defined two cohorts for the main analyses: a SARS-CoV-2 infection cohort [positive polymerase chain reaction (PCR) or rapid lateral flow test (LFT) result or clinical COVID-19 diagnosis] and a general population cohort. Individuals with less than 365 days of prior history or 120 days of follow-up were excluded. We estimated incidence rates (IRs) of the 25 WHO-proposed post-acute COVID-19 symptoms, considering symptoms that occurred ≥90 and ≤365 days after index date, excluding individuals with the respective symptoms 180 days prior to the index event. Stratified analyses were conducted by age and sex. Incidence rate ratios (IRRs) were calculated comparing rates in the infected cohort versus the general population. Results from the different databases were combined using random-effects meta-analyses.</p><p><strong>Findings: </strong>3,019,408 individuals were included in the infection cohort. 1,585,160 of them were female and 1,434,248 of them male. 929,351,505 individuals were included in the general population group. 461,195,036 of them were female and 466,022,004 of them male. The 1-year IR of any post-acute COVID-19 symptom in the COVID-19 infection cohort varied significantly across databases, from 4.4 (95% CI 3.8-5.1) per 100 person-years to 103.9 (95% CI 103.2-104.7). The five most common symptoms were joint pain (from 1.6 (95% CI 1.3-1.9) to 14.3 (95% CI 14.1-14.6)), abdominal pain (from 0.3 (95% CI 0.1-0.5) to 9.9 (95% CI 9.7-10.1)), gastrointestinal issues (from 0.6 (95% CI 0.4-0.9) to 13.3 (95% CI 13.1-13.6)), cough (from 0.3 (95% CI 0.2-0.5) to 9.1 (95% CI 8.9-9.3)), and anxiety (from 0.8 (95% CI 0.6-1.2) to 11.4 (95% CI 11.2-11.6)); whereas muscle spasms (from 0.01 (95% CI 0.008-0.2) to 1.7 (95% CI 1.6-1.8)), pins and needles (from 0.05 (95% CI 0.03-0.0.9) to 1.5 (95% CI 1.4-1.6)), memory issues (from 0.03 (95% CI 0.02-0.06) to 0.8 (95% CI 0.7-0.8)), cognitive dysfunction (from 0.007 (95% CI 0.004-0.01) to 0.6 (95% CI 0.4-0.8)), and altered smell and/or taste (from 0.04 (95% CI 0.03-0.04) to 0.7 (95% CI 0.6-0.8)) were least common. Incidence rates of any post-acute COVID-19 symptoms general
背景:世界卫生组织(WHO)已确定了一系列症状表现,以帮助临床诊断 COVID 后病症,在此称为急性 COVID-19 后症状。我们开展了一项国际网络队列研究,以估计这些症状在北美、欧洲和亚洲人群中的负担:我们进行了一项联合分析,包括来自英国、荷兰、挪威、爱沙尼亚、西班牙、法国、韩国和美国的 10 个数据库,时间跨度从 2020 年 9 月 1 日到最新数据提供日(从 2021 年 12 月 31 日到 2023 年 2 月 28 日),涵盖初级和二级护理、全国范围的登记和索赔数据,所有数据均映射到观察性医疗结果合作组织通用数据模型(OMOP CDM)。我们为主要分析定义了两个队列:SARS-CoV-2 感染队列(聚合酶链反应(PCR)或快速侧流试验(LFT)结果呈阳性或临床 COVID-19 诊断)和普通人群队列。既往病史少于 365 天或随访时间少于 120 天的个体被排除在外。我们估算了世界卫生组织提出的 25 种 COVID-19 急性期后症状的发病率 (IR),考虑了指数日期后≥90 天和≤365 天出现的症状,排除了指数事件发生前 180 天出现相应症状的个体。按年龄和性别进行了分层分析。将感染人群的发病率与普通人群的发病率进行比较,计算出发病率比(IRR)。使用随机效应荟萃分析将不同数据库的结果进行合并:感染人群中有 3,019,408 人。其中 1,585,160 人为女性,1,434,248 人为男性。普通人群组包括 929 351 505 人。其中 461 195 036 人为女性,466 022 004 人为男性。在COVID-19感染人群中,任何COVID-19急性感染后症状的1年IR在不同数据库中差异显著,从每100人年4.4(95% CI 3.8-5.1)到103.9(95% CI 103.2-104.7)不等。最常见的五种症状是关节痛(从 1.6 (95% CI 1.3-1.9) 到 14.3 (95% CI 14.1-14.6))、腹痛(从 0.3 (95% CI 0.1-0.5) 到 9.9 (95% CI 9.7-10.1))、胃肠道问题(从 0.6(95% CI 0.4-0.9)到13.3(95% CI 13.1-13.6))、咳嗽(从0.3(95% CI 0.2-0.5)到9.1(95% CI 8.9-9.3))和焦虑(从0.8(95% CI 0.6-1.2)到11.4(95% CI 11.2-11.6));而肌肉痉挛(从0.8)、认知功能障碍(从 0.007(95% CI 0.004-0.01)到 0.6(95% CI 0.4-0.8))以及嗅觉和/或味觉改变(从 0.04(95% CI 0.03-0.04)到 0.7(95% CI 0.6-0.8))最不常见。COVID-19急性期后症状的发病率一般随年龄增长而增加,某些症状在中年人(焦虑、抑郁障碍、头痛、嗅觉和味觉改变)中达到高峰,而其他症状则在学龄前儿童(肠胃问题和咳嗽)中达到高峰。在大多数症状中,女性的发病率较高。根据随机效应模型,感染人群中任何 COVID-19 后急性症状的发病率均高于普通人群,元分析发病率比为 1.4(1-2)。所有单个症状的情况也类似。元分析发病率比最高的是抑郁障碍(2.6(1.7-3.9))、焦虑(2.3(1.4-3.8))、过敏(2.1(1.7-2.8))和睡眠障碍(2.1(1.5-2.6))。嗅觉和/或味觉改变的元内比值为 1.9 (1.3-2.8):解释:COVID-19感染后通常会出现世界卫生组织列出的COVID-19急性期后症状。然而,即使在研究方法标准化后,不同医疗机构和地理位置的发病率仍存在显著的异质性。这是国际上首次使用世界卫生组织列出的症状对 COVID-19 急性感染后症状的流行病学进行研究。研究结果有助于从多国角度了解这种疾病的流行病学。这项研究的局限性包括对急性 COVID-19 后症状的定义缺乏共识,以及现有数据集难以反映急性 COVID-19 后症状对日常生活的影响:本研究由欧洲健康数据证据网络(EHDEN)通过证据生成基金(Evidence Generation Fund Grant)和英国国家健康与护理研究所(NIHR)牛津生物医学研究中心(BRC)资助。
