Double ethical review of North–South collaborative clinical research: hidden paternalism or real partnership?

Despite their universal character, the ethical principles governing clinical research need to be translated into procedures and practices, which will vary among countries and regions because of differences in local cultural norms and in the available resources. Double ethical review, by which a research protocol is submitted for ethical clearance both in the country or countries where the research takes place and in the country of the sponsor or funding agency, will then help ensure that all relevant perspectives are taken into account. In addition, a geographically and culturally close ethics committee can do a much better informed and comprehensive assessment of the respective skills of the clinical sites and of the sponsor. But the practical implementation of double ethical review can bring significant difficulties and delays, especially in multi-site and multi-country researches. Currently, most ethics committees do not proactively seek communication with others evaluating the same research protocol in different socio-economical and cultural contexts, so in practice there is no mutual learning process. Proactive communication would help to build collaborative partnership among ethical bodies, promoting common practices and resolving conflicting opinions.     

Systematic review: handwashing behaviour in low- to middle-income countries: outcome measures and behaviour maintenance

Objectives To describe global approaches to handwashing research in low‐ and middle‐income communities, schools and health care settings using behavioural outcome measurement and temporal study design. Methods Peer‐reviewed and grey literature was screened for handwashing studies that evaluated behaviour change. Relevant articles were assessed by their research approach, including the investigator’s selected outcome measure and time frame of various study components (e.g., formative research, intervention and evaluation). Results The initial search yielded 527 relevant articles. After application of exclusion criteria, we identified 27 unique studies (30 total articles). Of the 27 articles, most were focused in the community setting. Fifteen (56%) documented observed handwashing behaviour, while 18 (67%) used proxy measures (e.g., soap presence, diarrhoea) and 14 (52%) used self‐reported behaviour. Several studies used multiple outcome measures. While all studies had an evaluation of behaviour change, there was a dearth of studies that evaluated long‐term maintenance of behaviour change after the intervention’s conclusion. Conclusions While the literature is replete with a variety of handwashing studies in community, school and health care settings, none have been able to definitively document long‐term behaviour change, thereby challenging the sustainability of various interventions. Additionally, there is a need to better understand which research approach is most effective in promoting long‐term behaviour compliance in global low‐ and middle‐income settings.     

Effectiveness of pharmacy interventions in improving availability of essential medicines at the primary healthcare level

Objective To assess the effectiveness of pharmaceutical systems interventions in improving the availability of essential medicines at the primary care level. Methods Literature search for examples of pharmaceutical systems interventions in low and middle income countries that evaluated the impact of specific interventions on medicines’ availability. Qualitative and quantitative studies were included. Results Seventeen studies were included, on privatisation of drug distribution, user‐fees, revolving drug funds (RDFs), supervisory visitation programmes, staff training initiatives, community‐directed interventions (CDIs) and disease‐specific drug programmes. We found no studies on non‐monetary staff incentives or the use of national pharmacy standards. Generally, the quantity and quality of evidence was low; evidence was strongest for supervisory visitation programmes and CDIs. Conclusion Several interventions have the potential for improving medicines’ availability without requiring large‐scale international cooperation or global policy change. The absence of evidence in this field does not prove lack of effect. There is a need for more systematic studies of multi‐faceted pharmaceutical interventions to improve drug availability in the context of difficult health systems, such as structured supervision of remote health facilities, CDIs, staff training, integration of disease‐specific programmes, implementation of national pharmacy standards, non‐monetary staff incentives and measures to ensure cost is not a barrier to access. A standardised approach to measuring the availability of essential medicines is needed.     

SARS--my personal battle

It isn’t every day that a doctor becomes a patient. It is more peculiar when it occurs with an unknown mysterious epidemic respiratory illness that kills. Severe acute respiratory syndrome (SARS) gripped the world in 2003, spreading via air-links and throwing the global economy into disarray. As a practicing physician in Singapore, one of the first countries affected, I describe my first-hand account of my battle with this illness, how I acquired this illness in Singapore, and eventually quarantine in Frankfurt am Main, Germany.     

急性期脑卒中患者抑郁发生情况及相关因素研究

目的 对脑卒中后发生抑郁患者进行发病率及多种相关因素的研究,期望对这些患者的早期诊断和干预治疗提供帮助.方法 采用病例一对照研究方案.选用符合标准的所有脑卒中住院患者,抑郁患者为病例组,其余患者为对照组,对各相关因素进行统计学分析.结果 共调查116例患者,最后能够配合完成所有调查任务的有114例.抑郁发病人数为54例,占47.4％.单因素分析发现:神经功能缺损程度,日常生活能力指数,婚姻,卒中性质,病程与抑郁发生有关.多因素Logistic回归分析显示:神经功能缺损程度,日常生活能力是影响抑郁发生的主要因素.结论 神经功能缺损程度为脑卒中后抑郁的危险因素,日常生活能力为保护因素.     

