纳入研究的质量评价:数据提取形式的新建议

纳入研究的方法学质量评价是Cochrane系统评价不可或缺的组成部分之一。目前,《Cochrane干预措施系统评价手册》对分配隐藏的评价提出了具体的指导意见(分为“充分”、“不充分”或“不清楚”),且这些评价结果可直接进入RevMan。但对于其它方面的质量,如盲法和意向治疗分析的使用,却是由不同的系统评价小组以不同的方式在阐述。Cochrane协作网指导小组出资开展了一项质     

七种军队医学期刊临床随机对照试验的报告质量评价

目的 调查7 种军队综合性医学期刊2007 年发表的随机对照试验（RCT）的报告质量，了解当前军队医学期刊临床试验报告质量的现状。 方法 手工检索2007 年《解放军医学杂志》、《南方医科大学学报》、《第二军医大学学报》、《第三军医大学学报》、《第四军医大学学报》、《军事医学科学院院刊》和《军医进修学院学报》发表的文献，纳入声明采用“随机”方法分组的RCT，并采用国际公认的CONSORT 标准进行报告质量评价。 结果 共纳入99篇RCT，其中6 篇随机方法错误。根据CONSORT 条目对随机方法正确的93 篇RCT 进行评价，其中62 篇（66.7%）描述了各组的基线情况和临床特征；16 篇（17.2%）提及了产生随机分配序列的方法，其中5 篇（5.4%）提及用计算机产生随机分配序列；9 篇（9.7%）采用盲法的文献中2 篇仅提及“盲法”二字，1 篇采用单盲，6 篇采用双盲（其中2篇盲法正确）；仅1 篇文献采用意向治疗分析法；1 篇分配方案隐藏充分。99 篇均未提及样本含量的计算，且样本量多较小。 结论 目前军队综合性医学期刊发表的RCT 报告质量与CONSORT 标准比较尚有较大差距，今后应进一步进行规范报告。     

我国干预性护理研究论文的质量评价

目的制订严格的质量评价标准,对我国内地干预性护理研究论文进行质量评价。方法检索我国内地干预性护理研究论文,阅读全文并按照质量评价标准进行评价。结果经过初筛,对4225篇期刊论文和179篇学位论文进行了严格的质量评价,纳入1257篇期刊论文和152篇学位论文,发现纳入论文中达标率较低的质量评价项目依次是盲法、样本流失的描述和随机分配。结论我国干预性护理研究论文的方法学质量和报告规范有待提高。     

Cochrane系统评价中如何处理分配方案隐藏

目的 ①记录和分析纳入Cochrane系统评价研究的分配方案隐藏描述和分级情况;②向各评价小组反馈存在的问题或错误的分级及分级方式; ③建议怎样正确描述和分级分配方案隐藏.方法提取Cochrane图书馆2003年第1期的1 596篇系统评价有关分配方案隐藏分级和描述情况.共提取了来自10个Cochrane系统评价小组(CRGs)的10.8%(173/1 596)系统评价(共1 844个研究)的资料;记录和分析了分配方案隐藏描述和分级与Cochrane系统评价手册的方法有差异或矛盾的研究.结果目前,纳入Cochrane系统评价研究的分配方案隐藏的分级方式有可能不太准确.其原因在于对分配方案隐藏方法的描述有误(占1 844个研究中38.6%),而其中分级错误至少占9.2%.分配方案隐藏为A的研究中,最常见的是各种信封法 (133/675 ,占19.7%).而在分配方案隐藏为B的研究中,最常见的是分配方案隐藏方法不清楚或未提及(26/665, 占64%).结论因正确的分配方案隐藏对防止随机对照试验出现偏倚至关重要,所以必须对分配方案隐藏进行准确的分级和描述.我们需要改进Cochrane系统评价纳入研究中的分配方案隐藏的描述和分级.因半数以上分配方案隐藏为D的研究是系统评价员疏漏了分级造成缺省,这种缺省不应分级为D而应被描述为"缺乏分级信息".建议改变RevMan软件的结构:即加入一个具有固定标题便于录入原内文文本功能的独立研究质量表.关于如何改进特定系统评价分级的建议将在下一阶段计划中反馈给各系统评价小组.同时也将对系统评价手册中如何补充(分配方案隐藏分级和描述)提出建议.     