{"title":"Incidence of post-acute COVID-19 symptoms across healthcare settings in seven countries: an international retrospective cohort study using routinely-collected data.","authors":"Junqing Xie, Kim López-Güell, Daniel Dedman, Talita Duarte-Salles, Raivo Kolde, Raúl López-Blasco, Álvaro Martínez, Gregoire Mercier, Alicia Abellan, Johnmary T Arinze, Zara Cuccu, Antonella Delmestri, Dominique Delseny, Sara Khalid, Chungsoo Kim, Ji-Woo Kim, Kristin Kostka, Cora Loste, Lourdes Mateu, Miguel A Mayer, Jaime Meléndez-Cardiel, Núria Mercadé-Besora, Mees Mosseveld, Akihito Nishimura, Hedvig M E Nordeng, Jessie O Oyinlola, Laura Pérez-Crespo, Marta Pineda-Moncusí, Juan Manuel Ramírez-Anguita, Nhung T H Trinh, Anneli Uusküla, Bernardo Valdivieso, Theresa Burkard, Edward Burn, Martí Català, Daniel Prieto-Alhambra, Roger Paredes, Annika M Jödicke","doi":"10.1016/j.eclinm.2024.102903","DOIUrl":"10.1016/j.eclinm.2024.102903","url":null,"abstract":"<p><strong>Background: </strong>The World Health Organisation (WHO) has identified a range of symptomatic manifestations to aid in the clinical diagnosis of post-COVID conditions, herein referred to as post-acute COVID-19 symptoms. We conducted an international network cohort study to estimate the burden of these symptoms in North American, European, and Asian populations.</p><p><strong>Methods: </strong>A federated analysis was conducted including 10 databases from the United Kingdom, Netherlands, Norway, Estonia, Spain, France, South Korea, and the United States, between September 1st 2020 and latest data availability (which varied from December 31st 2021 to February 28th 2023), covering primary and secondary care, nationwide registries, and claims data, all mapped to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM). We defined two cohorts for the main analyses: a SARS-CoV-2 infection cohort [positive polymerase chain reaction (PCR) or rapid lateral flow test (LFT) result or clinical COVID-19 diagnosis] and a general population cohort. Individuals with less than 365 days of prior history or 120 days of follow-up were excluded. We estimated incidence rates (IRs) of the 25 WHO-proposed post-acute COVID-19 symptoms, considering symptoms that occurred ≥90 and ≤365 days after index date, excluding individuals with the respective symptoms 180 days prior to the index event. Stratified analyses were conducted by age and sex. Incidence rate ratios (IRRs) were calculated comparing rates in the infected cohort versus the general population. Results from the different databases were combined using random-effects meta-analyses.</p><p><strong>Findings: </strong>3,019,408 individuals were included in the infection cohort. 1,585,160 of them were female and 1,434,248 of them male. 929,351,505 individuals were included in the general population group. 