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Post-infectious autoimmune disorder involving the CNS and PNS following SARS-CoV-2 infection - a clinical-morphological case report. SARS-CoV-2感染后涉及中枢神经系统和PNS的感染后自身免疫性疾病-临床形态学病例报告
IF 3.2 Q2 Medicine Pub Date : 2025-10-15 DOI: 10.1186/s42466-025-00436-6
Vincent Umathum, Carolin König, Dirk Bandorski, Lukas Scheffer, Joachim Weis, Heidrun H Krämer, Jens Allendörfer, Anne Schänzer

Post-COVID can be associated with neurological symptoms such as neuropathy or fatigue. Histological analysis of affected nerves is rarely described and post mortem study of the brain and peripheral nerves are carried out only in few cases.In the case report, we describe the clinical and neuropathological findings of a 75-year-old female patient who presented with a motor and sensory axonal neuropathy after a SARS-CoV-2 infection seven weeks before and suddenly died. Laboratory testing of serum and CSF revealed no signs of systemic vasculitis or infectious diseases. A post mortem investigation was performed. Samples from the brain including the cranial nerves, peripheral nerves and skeletal muscles from different regions were analysed.The brain revealed lymphocytic cells predominantly in the basal ganglia and brain stem with involvement of the cranial nerves. Interestingly, a CNS involvement was not observed during lifetime. The sensory and motor peripheral nerves revealed a severe axonal neuritis. Skeletal muscle showed a neurogenic atrophy.This case report highlights that a post-infectious autoimmune disorder with CNS and PNS involvement should be considered in patients with post-COVID. The diagnosis of an ongoing inflammation may influence the treatment options.

新冠肺炎后可能与神经病变或疲劳等神经系统症状有关。受影响神经的组织学分析很少被描述,脑和周围神经的死后研究仅在少数情况下进行。在病例报告中,我们描述了一名75岁女性患者的临床和神经病理学结果,她在7周前感染SARS-CoV-2后出现运动和感觉轴索神经病变并突然死亡。血清和脑脊液的实验室检测未发现系统性血管炎或传染病的迹象。进行了验尸调查。分析了来自大脑不同区域的样本,包括脑神经、周围神经和骨骼肌。脑显示淋巴细胞主要分布于基底神经节和脑干,并累及脑神经。有趣的是,在一生中没有观察到中枢神经系统受累。感觉和运动周围神经显示严重的轴突神经炎。骨骼肌表现为神经源性萎缩。本病例报告强调,covid后患者应考虑感染后自身免疫性疾病并累及中枢神经系统和PNS。持续炎症的诊断可能会影响治疗方案。
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引用次数: 0
The race against time: patterns and variables of spine surgery timing in traumatic spinal cord injury: a retrospective cohort study from the TraumaRegister DGU®. 与时间赛跑:外伤性脊髓损伤脊柱手术时机的模式和变量:来自《创伤登记》杂志DGU®的回顾性队列研究。
IF 3.2 Q2 Medicine Pub Date : 2025-10-10 DOI: 10.1186/s42466-025-00429-5
Till Kamradt, Stefan Hemmer, Raphael Trefzer, Gerhard Schmidmaier, Andreas Hug, Rüdiger Rupp, Rolf Lefering, Norbert Weidner

Background: Numerous uncontrolled observational studies suggest that early spinal decompression and stabilization within 24 h of spinal cord injury (SCI) improve neurological recovery, forming the basis for recently published best practice guidelines. In this study, we aim to investigate current surgical practices in trauma centers across Germany, Austria, and Switzerland and to elucidate trauma- and patient-related factors influencing the timing of spine surgery.

Methods: We identified patients aged 16 years or older with traumatic SCI and permanent neurological deficits from the TraumaRegister DGU® of the German Trauma Society (2008-2022). Trauma severity was assessed using the Abbreviated Injury Scale. Patients were categorized based on the timing of spine surgery (early surgery: day of admission; late surgery: subsequent days) and functional impairment (moderate vs. severe, based on the Glasgow Outcome Scale). Multivariate regression analyses were conducted to correlate patient and trauma-related factors with these endpoints.

