Bone Mineral Density Reporting Underestimates Fracture Risk in Ontario

Objective: Analysis of clinical documents such as bone mineral density (BMD) reports is an important component of program evaluation because it can provide insights into the accuracy of assessment of fracture risk communicated to patients and practitioners. Our objective was to compare fracture risk calculations from BMD test reports to those based on the 2010 Canadian guidelines. Methods: We retrieved BMD reports from fragility fracture patients screened through a community hospital fracture clinic participating in Ontario’s Fracture Clinic Screening Program. Fracture risk was determined according to the 2010 Canadian guidelines using age, sex, and T-score at the femoral neck, in addition to three clinical factors. Three researchers classified patients’ fracture risk until consensus was achieved. Results: We retrieved reports for 17 patients from nine different BMD clinics in the Greater Toronto Area. Each patient had a different primary care physician and all BMD tests were conducted after the 2010 Canadian guidelines were published. The fracture risk of 10 patients was misclassified with 9 of the 10 reports underestimating fracture risk. Nine reports acknowledged that the prevalence of a fragility fracture raised the risk category by one level but only four of these reports acknowledged that the patient had, or may have sustained, a fragility fracture. When we raised fracture risk by one level according to these reports, eight patients were still misclassified. Fracture risk in the majority of these patients remained underestimated. Inconsistent classification was found in the majority of cases where reports came from the same clinic. Four reports described risk levels for two different types of risk. Conclusions: More than half of patients received BMD reports which underestimated fracture risk. Bone health management recommendations based on falsely low fracture risk are likely to be sub-optimal.

Six families with balanced chromosome translocation associated with reproductive risks in Hainan Province: Case reports and review of the literature

BACKGROUND Balanced translocation refers to the process where breakage and reconnection of chromosomes occur at abnormal positions.As the genetic substance with balanced translocation in individuals does not change,which is usually characterized by normal phenotype and intelligence,the individuals seek medical service after many miscarriages,resulting in considerable mental and physical burdens of the family members.In the current era with rapid advances in detection technology,cytogenetic examination,as a definitive approach,still plays an essential role.CASE SUMMARY We report six cases with balanced chromosome translocation:Case 1:46,XY,t(3;12)(q27;q24.1),infertility after 3 years of marriage;Case 2:46,XX,t(4;16)(q31;q12),small uterus and irregular menstruation;Case 3:46,XY,t(4;5)(q33;q13),9qh+,not pregnant after arrested fetal development;Case 4:46,XX,t(11;17)(q13;p11.2),not pregnant after two times of spontaneous abortion;Case 5:46,XX,t(10;13)(q24;q21.2),not pregnant after arrested fetal development for once;Case 6:46,XX,t(1;4)(p36.1;q31.1),not pregnant after arrested fetal development for two times.The first four cases had chromosomal aberration karyotypes.CONCLUSION These results suggested that balanced chromosomal translocation carriers are associated with reproductive risks and a very high probability of abnormal pregnancy.The discovery of the first four reported chromosomal aberration karyotypes provides an important basis for studying the occurrence of genetic diseases.

Assessment of Dose and Lifetime Risk of Exposure Induced Cancer in Adult Common Computed Tomography Scans in Douala-Cameroon

