U.S. initiatives to strengthen forensic science & international standards in forensic DNA

A number of initiatives are underway in the United States in response to the 2009 critique of forensic science by a National Academy of Sciences committee. This article provides a broad review of activities including efforts of the White House National Science and Technology Council Subcommittee on Forensic Science and a partnership between the Department of Justice (DOJ) and the National Institute of Standards and Technology (NIST) to create the National Commission on Forensic Science and the Organization of Scientific Area Committees. These initiatives are seeking to improve policies and practices of forensic science. Efforts to fund research activities and aid technology transition and training in forensic science are also covered.The second portion of the article reviews standards in place or in development around the world for forensic DNA. Documentary standards are used to help define written procedures to perform testing. Physical standards serve as reference materials for calibration and traceability purposes when testing is performed. Both documentary and physical standards enable reliable data comparison, and standard data formats and common markers or testing regions are crucial for effective data sharing. Core DNA markers provide a common framework and currency for constructing DNA databases with compatible data. Recent developments in expanding core DNA markers in Europe and the United States are discussed.     

Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.     

Ischemic stroke in Morocco: Prehospital delay and associated factors

ObjectivesThis study aimed to estimate prehospital delay and to identify the factors associated with the late arrival of patients with ischemic stroke at the Souss Massa Regional Hospital Center in Morocco.Patients and methodsAn observational, prospective, cross-sectional study was conducted from March 2019 to September 2019 in the Souss Massa regional hospital center, which is a public hospital structure. A questionnaire was administered to patients with ischemic stroke and to bystanders (family or others), while clinical and paraclinical data were collected from medical records. Univariate and multivariate logistic regression analyses were used to identify the factors associated with delayed arrival at emergency department.ResultsA total of 197 patients and 197 bystanders who fulfilled the criteria for the study were included. The median time from symptom onset to hospital arrival was 6 hours (IQR, 4–16). Multiple regression analysis showed that illiteracy (OR 38.58; CI_95%: 3.40–437.27), waiting for symptoms to disappear (patient behavior) (OR 11.24; CI_95%: 1.57–80.45), deciding to go directly to the hospital (patient behavior) (OR 0.07; CI_95%: 0.01–0.57), bystander's knowledge that stroke is a disease requiring urgent care within a limited therapeutic window (OR 0.005; CI_95%: 0.00–0.36), and direct admission without reference (OR 0.005; CI_95%: 0.00–0.07), were independently associated with late arrival (> 4.5 hours) of patients with acute ischemic stroke. In addition, illiteracy (OR 24.62; CI_95%: 4.37–138.69), vertigo and disturbance of balance or coordination (OR 0.14; CI_95%: 0.03–0.73), the relative's knowledge that stroke is a disease requiring urgent care and within a limited therapeutic window (OR 0.03; CI_95%: 0.00–0.22), calling for an ambulance (relative's behavior) (OR 0.16; CI_95%: 0.03–0.80), distance between 50 and 100 km (OR 10.16; CI_95%: 1.16–89.33), and direct admission without reference (OR 0.03; CI_95%: 0.00–0.14), were independently associated with late arrival (> 6 hours) of patients with acute ischemic stroke.ConclusionPatient behavior, bystander knowledge and direct admission to the competent hospital for stroke care are modifiable factors potentially useful for reducing onset-to-door time, and thereby increasing the implementation rates of acute stroke therapies.     

Why common carrier and network neutrality principles apply to the Nationwide Health Information Network (NWHIN)

The Office of the National Coordinator will be defining the architecture of the Nationwide Health Information Network (NWHIN) together with the proposed HealtheWay public/private partnership as a development and funding strategy. There are a number of open questions—for example, what is the best way to realize the benefits of health information exchange? How valuable are regional health information organizations in comparison with a more direct approach? What is the role of the carriers in delivering this service? The NWHIN is to exist for the public good, and thus shares many traits of the common law notion of ‘common carriage’ or ‘public calling,’ the modern term for which is network neutrality. Recent policy debates in Congress and resulting potential regulation have implications for key stakeholders within healthcare that use or provide services, and for those who exchange information. To date, there has been little policy debate or discussion about the implications of a neutral NWHIN. This paper frames the discussion for future policy debate in healthcare by providing a brief education and summary of the modern version of common carriage, of the key stakeholder positions in healthcare, and of the potential implications of the network neutrality debate within healthcare.     