随机对照临床试验中盲法质量评价现状

正确使用盲法可以有效控制和减少临床试验过程中由于试验参与人员主观因素所引入的偏倚,但盲法失败时反而会引入更大偏倚。因此,对涉及盲法的临床试验,有必要对其进行盲法质量评价。笔者对目前国际上盲法质量评价的相关文献和方法进行了梳理总结,发现目前盲法质量评价尚未引起研究者的足够重视,相关研究报道较少;更缺乏全面综合的盲法评价方法和工具,对盲法评价时点也无统一意见。因此,有必要对盲法评价方法进行多方面的深入研究,并建议根据影响盲法实施的关键因素开发综合的盲法评价量表,通过评估各关键因素的执行情况,确定研究的盲法风险和等级,便于更好地解释和评估研究结果。     

康复的随机对照试验中独立评定的准则

<正> 随机对照试验(RCTs)是一种重要的增进康复知识的手段。在RCTs过程中,提倡独立评定,即评定者在不知道患者的分组情况下对某一种试验或若干联合试验的结果进行评定,以避免偏差。本文中使用“失盲”(unblinding)这一词是指独立评定者已经了解到试验中的分组情况,而防止偏差和预知分组情况乃是独立评定的中心问题。但是康复研究中很难作到使病人和评定者“全盲”。本文旨在讨论在分组时的失盲,对失盲的监测以及在评定结果时怎样避免出现偏差等问题,并对引起失盲的3个主要原因作出分析。     

周士枋教授给本刊编辑部的一封来信

编辑部同志： 最近我接到很多送审稿件．从总体看，来稿质量较过去有较大程度提高，尤其是研究生的论文。一般临床稿件也都注意了对照组的设置、观察指标的可比性，以及结果分析的合理性。但从中也发现一些问题。特提醒如下： 1 对照组设置不能“随意”而应随机化：随机化是指临床观察和试验中的受试者，有同等机会被分配到实验组或对照组中，而不受研究者、观察者或受试者主观意愿的影响，可以使各组各影响因素（包括已知和未知的因素）分布趋于平衡。     

《中华医学杂志》20年随机对照试验文献的方法学评价

目的：评价《中华医学杂志》临床治疗文献中随机对照试验论文的研究质量。方法：逐期逐页手工检索《中华医学杂志》1982—2001年中发表的治疗性试验论文，按Cochrane协作网RCT、CCT资料库中的判定标准进行严格分析评价。结果：近20年240期杂志中，共检出随机对照试验的治疗性文献70篇，发表数量呈逐年增加趋势。正确使用随机分配方法的8篇，占11．4％，无1篇文献提到实施随机方案的隐藏。各试验选择了对照。16篇(22．9％)文献中显示采用盲法试验，并且75％都应用的双盲。结论：《中华医学杂志》临床随机对照试验论文逐年增多，但仍存在一些问题，质量有待提高加强。     

随机分配方案的隐藏

随机分配是保证组间基线可比和避免选择性偏倚的最好方法.随机分配的成功实施取决于相互关联的两个过程.一是采用随机的方法产生不可预测的随机分配序列,二是必须采用分配方案隐藏的方法严格执行随机分配序列,以防止选择和分配受试对象入组的研究人员预先知道随后的分配情况.随机分配方案隐藏不完善会改变和破坏预先制订的不可预测的分配序列.     

论文作者署名的要求

作者排序应在投稿时确定 ,在编排过程中不应再作变更。作者应是 :①参与选题和设计 ,或参与资料的分析和解释者 ;②起草或修改论文中关键性理论或其他主要内容 ;③能对编辑部的修改意见进行核修 ,在学术上进行答辩 ,并最终同意论文发表者。以上三条均需具备。仅参与获得资金或收集资料者不能列为作者。对文章中的各主要结论 ,均必须至少有一位作者负责。集体署名的文章必须明确对该文负责的关键人物 ;其他对该研究有贡献者应列入志谢部分。作者中如有外籍作者 ,应征得本人同意 ,并有证明信。论文作者署名的要求     

NO and HNO donors,nitrones, and nitroxides: Past,present, and future

The biological effects attributed to nitric oxide (^?NO) and nitroxyl (HNO) have been extensively studied, propelling their array of putative clinical applications beyond cardiovascular disorders toward other age‐related diseases, like cancer and neurodegenerative diseases. In this context, the unique properties and reactivity of the N‐O bond enabled the development of several classes of compounds with potential clinical interest, among which ^?NO and HNO donors, nitrones, and nitroxides are of particular importance. Although primarily studied for their application as cardioprotective agents and/or molecular probes for radical detection, continuous efforts have unveiled a wide range of pharmacological activities and, ultimately, therapeutic applications. These efforts are of particular significance for diseases in which oxidative stress plays a key pathogenic role, as shown by a growing volume of in vitro and in vivo preclinical data. Although in its early stages, these efforts may provide valuable guidelines for the development of new and effective N‐O‐based drugs for age‐related disorders. In this report, we review recent advances in the chemistry of NO and HNO donors, nitrones, and nitroxides and discuss its pharmacological significance and potential therapeutic application.     

