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Psychotherapy's Role in Evaluating the Invisible Wounds of Moral Injury. 心理疗法在评估道德伤害的隐形伤口中的作用。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
Ben Onnink, Matthew C Correll, Andrew Correll, Terry Correll

Moral injury is a relatively new concept with varying definitions that attempts to define a profound and lasting insult to one's conscience caused by perpetration of or directly witnessing harm to another person in a high-pressure situation. This entity is separate from posttraumatic stress disorder (PTSD), but it can coexist with PTSD. This article provides psychotherapeutic examples of the diagnosis of moral injury from a psychodynamic perspective, focusing on morally challenging situations related to warfare and the healthcare system.

道德伤害是一个相对较新的概念,其定义不尽相同,它试图定义在高压环境下对他人造成或直接目睹对他人造成伤害所导致的对个人良知的深刻而持久的侮辱。这种实体与创伤后应激障碍(PTSD)是分开的,但它可以与创伤后应激障碍共存。本文从心理动力学的角度出发,提供了道德伤害诊断的心理治疗实例,重点关注与战争和医疗系统相关的具有道德挑战性的情况。
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引用次数: 0
Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward. 应对中枢神经系统临床试验中安慰剂反应挑战的现有技术和新兴技术:前景、陷阱和前进之路》。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
William P Horan, Gary Sachs, Dawn I Velligan, Michael Davis, Richard S E Keefe, Ni A Khin, Florence Butlen-Ducuing, Philip D Harvey

Excessive placebo response rates have long been a major challenge for central nervous system (CNS) drug discovery. As CNS trials progressively shift toward digitalization, decentralization, and novel remote assessment approaches, questions are emerging about whether innovative technologies can help mitigate the placebo response. This article begins with a conceptual framework for understanding placebo response. We then critically evaluate the potential of a range of innovative technologies and associated research designs that might help mitigate the placebo response and enhance detection of treatment signals. These include technologies developed to directly address placebo response; technology-based approaches focused on recruitment, retention, and data collection with potential relevance to placebo response; and novel remote digital phenotyping technologies. Finally, we describe key scientific and regulatory considerations when evaluating and selecting innovative strategies to mitigate placebo response. While a range of technological innovations shows potential for helping to address the placebo response in CNS trials, much work remains to carefully evaluate their risks and benefits.

长期以来,过高的安慰剂反应率一直是中枢神经系统(CNS)药物研发面临的一大挑战。随着中枢神经系统试验逐步转向数字化、分散化和新型远程评估方法,人们开始质疑创新技术是否有助于减轻安慰剂反应。本文首先介绍了理解安慰剂反应的概念框架。然后,我们对一系列可能有助于减轻安慰剂反应和增强治疗信号检测的创新技术和相关研究设计的潜力进行了批判性评估。这些技术包括:为直接解决安慰剂反应而开发的技术;基于技术的方法,重点关注与安慰剂反应潜在相关的招募、保留和数据收集;以及新型远程数字表型技术。最后,我们介绍了在评估和选择减轻安慰剂反应的创新策略时在科学和监管方面的主要考虑因素。虽然一系列技术创新显示出帮助解决中枢神经系统试验中安慰剂反应的潜力,但仍有许多工作需要仔细评估其风险和益处。
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引用次数: 0
Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis. 精神分裂症患者开始接受阿立哌唑劳罗昔治疗后的功能和认知能力:次要结果和事后分析。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
Mark G A Opler, Amy Claxton, James McGrory, Sabina Gasper, Meihua Wang, Sergey Yagoda

Background: Clinical practice guidelines support efforts to improve functioning in patients with schizophrenia. Discrepancies in the perception of cognitive status between clinicians, patients with schizophrenia, and their caregivers have been associated with impaired functional abilities in patients; medication side effects might worsen both cognition and daily functioning. We assessed daily/social functioning and cognition in stable patients with schizophrenia who switched to the long-acting injectable (LAI) antipsychotic aripiprazole lauroxil (AL).