Background: Among medical technologies that use ionizing radiation, CT is currently the radio diagnostic technic that can deliver the highest radiation to the Patient compared with other conventional procedures. In developing countries, the uses and risks of CT have not been well characterized. Objective: To estimate the lifetime attributable risk (LAR) incidence and mortality for cancer for each procedure for adult’s patients who had Computed Tomography examinations in 10 imaging centers in the city of Douala-Cameroon so as to provide a reference data. Materials and Methods: We conducted a cross-sectional study describing radiation dose associated with the 8 most common types of diagnostic CT studies performed on 1287 consecutive adult patients at 10 Douala radiology department. We estimated lifetime attributable risks of cancer by study type from these measured doses. Estimation of LAR for cancer incidence and mortality was based on the effective dose, patient’s sex and age at exposure using the BIER VII preferred models. Results: Mean effective dose from CT scans examinations varied from: 0.30 and 8.81 mSv. The highest doses were observed for lumbar spine CT (8.81 mSv), followed by abdomen-pelvis procedure (6.46 mSv), chest-abdomen-pelvic CT (6.61 mSv), chest CT (3.90 mSv), cervical Spine CT (3.05 mSv), head CT (1.7 mSv) and lower for sinus CT (0.30 mSv). The LAR values of all cancer from patients’ CT scans obtained vary from 67.13 excess per 100,000 (about 1 in 1489) and 0.45 excess per 100,000 (about 1 in 222,222). All cancer risk was high for lumbar spine CT in women 20 years old (67.13 excess deaths in 100,000 scans) followed by chest-abdomen-pelvic CT (50.36 excess deaths in 100,000 scans) and abdomen-pelvic CT (49.22 excess deaths in 100,000 scans) for the same age group. The LAR of incidence and mortality values were higher from female’s patients than males and higher for younger than older patients. Conclusion: This study was set out to estimate the LAR values associated with adult common CT scans procedures. The data indicates, LAR risks related to induced cancer from CT exposures were estimated to be low. This risk can be relatively significant for younger age group compared to older age group. The LAR values obtained will help to better evaluate radiation exposure risk, before ordering a CT scans examinations.

Obstetrics Risk Management in 5 Iranian Hospitals (Tehran-2012)

Background: Risk management is improving quality of health care services and creating a safer system of care. We determined the main maternal and fetal risks in five Hospitals (Tehran-Iran) to offer some practical strategies to decline obstetric adverse events and provide better pregnancy outcome. Methods: A descriptive, cross-sectional study was carried out in 5 Iranian hospitals (2011-2012).?Twelve Obstetricians/perinatalogists and midwives from 5 hospitalswho were in charge of Maternity Units, were our assistants in these hospitals. We organized a secretariat including Obstetricians/perinatalogists and midwives. The principles of Obstetrics Risk Management were introduced to them in a 2 days’ workshop. Then the delegates from each hospital were asked to report the most common obstetrical complications of their hospitals. The main results were 24 complications. Then for sorting these risks we asked them to do scoring of the 24 complication with 1 - 10 grading in 4 aspects of probability of occurrence, possibility of prevention, priority of interventions and short term response to interventions. Post partum haemorrhage, labor management problems, and neonatal hypothermia got the highest scores in these regards, and then these 24 items were categorized in 2 groups of risk assessment and hospital management. Finally based on Risk Management Rules in Clinical Governance, the complications analysis was done with use of failure mode, effects analysis and practical strategies to decline obstetrical adverse events were suggested. Results: We understood all reported complications had common infrastructural problems: defects in Risk Assessment and Hospital Management Policies. We focused on basic infrastructural management in these 2 main subjects and in these two: our main problems were related to staff management and hospital management issues. Conclusion: Since managerial and staff dependent problems were our main problems, these two should be considered as our main priorities in risk management program.

Acute Generalized Exanthematous Pustulosis during Puerperal Period Induced by Azithromycin: Case Report

Background: The use of antibiotics, especially beta-lactams and macrolides, may be associated with dermatopathies, such as Acute Generalized Exanthematous Pustulosis (AGEP), which is an uncommon cutaneous adverse reaction. Case: We report a case of AGEP, in a 36-year-old multiparous (G5P3C1A1) woman, with 38 weeks of gestation, admitted to the hospital to induce labor. Due to cephalopelvic disproportion, the cesarean section was indicated. In the postoperative period, the patient evolved with cutaneous rash, accompanied by productive cough and dyspnea. Because it was a fever of obscure origin, the treatment with antibiotics, including azithromycin, was initiated. On subsequent days, she presented pustules on the back, abdomen and extremities. Such reaction was attributed to the use of azithromycin. When the drug was discontinued, the lesions regressed significantly. Conclusion: The clinical picture of AGEP may occur with persistent high fever and therefore could be confused with systemic infections, consequently, being treated with wrong medications capable of aggravating the adverse cutaneous reaction, worsening the course of the disease that could be easily treated by stopping the use of the causative drug. This case shows the importance of including AGEP as a differential diagnosis of dermatopathies in the pregnancy-puerperal cycle, especially in women who are using various medications, including antibiotics.