461,195,036 of them were female and 466,022,004 of them male. The 1-year IR of any post-acute COVID-19 symptom in the COVID-19 infection cohort varied significantly across databases, from 4.4 (95% CI 3.8-5.1) per 100 person-years to 103.9 (95% CI 103.2-104.7). The five most common symptoms were joint pain (from 1.6 (95% CI 1.3-1.9) to 14.3 (95% CI 14.1-14.6)), abdominal pain (from 0.3 (95% CI 0.1-0.5) to 9.9 (95% CI 9.7-10.1)), gastrointestinal issues (from 0.6 (95% CI 0.4-0.9) to 13.3 (95% CI 13.1-13.6)), cough (from 0.3 (95% CI 0.2-0.5) to 9.1 (95% CI 8.9-9.3)), and anxiety (from 0.8 (95% CI 0.6-1.2) to 11.4 (95% CI 11.2-11.6)); whereas muscle spasms (from 0.01 (95% CI 0.008-0.2) to 1.7 (95% CI 1.6-1.8)), pins and needles (from 0.05 (95% CI 0.03-0.0.9) to 1.5 (95% CI 1.4-1.6)), memory issues (from 0.03 (95% CI 0.02-0.06) to 0.8 (95% CI 0.7-0.8)), cognitive dysfunction (from 0.007 (95% CI 0.004-0.01) to 0.6 (95% CI 0.4-0.8)), and altered smell and/or taste (from 0.04 (95% CI 0.03-0.04) to 0.7 (95% CI 0.6-0.8)) were least common. Incidence rates of any post-acute COVID-19 symptoms general","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102903"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11564986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647666","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}
Pub Date : 2024-10-30eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102891
Ahmed Salih, Aksaan Arif, Madhur Varadpande, Rafael Tiza Fernandes, Dragan Jankovic, Darius Kalasauskas, Malte Ottenhausen, Andreas Kramer, Florian Ringel, Santhosh G Thavarajasingam
Background: Idiopathic normal pressure hydrocephalus (iNPH) is commonly treated using cerebrospinal fluid (CSF) diversion procedures, most commonly ventriculoperitoneal (VP) but also lumboperitoneal (LP), ventriculoatrial (VA) shunting, and endoscopic third-ventriculostomy (ETV). Despite the prevalence of these interventions and recent advancements in iNPH diagnostic processes, there is limited up-to-date evidence regarding surgical outcomes.
Methods: A systematic review and meta-analysis were conducted to analyse the effects of CSF diversion surgeries among iNPH patients. The primary outcome was efficacy of the CSF diversion procedure, defined as symptomatic improvement, and secondary outcomes included surgical complications. Several major databases were searched for original studies from inception up to June 4, 2024, which were evaluated using random-effects meta-analyses, meta-regression, and influence analyses. This study was registered with PROSPERO: CRD42023458526.
Findings: Out of the 1963 studies screened, 54 were included in this review, and 4811 patients were pooled. Overall, more than 74% of patients experienced improvement after surgical treatment (95% CI: 70-78%). VP shunting demonstrated an efficacy of 75% (95% CI 70-79%), VA shunting at 75% (95% CI: 70-80%), and LP shunting at 70% (95% CI: 52-83%). ETV had a success rate of 69% (95% CI: 58-78%). Gait improvement was high at 72% (95% CI: 67-77%), while urinary and cognitive dysfunction each improved in approximately 50% of patients. The efficacy of surgery did not increase between 2005 and 2024 (p = 0.54). Complications occurred in 20.6% of cases, with a surgery revision rate of 15.1%.
Interpretation: This meta-analysis found that the overall efficacy of CSF diversion procedures for iNPH remained unchanged from 2005 to 2024, with 74% of cases showing improvement. No procedure was found to be clearly superior, and only half of the patients saw improvements in urinary and cognitive dysfunction. The stagnant efficacy over time and frequent complications highlight the need for improved patient selection criteria to best identify those most likely to benefit from CSF shunting.