Methods: Clinically stable adults with residual symptoms of schizophrenia or intolerance following three or more doses of paliperidone palmitate or risperidone LAI were switched to flexibly dosed open-label AL treatment (441mg, 662mg, or 882mg every 4 weeks or 882mg every 6 weeks) for six months (ClinicalTrials.gov identifier: NCT02634320). Daily/social functioning was assessed using the Personal and Social Performance Scale (PSP); total and subscale scores were summarized using descriptive statistics. The cognitive status of patients was assessed using the New York Assessment of Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) at baseline and Month 6 or early termination, providing patient, caregiver, and clinician perspectives. A post hoc analysis assessed level of agreement in ratings of cognitive status among respondents, evaluated at baseline and last assessment, using weighted kappa coefficients (0.01-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement.).

Results: All 51 enrolled patients received one or more AL doses; 35 completed the study, and 45 contributed data at last assessment. Mean age was 40.6 years; 72.5 percent of patients were male. Based on PSP total score, functioning was maintained from baseline (mean [standard deviation (SD)]: 55.1 [10.5]) through six months of AL treatment (mean [SD]: 57.7 [13.2]). Proportions of patients rating personal and social functioning issues as "not present" or "mild" remained stable between baseline and Month 6 for each PSP subscale. At baseline (n=50), cognitive difficulties were most commonly rated "not present" or "mild" in all NY-AACENT domains by patients (58-86% across domains), clinicians (62-94%), and caregivers (50-92%), and these rates were maintained or increased at last assessment for all reporters. Weighted kappa coefficients indicated fair-to-substantial agreement between patients and clinicians across domains at last assessment (0.32-0.64; baseline: 0.14-0.55); patient-caregiver agreement ranged from 0.07 to 0.50 at last assessment (baseline: 0.25-0.60).

Conclusion: In clinically stable patients with schizophrenia who initiated AL, self-reported functioning was maintained over six months of treatment. Clinician-, caregiver-, and patient-reported cognitive func

背景:临床实践指南支持努力改善精神分裂症患者的功能。临床医生、精神分裂症患者及其护理人员对认知状态的认知存在差异,这与患者功能受损有关;药物副作用可能会使认知和日常功能恶化。我们对改用长效注射(LAI)抗精神病药物阿立哌唑月桂昔(AL)的稳定期精神分裂症患者的日常/社会功能和认知能力进行了评估:临床症状稳定的成人精神分裂症患者在服用帕利哌酮棕榈酸酯或利培酮LAI三剂或三剂以上后出现残留症状或不耐受,改用剂量灵活的开放标签AL治疗(每4周服用441毫克、662毫克或882毫克,或每6周服用882毫克),为期6个月(ClinicalTrials.gov标识符:NCT02634320)。日常/社会功能采用个人和社会表现量表(PSP)进行评估;总分和分量表得分采用描述性统计进行总结。在基线和第 6 个月或提前终止治疗时,使用纽约神经精神治疗不良认知影响评估(NY-AACENT)对患者的认知状况进行评估,提供患者、护理人员和临床医生的观点。一项事后分析使用加权卡帕系数(0.01-0.20,略有一致;0.21-0.40,一般一致;0.41-0.60,中等一致;0.61-0.80,基本一致)评估了受访者在基线和最后一次评估时对认知状况评分的一致程度:所有 51 名入选患者均接受了一次或多次 AL 剂量治疗;35 人完成了研究,45 人提供了最后一次评估的数据。平均年龄为 40.6 岁;72.5% 的患者为男性。根据 PSP 总分,患者的功能与基线相比保持不变(平均值 [标准差 (SD)]:55.1 [10.5]:从基线(平均值 [标准差 (SD)]:55.1 [10.5])到 AL 治疗的 6 个月(平均值 [标准差 (SD)]:57.7 [13.2]),患者的功能保持不变。对于每个 PSP 分量表,将个人和社会功能问题评为 "不存在 "或 "轻度 "的患者比例在基线和第 6 个月之间保持稳定。在基线(n=50)时,患者(58%-86%)、临床医生(62%-94%)和护理人员(50%-92%)对 NY-AACENT 所有领域的认知障碍最常见的评价是 "不存在 "或 "轻度",在最后一次评估时,所有报告者的这一比例均保持不变或有所增加。加权卡帕系数显示,在最后一次评估时,患者与临床医生在各领域的一致性尚可至基本一致(0.32-0.64;基线:0.14-0.55);在最后一次评估时,患者与护理人员的一致性从0.07到0.50不等(基线:0.25-0.60):结论:在开始接受AL治疗的临床稳定的精神分裂症患者中,自我报告的功能在六个月的治疗中得以维持。临床医生、护理人员和患者报告的认知功能在基线时保持稳定,并在 NY-AACENT 的所有领域中保持稳定;使用 AL 治疗 6 个月后,患者与临床医生在认知功能障碍程度上的一致程度有所提高。
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引用次数: 0
Ensuring Stakeholder Feedback in the Design and Conduct of Clinical Trials for Rare Diseases: ISCTM Position Paper of the Orphan Disease Working Group. 在罕见病临床试验的设计和实施过程中确保利益相关者的反馈:孤儿病工作组的 ISCTM 立场文件。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
Gahan J Pandina, Joan Busner, Lucas Kempf, Joan Fallon, Larry D Alphs, Maria T Acosta, Anna-Karin Berger, Simon Day, Judith Dunn, Victoria Villalta-Gil, Margaret C Grabb, Joseph P Horrigan, William Jacobson, Judith C Kando, Thomas A Macek, Manpreet K Singh, Arielle D Stanford, Silvia Zaragoza Domingo