Results: A total of 9938 patients with SCI at cervical, thoracic, and lumbar levels were identified. Among the 5025 patients who underwent spine surgery, 69% were operated on the day of admission, while 31% received surgery on subsequent days. Elderly patients (≥ 60 years) had a higher likelihood of delayed surgery (odds ratio [OR] 0.68-0.76). Trauma-related factors, including high cervical SCI, significant injuries beyond the spine, traumatic brain injury, and signs of hemorrhage, were strongly associated with late surgery (OR 0.38-0.83; p < 0.05). Conversely, patients with complete SCI or SCI at the thoracic or lumbar levels were more likely to undergo early surgery (OR 1.45-1.8; p < 0.001). Severe functional impairment was associated with advanced age (≥ 70 years), complete SCI, high cervical SCI, concomitant traumatic brain, signs of hemorrhage and comorbidities (OR 1.27-4.59; p < 0.01), whereas SCI at thoracic (OR 0.8) and lumbar (OR 0.4) levels correlated with moderate functional impairment (p < 0.01).

Conclusion: The majority of SCI patients in trauma centers across Germany, Austria, and Switzerland undergo early spinal surgery, reflecting adherence to best practice recommendations. Timing of surgery is significantly influenced by patient age and trauma complexity. Delays are more common in elderly patients and those with high cervical injuries or associated trauma, underscoring the need for individualized surgical decision-making. Given the strong correlation between injury severity, surgical timing, and functional impairment, future guidelines should refine criteria for early intervention to further optimize neurological recovery.

背景:大量未对照的观察性研究表明,脊髓损伤(SCI)后24小时内的早期脊髓减压和稳定可以改善神经功能恢复,这为最近发表的最佳实践指南奠定了基础。在这项研究中,我们旨在调查德国、奥地利和瑞士创伤中心目前的外科实践,并阐明影响脊柱手术时机的创伤和患者相关因素。方法:我们从德国创伤学会的创伤登记DGU®(2008-2022)中筛选年龄在16岁或以上的创伤性脊髓损伤和永久性神经功能缺损患者。使用简易损伤量表评估创伤严重程度。根据脊柱手术的时间(早期手术:入院当天;晚期手术:随后几天)和功能损害(根据格拉斯哥结局量表,中度与重度)对患者进行分类。进行多变量回归分析,将患者和创伤相关因素与这些终点联系起来。结果:共确定了9938例颈椎、胸椎和腰椎水平的脊髓损伤患者。在5025例接受脊柱手术的患者中,69%的患者在入院当天接受手术,31%的患者在随后的几天接受手术。老年患者(≥60岁)延迟手术的可能性较高(优势比[OR] 0.68-0.76)。创伤相关因素,包括高度颈椎损伤、脊柱外严重损伤、创伤性脑损伤和出血迹象,与晚期手术密切相关(OR 0.38-0.83; p)。结论:在德国、奥地利和瑞士的创伤中心,大多数脊髓损伤患者接受了早期脊柱手术,反映了对最佳实践建议的遵守。手术时机受患者年龄和创伤复杂性的显著影响。延迟在老年患者和颈椎高度损伤或相关创伤的患者中更为常见,强调了个性化手术决策的必要性。考虑到损伤严重程度、手术时机和功能损害之间的相关性,未来的指南应该完善早期干预的标准,以进一步优化神经系统恢复。
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引用次数: 0
State of the art: glioma-associated epilepsy-bridging tumor biology and epileptogenesis. 最新进展:神经胶质瘤相关的癫痫桥接肿瘤生物学和癫痫发生。
IF 3.2 Q2 Medicine Pub Date : 2025-10-10 DOI: 10.1186/s42466-025-00434-8
Iris Divé, Anna-Luisa Luger, Dorothea Muench, Katharina J Weber, Joachim P Steinbach, Felix Rosenow, Frank Winkler, Pia S Zeiner

