Clinical importance,statistical significance and the assessment of economic and quality-of-life outcomes

The assessment of economic and quality-of-life outcomes of health care interventions is moving into a new era, with such assessments increasingly being made within the context of controlled clinical trials. Traditionally the measurement of many variables in economic evaluations, particularly costs, has been deterministic. In the context of clinical trials the measurement of variables is stochastic, with the standard principles of statistical inference being applied to analyse differences between treatments in terms of effectiveness. Economists participating in clinical research are therefore being called upon to specify the sample size for the economic component of the evaluation and to undertake statistical tests for differences in cost or cost-effectiveness. This paper discusses the current methodological issues surrounding stochastic measurement in clinical trials, discusses the additional issues raised by the assessment of economic and quality-of-life outcomes and specifies the challenges facing economists if they are to answer the questions now being posed about economic analysis by statisticians and clinical researchers. It is concluded that application of the standard principles of statistical inference to economic data is not straightforward and will require value judgements to be made about statistical significance and economic importance, which may differ from those already made in purely clinical studies.     

胎儿宫内窘迫对新生儿神经行为的影响

目的：测定宫内窘迫的新生儿神经行为，以探讨宫内窘迫与新生儿神经行为表现、预后的关系。方法：用ＮＢＮＡ神经行为２０项指标进行测定。结果：宫内窘迫新生儿６０例与正常新生儿６０例比较，测定总分之间差异有显著性（Ｐ＜０．０１）。窘迫组中４１例无窒息者与正常对照差异有显著性（Ｐ＜０．０１），窘迫组中１９例有窒息者与正常对照组差异更为显著，急性窘迫３８例与慢性窘迫２２例之间也有显著差异（Ｐ＜０．００１）。结论：胎儿宫内窘迫影响新生儿的神经行为能力。     

Magnetic resonance imaging reveals no ventriculomegaly in polydrug abusers

Previous studies of cerebral structure in substance abusers yielded controversial results, largely due to issues of subject selection and/or limitations of experimental techniques. The purpose of the present study was to assess whether the ventricle-to-brain ratio (VBR), determined volumetrically by magnetic resonance imaging (MRI), differed in polysubstance abusers (n = 10), as compared with age-matched controls (n = 10). Subjects were male volunteers 21–39 years of age. The values of VBR in the polydrug abuse group were not larger than those in control group, nor was there any tendency toward relative ventriculomegaly in the substance abusers. Therefore, the present findings provide no evidence that polysubstance abuse produces abnormalities of gross brain structure in relatively young and physically healthy men.     

An evaluation of the CELL-DYN 1700® haematology analyser: automated cell counting and three-part leucocyte differentiation

The performance of the CELL-DYN 1700® (Abbott Diagnostics, Abbott Park, IL, USA) was evaluated in a tertiary care hospital laboratory using the guidelines proposed by the German Society of Clinical Chemistry. Precision, accuracy, linearity, background counts, and carry-over were satisfactory for all measured standard parameters including haemoglobin concentration, haematocrit, red blood cell count, mean corpuscular volume (MCV), red cell distribution width (RDW), white blood cell count and platelet count. With 259 selected normal and abnormal blood samples the results of the CELL-DYN 1700® (CD1700) compared very well (r > 0.96 for all parameters with exception of RDW) with those obtained with the Bayer Diagnostic H-1 and the Hoffmann-La Roche Cobas Argos systems. This study considered in particular the performance of the CD1700 three-part leucocyte differential. For those samples without instrument-generated suspect flags, the neutrophil and lymphocyte percentages were highly correlated with the results of the H-1 blood cell counter (r = 0.97 and 0.98, respectively) and with manual 400-cell differentials (r = 0.91 and 0.88, respectively). In contrast, the CD1700 mid-fraction which comprised the composite total of mono cytes, eosinophils, basophils and precursor white cells (when present) could not be directly compared to the differentials from the H-1 system or from manual microscopy. For those samples with CD1700 instrument suspect flags, the neutrophil and lymphocyte differential results also compared well with both the H-1 (r = 0.93 and 0.93, respectively) and manual estimates (r = 0.89 and 0.87, respectively). In conclusion, the CD1700 is an accurate haematology analyser for cellular blood counts and three-part leucocyte differentiation.     

Special issue: Group treatment after child and adolescent sexual abuse: Introduction

This introduction traces the increasing awareness of the prevalence of child sexual abuse over the last 20 years, examines the nature and consequences of such abuse and summarizes current information on the use of group treatment and its evaluation with sexually abused children and adolescents and their parents. Four examples of group treatment with different populations of abused children are described in this issue.     

