The role of National Immunization Technical Advisory Groups (NITAG) in strengthening health system governance: Lessons from three middle-income countries—Argentina,Jordan, and South Africa (2017–2018)

IntroductionToward the Global Vaccine Action Plan 2020 goal, almost 90% of countries have established a National Immunization Technical Advisory Group (NITAG). However, little is known about NITAG's contributions to governance.MethodsIn 2017–2018, a two-step, qualitative retrospective study was conducted. Jordan (JO), Argentina (AR), and South Africa (SA) were selected owing to government-financed NITAGs from middle-income countries (MICs), geographic diversity, and a vaccine introduction with NITAG support. Country case studies were developed, collecting data through desk review and face-to-face key informant interviews (KIIs) from Ministry of Health (MoH) and NITAG. Case studies were analyzed together, to assess governance applying the European Observatory on Health Systems and Policies framework focusing on transparency, accountability, participation, integrity, and policy capacity (TAPIC).ResultsDocument review and 53 KII (22 AR, 20 SA, 11 JO) showed NITAGs played a pivotal role as advisors promoting a culture of evidence-informed policies. NITAGs strengthened governance, although practices varied among countries. Meetings were conducted behind-closed-doors, participation restricted to members, only in one country agendas, and recommendations were public (AR). To increase participation, policy capacity, and transparency, countries considered adding experts in communications, advocacy, and economics. AR and SA contemplated including community members. NITAGs functioned autonomously from the government, with no established internal or external monitoring or supervision. NITAG meeting minutes allowed the review of integrity, adherence to terms of reference, standard operating procedures, and conflict of interest (CoI). For the most part, NITAGs abided by their mandates. Significant issues were related to the level of MoH support and oversight of CoI declaration and documentation.ConclusionsSystematically implementing governance approaches could improve processes, better tailor policies, and implementation. The long-term survival and resilience of NITAGs in these countries showed they play a significant role in strengthening governance. Lessons learned could be useful to those promoting country-driven evidence-informed decision-making.     

尿液10项肾损伤标志物检测试剂的性能评价

摘要:目的对尿液 10项肾损伤标志物检测试剂进行性能评价,并评估其临床适用性。方法对北京利德曼公司尿液a1 微球蛋白(u-a|MG)、总蛋白(u-TP)、免疫球蛋白G(u-IgG) 、微量清蛋白(u-Alb)、中性粒细胞明胶酶相关脂质运载蛋白(u-NGAL)、半胱氨酸蛋白酶抑制剂C(u-CysC).视黄醇结合蛋白(u-RBP)、β2微球蛋白(u-β2MG)、N-乙酰-β-D-氨基葡萄糖苷酶(u-NAG).、转铁蛋白(u-Trf)检测试剂盒进行性能评价。正确度和精密度验证参考美国临床和实验室标准协会(CLSI)EP15-A3,验证物质采用ERM-DA470k、ERM-DA471、B2M-NIBSC等参考物质及纯度物质;线性验证参考CLSI EP06;抗干扰能力参考CISI EP07;不同检测系统间比对参考CISI EP09。结果正确度方面,10 项标志物检测试剂测定标准物质在低值、中值、高值的偏倚分别为-2.69% ~4.67%、-3.60% ~3.33% .-2.38% ~3.02%;不精密度方面,重复性以不精密度表示,在低值和高值处分别为1.90%~5.43%、0.63% ~2.42%,室内不精密度为2.27%~5.63%、1.09%~3.41%,均满足临床要求;10项尿液标志物线性范围在0.06~4.40 mg/L至21.83~2 146.77 mg/L之间。抗干扰方面,u-1 MG、u-Alb、u-β2MG、u-Trf 、u-CysC、u-NAG分别在血红蛋白终浓度≤8 g/L、≤8 g/L、≤4 g/L、≤4 g/L、≤2g/L、≤1 g/L时,未受到明显干扰(百分偏差≤+ 10%) ,而u-TP、u-IgG、 u-RBP、u-NGAL在血红蛋白终浓度≥0.125 g/L时即受干扰。不同检测系统间偏差超出临床允许范围。结论尿液 10项肾损伤标志物的正确度、精密度、线性范围和抗血红蛋白干扰能力满足临床需要,不同检测系统间标志物测量结果可比性欠佳。     

针刺辅助治疗难治性肠易激综合征临床试验方案关键点设计的思考＊

肠易激综合征（Irritable bowel syndrome，IBS）是临床常见病、多发病，其治疗方法丰富，但部分患者疗效欠佳，发展成难治性IBS。目前国内外关于针灸治疗难治性IBS的临床随机对照试验尚不多见。本文立足试验方案设计的“PICOS”原则，从研究对象及诊断标准、干预措施、对照措施、结局指标四个方面入手，重点探讨针刺辅助治疗难治性肠易激综合征临床试验设计的关键要点。从选择特色优势病种、明确诊断标准、制定符合临床实际的干预方案、运用符合目标的安慰针刺、结合研究设计和目的选定结局指标几个角度，阐述试验相关环节设计的原因和思考。     

Clinical implications,diagnosis,and management of diabetes in patients with chronic liver diseases

Diabetes mellitus(DM) negatively affects the development and progression of chronic liver diseases(CLD) of various etiologies. Concurrent DM and CLD are also associated with worse clinical outcomes with respect to mortality, the occurrence of hepatic decompensation, and the development of hepatocellular carcinoma(HCC). Unfortunately, early diagnosis and optimal treatment of DM can be challenging, due to the lack of established clinical guidelines as well as the medical complexity of this patient population. We conducted an exploratory review of relevant literature to provide an up-to-date review for internists and hepatologists caring for this patient population. We reviewed the epidemiological and pathophysiological associations between DM and CLD, the impact of insulin resistance on the progression and manifestations of CLD, the pathogenesis of hepatogenic diabetes, as well as the practical challenges in diagnosis and monitoring of DM in this patient population. We also reviewed the latest clinical evidence on various pharmacological antihyperglycemic therapies with an emphasis on liver disease-related clinical outcomes. Finally, we proposed an algorithm for managing DM in patients with CLD and discussed the clinical and research questions that remain to be addressed.     

