Neurology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-22DOI: 10.1007/s40120-024-00666-x
Heling Chu, Chuyi Huang, Fang Xie, Qihao Guo
{"title":"The Association Between Constipation and Positron Emission Tomography and Blood-Based Biomarkers in Older Cognitively Unimpaired Adults with Higher Amyloid-β Burden.","authors":"Heling Chu, Chuyi Huang, Fang Xie, Qihao Guo","doi":"10.1007/s40120-024-00666-x","DOIUrl":"10.1007/s40120-024-00666-x","url":null,"abstract":"<p><strong>Introduction: </strong>Constipation may be linked to cognitive decline and a higher risk of Alzheimer's disease (AD). We aimed to investigate the association between constipation and positron emission tomography (PET) and blood-based AD biomarkers in older cognitively unimpaired (CU) adults with higher Aβ burden.</p><p><strong>Methods: </strong>Constipation was diagnosed according to Rome IV criteria and the severity of constipation was evaluated by using a validated self-reported questionnaire. The participants underwent the examination of plasma AD biomarkers and <sup>18</sup>F-florbetapir PET and <sup>18</sup>F-MK6240 PET scans; the latter was only performed in the validation cohort. Correlation and multiple linear regression analyses were used to investigate the association between constipation and AD biomarkers.</p><p><strong>Results: </strong>Two cohorts were included in our study. A total of 404 older participants with 126 of whom Aβ-PET positive were enrolled in the development cohort. Multiple linear regression analysis showed constipation was associated with plasma t-Tau, p-Tau-181, and neurofilament light chain (NfL) in participants with Aβ-PET (+). Meanwhile, no/mild constipation was associated with lower Aβ-PET standard uptake value ratio. The association between constipation and plasma biomarkers was different in the subgroups stratified by age, sex and APOE ε4 genotype. The above associations were further validated in the validation cohort containing 36 Aβ-PET (+) participants. Importantly, no/mild constipation was associated with less Tau burden evaluated by <sup>18</sup>F-MK6240 PET Braak stages.</p><p><strong>Conclusion: </strong>Our data indicate that no/mild constipation may be associated with lower plasma t-Tau, p-Tau-181, and NfL as well as less Aβ and Tau burden in older CU adults with Aβ deposition. Improving constipation and being away from defecation disorders may help reduce the risk of AD development.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1701-1715"},"PeriodicalIF":3.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142470988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Neurology and TherapyPub Date : 2024-12-01Epub Date: 2024-09-06DOI: 10.1007/s40120-024-00657-y
Michael Lane, Michael Polydefkis
{"title":"Symptoms of Hereditary Transthyretin Amyloidosis: The Patient and Physician Perspective.","authors":"Michael Lane, Michael Polydefkis","doi":"10.1007/s40120-024-00657-y","DOIUrl":"10.1007/s40120-024-00657-y","url":null,"abstract":"<p><p>This article has been co-authored by a patient living with hereditary transthyretin (ATTRv) amyloidosis and a neurologist. This rare, progressive disease is associated with impairment of multiple organ systems, including the nerves, heart, and the gastrointestinal tract, forcing patients to live with and adapt to a range of debilitating symptoms. Here, the patient and physician discuss how the symptoms of ATTRv amyloidosis profoundly impact day to day life, the difficulties with identifying the disease, and how this effects the diagnosis experience. In recent years, significant advancements have been made in the treatment and management of ATTRv amyloidosis. However, the authors highlight the urgency of increasing awareness of the disease among the wider medical community, as well as in patients who notice the symptoms, to ensure that earlier diagnosis and appropriate treatment are achieved.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1527-1533"},"PeriodicalIF":3.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Neurology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-08DOI: 10.1007/s40120-024-00664-z
Alexandra Wicker, Jahnavi Shriram, Boris Decourt, Marwan Noel Sabbagh
{"title":"Passive Anti-amyloid Beta Monoclonal Antibodies: Lessons Learned over Past 20 Years.","authors":"Alexandra Wicker, Jahnavi Shriram, Boris Decourt, Marwan Noel Sabbagh","doi":"10.1007/s40120-024-00664-z","DOIUrl":"10.1007/s40120-024-00664-z","url":null,"abstract":"<p><p>Alzheimer's disease (AD) is a neurodegenerative disorder that significantly impairs cognitive and functional abilities, placing a substantial burden on both patients and caregivers. Current symptomatic treatments fail to halt the progression of AD, highlighting the urgent need for more effective disease-modifying therapies (DMTs). DMTs under development are classified as either passive or active on the basis of their mechanisms of eliciting an immune response. While this review will touch on active immunotherapies, we primarily focus on anti-amyloid beta monoclonal antibodies (mAbs), a form of passive immunotherapy, discussing their multifaceted role in AD treatment and the critical factors influencing their therapeutic efficacy. With two mAbs now approved and prescribed in the clinical setting, it is crucial to reflect on the lessons learned from trials of earlier mAbs that have shaped their development and contributed to their current success. These insights can then guide the creation of even more effective mAbs, ultimately enhancing therapeutic outcomes for patients with AD while minimizing adverse events.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1571-1595"},"PeriodicalIF":3.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142392096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Neurology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-25DOI: 10.1007/s40120-024-00672-z