{"title":"The effectiveness of various CSF diversion surgeries in idiopathic normal pressure hydrocephalus: a systematic review and meta-analysis.","authors":"Ahmed Salih, Aksaan Arif, Madhur Varadpande, Rafael Tiza Fernandes, Dragan Jankovic, Darius Kalasauskas, Malte Ottenhausen, Andreas Kramer, Florian Ringel, Santhosh G Thavarajasingam","doi":"10.1016/j.eclinm.2024.102891","DOIUrl":"10.1016/j.eclinm.2024.102891","url":null,"abstract":"<p><strong>Background: </strong>Idiopathic normal pressure hydrocephalus (iNPH) is commonly treated using cerebrospinal fluid (CSF) diversion procedures, most commonly ventriculoperitoneal (VP) but also lumboperitoneal (LP), ventriculoatrial (VA) shunting, and endoscopic third-ventriculostomy (ETV). Despite the prevalence of these interventions and recent advancements in iNPH diagnostic processes, there is limited up-to-date evidence regarding surgical outcomes.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted to analyse the effects of CSF diversion surgeries among iNPH patients. The primary outcome was efficacy of the CSF diversion procedure, defined as symptomatic improvement, and secondary outcomes included surgical complications. Several major databases were searched for original studies from inception up to June 4, 2024, which were evaluated using random-effects meta-analyses, meta-regression, and influence analyses. This study was registered with PROSPERO: CRD42023458526.</p><p><strong>Findings: </strong>Out of the 1963 studies screened, 54 were included in this review, and 4811 patients were pooled. Overall, more than 74% of patients experienced improvement after surgical treatment (95% CI: 70-78%). VP shunting demonstrated an efficacy of 75% (95% CI 70-79%), VA shunting at 75% (95% CI: 70-80%), and LP shunting at 70% (95% CI: 52-83%). ETV had a success rate of 69% (95% CI: 58-78%). Gait improvement was high at 72% (95% CI: 67-77%), while urinary and cognitive dysfunction each improved in approximately 50% of patients. The efficacy of surgery did not increase between 2005 and 2024 (p = 0.54). Complications occurred in 20.6% of cases, with a surgery revision rate of 15.1%.</p><p><strong>Interpretation: </strong>This meta-analysis found that the overall efficacy of CSF diversion procedures for iNPH remained unchanged from 2005 to 2024, with 74% of cases showing improvement. No procedure was found to be clearly superior, and only half of the patients saw improvements in urinary and cognitive dysfunction. The stagnant efficacy over time and frequent complications highlight the need for improved patient selection criteria to best identify those most likely to benefit from CSF shunting.</p><p><strong>Funding: </strong>None for this study.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102891"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616878","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}
<p><strong>Background: </strong>The survival rate of patients with distant metastasis (DM) of papillary thyroid carcinoma (PTC) is significantly reduced. It is of great significance to find an effective method for early prediction of the risk of DM for formulating individualized diagnosis and treatment plans and improving prognosis. Previous studies have significant limitations, and it is still necessary to develop new models for predicting the risk of DM of PTC. We aimed to develop and validate interpretable machine learning (ML) models for early prediction of DM in patients with PTC using a multicenter cohort.</p><p><strong>Methods: </strong>We collected data on patients with PTC who were admitted between June 2013 and May 2023. Data from 1430 patients at Yunnan Cancer Hospital (YCH) served as the training and internal validation set, while data from 434 patients at the First Affiliated Hospital of Kunming Medical University (KMU 1st AH) was used as the external test set. Nine ML methods such as random forest (RF) were used to construct the model. Model prediction performance was compared using evaluation indicators such as the area under the receiver operating characteristic curve (AUC). The SHapley Additive exPlanation (SHAP) method was used to rank the feature importance and explain the final model.</p><p><strong>Findings: </strong>Among the nine ML models, the RF model performed the best. The RF model accurately predicted the risk of DM in patients with PTC in both the internal validation of the training set [AUC: 0.913, 95% confidence interval (CI) (0.9075-0.9185)] and the external test set [AUC: 0.8996, 95% CI (0.8483-0.9509)]. The calibration curve showed high agreement between the predicted and observed risks. In the sensitivity analysis focusing on DM sites of PTC, the RF model exhibited outstanding performance in predicting "lung-only metastasis" showing high AUC, specificity, sensitivity, F1 score, and a low Brier score. SHAP analysis identified variables that contributed to the model predictions. An online calculator based on the RF model was developed and made available for clinicians at https://predictingdistantmetastasis.shinyapps.io/shiny1/. 