Functional restoration in chronic low back pain

Conventional treatments have not slowed down the ever expanding low back pain (LBP) problem. Traditional treatment has most probably contributed to the growth of the problem. Therefore, in a search for new solutions, 'functional restoration' has been devised. In connection with chronic LBP the term has been associated with a full-day program lasting from 3 to 5 weeks. it includes multidisciplinary treatment of patients in groups with intensive physical and ergonomic training, psychological pain management, back school, as well as teaching in social/work related issues. The key concepts are 'acceptance of the pain', 'activity', 'self-responsibility', 'multidisciplinary' and 'quantitative functional evaluation (QFE)'. The latter is aimed so that the participants can feel the physical improvement, encouraging them to be able to go back to work, or at least to lead a more active life style. Several controlled studies suggest a lasting effect in terms of regaining their ability to work and improving pain behavior for a good part of disabled chronic LBP patients. However, it is noteworthy that randomized studies seemingly show poorer results than studies not employing randomized controls.     

The Italian mental health reform nine years on

It is 9 years since the mental health reform was passed by the Italian Parliament. The author presents a data-based evaluation of the effects of the Italian mental health reform. There are still many problems to be resolved: More than 30,000 inpatients are still in psychiatric hospitals and little is known of the fate of those discharged in recent years. District mental health services are still lacking, especially in the south of the country; Psychiatric units in the general hospital function much the same way as the "old" psychiatric hospitals. The pattern of mental health services consumers have changed: They are younger with less severe psychiatric diagnosis and come from a higher social background.     

The Evaluation of Routine Andrological Parameters in Human Semen/Auswertung der Routine-Parameter der Andrologie am Sperma

A study was carried out to evaluate the andrological parameters in 540 human semen specimens divided into groups according to sperm counts. The parameters were: motility percentage and grade, percentage of viability and of morphologically normal sperm and immature cells. The Duncan multiple range test and the Kruskal-Wallis test with multiple comparison of ranks were used in the statistical analyses. Of particular interest, among other our findings, were the significant differences obtained by comparing the group with sperm counts up to 5 x 10(6) per ml semen and that with counts ranging from 5.1 to 10 x 10(6) per ml semen. This was true for all parameters with the exception of semen volume. Comparison of the oligozoospermic groups (up to 20 x 10(6)/ml) with those having higher sperm counts also showed significant differences. There was a trend towards improvement of the examined parameters with the increase in sperm density, but with a remarkable heterogeneity particularly within the oligozoospermic groups. In all groups motility, viability and morphological normality of sperm showed a positive correlation with each other. "Normal values" of the parameters studied could be derived from scatterplot charts over the entire range of sperm counts and from the statistical evaluation of the grouped material.     

全科医生内隐胜任力量表的编制及应用研究

背景 全科医生是基层医疗服务的“主力军”,现有关于全科医生胜任力的研究大部分强调应着力提升全科医生的知识和技能水平,忽略了全科医生内隐素质的重要性。目前我国仍缺乏评估全科医生内隐胜任力的有效工具,开发全科医生内隐胜任力量表（GPICRS）对于提高基层医疗服务质量具有重要意义。目的 编制GPICRS,并对其进行评价,旨在为提升全科医生胜任力提供一定的参考。方法 在文献分析和行为事件访谈的基础上,形成初始版量表。于2021年9—12月,采用随机抽样法,从全国选取380例全科医生为研究对象,采用初始版GPICRS对其进行调查,通过项目净化、探索性因子分析、验证性因子分析、信效度分析验证量表的合理性,基于加权平均法评价全科医生的内隐胜任力水平,比较不同特征全科医生的GPICRS平均总得分及各维度得分。结果 共回收有效问卷335份（88.2%）。GPICRS由工作动机、自我效能感、医学人文关怀和医学职业素养4个维度14个条目构成。探索性因子分析结果显示,KMO值为0.737,Bartlett’s球形检验χ2=592.715、P<0.001,表明数据适合进行因子分析;按特征根>1.00...     

我国中央层面家庭医生签约服务政策量化评价：基于PMC指数模型

背景 我国人口老龄化形势日益严重,家庭医生签约服务对助推分级诊疗制度建设、建立合理有序就医秩序发挥着重要作用,目前学者对家庭医生签约服务政策的研究主要集中于定性评价,较少有学者利用工具聚焦代表性政策对各篇进行定量评价。目的 定量评价我国中央层面的6篇家庭医生签约服务相关政策,分析政策优劣,在此基础上,提出促进我国家庭医生签约服务高质量发展的对策和措施,助力健康中国战略实施。方法 于2022-04-30,以“家庭医生”为关键词在北大法宝数据库进行全文检索,并在国务院网站进行相关内容检索,检索时限为2015-01-01至今。采用ROSTCM 6.0软件进行文本挖掘,然后以其结果为依据选择其中具有代表性的中央层面家庭医生签约服务相关政策,并基于政策一致性评价（PMC）指数模型对其进行量化评价。结果 依据纳入与排除标准检索获得相关政策32篇,家庭医生签约服务领域排名前5位的高频关键词为“签约服务”（274次）、“健康”（272次）、“医疗”（264次）、“家庭医生”（225次）、“签约”（180次）,以其为依据共选择中央层面有代表性的家庭医生签约服务相关政策6篇,分别标记为P1～P6。政策量化...