Large cutaneous epithelioid angiomatous nodules in a patient with nephrotic syndrome: A case report

BACKGROUND Cutaneous epithelioid angiomatous nodules(CEAN) are rare, benign, vascular lesions characterized by benign proliferation of endothelial cells with prominent epithelioid features, which can be easily confused with benign and malignant vascular tumors. However, the etiology of CEAN remains unclear, and no association with infection, trauma, or immunosuppression has been described.This case study indicated that CEAN is closely related to the patient’s impaired immune status and may be induced by cyclosporine.CASE SUMMARY A 19-year-old boy with nephrotic syndrome(NS) developed large CEAN on the left foot during treatment for NS. He had repeated relapses of edema in the past 6 years and different types of immunosuppressants were administered including methylprednisolone, mycophenolate mofetil, tacrolimus and cyclosporine;the dosages of these drugs were frequently adjusted. The patient had been receiving cyclosporine and methylprednisolone for 7 mo before he developed CEAN.Cyclosporine was discontinued due to its side effects on skin. After cessation of cyclosporine and 16 mo follow-up, the nodules gradually disappeared without any other treatment for the CEAN.CONCLUSION Impaired immune status is proposed to be a risk factor for CEAN, which may be induced by cyclosporine.

上市公司审计委员会与年报风险信息披露--基于管理层信息操纵视角

上市公司年报风险信息是了解公司经营现状与预测未来发展的重要信息来源,它具有信息增量价值,但容易受到管理层信息操纵的影响。审计委员会作为公司治理的独立机制,对管理层具有内部监督作用。基于此,利用2010—2021年上市公司风险信息披露数据,实证检验了审计委员会对管理层信息操纵的治理作用。研究发现,审计委员会独立性、勤勉性和专业性越强,年报风险信息披露水平越高,且在不同性质市场环境中审计委员会的治理作用存在差异。机制检验结果表明,内部控制发挥了部分中介作用;此外,在内部治理环境较弱与外部监督压力较大时,审计委员会的治理作用更加显著。结论拓展了年报风险信息披露的影响因素研究,并通过构建不同维度的风险信息指标来综合衡量披露水平,证实了审计委员会对管理层信息操纵的治理效应,为审计委员会更好发挥监督效果以及监管部门进一步完善上市公司风险信息披露制度提供了重要支撑。

审计意见质量与关键审计事项报告积极性

KAM作为审计报告新增要素,其报告内容与方式必须服从、服务于审计报告核心要素——审计意见的质量保证要求。选取2016年A+H股和2017—2021年沪深A股上市公司作为样本,研究审计意见质量保证要求对KAM报告的影响,发现审计意见质量低时,KAM披露的数量越多、篇幅越大、可读性越强、语调越消极,差异度越大,KAM报告积极性越高。事务所规模越大、客户风险越低,上述关系越显著。通过一系列稳健性检验,结论依然成立。进一步研究发现:审计意见质量对KAM报告积极性的影响,不仅有利于提高审计报告沟通价值,而且有利于降低被审计报表的财务重述,控制审计失败。研究结论对审计师有效编制、监管部门适当监管、投资者正确理解新审计报告,充分发挥其功能作用,具有重要的启示意义。

交易所问询监管与股权融资成本--基于投资者风险感知视角

本文以2013—2021年中国沪深A股上市公司为样本,从投资者风险感知视角实证检验交易所问询监管对股权融资成本的影响。结果显示:公司收到定期报告问询函后股权融资成本显著上升,并且同年收到定期报告问询函数量越多、同一份定期报告被问询次数越多、定期报告问询函中的问题总数量越多,股权融资成本上升幅度越大,说明交易所问询监管会增加投资者的风险感知,进而导致股权融资成本升高。异质性检验结果显示,当投资者专业能力较强、交易风险较大、市场化程度较低和审计质量较低时,投资者对定期报告问询函所披露风险的感知能力更强,交易所问询监管对股权融资成本的正向影响更大。进一步研究发现,作为一种非处罚性监管,交易所问询监管是处罚性监管的有力补充,二者都具有良好的市场监管效果。本文的研究结论为证券监管部门依法保护投资者合法权益和防范市场风险提供了政策参考。