Conghui Wei, Jinling Chen, Qu Yang, Jingjing Xu, Qingsong Li, Fulin Li, Yu Liu, Jun Luo
{"title":"Effects of Manual Acupuncture Versus Sham Acupuncture in patients with Post-Stroke Depression: A Randomized Clinical Trial.","authors":"Conghui Wei, Jinling Chen, Qu Yang, Jingjing Xu, Qingsong Li, Fulin Li, Yu Liu, Jun Luo","doi":"10.1007/s40120-024-00672-z","DOIUrl":"10.1007/s40120-024-00672-z","url":null,"abstract":"<p><strong>Background: </strong>Post-stroke depression (PSD) is a prevalent psychiatric complication in stroke patients, severely reducing quality of life and delaying social recovery in stroke survivors. Clinical studies have shown that acupuncture can be used as an alternative approach for PSD. The aim of this study was to examine the safety, efficacy, and electroencephalogram (EEG) mechanism of acupuncture in treating PSD patients.</p><p><strong>Methods: </strong>From October 28, 2022 to May 16, 2023, this single-center, single-blind, randomized clinical trial was conducted at the Second Affiliated Hospital of Nanchang University. A total of 56 eligible subjects were assigned in a random manner, with an equal distribution between two groups: the manual acupuncture (MA) group and the sham acupuncture (SA) group. The primary outcome was the Hamilton Depression Scale-24 (HAMD-24); the secondary outcomes included the Pittsburgh Sleep Quality Index (PSQI), the National Institutes of Health Stroke Scale (NIHSS), the Barthel index, EEG power spectrum, and EEG imaginary coherent (iCOH).</p><p><strong>Results: </strong>Compared to the SA group, the MA group exhibited significant improvements in HAMD-24, NIHSS, PSIQ, and Barthel index at week 6. The total improvement rate was 85.71% in the MA group and 28.57% in the SA group. After 6 weeks of treatment, the alpha and beta bands power spectrum increased significantly, while the delta and theta bands power spectrum decreased significantly in the MA group compared to the SA group. The iCOH analysis showed that the MA group had significantly higher functional connectivity in the four bands than the SA group.</p><p><strong>Conclusions: </strong>Acupuncture might be regarded as an adjunctive treatment for PSD patients with improvements in their neurological deficits, sleep quality, and depression. Meanwhile, the mechanism of acupuncture in treating PSD patients may be through decreasing the slow wave power spectrum and increasing the fast wave power spectrum, and enhancing brain functional connectivity.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR2200065112/2022-10-28).</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1717-1735"},"PeriodicalIF":3.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142504891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Neurology and TherapyPub Date : 2024-12-01Epub Date: 2024-09-18DOI: 10.1007/s40120-024-00649-y
Malaz Boustani, Erin G Doty, Louis P Garrison, Lee J Smolen, Timothy M Klein, Daniel R Murphy, Andrew W Spargo, Mark Belger, Joseph A Johnston
{"title":"Estimating the Economically Justifiable Price of Limited-Duration Treatment with Donanemab for Early Symptomatic Alzheimer's Disease in the United States.","authors":"Malaz Boustani, Erin G Doty, Louis P Garrison, Lee J Smolen, Timothy M Klein, Daniel R Murphy, Andrew W Spargo, Mark Belger, Joseph A Johnston","doi":"10.1007/s40120-024-00649-y","DOIUrl":"10.1007/s40120-024-00649-y","url":null,"abstract":"<p><strong>Introduction: </strong>The goal of this economic model is to estimate an economically justifiable price (EJP) for using donanemab for the treatment of early symptomatic Alzheimer's disease (AD) in the United States based on clinical data from the phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511).</p><p><strong>Methods: </strong>We adapted an AD Markov state-transition model developed by the Institute for Clinical and Economic Review to estimate the EJP for donanemab at different willingness-to-pay (WTP) thresholds from the health care system perspective and the societal perspective as co-base cases.