黑龙江省五常市结核分枝杆菌基因型及传播特征

目的 根据黑龙江省结核分枝杆菌差异区域105(RD105)缺失基因检测与北京基因型菌株的相关性分析,了解黑龙江省五常市结核分枝杆菌基因型特征及传播特征,为该地区控制结核病提供有效的工具。方法 对黑龙江省五常市结核病防治(简称“结防”)所登记并培养阳性的121例肺结核患者的结核分枝杆菌分离株,采用比例法药敏试验检测其耐药性,用RD105缺失基因检测和7个位点可变数目串联重复序列(variable number of tandem repeats,VNTR)进行分子分型, 计算耐药率、Hunter-Gaston指数(Hunter-Gaston Index,HGI)、成簇率,分析结核分枝杆菌DNA多态性及北京基因型菌株与耐药的相关性。结果 在黑龙江省五常市121株结核分枝杆菌菌株中,通过RD105缺失基因检测,其结果显示有101株为北京基因型菌株,占83.5 %.(101/121),其余20株为非北京基因型菌株,占16.5%(20/121)。121株菌株对异烟肼、利福平、乙胺丁醇、链霉素的耐药率分别为5.8%(7/121)、3.3% (4/121) 、 5.0%(6/121)、15.7%(19/121);其中北京基因型菌株对上述药物的耐药率分别为5.0%(5/101)、3.0% (3/101)、5.9%(6/101)、17.8%(18/101),非北京基因型菌株对上述药物的耐药率分别为10.0%(2/20)、 5.0% (1/20) 、 5.0%(1/20)、未检出对乙胺丁醇耐药0.0%(0/20)。两者比较差异无统计学意义(χ ²=1.090,P=0.296)。121株菌株中耐多药率为2.5%(3/121),其中2株为北京家族基因型,1株为非北京基因型;北京基因型和非北京基因型耐多药率分别为2.0%(2/101)和5.0%(1/20),两者比较差异无统计学意义(χ ²=0.531,P=0.460)。进一步使用7位点VNTR分型技术检测,结果显示121株菌株可分为17个基因簇和64个独立的基因型;每个簇包括2~14株临床分离株,最大的簇由14株结核分枝杆菌菌株构成,所占比较高为11.6%(14/121);121株结核分枝杆菌菌株中成簇菌株57株,成簇率为 47.1%(57/121)。近期感染率最小估计值为33.1%(40/121)。7位点VNTR检测结果表现出高度多态性,各位点的HGI值为0.513~0.786;经聚类分析,121株结核分枝杆菌菌株可分为3个大的基因群(Ⅰ群、Ⅱ群、Ⅲ群),81个基因型。分别为:Ⅰ群占14.9%(18/121),含15 个基因型;Ⅱ群占76.9%(93/121),含59个基因型,Ⅲ群占8.2%(10/121),含7个基因型。结论 北京基因型为黑龙江省五常市主要流行株,且该地区的结核分枝杆菌呈明显的基因多态性。耐药菌株中北京基因型菌株所占比率较高,要加强对耐药优势菌群的监测和防控。     

结核性脑膜炎临床治疗的研究进展

结核性脑膜炎(tuberculous meningitis,TBM)是致残、致死率最高的结核病,临床发病率有逐渐升高趋势。近年来,对于TBM的治疗有较多进展,笔者对TBM的化学治疗、辅助治疗和并发症的治疗等领域相关研究进行综述,以期为TBM的临床治疗提供帮助。     

2014—2018年四川甘孜藏族自治州肺结核流行病学特征分析

目的 分析2014—2018年四川省甘孜藏族自治州肺结核流行病学特征,为肺结核防控提供科学依据。方法 收集《中国传染病报告信息管理系统》中2014—2018年甘孜藏族自治州18个县(市)的肺结核患者资料,采用描述性流行病学方法,对肺结核患者在不同时间、地区和人群的分布特征进行统计学分析。结果 2014—2018年甘孜藏族自治州共报告肺结核患者13017例,报告发病率从2014年的261.08/10万(2937/1124929),下降至2018年的194.13/10万(2303/1186298),报告发病率呈现逐年下降的趋势( {\chi }_{\mathit{趋势}}^2 =114.99,P<0.01)。年平均报告发病率前五位的地区为石渠县(410.28/10万,1813/441898)、雅江县(399.74/10万,1059/264922)、白玉县(391.68/10万,1167/297944)、甘孜县(337.17/10万,1231/365096)和理塘县(286.19/10万,1045/365144);2014—2018年年均报告发病率男性(240.21/10万,7131/2968651)明显高于女性(208.00/10万,5886/2829811)(χ ²=31200.06),P<0.01);15~岁年龄组年均报告发病率最高(545.55/10万,2357/432045);患者职业构成前三位的是农民(48.50%,6313/13017)、牧民(14.55%,1894/13017)和学生(14.33%,1865/13017)。结论 四川甘孜藏族自治州肺结核发病呈逐年下降的趋势,但仍然维持在高位;地处西北和高海拔的县为高发地区,农牧民和学生为高发人群。