基于SIRS模型的核电事故致因传播机制研究

文章用自然语言处理技术对152起核电厂执照运行事件报告(Licensed Operation Event Report,LOER)进行风险致因分析,得出风险致因复杂网络的相关数据,借助改进SIR传染病模型,结合核电运行事件风险传播的特征,构建了适用于核电领域的改进传播模型。文章对核电运行事件致因传播过程进行动态仿真,对比了不同因素对传播风险的影响差异,对当前的核电安全管理工作进行优化。

卵巢-附件报告和数据系统超声2022版(O-RADS US v2022)及其联合恶性风险指数4鉴别附件良、恶性肿瘤

目的观察卵巢-附件报告和数据系统超声2022版(O-RADS US v2022)及其联合恶性风险指数4(RMI4)鉴别附件良、恶性肿瘤的价值。方法回顾性分析126例手术病理诊断为附件肿瘤患者,根据O-RADS US v2022将1~3类归为良性病变、4~5类归为恶性病变,以450为RMI4分类的临界值,基于二者进行联合分类。以病理结果为金标准,绘制受试者工作特征(ROC)曲线,计算曲线下面积(AUC),评估单一O-RADS US v2022、RMI4及其联合鉴别附件良、恶性肿瘤的效能。结果126例附件肿瘤中,良性94例、恶性32例。O-RADS US v2022鉴别附件良、恶性肿瘤的敏感度、特异度、准确率及AUC分别为78.13%、80.85%和80.16%、0.795,RMI4分别为71.88%、84.04%和80.95%、0.780;二者联合的特异度及准确率(93.62%、92.06%)均高于单一O-RADS US v2022(χ^(2)=7.322、5.967,P=0.007、0.015)或RMI4(χ^(2)=4.625、5.331,P=0.032、0.021),而敏感度及AUC(87.50%、0.906)差异均无统计学意义(P均>0.05)。结论O-RADS US v2022能有效鉴别附件良、恶性肿瘤,联合RMI4可提高鉴别特异度及准确率。

医疗器械检验报告审核和质量管理探讨

目的:医疗器械具有复杂性、特殊性、专业性、涉及门类广等特点,面对医疗器械开放自检及检验市场竞争日益加剧的形势,如何提升检验能力,适应产业的迅速发展,确保检验结果的科学性、公正性、权威性,是各医疗器械检验机构面临的共同挑战。方法:从医疗器械检验面临的挑战、法律法规要求、质量管理体系关注要点等方面进行阐述。结果:通过对报告审核中发现的问题,提出质量改进措施及建议。结论:医疗器械检验机构应持续提升检验能力,发展特色优势领域,积极应对医疗器械快速发展的需要及检验新形势,提质增效,应在医疗器械的质量检验工作中,引入风险管理理念并加强过程控制,从人、机、料、法、环等方面构建起全方位的保障体系,提高检验质量和效率,助力医疗器械高质量发展。

外部环境不确定性对企业持续经营审计风险的影响研究

目前,外部环境不确定性增多,有些企业面临利润下滑、成本费用上升、资金链压力陡增等经营风险。由于企业持续经营能力的职业判断标准差异、治理层与管理层的舞弊行为及凌驾于内部控制之上、审计范围受限的原因,注册会计师对企业年报审计中的持续经营风险相应增加。会计师事务所与审计人员应充分认清其风险的危害性,拓宽审计方法与思路创新、持续经营指标的评判,关注年报的持续经营披露与期后事项,严格遵守职业道德规范与质量控制程序,将审计风险降至最低。