</p><p><strong>Results: </strong>Assuming a WTP threshold of $150,000 per quality-adjusted life-year (QALY) gained, the model estimates a 1-year (13-dose) EJP for donanemab of $80,538 from the health care system perspective and $91,126 from the societal perspective; at a WTP threshold of $100,000 per QALY gained, the model estimates a 1-year (13-dose) EJP for donanemab of $44,691 from the health care system perspective and $55,419 from the societal perspective. Mean total treatment costs per patient at the $150,000 per QALY gained EJP derived from the health care system perspective were estimated at $77,812 based on the average number of doses of donanemab patients received in the co-base case analysis. One-way sensitivity analysis (OWSA) indicated that treatment efficacy, disease severity at the time of treatment initiation, and duration of treatment effect were the main drivers of the potential EJP.</p><p><strong>Conclusions: </strong>Results from this modeling simulation informed by the TRAILBLAZER-ALZ 2 study support an EJP for limited-duration treatment with donanemab that exceeds per-dose list prices for currently available amyloid-targeting therapies, implying potentially lower lifetime costs and better value for money.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"1641-1659"},"PeriodicalIF":3.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142292222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jesús Pérez-Pérez, Sofía García-López, Tamara Fernández Valle, Cèlia Painous, Maria Rosa Querol-Pascual, Pedro J García Ruiz, Elena Bellosta Diago, Esther Cubo Delgado, Barbara Vives Pastor, María Carmen Peiró Villaplana, Idaira Martín Santana, Marta Blázquez Estrada, Matilde Calopa Garride, Pablo Mir, Carmen Álvarez, Jorge Maurino, Anna de Prado, José Luis López-Sendón
{"title":"Correction: Huntington Disease Health Related Quality of Life, Function and Well Being: The Patient's Perspective.","authors":"Jesús Pérez-Pérez, Sofía García-López, Tamara Fernández Valle, Cèlia Painous, Maria Rosa Querol-Pascual, Pedro J García Ruiz, Elena Bellosta Diago, Esther Cubo Delgado, Barbara Vives Pastor, María Carmen Peiró Villaplana, Idaira Martín Santana, Marta Blázquez Estrada, Matilde Calopa Garride, Pablo Mir, Carmen Álvarez, Jorge Maurino, Anna de Prado, José Luis López-Sendón","doi":"10.1007/s40120-024-00683-w","DOIUrl":"https://doi.org/10.1007/s40120-024-00683-w","url":null,"abstract":"","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142682249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeff Schein, Martin Cloutier, Marjolaine Gauthier-Loiselle, Maryaline Catillon, Yan Meng, Beatrice Libchaber, Fanny Jiang, Ann Childress
{"title":"Treatment Preferences of Physicians Treating Adult Patients with Attention-Deficit/Hyperactivity Disorder in the United States and Canada: A Discrete Choice Experiment.","authors":"Jeff Schein, Martin Cloutier, Marjolaine Gauthier-Loiselle, Maryaline Catillon, Yan Meng, Beatrice Libchaber, Fanny Jiang, Ann Childress","doi":"10.1007/s40120-024-00681-y","DOIUrl":"https://doi.org/10.1007/s40120-024-00681-y","url":null,"abstract":"<p><strong>Introduction: </strong>Factors influencing attention-deficit/hyperactivity disorder (ADHD) treatment preferences have been studied among patients but not physicians in the United States (US) and Canada. This study assessed treatment preferences of physicians treating adult patients with ADHD in both countries.</p><p><strong>Methods: </strong>An online discrete choice experiment (DCE) was conducted (October 4-20, 2023) among physicians from Dynata's US and Canadian panel who treated adult patients with ADHD. Preference weights for efficacy (improvement in ADHD symptoms) and safety [risks of adverse events (AEs)] attributes were estimated using a conditional logistic regression model, and were used to calculate the willingness to trade-off and relative importance of the attributes.</p><p><strong>Results: </strong>Among 510 US and 347 Canadian physicians (64.1% and 69.2% male, respectively), improvement in ADHD symptoms had a significant positive impact, and the risks of AEs (except the risk of feeling jittery in Canada) had a significant negative impact on physician preferences for ADHD treatments. US physicians were willing to tradeoff 0.44, 0.35, 0.20, 0.17, and 0.17 percentage points of improvement in ADHD symptoms to avoid a one-percentage-point risk of insomnia, nausea, feeling jittery, anxiety, and dry mouth, respectively; among Canadian physicians, these were 0.31, 0.21, 0.12, 0.20, and 0.07, respectively. The relative importance of the efficacy versus safety attributes (i.e., the risks of AEs included in the DCE taken together) was 45.5% versus 54.5% in the US and 56.3% versus 43.7% in Canada.</p><p><strong>Conclusion: </strong>Efficacy was the most important single attribute for physicians treating adult patients with ADHD in both the US and Canada; however, the risks of AEs taken together had greater relative importance than efficacy alone among US but not Canadian physicians. These findings highlight potential discrepancies in physician and patient preferences based on existing evidence and underscore the importance of shared decision-making, which may in turn increase patients' treatment satisfaction.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pierre Labauge, Alain Créange, Thibault Moreau, Jocelyne Nouvet-Gire, Bernard Pedespan, Olivier Heinzlef, Nathalie Texier, Marilyn Gros, Catherine Marti, Marta Ruiz, Mikel Martinez, Giovanni Castelnovo
