The ratio of vision to data: Promoting emergent science and technologies through promissory regulation,the case of the FDA and personalised medicine

Pharmacogenetic tests provide genetic data to tailor drug treatment and were widely predicted to be one of the first fruits of the Human Genome Project. In the mid-2000s, the US Food and Drugs Administration (FDA) became an advocate for pharmacogenetic testing, but its efforts to build a market for this new technology brought the agency into dispute with other regulatory actors over the type of evidence needed for the adoption of pharmacogenetic testing, in particular the importance of randomized control trials. The warfarin case highlights the tension between a new form of promissory regulation driven by future expectations and FDA's established role as protector of public health; and the controversy can be conceptualized as a struggle over regulatory epistemologies within a complex polycentric regulatory space. Our case study addresses two themes central to the burgeoning scholarship on the governance of emergent science and technologies (EST): the political economy of regulation, in particular the role that regulators play in creating markets for EST; and the epistemological politics of regulatory science, in particular the controversy that arises when regulators modify scientific standards to accommodate EST. Linking these two themes is the concept of promissory regulation: the idea that regulatory policy may be shaped by an institutional commitment to the transformational potential of EST. This concept sheds new light on the neo-mercantilist nature of contemporary regulatory capitalism.     

Policy beliefs,policy learning,and risk perception: Exploring the formation of local creative Placemaking-catalyzed policy network

This article studies the formation of a local Creative Placemaking (CPM) policy network based on the Advocacy Coalition Framework (ACF) and social capital perspective of policy networks. This article hypothesizes that policy beliefs, policy learning, social capital, and the perceived risks induced by defections, as well as macro-level changes in the broader political and socio-economic system, influence partner selection in the local CPM policy networks. The study collected survey data from policy actors participating in the Franklinton CPM-catalyzed revitalization project in Columbus, Ohio. An exponential random graph model (ERGM) was applied to test the hypotheses. The findings partially support the hypotheses: policy learning, certain secondary policy beliefs, and risk perceptions of changes in economic and political factors are correlated with tie formation. The reciprocity-driven bonding structure underlies the Franklinton CPM policy network, suggesting that policy actors perceive the Franklinton CPM policy network as a high-defection-risk network. This study has implications for policy makers in designing engagement strategies to better involve stakeholders holding different beliefs and occupying different network positions.     

Automatic Classification of Bloodstain Patterns Caused by Gunshot and Blunt Impact at Various Distances

The forensics discipline of bloodstain pattern analysis plays an important role in crime scene analysis and reconstruction. One reconstruction question is whether the blood has been spattered via gunshot or blunt impact such as beating or stabbing. This paper proposes an automated framework to classify bloodstain spatter patterns generated under controlled conditions into either gunshot or blunt impact classes. Classification is performed using machine learning. The study is performed with 94 blood spatter patterns which are available as public data sets, designs a set of features with possible relevance to classification, and uses the random forests method to rank the most useful features and perform classification. The study shows that classification accuracy decreases with the increasing distance between the target surface collecting the stains and the blood source. Based on the data set used in this study, the model achieves 99% accuracy in classifying spatter patterns at distances of 30 cm, 93% accuracy at distances of 60 cm, and 86% accuracy at distances of 120 cm. Results with 10 additional backspatter patterns also show that the presence of muzzle gases can reduce classification accuracy.     

Bacterial Profiling of Soil For Forensic Investigations: Consideration of Ex Situ Changes in Questioned and Known Soil Samples

Soil, being diverse and ubiquitous, can potentially link a suspect or victim to a crime scene. Recently scientists have examined the microbial makeup of soil for determining its origin, and differentiating soil samples is well-established. However, when soil is transferred to evidence its microbial makeup may change over time, leading to false exclusions. In this research, “known” soils from diverse habitats were stored under controlled conditions, while evidence soils were aged on mock evidence. Limited quantities of soil were also assayed. Bacterial profiles were produced using next-generation sequencing of the 16S rRNA gene. Overall, known soils stored open at room temperature were more similar to evidence soils over time than were known soils stored bagged and/or frozen. Evidence soils, even as little as 1 mg, associated with the correct habitat 99% of the time, accentuating the importance of considering ex situ microbial changes in soil for its successful use as forensic evidence.     