关键审计事项信息披露与债务融资成本——基于风险词频的分析

新审计报告改革要求在关键审计事项中披露风险信息,该信息的外部感知是一种风险吸收还是风险溢出,是一个亟待检验的理论命题。为此,以2017—2021年A股上市公司为研究样本,通过统计关键审计事项段文本的风险词频考察风险信息披露对债务融资成本的影响。结果表明,关键审计事项风险信息的披露显著降低了债务融资成本,符合信息观的预期。进一步研究发现:关键审计事项的风险披露主要是通过缓解信息不对称和降低债务违约风险影响债务融资成本;在企业代理成本较高、银行业竞争度较低的子样本中,关键审计事项风险信息披露对债务融资成本的降低作用更为明显。这不仅为新审计报告改革的效果提供了增量的经验证据,而且对于推进准则贯彻实施、完善资本市场监管规则体系也有一定的借鉴参考价值。

企业ESG表现影响关键审计事项披露吗?

基于2017-2021年我国A股上市公司的经验证据,实证检验企业ESG表现对关键审计事项披露的影响。研究发现,企业ESG表现越差,审计师为应对风险披露的关键审计事项越充分,具体表现为披露数量更多、披露内容更详细。进一步分析发现,ESG表现通过影响企业的经营风险和信息风险,从而影响到关键审计事项披露的信息量,并且在审计师具有行业专长和媒体关注度较高的情况下,企业ESG表现对关键审计事项披露的影响更明显。研究结论不仅丰富了企业ESG表现经济后果的相关文献,而且对新审计报告准则实施后审计师更准确地识别审计风险、提供更有效的审计服务具有启示意义。

深度学习联合C-TIRADS在甲状腺4a类结节风险分层管理的应用

目的探讨深度学习联合中国超声甲状腺影像报告和数据系统(C-TIRADS)在甲状腺4a类结节风险分层管理的应用。方法纳入陕西省人民医院2018年12月~2022年10月收治的179例甲状腺结节患者,依据病理结果分为良性组(n=76)与恶性组(n=103),所有患者均予以超声检查,按照C-TIRADS指南标准、深度学习进行观察诊断。利用多因素Logistic回归分析获取独立预测指标;利用ROC曲线评估预测变量准确性。结果多因素Logistic分析显示,甲状腺结节图像特征的结构、方位、边缘、回声、局灶性强回声及年龄是独立预测甲状腺结节性质的指标(P<0.05)。以病理结果为金标准,深度学习联合C-TIRADS与病理结果完全符合率为96.65%,Kappa值为0.932,一致性好;联合诊断甲状腺4a类结节的符合率、特异度、阳性预测值显著高于深度学习、C-TIRADS(P<0.05)。联合诊断疾病的敏感度、阴性预测值高于深度学习(P<0.001),但与C-TIRADS的差异无统计学意义(P<0.05)。ROC曲线分析显示,C-TIRADS、深度学习及联合诊断的AUC分别为0.873、0.819、0.967;与Az=0.5相比,差异有统计学意义(P<0.001)。结论C-TIRADS在甲状腺4a类结节风险分层管理中敏感性较高,结合深度学习辅助诊断能够准确进行甲状腺结节良恶性鉴别,具备较高诊断效能。

基于药品不良反应监测数据的心脏器官伤害风险信号挖掘分析

目的挖掘与分析药品不良反应监测数据库中可能导致心脏器官伤害的药品不良反应(ADR)风险信号,为临床安全合理用药及药品上市后安全性研究提供参考。方法提取2021年1月1日至2023年12月31日期间某省药品不良反应监测数据库的ADR报告,进行数据清洗,采用报告比值比(ROR)法进行ADR信号检测,计算ADR累及心脏器官系统药品的ROR值及其95%置信区间,对挖掘出的风险信号进行分析与评价。结果检索近3年ADR报告共72398例,排除重复报告及不完整报告,最终纳入分析的累及心脏器官系统ADR报告3697例。女性患者数量多于男性患者,65岁以上的老年患者用药后发生ADR的例数最多,原患疾病为呼吸系统、胸及纵隔疾病,血管与淋巴管类疾病和心脏器官疾病占比近60%,给药疗程1 d以内的报告超过50%,患者用药当天发生ADR的超60%,不良反应转归情况总体良好。263个药品被纳入分析,ROR法挖掘出可能导致心脏器官伤害风险信号共70个,包含62个说明书记载的已知信号和8个说明书未记载的新的信号。结论ROR法挖掘本省可能导致心脏器官伤害ADR风险信号,初步产生风险信号,但还需要进一步深入研究予以证实。药物警戒除重点关注可能导致心脏器官伤害的药品外,还应注意患者个体差异、临床用药因素的影响,将药源性心脏风险降至最低,确保用药安全。