{"title":"TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.","authors":"Pierre Labauge, Alain Créange, Thibault Moreau, Jocelyne Nouvet-Gire, Bernard Pedespan, Olivier Heinzlef, Nathalie Texier, Marilyn Gros, Catherine Marti, Marta Ruiz, Mikel Martinez, Giovanni Castelnovo","doi":"10.1007/s40120-024-00674-x","DOIUrl":"https://doi.org/10.1007/s40120-024-00674-x","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies.</p><p><strong>Methods: </strong>TEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase 4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month 0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs).</p><p><strong>Results: </strong>Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain.</p><p><strong>Conclusion: </strong>These outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04221191.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142624959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lukas G Reeß, Hadi Salih, Murat Delikaya, Friedemann Paul, Frederike Cosima Oertel
{"title":"Barriers in Healthcare to the Use of Optical Coherence Tomography Angiography in Multiple Sclerosis.","authors":"Lukas G Reeß, Hadi Salih, Murat Delikaya, Friedemann Paul, Frederike Cosima Oertel","doi":"10.1007/s40120-024-00670-1","DOIUrl":"https://doi.org/10.1007/s40120-024-00670-1","url":null,"abstract":"<p><p>Optical coherence tomography angiography (OCT-A) is a state-of-the-art imaging technique for the retinal vasculature to accurately segment the capillary network and assign it to retinal layers. OCT-A is a promising technique to better understand neurological diseases with visual system manifestations, such as multiple sclerosis (MS), and to identify and characterize vascular biomarkers. Initial studies suggested vascular changes in MS and its differential diagnoses such as myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and neuromyelitis optica spectrum disorder (NMOSD). Here we review clinical and technical aspects of OCT-A imaging and discuss the potential for the MS field as well as barriers that need to be overcome before OCT-A can be established in clinical application.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yuhui Chen, Li Chen, Liang Xian, Haibing Liu, Jiaxing Wang, Shaohuai Xia, Liangfeng Wei, Xuewei Xia, Shousen Wang
{"title":"Development and Validation of a Novel Classification System and Prognostic Model for Open Traumatic Brain Injury: A Multicenter Retrospective Study.","authors":"Yuhui Chen, Li Chen, Liang Xian, Haibing Liu, Jiaxing Wang, Shaohuai Xia, Liangfeng Wei, Xuewei Xia, Shousen Wang","doi":"10.1007/s40120-024-00678-7","DOIUrl":"https://doi.org/10.1007/s40120-024-00678-7","url":null,"abstract":"<p><strong>Introduction: </strong>Open traumatic brain injury (OTBI) is associated with high mortality and morbidity; however, the classification of these injuries and the determination of patient prognosis remain uncertain, hindering the selection of optimal treatment strategies. This study aimed to develop and validate a novel OTBI classification system and a prognostic model for poor prognosis.</p><p><strong>Methods: </strong>This retrospective study included patients with isolated OTBI who received treatment at three large medical centers in China between January 2020 and June 2022 as the training set. Data on patients with OTBI collected at the Fuzong Clinical Medical College of Fujian Medical University between July 2022 and June 2023 were used as the validation set. Clinical parameters, including clinical data at admission, radiological and laboratory findings, details of surgical methods, and prognosis were collected. Prognosis was assessed through a dichotomized Glasgow Outcome Scale (GOS). A novel OTBI classification was proposed, categorizing patients based on a combination of intracranial hematoma and midline shift observed on imaging, and logistic regression analyses were performed to identify risk factors associated with poor prognosis and to investigate the association between the novel OTBI classification and prognosis. Finally, a nomogram suitable for clinical application was established and validated.</p><p><strong>Results: </strong>Multivariable logistic regression analysis identified OTBI classification type C (p < 0.001), a Glasgow Coma Scale score (GCS) ≤ 8 (p < 0.001), subarachnoid hemorrhage (SAH) (p = 0.004), subdural hematoma (SDH) (p = 0.011), and coagulopathy (p = 0.020) as independent risk factors for poor prognosis. The addition of the OTBI classification to a model containing all the other identified prognostic factors improved the predictive ability of the model (Z = 1.983; p = 0.047). In the validation set, the model achieved an area under the curve (AUC) of 0.917 [95% confidence interval (CI) = 0.864-0.970]. The calibration curve closely approximated the ideal curve, indicating strong predictive performance of the model.</p><p><strong>Conclusions: </strong>The implementation of our proposed OTBI classification system and its use alongside the other prognostic factors identified here may improve the prediction of patient prognosis and aid in the selection of the most suitable treatment strategies.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.9,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}