医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。     

基于正交试验的肾造瘘管固定方案研究

目的 探讨基于正交试验的肾造瘘管不同固定方案的比较效果。方法 将14Fr硅胶肾造瘘管固定在聚乙烯展板和拉力显示器上，以固定材料、固定方法、面积为3个影响因素，每个因素3个水平，每组进行3次试验再求平均值作为最后拉力值F，共进行9个固定方案共27次试验。利用L9（33）正交试验矩阵研究不同材料（医用橡皮膏、医用透气胶带、医用无纺布胶带）、固定方法（交叉固定法、“工”字固定法和改良“工”字固定法）及面积(16 cm2、24 cm2、32 cm2）对肾造瘘管固定强度的影响。结果 正交试验所选的3种影响因素中，对拉力值影响显著性排序为：材料＞方法＞面积；3种固定材料中，医用橡皮膏固定强度最大。结论 肾造瘘管固定方案中，最佳固定组合为以医用橡皮膏结合改良“工”字法固定，可为临床管道固定方案的选择提供参考。     

Interoception Primes Emotional Processing: Multimodal Evidence from Neurodegeneration

Recent frameworks in cognitive neuroscience and behavioral neurology underscore interoceptive priors as core modulators of negative emotions. However, the field lacks experimental designs manipulating the priming of emotions via interoception and exploring their multimodal signatures in neurodegenerative models. Here, we designed a novel task that involves interoceptive and control-exteroceptive priming conditions followed by post-interoception and post-exteroception facial emotion recognition (FER). We recruited 114 participants, including healthy controls (HCs) as well as patients with behavioral variant frontotemporal dementia (bvFTD), Parkinson''s disease (PD), and Alzheimer''s disease (AD). We measured online EEG modulations of the heart-evoked potential (HEP), and associations with both brain structural and resting-state functional connectivity patterns. Behaviorally, post-interoception negative FER was enhanced in HCs but selectively disrupted in bvFTD and PD, with AD presenting generalized disruptions across emotion types. Only bvFTD presented impaired interoceptive accuracy. Increased HEP modulations during post-interoception negative FER was observed in HCs and AD, but not in bvFTD or PD patients. Across all groups, post-interoception negative FER correlated with the volume of the insula and the ACC. Also, negative FER was associated with functional connectivity along the (a) salience network in the post-interoception condition, and along the (b) executive network in the post-exteroception condition. These patterns were selectively disrupted in bvFTD (a) and PD (b), respectively. Our approach underscores the multidimensional impact of interoception on emotion, while revealing a specific pathophysiological marker of bvFTD. These findings inform a promising theoretical and clinical agenda in the fields of nteroception, emotion, allostasis, and neurodegeneration.SIGNIFICANCE STATEMENT We examined whether and how emotions are primed by interoceptive states combining multimodal measures in healthy controls and neurodegenerative models. In controls, negative emotion recognition and ongoing HEP modulations were increased after interoception. These patterns were selectively disrupted in patients with atrophy across key interoceptive-emotional regions (e.g., the insula and the cingulate in frontotemporal dementia, frontostriatal networks in Parkinson''s disease), whereas persons with Alzheimer''s disease presented generalized emotional processing abnormalities with preserved interoceptive mechanisms. The integration of both domains was associated with the volume and connectivity (salience network) of canonical interoceptive-emotional hubs, critically involving the insula and the anterior cingulate. Our study reveals multimodal markers of interoceptive-emotional priming, laying the groundwork for new agendas in cognitive neuroscience and behavioral neurology.     

Internet-delivered exposure therapy versus internet-delivered cognitive behavioral therapy for panic disorder: A pilot randomized controlled trial

AimTo compare the efficacy and acceptability of internet-delivered exposure therapy for panic disorder, to multi-component internet-delivered cognitive behavioral therapy (iCBT) that included controlled breathing, cognitive restructuring and exposure.MethodsParticipants with panic disorder, with or without agoraphobia, were randomized to internet-delivered exposure therapy (n = 35) or iCBT (n = 34). Both programs were clinician guided, with six lessons delivered over eight weeks. Outcomes included panic disorder and agoraphobia symptom severity, as well as depression symptom severity, functional impairment and days out of role.ResultsParticipants in both conditions displayed a large reduction in panic disorder symptom severity (ds >1.30) from pre- to post-treatment. Participants in both conditions displayed medium to large reduction in agoraphobia and depression symptom severity, functional impairment and days out of role. Effects were maintained at three- and six-month follow-up. There was no significant difference between the interventions in clinical outcomes, adherence or treatment satisfaction.ConclusionsInternet-delivered exposure therapy appeared to be as acceptable and efficacious as more established iCBT, despite including less strategies. However, a fully powered replication is now needed to compare the two approaches.     