Background: Glioma-associated epilepsy (GAE) is a frequent and clinically significant complication in neuro-oncological practice. Its prevalence varies across glioma subtypes and is influenced by tumor biology, cortical involvement, tumor size, extent of resection, and disease progression. Despite its substantial impact on quality of life and clinical outcomes, GAE remains underrepresented in neurological and neuro-oncological guidelines. Moreover, novel findings in molecular subtyping and their relevance to tumor biology and GAE pathogenesis are not yet adequately reflected in clinical frameworks. Here, we aim to provide a comprehensive synthesis of epidemiology, pathophysiology, and management strategies for GAE based on the recent advances in glioma biology, cancer neuroscience, and epileptology.

Main body: This review highlights recent insights into the epidemiology, clinical impact, pathophysiology, and therapeutic strategies for GAE. We focus on both lower-grade gliomas, in which GAE is most prevalent over lifetime-particularly in tumors harboring isocitrate dehydrogenase (IDH) mutations-as well as high-grade gliomas where GAE remains a clinically relevant and complex issue. In addition to diffuse glioma subtypes, this review also addresses low-grade epilepsy-associated tumors (LEAT), a distinct and heterogeneous group with an inherently high risk of seizures. The pathomechanisms of GAE are reviewed with regard to glioma subtype-specific alterations of the tumor metabolism, neuroinflammation, increased glutamatergic activity, as well as the interaction between tumor cells and non-neoplastic cells. Key pathways implicated in both GAE and tumor biology include the IDH and mTOR signaling and a range of tumor related somatic mutations. With regard to the prognostic and therapeutic significance of GAE, we highlight the essential importance of accurate molecular tumor classification. In addition to reviewing common and tumor-specific side effects of anti-seizure medication (ASM), the emerging role of therapeutic approaches targeting both tumor growth and epileptogenesis is discussed.

Conclusion: Glioma (subtype) specific mechanisms of epileptogenesis and selection of ASM is an emerging topic with future potential to improve the therapy of GAE and tumor growth alike.

背景:胶质瘤相关性癫痫(GAE)是神经肿瘤学实践中常见且具有临床意义的并发症。其患病率因胶质瘤亚型而异,受肿瘤生物学、皮层受累、肿瘤大小、切除程度和疾病进展的影响。尽管GAE对生活质量和临床结果有重大影响,但它在神经学和神经肿瘤学指南中的代表性仍然不足。此外,分子分型的新发现及其与肿瘤生物学和GAE发病机制的相关性尚未在临床框架中得到充分反映。在这里,我们的目标是根据胶质瘤生物学,癌症神经科学和癫痫学的最新进展,提供GAE的流行病学,病理生理学和管理策略的综合。正文:本文综述了GAE的流行病学、临床影响、病理生理学和治疗策略方面的最新见解。我们关注的是低级别胶质瘤,其中GAE在一生中最普遍,特别是在异柠檬酸脱氢酶(IDH)突变的肿瘤中,以及GAE仍然是临床相关和复杂问题的高级别胶质瘤。除了弥漫性胶质瘤亚型外,本综述还涉及低级别癫痫相关肿瘤(LEAT),这是一种独特且异质性的群体,具有固有的高癫痫发作风险。本文从胶质瘤亚型特异性肿瘤代谢改变、神经炎症、谷氨酸能活性升高以及肿瘤细胞与非肿瘤细胞的相互作用等方面综述了GAE的病理机制。涉及GAE和肿瘤生物学的关键途径包括IDH和mTOR信号传导以及一系列与肿瘤相关的体细胞突变。关于GAE的预后和治疗意义,我们强调准确的分子肿瘤分类至关重要。除了回顾抗癫痫药物(ASM)的常见和肿瘤特异性副作用外,还讨论了针对肿瘤生长和癫痫发生的治疗方法的新兴作用。结论:神经胶质瘤(亚型)癫痫发生的特异性机制和ASM的选择是一个新兴的主题,具有未来改善GAE和肿瘤生长治疗的潜力。
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引用次数: 0
Epilepsy in women of childbearing age: a focused review. 育龄妇女癫痫:一项重点综述。
IF 3.2 Q2 Medicine Pub Date : 2025-10-06 DOI: 10.1186/s42466-025-00430-y
Jan Heckelmann, Bettina Schmitz, Yvonne G Weber, Catrin Mann