‘Gross inefficiency and criminal negligence’: the Services Reconnaissance Department in Timor in 1943–45 and the Darwin war crimes trials in 1946

The post-World War II Australian military war crimes trials of Japanese from 1945–51 have been criticised for using a rule of evidence considerably relaxed from the ordinary requirements of a criminal trial, one that did not require witnesses to give evidence in person. Circumstantial evidence suggests that, in relation to a trial held in Darwin in March 1946 for war crimes committed in Timor, the secretive Special Operations Australia, otherwise known as the Services Reconnaissance Department (SRD), took advantage of the rule. This article argues that the SRD did not allow their members to give evidence in person in an attempt to control and limit the dissemination of information about their operational and security failures in Timor from 1943–45. The SRD operation was adjudged by its own official historian as displaying ‘gross inefficiency and criminal negligence’. While the SRD’s failures were known to select personnel at the time, access restrictions to archival records in the post-war period, including the war crimes trials, meant that the extent of its failures and how it appeared to manage knowledge of them has not been widely known.     

针刺治疗神经根型颈椎病系统评价

目的 系统评价针刺与牵引相比较治疗神经根型颈椎病（cervical spondylotic radiculopathy,CSR）的疗效和安全性。方法 广泛检索国内外各数据库中针刺与牵引治疗CSR的随机对照试验。严格按最新版Cochrane系统评价员手册5.1进行方法学质量评价并计算其效应量,进行Meta分析或描述性分析。结果 14个研究包括1 542例病例被纳入,结果显示针刺治疗CSR是安全的;针刺治疗CSR总体疗效较牵引治疗具有优效性(RR:1.20;95% CI:1.13～1.27 vs RR:1.14;95% CI:1.09～1.20)。针刺较牵引对CSR患者更具镇痛效果,且能减少复发。结论 针刺较牵引治疗CSR具有优越性,但证据等级较低,结论并不可靠。     

稳心颗粒治疗心房颤动疗效及安全性Meta分析

目的 系统评价稳心颗粒治疗心房颤动的临床疗效及安全性。方法 计算机检索中国知网、万方数据知识服务平台、读秀中文学术搜索、PubMed数据库中关于稳心颗粒治疗心房颤动的临床随机对照试验,经质量评价最终纳入文献后,采用Review Manager 5.0软件进行Meta分析。结果 共纳入13个研究,全部为中文,Jadad评分均为1分。Meta分析结果显示,稳心颗粒组与西药常规治疗组比较,稳心颗粒可提高临床疗效（OR=3.40,95% CI为2.41～4.80,P<0.01）,降低心室率（WMD=-5.86,95% CI为－6.73～－4.99,P<0.01）,提高转复率（OR=2.76,95% CI为1.29～5.92,P<0.01）,降低不良反应率（OR=0.52,95% CI为0.29～0.94,P=0.03）。结论 与西药常规疗法比较,稳心颗粒治疗心房颤动可进一步提高临床疗效,降低心室率,提高转复率,降低不良反应率。     

