Navigating the passage between Charybdis and Scylla: Recognizing the achievements of Noel Rose

This special edition of the Journal of Autoimmunity is dedicated to celebrate the enormous contributions of Dr. Noel Rose, a physician-scientist, someone that can be readily anointed as a gifted scientist who laid down the foundation and fundamental concepts of human autoimmunity. Dr. Rose performed a series of landmark studies that extend back more than 50 years and whose work is the cornerstone of the commonly used term “from the bench to the bedside.” The studies included not only characterization of a normal immune response but, more importantly, defining the nature of not only the antigen, but also the aberrant response that results in organ, tissue specific reactions and immunopathology. These pioneering studies contributed to the biochemical nature of antigens, dissection of the immune repertoire, the recognition of the importance of genetics and environment, and the distinctions between a normal and an autoimmune response. Hence, this volume has been coined “Navigating the Passage Between Charybdis and Scylla: Recognizing the Achievements of Noel Rose.”     

Partisan Perspectives in the Medical Literature: A Study of High Frequency Editorialists Favoring Hormone Replacement Therapy

Background  

Unfavorable results of major studies have led to a large shrinkage of the market for hormone replacement therapy (HRT) in the last 6 years. Some scientists continue to strongly support the use of HRT.     

Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials

Context  Specific features of trial quality may be associated with exaggeration or shrinking of the observed treatment effect in randomized studies. Therefore, assessment of trial quality is often used in meta-analysis. However, the degree to which specific quality measures are associated with treatment effects has not been well established across a broad range of clinical areas. Objective  To determine if quality measures are associated with treatment effect size in randomized controlled trials (RCTs). Design  Quality measures from published quality assessment scales were evaluated in RCTs included in meta-analyses from 4 medical areas (cardiovascular disease, infectious disease, pediatrics, and surgery). Included meta-analyses incorporated at least 6 RCTs, examined dichotomous outcomes, and demonstrated significant between-study heterogeneity in the odds ratio (OR) scale. Main Outcome Measures  Relative ORs comparing overall treatment effect (summary OR) of high vs low-quality studies, as determined by each quality measure, with relative ORs less than 1 indicating larger treatment effect in low-quality studies. Results  Twenty-four quality measures were analyzed for 276 RCTs from 26 meta-analyses. Relative ORs of high vs low-quality studies for these quality measures ranged from 0.83 to 1.26; none was statistically significantly associated with treatment effect. The proportion of studies fulfilling specific quality measures varied widely in the 4 medical areas. In analyses limited to specific medical areas, placebo control, multicenter studies, study country, caregiver blinding, and statistical methods were significantly associated with treatment effect on 7 occasions. These relative ORs ranged from 0.40 to 1.74. However, the directions of these associations were not consistent. Conclusions  Individual quality measures are not reliably associated with the strength of treatment effect across studies and medical areas. Although use of specific quality measures may be appropriate in specific well-defined areas in which there is pertinent evidence, findings of associations with treatment effect cannot be generalized to all clinical areas or meta-analyses.      

挑战传统锐意创新——记循证医学专家David Eddy教授

David Eddy教授是循证医学的奠基人之一、美国著名循证医学专家,1990年以第一作者身份在JAMA上撰文,首次提出"循证"一词。他在医疗决策、应用数学、卫生经济学等众多领域都做出了杰出贡献,并长期致力于循证指南的制定与推广。本文简要介绍了他的个人奋斗历程与学术研究过程,阐述了他对循证医学的独特见解与全新诠释。     

Markov模型在卫生经济评价中的应用

Introduction Several research designs usually underpin economic evaluations in healthcare regulatory systems. These include clinical trials,cohort studies,database studies and decision-analytical modelling.[第一段]     

临床试验注册制度与循证医学

本文介绍了当前新药临床试验,院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台的结构和运作机制以及全球临床试验注册制度的建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;提出以循证医学基本思想作为临床试验研究者的思想和行为准则是临床试验真实性的内部保障系统。     

Decision-analytical modelling in health-care economic evaluations

Objective  Decision-analytical modelling is widely used in health-care economic evaluations, especially in situations where evaluators lack clinical trial data, and in circumstances where such evaluations factor into reimbursement pricing decisions. This paper aims to improve the understanding and use of modelling techniques in this context, with particular emphasis on Markov modelling. Methods  We provide an overview, in this paper, of the principles and methodological details of decision-analytical modelling. We propose a common route for practicing modelling that accommodates any type of decision-analytical modelling techniques. We use the treatment of chronic hepatitis B as an example to indicate the process of development, presentation and analysis of the Markov model, and discuss the strengths, weaknesses and pitfalls of different approaches. Conclusions  Good practice of modelling requires careful planning, conduct and analysis of the model, and needs input from modellers and users.