Epilepsy affects over 50 million individuals worldwide, a significant proportion of whom are women with epilepsy (WWE) of childbearing age. This population faces unique challenges related to hormonal fluctuations, e.g., during life stages such as breastfeeding or menopause. Antiseizure medications (ASMs) further complicate reproductive health by influencing menstrual function, contraception, pregnancy outcomes, bone health, and menopausal transition due to their teratogenic potential and hormonal interactive effects. Consequently, treatment strategies for WWE must consider these interactions and the risks associated with ASMs during pregnancy. This review aims to consolidate current data and guidelines for managing WWE throughout their reproductive years. These findings emphasize the importance of preconception counseling to optimize ASM regimens, ensuring both maternal well-being and fetal safety. Key recommendations from major international pregnancy registries are summarized to guide clinicians in selecting ASMs that minimize the risk of congenital malformations while maintaining effective seizure control. Additionally, this review explores the role of folic acid supplementation in preventing neural tube defects and outlines contraceptive options tailored for WWE. In conclusion, comprehensive education on the implications of epilepsy for reproductive health is crucial for WWE. By fostering informed decision-making through personalized counseling and careful medication management before, during, and after pregnancy, healthcare providers can significantly improve outcomes for both mothers and their children.

全世界有5000多万人患有癫痫,其中很大一部分是育龄癫痫妇女。这一人口面临着与荷尔蒙波动有关的独特挑战,例如在母乳喂养或更年期等生命阶段。抗癫痫药物(asm)由于其致畸潜能和激素相互作用,通过影响月经功能、避孕、妊娠结局、骨骼健康和更年期过渡,使生殖健康进一步复杂化。因此,WWE的治疗策略必须考虑这些相互作用和妊娠期间与asm相关的风险。本综述旨在巩固现有的数据和指导方针,以管理WWE在整个生育年龄。这些发现强调了孕前咨询对优化ASM方案的重要性,确保了母亲的健康和胎儿的安全。本文总结了主要国际妊娠登记处的主要建议,以指导临床医生选择最大限度地减少先天性畸形的风险,同时保持有效的癫痫控制。此外,这篇综述探讨了叶酸补充剂在预防神经管缺陷中的作用,并概述了为WWE量身定制的避孕选择。总之,全面教育癫痫对生殖健康的影响对WWE至关重要。在怀孕前、怀孕期间和怀孕后,通过个性化的咨询和仔细的药物管理来促进明智的决策,医疗保健提供者可以显着改善母亲和孩子的结果。
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引用次数: 0
Mortality within three months after nonfatal ischemic stroke treated by mechanical thrombectomy in routine care-data from the German Stroke Registry. 非致死性缺血性卒中机械取栓治疗后3个月内的死亡率——来自德国卒中登记中心的常规护理数据。
IF 3.2 Q2 Medicine Pub Date : 2025-10-01 DOI: 10.1186/s42466-025-00427-7
Marianne Hahn, Sonja Gröschel, Livia Sophie Lang, Ahmed E Othman, Klaus Gröschel, Timo Uphaus

Background: Mechanical thrombectomy (MT) is a highly effective treatment for large vessel occlusion (LVO) ischemic stroke. However, a substantial share of patients have lethal outcome within 3 months. Individualization of outcome prognostication is needed to support clinical decision-making throughout the care pathway after MT. We investigate predictors of lethal outcome in patients with nonfatal LVO, defined by discharge alive from primary treating hospital, in a large prospective registry study of MT under routine care conditions.

Methods: 6,518 patients with nonfatal LVO treated by MT enrolled in the German Stroke Registry-Endovascular Treatment from May 2015-December 2021 were analysed with regard to lethal outcome by 3 month follow-up. Univariate group comparisons and multiple logistic regression analysis were performed to identify patients with high odds for survival or lethal outcome.