丹红注射液联合西药常规治疗不稳定型心绞痛疗效和安全性系统评价

［摘要］目的 系统评价丹红注射液联合西药常规治疗不稳定型心绞痛的有效性与安全性。方法 检索PubMed、Medline、中国期刊全文数据库、万方数据知识服务平台中丹红注射液联合西药常规治疗不稳定型心绞痛的临床随机对照试验文献,按照Cochrane协作网推荐的方法评价纳入研究文献的质量后,采用RevMan 4.2软件进行Meta分析。结果 经筛选纳入23篇文献,共2 675例,其中治疗组（丹红注射液联合西药常规治疗）1 382例,对照组（单纯西药治疗）1 293例。各研究基线情况具有可比性。Meta分析结果显示：丹红注射液加西药常规治疗在提高心电图疗效[RR=2.84, 95% CI(2.28,3.55)]、心绞痛疗效[RR=4.13,95% CI（3.12,5.47）],升高高密度脂蛋白-胆固醇[high density lipoprotein-cholesterol, HDL-C）（WMD=0.29,95% CI（0.05,0.52）],降低低密度脂蛋白-胆固醇（low density lipoprotein-cholesterol, LDL-C）[WMD=-0.98, 95% CI(-1.33,-0.63）]和高敏C反应蛋白（high sensitive C-reactive protein, hs-CRP）[WMD=-1.42, 95% CI(-2.18, -0.65)]方面均优于西药常规治疗组。结论 丹红注射液联合西药常规治疗在改善不稳定型心绞痛患者的心电图疗效,升高HDL-C,降低LDL-C和hs-CRP水平方面优于对照组。受纳入文献质量的限制,本研究结论尚需更多高质量大样本的临床随机双盲对照研究加以验证。     

通督调神针法结合夹脊穴治疗脑卒中后痉挛性瘫痪

目的 观察比较通督调神针法结合夹脊穴与单纯通督调神针法治疗脑卒中后痉挛性瘫痪的疗效差异。方法 将61例患者随机分为观察组（通督调神针法结合夹脊穴）31例和对照组（单纯通督调神针法）30例,两组患者均给予康复治疗,对照组针刺取督脉穴百会、风府、水沟、大椎、至阳、腰阳关为主穴;观察组在对照组基础上结合夹脊穴针刺,取颈2—7、腰1—5夹脊穴,双侧交替针刺,每日针刺1次,每次40 min,每周6次,共治疗4周。两组患者均采用简易Fugl- Meyer运动功能量表和修订的Barthel指数（Barthel index,BI）量表评定运动功能,比较两组的疗效差异。结果 治疗4周后,观察组肢体痉挛改善程度与对照组相当,差异无统计学意义（P>0.05）;两组治疗后Fugl- Meyer和BI评分均较治疗前显著升高（P<0.05）,观察组治疗后Fugl- Meyer和BI评分较对照组升高更为显著（P＜0.05）。结论 通督调神针法结合夹脊穴在改善脑卒中后痉挛性瘫痪患者的痉挛状态方面与单纯通督调神针法疗效相当,但在提高肢体运动功能和日常生活活动能力方面,通督调神针法结合夹脊穴均优于单纯通督调神针法。     

A novel multiplex assay system based on 10 methylation markers for forensic identification of body fluids

Identifying the source of body fluids found at a crime scene is an essential forensic step. Some methods based on DNA methylation played significant role in body fluids identification. Since DNA methylation is related to multiple factors, such as race, age, and diseases, it is necessary to know the methylation profile of a given population. In this study, we tested 19 body fluid-specific methylation markers in a Chinese Han population. A novel multiplex assay system based on the selected markers with smaller variation in methylation and stronger tissue-specific methylation were developed for the identification of body fluids. The multiplex assay were tested in 265 body fluid samples. A random forest model was established to predict the tissue source based on the methylation data of the 10 markers. The multiplex assay was evaluated by testing the sensitivity, the mixtures, and old samples. For the result, the novel multiplex assay based on 10 selected methylation markers presented good methylation profiles in all tested samples. The random forest model worked extremely well in predicting the source of body fluids, with an accuracy of 100% and 97.5% in training data and test data, respectively. The multiplex assay could accurately predict the tissue source from 0.5 ng genomic DNA, six-months-old samples and distinguish the minor component from a mixture of two components. Our results indicated that the methylation multiplex assay and the random forest model could provide a convenient tool for forensic practitioners in body fluid identification.