Vomiting, diarrhea, constipation, and gastroenteritis

Diseases that cause vomiting, diarrhea, constipation, and gastroenteritis are major problems for populations worldwide. Patients, particularly infants, elderly, and immunocompromised individuals, may present at any point in a wide spectrum of disease states, underscoring the need for the clinician to treat these ailments aggressively. Several promising new treatment modalities, from oral rehydration solutions to antiemetic therapies, have been introduced over the past decade. Future directions include the use of probiotic agents and better tolerated rehydration solutions. Gastrointestinal disease will continue to be a focus worldwide in the search for better ways to cure illnesses associated with vomiting and diarrhea.     

Platelets,thrombosis, coagulation,and atherosclerosis

When I first got the invitation to join a medical delegation going to Moldova, I thought for a moment that our destination was the fictional country in the old Marx Brothers movie Duck Soup. On further checking, it turns out that entertaining place was called Freedonia. I now know that Moldova is indeed a real country, bordered on the west by Romania and on the other three sides by the Ukraine. It is a proud country, rich with traditions, and its people are warm, giving, eager to learn ways to improve their healthcare system, and deeply appreciative of our attempts to help them in the task.     

Thoughts,images, worry,and anxiety

Recent models suggest that worry is primarily a verbal-linguistic process that enables images to be avoided and reduces somatic activation. Five-hundred and two subjects completed a questionnaire that assessed variables related to generalized anxiety disorder (GAD) criteria and also asked subjects to indicate the percentage of thoughts and images while worrying. Subjects were divided into excessive worriers (worry excessively about two or more topics more days than not for at least the last 6 months) and ordinary worriers (those who did not meet the previous criteria). As predicted, worry was reported as being composed predominantly of thoughts rather than images, and excessive worriers reported a significantly higher percentage of thoughts compared to ordinary worriers. The number of somatic symptoms was positively correlated with the percentage of images. This relationship was stronger among excessive worriers than ordinary worriers, specifically for autonomic hyperactivity symptoms. Further, in the excessive worry group only there was a significant negative correlation between the number of autonomic hyperactivity symptoms and the percentage of thoughts.This research was partially supported by grants from les Fonds de Recherche en Santé de Québec and the Medical Research Council of Canada. The study was completed while the first author was supported by the Medical Research Council of Canada.The authors gratefully acknowledge the assistance of France Blais for recruiting subjects, administering questionnaires, and entering data.     

Genomics, Nutrition, Obesity, and Diabetes

PURPOSE: To present evidence of genetic and environmental interactions as they relate to nutrition, diabetes, and obesity. METHODS: A review of seminal literature related to genetics, obesity, and diabetes. FINDINGS: Multifactorial interactions are important in the development of nutrition-related disorders, but the challenge remains to explain how these interactions are expressed. Treating subpopulations of people might be important and useful to some extent at present, but in the future treating people of given genetic predispositions and other personal and environmental factors will have greater effects on quality-of-life indicators and life expectancies. CONCLUSIONS: Individualization coupled with multifactorial interactions will lead to new and more effective preventive and treatment modalities of nutrition-related disorders. With obesity and diabetes, genomics will bridge the traditional use of diet, exercise, and weight reduction with other environmental factors, ultimately leading to healthier lives.     

Lipid messenger, diacylglycerol, and its regulator, diacylglycerol kinase, in cells, organs, and animals: history and perspective

Diacylglycerol kinase (DGK) metabolizes diacylglycerol (DG), a glycerolipid containing two acyl chains, to convert phosphatidic acid. DG is produced through phosphoinositide turnover within the membrane and is well known to act as a second messenger that modulates the activity of protein kinase C in the cellular signal transduction. Recent studies have revealed that DG also activates several proteins, including Ras guanine-nucleotide releasing protein and ion channels such as transient receptor potential proteins. Therefore, DGK is thought to participate in a number of signaling cascades by modulating levels of DG. Previous studies have disclosed that DGK is composed of a family of the isozymes, which differ in the structure, enzymological property, gene expression and localization, subcellular localization, and binding molecules. The present review focuses on the stories of phosphoinositide turnover and DG, including historical views, structural features, metabolism, and relevant cellular phenomena, together with the characteristics of DGK isozymes and the pathophysiological findings on animal studies using knockout mice and models for human diseases. Now it is being revealed that the structural and functional diversity and heterogeneity of and around DGK support the proper arrangement of the complex signal transduction machinery.