Results: We report 11.6% (757/6,518) 3 month mortality following hospital discharge after LVO treated by MT. Besides better functional outcome at discharge (modified Rankin scale < 4, odds ratio, OR [95% confidence interval, CI]: 2.38 [1.71-3.32], p < 0.001; National Institute of Health Stroke scale < 8, OR [95%CI]: 3.45 [2.55-4.66], p < 0.001), intravenous thrombolysis (OR [95%CI]: 1.48 [1.17-1.88], p = 0.001), successful recanalization (OR [95%CI]: 1.43 [1.08-1.90], p = 0.014) and discharge to a neurorehabilitative facility (versus nursing home: OR [95%CI]: 0.39 [0.26-0.58], p < 0.001; versus home: OR [95%CI]: 0.69 [0.49-0.97], p = 0.032) were independent predictors of survival. Predictors of lethal outcome were older age (OR [95%CI]: 1.09 [1.07-1.10], p < 0.001), male sex (OR [95%CI]: 1.24 [1.00-1.55], p = 0.049), premorbid disability (OR [95%CI]: 1.47 [1.08-2.02], p = 0.016), active smoking (OR [95%CI]: 1.51 [1.06-2.14], p = 0.023), anticoagulation therapy prior to LVO (OR [95%CI]: 1.45 [1.09-1.92], p = 0.010), stroke etiology, general anaesthesia during MT (OR [95%CI]: 1.31 [1.02-1.69], p = 0.035) and intracerebral haemorrhage (OR [95%CI]: 1.50 [1.13-1.99], p = 0.005).

Conclusions: Lethal outcome after hospital discharge within 3 months after MT is frequent, accounting for more than one quarter of overall 3-month mortality after MT of LVO. Predictors of survival enable individual outcome prognostication, which assists clinical decision-making with regard to surveillance concerning complications, rehabilitative resource allocation and counselling about goals of care.

Trial registration: ClinicalTrials.gov (Identifier: NCT03356392, Date of registration: 2017/11/22).

背景:机械取栓(MT)是治疗大血管闭塞缺血性脑卒中的一种非常有效的方法。然而,相当一部分患者在3个月内出现致命结果。预后预测的个体化是支持MT后整个护理路径的临床决策所必需的。我们在一项常规护理条件下MT的大型前瞻性登记研究中,研究了非致死性LVO患者致命结果的预测因素,其定义为从初级治疗医院活着出院。方法:2015年5月至2021年12月,在德国卒中登记-血管内治疗中心登记的6518例接受MT治疗的非致死性LVO患者,通过3个月的随访分析其致死性结局。进行单因素组比较和多元逻辑回归分析,以确定生存率高或死亡结局高的患者。结果:我们报告了11.6%(757/6,518)的LVO术后出院后3个月死亡率。除了出院时更好的功能预后(改进的Rankin量表)结论:MT术后3个月内出院后致命的结果是常见的,占LVO术后3个月总死亡率的四分之一以上。生存预测因子能够实现个体预后预测,这有助于有关并发症监测的临床决策,康复资源分配和关于护理目标的咨询。试验注册:ClinicalTrials.gov(标识符:NCT03356392,注册日期:2017/11/22)。
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引用次数: 0
The use of robotic arms for individuals with severe upper-limb disabilities. 为上肢有严重残疾的人使用机械臂。
IF 3.2 Q2 Medicine Pub Date : 2025-09-26 DOI: 10.1186/s42466-025-00403-1
Noémie Fortin-Bédard, Orthelo Léonel Gbètoho Atigossou, Véronique H Flamand, Jason Bouffard, François Routhier

This letter to the editor aims to comment on the article « User expectations and experiences of an assistive robotic arm in amyotrophic lateral sclerosis: a multicenter observational study » recently published by Spittel et al. (Neurol Res Pract, 6(1), 42).