11 variables were included in the final RF model: age of the patient with PTC, whether the tumor size is > 2 cm, whether the tumor size is ≤ 1 cm, lymphocyte (LYM) count, monocyte (MONO) count, monocyte/lymphocyte ratio (MLR), thyroglobulin (TG) level, thyroid peroxidase antibody (TPOAb) level, whether the T stage is T1/2, whether the T stage is T3/4, and whether the N stage is N0.</p><p><strong>Interpretation: </strong>On the basis of large-sample and multicenter data, we developed and validated an explainable ML model for predicting the risk of DM in patients with PTC. The model helps clinicians to identify high-risk patients early and provides a basis for individualized patient treatment plans.</p><p><strong>Funding: </strong>This work was supported by the National Natural Science Foundat
{"title":"Development and validation of an interpretable machine learning model for predicting the risk of distant metastasis in papillary thyroid cancer: a multicenter study.","authors":"Fei Hou, Yun Zhu, Hongbo Zhao, Haolin Cai, Yinghui Wang, Xiaoqi Peng, Lin Lu, Rongli He, Yan Hou, Zhenhui Li, Ting Chen","doi":"10.1016/j.eclinm.2024.102913","DOIUrl":"10.1016/j.eclinm.2024.102913","url":null,"abstract":"<p><strong>Background: </strong>The survival rate of patients with distant metastasis (DM) of papillary thyroid carcinoma (PTC) is significantly reduced. It is of great significance to find an effective method for early prediction of the risk of DM for formulating individualized diagnosis and treatment plans and improving prognosis. Previous studies have significant limitations, and it is still necessary to develop new models for predicting the risk of DM of PTC. We aimed to develop and validate interpretable machine learning (ML) models for early prediction of DM in patients with PTC using a multicenter cohort.</p><p><strong>Methods: </strong>We collected data on patients with PTC who were admitted between June 2013 and May 2023. Data from 1430 patients at Yunnan Cancer Hospital (YCH) served as the training and internal validation set, while data from 434 patients at the First Affiliated Hospital of Kunming Medical University (KMU 1st AH) was used as the external test set. Nine ML methods such as random forest (RF) were used to construct the model. Model prediction performance was compared using evaluation indicators such as the area under the receiver operating characteristic curve (AUC). The SHapley Additive exPlanation (SHAP) method was used to rank the feature importance and explain the final model.</p><p><strong>Findings: </strong>Among the nine ML models, the RF model performed the best. The RF model accurately predicted the risk of DM in patients with PTC in both the internal validation of the training set [AUC: 0.913, 95% confidence interval (CI) (0.9075-0.9185)] and the external test set [AUC: 0.8996, 95% CI (0.8483-0.9509)]. The calibration curve showed high agreement between the predicted and observed risks. In the sensitivity analysis focusing on DM sites of PTC, the RF model exhibited outstanding performance in predicting \"lung-only metastasis\" showing high AUC, specificity, sensitivity, F1 score, and a low Brier score. SHAP analysis identified variables that contributed to the model predictions. An online calculator based on the RF model was developed and made available for clinicians at https://predictingdistantmetastasis.shinyapps.io/shiny1/. 11 variables were included in the final RF model: age of the patient with PTC, whether the tumor size is > 2 cm, whether the tumor size is ≤ 1 cm, lymphocyte (LYM) count, monocyte (MONO) count, monocyte/lymphocyte ratio (MLR), thyroglobulin (TG) level, thyroid peroxidase antibody (TPOAb) level, whether the T stage is T1/2, whether the T stage is T3/4, and whether the N stage is N0.</p><p><strong>Interpretation: </strong>On the basis of large-sample and multicenter data, we developed and validated an explainable ML model for predicting the risk of DM in patients with PTC. The model helps clinicians to identify high-risk patients early and provides a basis for individualized patient treatment plans.</p><p><strong>Funding: </strong>This work was supported by the National Natural Science Foundat","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102913"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11567106/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647665","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}
Pub Date : 2024-10-30eCollection Date: 2024-11-01DOI: 10.1016/j.eclinm.2024.102892
Hannah Linne
{"title":"UK Congress on Obesity 2024.","authors":"Hannah Linne","doi":"10.1016/j.eclinm.2024.102892","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102892","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102892"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616882","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}