Determinants of Tobacco Use among Children of a Rural Village in India: An Exploratory Qualitative Study

Background: Tobacco is one of the leading causes of preventable deaths. It is both a major social and health problem. According to National Sample Survey Organization of Government of India about 20 million children of ages 10-14 are estimated to be tobacco-addicted. There are grave consequences of tobacco both socially and also on health thus it is of utmost importance to understand the factors leading to its use and to plan strategies to reduce its intake. However, the health implications of this social issue in a rural context have not been explored. Aims and Objective: this study makes an attempt to explore the health and social implications of tobacco usage by the children below the age of 14 years in hamlet. Materials and Methods:  The present study employed a qualitative study design. Data was collected using focus group discussion and in-depth interview of key informants. Thematic analysis for exploring the explicit and implicit meanings within the data was done. The themes which emerged were knowledge about tobacco and the various products available, children and parents’ tobacco use and habits, the health and social implication of tobacco use, reasons for tobacco use by the children. Results: It was found tobacco use by the children was very common in the community. Parent, peer pressure, sibling pressure were found to be playing important role in the initiation of tobacco habit by the child. Further illiteracy and lack of awareness was also lead to tobacco use among children. Conclusion: The study identifies education and awareness of parents about the ill-effects of tobacco play an important role as parents act as role model for their children, thus equal stress should be laid in improving the parental habits. Even raising the prices of tobacco products can help in controlling this habit.     

扬州地区肝硬化食管静脉曲张初次出血80例患者诊治分析

目的探讨扬州地区肝硬化食管静脉曲张初次出血患者诊治特点。方法回顾性分析2010年1月-2013年12月苏北人民医院消化内科收治的80例肝硬化食管静脉曲张初次出血患者病例资料。计数资料用率或构成比表示,率的比较采用χ2检验。结果由乙型肝炎导致肝硬化所引起的食管静脉曲张破裂出血所占比例最大;三腔二囊管临床运用可最大限度地挽救患者生命,为后期治疗提供时间;基础治疗包括止血、输血、抑酸、补液等,后期以硬化剂、套扎、硬化剂+套扎、手术、经颈静脉肝内门体分流术(TIPS)为主,但套扎运用最为广泛;患者出血初期各项指标变化有利于指导临床治疗,对患者预后具有良好的评估作用。结论扬州地区肝硬化引起的食管静脉曲张破裂出血病因呈现复杂交叉性,治疗方法仍需进一步完善,以达到个体化治疗水平;及时正确的救治,对提高临床疗效、降低病死率有重要意义;早期的健康体检,对疾病诊治起关键性的作用。     

Role of zinc supplementation in the management of chronic liver diseases: A systematic review and meta-analysis

Introduction and objectivesZinc deficiency has been associated with poor prognosis in chronic liver disease. This systematic review and meta-analysis aimed to evaluate the role of zinc supplementation in the management of chronic liver diseases.Materials and methodsWe searched MEDLINE, LILACS, EMBASE, and Cochrane CENTRAL databases from inception to August 2018. We included randomized controlled trials evaluating adult patients with chronic liver disease of any etiology receiving zinc supplementation. Studies with other designs or evaluating chronic conditions other than liver disease were excluded. Two reviewers independently screened and extracted data from eligible studies. Study quality was assessed using the Cochrane Collaboration's tool for assessing risk of bias in randomized studies.ResultsOf 1315 studies screened, 13 were included. Six assessed chronic hepatitis C treatment, with a relative risk of 0.83 indicating no protective effect of zinc supplementation on the improvement of sustained virological response. Three evaluated response to hepatic encephalopathy treatment, with a relative risk of 0.66 indicating a favorable effect of zinc supplementation on clinical improvement of this condition. Of four studies evaluating the management of cirrhosis, two analyzed the effect of zinc supplementation on serum albumin levels, with no statistical difference between zinc and placebo groups.ConclusionsClinical trials assessing zinc supplementation in liver diseases do not show benefits in terms of clinical improvement or disease halting. There are possible benefits of zinc supplementation on hepatic encephalopathy, however, this is based on limited evidence. This research question is still open for evaluation in larger, well-designed, clinical trials.     

Development of autoimmune hepatitis in primary biliary cirrhosis.

AIM/BACKGROUND: Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease of unknown aetiology. Up to 10% of patients with typical features of PBC will have additional features of autoimmune hepatitis (AIH). A subset, however, have no such features but go on to develop a 'sequential' AIH overlap syndrome. Objectives: Describe our experience with eight patients who developed AIH after the diagnosis of PBC was made. METHODS: We reviewed the charts of all PBC patients over a 9-year period (from 1996 to 2005). Only PBC patients with no features of AIH were included. RESULTS: There were 1476 patients with PBC. Of these, eight patients developed features of AIH overlap syndrome based on biochemical and histological parameters. Treatment included prednisone and azathioprine for 24 or more months. The majority of patients remained on ursodeoxycholic acid (UDCA) throughout treatment. Response to therapy was defined by improvement in enzymes, and was rapid for all patients. One patient was able to discontinue treatment with prednisone and azathioprine, while seven have continued on therapy to date. CONCLUSIONS: A 'sequential' overlap syndrome of AIH with PBC can occur. Treatment with prednisone and azathioprine may lead to a rapid improvement in aminotransferase levels.