The 1983 Orphan Drug Act in the United States (US) changed the landscape for development of therapeutics for rare or orphan diseases, which collectively affect approximately 300 million people worldwide, half of whom are children. The act has undoubtedly accelerated drug development for orphan diseases, with over 6,400 orphan drug applications submitted to the US Food and Drug Administration (FDA) from 1983 to 2023, including 350 drugs approved for over 420 indications. Drug development in this population is a global and collaborative endeavor. This position paper of the International Society for Central Nervous System Clinical Trials and Methodology (ISCTM) describes some potential best practices for the involvement of key stakeholder feedback in the drug development process. Stakeholders include advocacy groups, patients and caregivers with lived experience, public and private research institutions (including academia and pharmaceutical companies), treating clinicians, and funders (including the government and independent foundations). The authors articulate the challenges of drug development in orphan diseases and propose methods to address them. Challenges range from the poor understanding of disease history to development of endpoints, targets, and clinical trials designs, to finding solutions to competing research priorities by involved parties.

美国 1983 年颁布的《孤儿药法案》改变了罕见病或孤儿病治疗药物的开发格局,这些疾病共影响全球约 3 亿人,其中一半是儿童。从 1983 年到 2023 年,美国食品和药物管理局(FDA)共收到 6400 多份孤儿药申请,其中 350 种药物获批用于 420 多种适应症。针对这一人群的药物开发是一项全球性的合作努力。国际中枢神经系统临床试验和方法学会(ISCTM)的这份立场文件介绍了一些潜在的最佳实践,以便让主要利益相关者参与到药物开发过程中。利益相关者包括权益团体、患者和有生活经验的护理人员、公共和私营研究机构(包括学术界和制药公司)、治疗临床医生和资助者(包括政府和独立基金会)。作者阐述了孤儿病药物开发所面临的挑战,并提出了应对方法。所面临的挑战包括对疾病史的不甚了解、终点、靶点和临床试验设计的开发,以及为相关各方相互竞争的研究重点寻找解决方案。
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引用次数: 0
The Catastrophic Perception of Pain in Burning Mouth Syndrome May be Associated with Sympathetic Tone as Indicated by the QTc Interval. 灼口综合征的灾难性痛觉可能与 QTc 间期显示的交感神经张力有关。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
Takahiko Nagamine, Takeshi Watanabe
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引用次数: 0
ChatGPT and Transcranial Direct Current Stimulation for Chronic Pain. ChatGPT 和经颅直流电刺激治疗慢性疼痛。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
Edson Silva-Filho, Rodrigo Pegado

Objective: We aimed to open a discussion about the integration of artificial intelligence (AI) in science and clinical practice, specifically with regard to the use of transcranial direct current stimulation (tDCS) as a technique for managing chronic pain.

Main points of discussion: To analyze the responses generated by ChatGPT and the best literature about tDCS, we formulated three questions. The answers from ChatGPT, compared to the guidelines and Cochrane review, showed that AI can be a potential strategy to help clinicians and researchers. AI such as ChatGPT is revolutionizing the academic field and clinical practice. However, there is still an unmet scientific and clinical discussion about the insertion of AI to help researchers and clinicians in the neuromodulation area treat chronic pain.