Effect of a multi-disciplinary program on anthropometric and biochemical parameters in obese and overweight elementary school girls: A randomized clinical trial

Background and aimsObesity and overweight in children are associated with an increased risk of several health issues. The present study aimed to assess the effects of a multi-disciplinary program (including nutrition education using a smartphone game, physical activity, and cognitive behavioral therapy [CBT]) on the management of obesity and overweight in elementary school girls.Methods and resultsSixty-two school girls above the 85th percentile of body mass index (BMI) for age were randomly assigned to two groups. During 10 weeks of study, the intervention group received a multi-disciplinary intervention, including nutrition education using a smartphone game, aerobic exercise, and CBT. The control group received usual traditional nutritional education. Biochemical and metabolic factors were assessed, including fasting blood sugar (FBS), lipid profile, serum leptin, and anthropometric measurements. The Dutch Eating Behavior Questionnaire (DEBQ) and metabolic equivalent test (MET) were also conducted. The intervention group showed more promising results in weight loss, waist circumference (WC), hip circumference (HC), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and FBS compared to the control group (P < 0.05). In addition, MET and DEBQ scores in all three sections of emotions, stimuli, and restriction were better in the intervention group than in the control group (P < 0.05). However, there was no significant difference between groups regarding the results of serum leptin and waist-to-hip ratio (WHR; p > 0.05).ConclusionsThe results indicated that education through smartphone games could possibly affect performance in real life. In addition, the multi-disciplinary approach to childhood obesity might have better performance in most areas than the single-intervention approach in obesity management.     

Early Postpartum Maternal and Newborn Responses to Auditory,Tactile, Visual,Vestibular, and Olfactory Stimuli

ObjectiveTo compare maternal psychological well-being, newborn behavior, and maternal and newborn salivary oxytocin (OT) and cortisol before and after two maternally administered multisensory behavioral interventions or an attention control group.DesignRandomized prospective clinical trial.SettingU.S. Midwest community hospital.ParticipantsNewborns and their mothers (n = 102 dyads) participated. Mothers gave birth vaginally at term gestation and had no physical or mental health diagnoses. Newborns with low Apgar scores, receipt of oxygen, suspected infection, or congenital anomalies were excluded.MethodsDyads were randomly assigned to the auditory, tactile, visual, and vestibular (ATVV) intervention, the ATVV with odor from a baby lotion (ATVVO), or the attention control (AC) Group. Maternal psychological well-being, newborn behavior, and endocrine responses (salivary cortisol and OT) were measured before and after the intervention.ResultsNewborns in the ATVV and ATVVO groups exhibited increases in potent engagement behaviors (p < .0001 and p = .001, respectively). Newborns in the AC group exhibited a decrease in potent engagement (p = .013) and an increase in potent disengagement (p = .029). Mothers in the ATVVO group exhibited an increase in OT (p = .01) and the largest change in OT (p = .02) compared to mothers in the ATVV and AC groups. We noted no change in maternal psychological well-being or newborn endocrine responses.ConclusionInclusion of an odor via lotion with a behavioral intervention (ATVV) influenced maternal OT more than the behavioral intervention alone. Newborns were behaviorally responsive to the interventions; however, endocrine measures were not associated with intervention changes.     

Substance use and associated emotional and behavioral problems in Nepalese adolescents

Background: Research has demonstrated that problem behavior has been associated with substance use, but knowledge is lacking on such associations in a low-income country like Nepal. Aims: This study aimed to find associations between emotional and behavioral problems and substance use among Nepalese adolescents. Method: A cross-sectional study was conducted at the end of 2011, with participants from three schools in the Province 4 of Nepal. We selected 408 adolescents aged 12 to 18 (mean 15.2 years, 54% boys) at one urban and two rural schools. The data were collected using the Youth Self-Report and Adolescents’ Substance Use Measurement. Results: Higher scores on withdrawn/depressed symptoms, thought problems, attention problems, delinquent or aggressive behavior or internalizing or externalizing problems were associated with the use of tobacco, alcohol or other substances. In the broadband scales, only internalizing problems predicted the use of intoxicants. Higher scores for attention problems predicted the use of tobacco, any intoxicants, and high-risk user. Conclusion: Our findings indicated that problem behavior among Nepalese adolescents was associated with substance use. Future studies should explore the association between problem behavior and substance use, including causal factors, so that risky behavior among Nepalese adolescents can be prevented.