这封致编辑的信旨在评论Spittel等人最近发表的文章“肌萎缩性侧索硬化症辅助机械臂的用户期望和体验:一项多中心观察研究”(Neurol Res practice, 6(1), 42)。
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引用次数: 0
Response to Fortin-Bédard et al. "User expectations and experiences of an assistive robotic arm in amyotrophic lateral sclerosis: a multicenter observational study". 对fortin - b<s:1> datard等人的回应。肌萎缩性侧索硬化症患者对辅助机械臂的期望和体验:一项多中心观察性研究。
IF 3.2 Q2 Medicine Pub Date : 2025-09-26 DOI: 10.1186/s42466-025-00405-z
Susanne Spittel, Thomas Meyer, Ute Weyen, Torsten Grehl, Patrick Weydt, Robert Steinbach, Susanne Petri, Petra Baum, Moritz Metelmann, Anne-Dorte Sperfeld, Dagmar Kettemann, Jenny Norden, Annekathrin Rödiger, Benjamin Ilse, Julian Grosskreutz, Barbara Hildebrandt, Bertram Walter, Christoph Münch, André Maier
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引用次数: 0
Response to Schoene et al.: Brain death determination during crisis requires ethical context and clinical perspective. 对Schoene等人的回应:危机期间脑死亡的确定需要伦理背景和临床观点。
IF 3.2 Q2 Medicine Pub Date : 2025-09-25 DOI: 10.1186/s42466-025-00411-1
Calixto Machado

This correspondence responds to Schoene et al.'s study on the impact of the COVID-19 pandemic on brain death (BD) detection in German hospitals. While their data-driven approach provides valuable insights, this response emphasizes the need to contextualize BD determination within the lived clinical and ethical realities of the pandemic. It argues that the reduction in BD assessments cannot solely be attributed to organizational lapses but must also account for ethical dilemmas, safety concerns, and triage pressures faced by healthcare providers. The author highlights the limitations of rigid BD protocols during public health emergencies and advocates for flexible, ethically guided practices. Drawing on international experience, including temporary adaptations in Cuba's BD policies, the letter underscores the importance of physician support, context-sensitive decision-making, and humanistic engagement with families. Ultimately, it calls for a reexamination of how BD determinations are understood and implemented under crisis conditions, urging reforms that integrate medical standards with compassionate care and ethical reflection.

本文回应了Schoene等人关于COVID-19大流行对德国医院脑死亡(BD)检测影响的研究。虽然他们的数据驱动方法提供了有价值的见解,但这一回应强调需要在大流行的临床和伦理现实背景下确定双相障碍。它认为,BD评估的减少不能仅仅归因于组织的失误,还必须考虑到伦理困境、安全问题和医疗保健提供者面临的分诊压力。作者强调了在突发公共卫生事件中严格的BD协议的局限性,并倡导灵活的、道德指导的实践。这封信借鉴了国际经验,包括古巴对BD政策的临时调整,强调了医生支持、根据具体情况作出决策以及与家庭进行人文接触的重要性。最后,它呼吁重新审视在危机条件下如何理解和实施BD决定,敦促改革,将医疗标准与富有同情心的护理和道德反思结合起来。
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引用次数: 0
Author response to letter to the editor: "impact of the COVID-19 pandemic on brain death detection in German hospitals: a state-wide analysis of health data". 作者对致编辑的信的回复:“COVID-19大流行对德国医院脑死亡检测的影响:对全州卫生数据的分析”。
IF 3.2 Q2 Medicine Pub Date : 2025-09-25 DOI: 10.1186/s42466-025-00412-0
Daniela Schoene, Kristian Barlinn
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引用次数: 0
Consensus on the clinical utility of digital mobility outcomes for personalized clinical decision support in parkinson's disease. 关于数字移动结果在帕金森病个性化临床决策支持中的临床应用的共识。
IF 3.2 Q2 Medicine Pub Date : 2025-09-18 DOI: 10.1186/s42466-025-00426-8
Alan Castro Mejia, Stefano Sapienza, Ivana Paccoud, Lisa Alcock, Philip Brown, Heiko Gaßner, Heather Hunter, Walter Maetzler, Anat Mirelman, Alice Nieuwboer, Martin Regensburger, Lynn Rochester, Sabine Stallforth, Beatrix Vereijken, Alison Yarnall, Jochen Klucken