Risk analysis of main mycotoxins occurring in food for children: An overview

Mycotoxins are secondary metabolites produced by fungi contaminating the food chain that are toxic to animals and humans. Children up to 12 years old are recognized as a potentially vulnerable subgroup with respect to consumption of these contaminants. Apart from having a higher exposure per kg body weight, they have a different physiology from that of adults. Therefore they may be more sensitive to neurotoxic, endocrine and immunological effects. For these reasons, a specific and up-to-date risk analysis for this category is of great interest.In this review, an accurate analysis of the main mycotoxins occurring in food intended for children (deoxynivalenol, aflatoxins, ochratoxins, patulin and fumonisins) is presented. In particular, known mechanisms of toxicity and levels of exposure and bioaccessibility in children are shown. In addition, recent discoveries about the strategies of mycotoxins managing are discussed.     

Classifying errors in preventable and potentially preventable trauma deaths: a 9-year review using the Joint Commission's standardized methodology

Background

Benchmarking and classification of avoidable errors in trauma care are difficult as most reports classify errors using variable locally derived schemes. We sought to classify errors in a large trauma population using standardized Joint Commission taxonomy.

Methods

All preventable/potentially preventable deaths identified at an urban, level-1 trauma center (January 2002 to December 2010) were abstracted from the trauma registry. Errors deemed avoidable were classified within the 5-node (impact, type, domain, cause, and prevention) Joint Commission taxonomy.

Results

Of the 377 deaths in 11,100 trauma contacts, 106 (7.7%) were preventable/potentially preventable deaths related to 142 avoidable errors. Most common error types were in clinical performance (inaccurate diagnosis). Error domain involved primarily the emergency department (therapeutic interventions), caused mostly by knowledge deficits. Communication improvement was the most common mitigation strategy.

Conclusion

Standardized classification of errors in preventable trauma deaths most often involve clinical performance in the early phases of care and can be mitigated with universal strategies.     

The International Medical Graduate and Emergency Medicine

International medical graduates (IMGs) are medical graduates who have received their degree from international medical schools. IMGs must undertake a 3-step process to apply to the National Residency Matching Program match. First, they must obtain a valid standard certificate from the Educational Commission for Foreign Medical Graduates. Following certification, they must apply for and secure a position in a residency training program. Third, they must obtain a visa that would enable them to commence their training. In this article, we delve thoroughly into these stepladders to provide IMGs with a clear roadmap of the process as well as contacts to key agencies that may provide more comprehensive assistance.     

老年非小细胞肺癌患者术后生活质量的纵向研究

目的 纵向研究老年非小细胞肺癌(NSCLC)患者术后生活质量,并分析其影响因素。方法 通过便利抽样法对行根治术治疗的老年NSCLC患者术后1个月行一般情况及生活质量问卷调查,共发放190份问卷,收回有效问卷182份,以术后1个月肺癌患者生活质量测定量表(FACT-L)总分分组,分为生活质量良好组(≥平均分)及生活质量不良组(＜平均分);并对患者跟踪随访,在术后3、6个月时再次行生活质量调查。采用FACT-L调查患者生活质量。采用SPSS 24.0软件进行数据分析。根据数据类型,组间比较分别采用t检验、单因素重复测量方差分析及χ²检验。采用logistic回归分析评估老年NSCLC患者术后1个月生活质量不良的影响因素。结果 182例老年NSCLC患者在术后3个月时有3例患者不配合复查或失访,未获得二次生活质量调查,予以剔除,术后6个月时有8例患者失访,获得171份有效问卷。随着术后时间的延长,老年NSCLC患者各维度FACT-L评分及其总分逐渐升高,差异有统计学意义(P＜0.05)。生活质量不良组吸烟史占比、中转开胸率、术后肺部并发症发生率及癌因性疲乏率均高于生活质量良好组(P＜0.05)。logistic回归分析显示,吸烟史(OR=3.074,95%CI 1.461～6.468)、中转开胸(OR=2.377,95%CI 1.099～5.145)、术后肺部并发症(OR=4.088,95%CI 2.193～7.621)、癌因性疲乏(OR=3.016,95%CI 1.535～5.927)均为老年NSCLC患者术后1个月生活质量不良的危险因素(P＜0.05)。171例老年NSCLC患者中,术后1个月有癌因性疲乏者术后6个月FACT-L总分明显低于无癌因性疲乏者(P＜0.05)。结论 有吸烟史、中转开胸、术后肺部并发症及癌因性疲乏的老年NSCLC患者术后早期生活质量较差,但随着术后时间的延长,患者生活质量可逐渐提升,癌因性疲乏可对患者术后生活质量产生持续不良影响。