基于区块链的计算机通信网络安全风险评估

为实现计算机通信网络的全面安全管控,及时掌握风险态势,设计基于区块链技术的计算机通信网络安全风险评估模型。以区块链技术为基础生成私有化数据区块链并加密所有的数据区块,通过这些数据区块采集计算机通信网络数据后,对这些数据进行汇总并生成网络风险项目账本;依据计算机通信网络数据,构建计算机通信网络安全风险评估指标体系,评估计算机通信网络安全风险。测试结果显示:该模型具备良好的风险计算性能,可获取各个等级的风险,应用性良好,为网络风险管控提供可靠的链上溯源信息。

医疗器械定期风险评价报告的问题分析及对策

医疗器械定期风险评价报告(PRER)对产品上市后的安全性研究具有重要意义。该研究通过梳理、汇总国家医疗器械不良事件监测信息系统内山东省注册人提交的PRER,结合基层调研和工作开展的实际情况归纳PRER存在的问题,探讨加强医疗器械定期风险评价工作的创新举措,确保企业主体责任落实到位。

卵巢-附件超声报告和数据风险分层系统结合卵巢恶性肿瘤风险算法诊断卵巢癌的价值分析

目的探讨卵巢-附件超声报告和数据风险分层系统(O-RADS US)结合卵巢恶性肿瘤风险算法(ROMA)鉴别卵巢-附件肿瘤良恶性的价值。方法回顾性分析2021年6月至2023年5月于青岛市市立医院妇产科住院治疗的卵巢-附件肿瘤患者89例的临床资料。采用经阴道超声观察病灶的大小、回声、形态、内部分隔及血流分布等超声特征,按照O-RADS US对病灶进行分类,并通过糖类抗原125(CA125)和人附睾蛋白4(HE4)表达水平计算ROMA值。采用受试者操作特征(ROC)曲线分析O-RADS US、ROMA及其联合诊断卵巢癌的效能。结果本研究共收集到93个病灶,卵巢癌病灶的最大径及ROMA值均高于良性病灶,差异有统计学意义(P<0.05)。O-RADS US分类为2、3、4、5类的病灶分别占21.5%(20/93)、26.9%(25/93)、33.3%(31/93)和18.3%(17/93);联合ROMA对O-RADS US分类进行校正,则O-RADS US分类为2、3、4、5类的病灶分别占34.4%(32/93)、29.0%(27/93)、14.0%(13/93)、22.6%(21/93)。联合ROMA后,O-RADS US 2、3、4类卵巢-附件病灶分别有4、6、9个升级为O-RADS US 3、4、5类;同样,O-RADS US 5、4、3类卵巢-附件病灶分别有5、20、16个降级为O-RADS US 4、3、2类。O-RADS US诊断卵巢癌的敏感度、特异度、准确度、曲线下面积分别为80.0%、75.3%、76.3%、0.861。ROMA诊断绝经前和绝经后患者卵巢癌的敏感度、特异度、准确度及曲线下面积分别为85.0%、82.2%、82.8%、0.876及90.0%、89.0%、89.2%、0.904。O-RADS US联合ROMA诊断卵巢癌的敏感度、特异度、准确度及曲线下面积分别为95.0%、91.8%、92.5%、0.926。以O-RADS US联合ROMA诊断卵巢癌的曲线下面积最大,其次是ROMA,差异有统计学意义(P<0.05)。结论O-RADS US分类系统可以有效识别卵巢癌,与ROMA联合应用,能够克服单独应用的不足,提高卵巢癌诊断的性能,减少不必要的穿刺活检。