Conclusion: We need to know the limits of the use of AI. Even though ChatGPT might be helpful, it should be used with caution in the academic field and clinical practice.

目的:我们旨在就人工智能(AI)与科学和临床实践的结合展开讨论,特别是关于经颅直流电刺激(tDCS)作为慢性疼痛管理技术的使用:为了分析 ChatGPT 生成的回答和有关 tDCS 的最佳文献,我们提出了三个问题。与指南和 Cochrane 综述相比,ChatGPT 的回答表明,人工智能可以成为帮助临床医生和研究人员的潜在策略。像 ChatGPT 这样的人工智能正在彻底改变学术领域和临床实践。然而,关于插入人工智能以帮助神经调节领域的研究人员和临床医生治疗慢性疼痛的科学和临床讨论仍未得到满足:我们需要了解人工智能使用的局限性。尽管 ChatGPT 可能有所帮助,但在学术领域和临床实践中应谨慎使用。
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引用次数: 0
Health Anxiety, Fear of COVID-19, Nosophobia, and Health-protective Behaviors Among Healthcare Professionals. 医疗保健专业人员的健康焦虑、对 COVID-19 的恐惧、厌食症和健康保护行为。
Q3 Medicine Pub Date : 2024-03-01 eCollection Date: 2024-01-01
Uzma Ilyas, Farwa Aslam, Muqadas Fatima, Zarmin Tariq, Usman Hotiana

Objective: This study examined fear of COVID-19, nosophobia, health anxiety, and health-protective behaviors among healthcare professionals during the COVID-19 pandemic.

Methods: A cross-sectional, correlational research design was used in this study. The data of healthcare professionals (N=300) from three disciplines of medicine (Bachelor of Medicine and Bachelor of Surgery [MBBS], Bachelor of Dental Surgery [BDS], Doctor of Physiotherapy [DPT]) were collected using a purposive sampling technique. The Fear of COVID-19 Scale (FCV-19S), Medical Student Disease Perception and Distress Scale (MSD), Short Health Anxiety Inventory (SHAI), and Health Protective Behavior Scale (HBPS) were used as assessment measures. Statistical Package of Social Sciences (SPSS) version 22 was used to analyze the data obtained.

Results: Of the 300 participants, 132 (44%) were male and 168 (56%) were female. A total of 199 participants (63.3%) had a MBBS degree, 59 (19.7%) had a BDS degree, and 41 (14%) had a DPT degree. The findings revealed a significant positive correlation between nosophobia, health anxiety, and fear of COVID-19, whereas health-protective behavior showed a negative association with health anxiety. Sex, health anxiety, and nosophobia were significant predictors of health-protective behaviors among medical professionals.

Conclusion: The fear related to COVID-19 is associated with nosophobia and health anxiety among medical professionals, which has a substantial impact on health, work performance, and vulnerability to developing psychological distress if left unmonitored.

研究目的本研究探讨了在 COVID-19 大流行期间,医疗保健专业人员对 COVID-19 的恐惧、厌食症、健康焦虑以及健康保护行为:本研究采用横断面相关研究设计。采用目的性抽样技术收集了来自三个医学专业(内科和外科学士[MBBS]、牙科学士[BDS]、物理治疗学博士[DPT])的医护人员(N=300)的数据。采用 COVID-19 恐惧量表 (FCV-19S)、医学生疾病认知和压力量表 (MSD)、简短健康焦虑量表 (SHAI) 和健康保护行为量表 (HBPS) 作为评估指标。使用社会科学统计软件包(SPSS)第 22 版对所得数据进行分析:在 300 名参与者中,132 人(44%)为男性,168 人(56%)为女性。共有 199 人(63.3%)拥有 MBBS 学位,59 人(19.7%)拥有 BDS 学位,41 人(14%)拥有 DPT 学位。研究结果表明,恐惧症、健康焦虑和对 COVID-19 的恐惧之间存在明显的正相关,而健康保护行为则与健康焦虑呈负相关。性别、健康焦虑和恐高症是医务人员健康保护行为的重要预测因素:结论:与 COVID-19 相关的恐惧与医务人员的恐高症和健康焦虑有关,如果不加以监控,恐高症和健康焦虑会对医务人员的健康、工作表现和心理压力产生重大影响。
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引用次数: 0
Morphological and Functional Changes of Cerebral Cortex in Autism Spectrum Disorder. 自闭症谱系障碍患者大脑皮层的形态和功能变化。
Q3 Medicine Pub Date : 2023-12-01 eCollection Date: 2023-10-01
Leong Tung Ong, Si Wei David Fan

Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder characterized by early-onset impairments in socialization, communication, repetitive behaviors, and restricted interests. ASD exhibits considerable heterogeneity, with clinical presentations varying across individuals and age groups. The pathophysiology of ASD is hypothesized to be due to abnormal brain development influenced by a combination of genetic and environmental factors. One of the most consistent morphological parameters for assessing the abnormal brain structures in patients with ASD is cortical thickness. Studies have shown changes in the cortical thickness within the frontal, temporal, parietal, and occipital lobes of individuals with ASD. These changes in cortical thickness often correspond to specific clinical features observed in individuals with ASD. Furthermore, the aberrant brain anatomical features and cortical thickness alterations may lead to abnormal brain connectivity and synaptic structure. Additionally, ASD is associated with cortical hyperplasia in early childhood, followed by a cortical plateau and subsequent decline in later stages of development. However, research in this area has yielded contradictory findings regarding the cortical thickness across various brain regions in ASD.

自闭症谱系障碍(ASD)是一种复杂的神经发育障碍,其特征是早发性社交障碍、沟通障碍、重复行为和兴趣受限。自闭症表现出相当大的异质性,临床表现因个体和年龄组而异。ASD 的病理生理学假设是由于大脑发育异常,并受到遗传和环境因素的共同影响。皮质厚度是评估 ASD 患者大脑结构异常最一致的形态学参数之一。研究表明,ASD 患者额叶、颞叶、顶叶和枕叶的皮质厚度发生了变化。这些皮层厚度的变化往往与在 ASD 患者身上观察到的特定临床特征相对应。此外,异常的大脑解剖特征和皮质厚度变化可能会导致大脑连接和突触结构异常。此外,ASD 与儿童早期的皮质增生有关,随后出现皮质高原,并在发育后期随之下降。然而,关于 ASD 患者大脑各区域皮质厚度的研究结果却相互矛盾。
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引用次数: 0
RISK MANAGEMENT: Pop Quiz. 风险管理: 突击测验。
Q3 Medicine Pub Date : 2023-12-01 eCollection Date: 2023-10-01
Donna Vanderpool

This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS (www.prms.com), a manager of medical professional liability insurance programs with services that include risk management consultation and other resources offered to health care providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers might provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other health care professionals so "clinician" is used to indicate all treatment team members.

本栏目致力于为读者提供与医疗实践相关的法律风险管理信息。我们诚邀读者提问。答案由 PRMS (www.prms.com) 提供,PRMS 是一家医疗专业责任保险计划管理公司,其服务包括为医疗服务提供者提供风险管理咨询和其他资源,以帮助改善患者治疗效果并降低专业责任风险。本专栏公布的答案仅代表一家风险管理咨询公司的答案。其他风险管理咨询公司或保险公司可能会提供不同的建议,读者应对此加以考虑。本专栏中的信息不构成法律建议。如需法律建议,请联系您的个人律师。注:本文中的信息和建议适用于医生和其他医疗保健专业人员,因此 "临床医生 "用于指所有治疗团队成员。
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引用次数: 0
Whether Telerehabilitation is Actually Beneficial in Iatrogenic Facial Palsy Needs to be Confirmed by Prospective, Multicenter, Controlled Studies. 远程康复是否真的有益于先天性面瘫,还需要前瞻性、多中心、对照研究来证实。
Q3 Medicine Pub Date : 2023-12-01 eCollection Date: 2023-10-01
Josef Finsterer, Fulvio A Scorza
{"title":"Whether Telerehabilitation is Actually Beneficial in Iatrogenic Facial Palsy Needs to be Confirmed by Prospective, Multicenter, Controlled Studies.","authors":"Josef Finsterer, Fulvio A Scorza","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":13635,"journal":{"name":"Innovations in clinical neuroscience","volume":"20 10-12","pages":"8"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10773603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Innovations in clinical neuroscience
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