Background: Digital mobility outcomes (DMOs) have emerged as novel biomarkers offering objective, quantitative, and examiner-independent outcome measures for clinical studies. Unfortunately, research efforts on DMOs have not yet investigated the domain of clinical utility in Parkinson's disease, i.e. providing evidence of improvements in health outcomes, diagnosis, decision-making, or prevention when compared to e.g. standard-of-care procedures. This manuscript, via a consensus building approach, aims to create a structured conceptual framework to map the knowledge generated by DMOs with clinical domains that could benefit from it.

Methods: We conducted a three-round consensus-building study with 12 experts recruited from the Mobilise-D consortium's Parkinson's Disease Working Group. The experts designed and ranked different aspects of the conceptual framework via a 5-level Likert scale for level of agreement. Consensus for the different points evaluated was based on a double threshold: the simultaneous presence of a high level of agreement had to be accompanied by a low level of disagreement. As secondary objectives, the experts were asked to rate the practical application of DMOs by evaluating the timeline to applicability, the foreseen challenges for their implementation in clinical settings, and their main role in the decision-making process.

Results: A full consensus on the clinical utility framework was achieved after three rounds. The final framework consisted of three main categories (Disease Diagnosis, Patient Evaluation, and Treatment Evaluation) and six underlying domains (Enhancing Diagnostic Procedure, Predicting Risk, Timely Detecting Deterioration, Enhancing Clinical Judgment, Selecting Treatment, and Monitoring Treatment Response). The experts believed in the next 1-5 years DMOs will play a relevant role in clinical decision making, complementing care knowledge with useful digital biomarkers information. However, the main challenge to address is the definition of clear reference value for DMOs interpretability.

Conclusions: This framework provides a structure for subsequent studies to build into by diversifying expert cohorts and expand our findings beyond PD. Additionally, our results support researchers planning future clinical trials where DMOs can play a valuable role for clinical decision support. Ultimately, this is the first step toward developing guidelines to assess DMOs' clinical utility and support their integration into Real World clinical practice.

背景:数字移动结果(DMOs)已经成为一种新的生物标志物,为临床研究提供客观、定量和独立于检查者的结果测量。不幸的是,关于DMOs的研究工作尚未调查帕金森病的临床应用领域,即与标准护理程序相比,提供健康结果、诊断、决策或预防方面的改善证据。本文通过建立共识的方法,旨在创建一个结构化的概念框架,将dmo产生的知识与可以从中受益的临床领域进行映射。方法:我们与动员- d联盟帕金森病工作组招募的12名专家进行了三轮共识建立研究。专家们通过5级李克特量表对概念框架的不同方面进行了设计和排名。对不同评价点的协商一致意见是基于双重门槛的:高度一致的同时必须伴随着低程度的分歧。作为次要目标,专家们被要求评估dmo的实际应用,通过评估时间表的适用性,在临床环境中实施的预期挑战,以及他们在决策过程中的主要作用。结果:经过三轮讨论,对临床应用框架达成了全面共识。最终的框架包括三个主要类别(疾病诊断、患者评估和治疗评估)和六个基本领域(加强诊断程序、预测风险、及时发现恶化、加强临床判断、选择治疗和监测治疗反应)。专家们认为,在未来1-5年内,dmo将在临床决策中发挥重要作用,用有用的数字生物标志物信息补充护理知识。然而,要解决的主要挑战是为dmo的可解释性定义明确的参考值。结论:该框架为后续研究提供了一个结构,可以通过多样化的专家群体来构建,并将我们的发现扩展到PD之外。此外,我们的结果支持研究人员计划未来的临床试验,其中DMOs可以在临床决策支持中发挥有价值的作用。最终,这是制定指导方针的第一步,以评估DMOs的临床效用,并支持其融入现实世界的临床实践。
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引用次数: 0
期刊
Neurological research and practice
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