Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

BackgroundUsing potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer.MethodsTime-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006–2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1–9).ResultsFor pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items.ConclusionThe formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.     

《药理实验方法学》教学实践和探讨

《药理实验方法学》是一门以实验研究为主要内容的一门学科，因此此门功课在教学中有自己的一些特点。在教学中应特别要注重对学生创新思维、综合科研能力的培养，为学生以后的科研工作大好基础。注重加强教与学的双向信息反馈以增加教师和学生的双向交流。同时有效利用多媒体技术能极大的活跃课堂气氛。     

The CarerQol instrument: A new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations

The societal perspective in economic evaluations dictates that costs and effects of informal care are included in the analyses. However, this incorporation depends on practically applicable, reliable and valid methods to register the impact of informal care. This paper presents the conceptualisation and a first test of the CarerQol instrument, aimed at measuring care-related quality of life in informal caregivers. The instrument combines the information density of a burden instrument (encompassing seven important burden dimensions) with a valuation component (a VAS scale for happiness). The instrument was tested in a Dutch sample of heterogeneous caregivers (n = 175) approached through regional caregiver support centres. This first test describes the feasibility as well as convergent and clinical validity of the CarerQol instrument. The seven burden dimensions related well with differences in VAS scores. In all instances, the average CarerQol-VAS scores decreased as the severity of problems increased. Multivariate analyses showed that the seven burden dimensions explained 37–43% of the variation in CarerQol-VAS scores, depending on the model used. The CarerQol seems a promising new instrument to register the impact of informal caregivers in economic evaluations.     

A comparison of different time series techniques to analyze phasic coupling: a case study of cardiac and electrodermal activity

This study examined the efficiency of different time series analysis techniques to extract information on the coupling of spontaneous phasic physiological responses. We compared four bivariate approaches, cross-spectral, cross-covariance, cross-covariance with prewhitening, and dynamic factor analysis, in their ability to yield unbiased estimates of (a) shared variance, (b) covariance, (c) strength of relationship, and (d) interchannel time-lag in empirical and simulated interbeat interval-electrodermal activity (IBI-EDA) time series. All methods produced similar estimates of the grand-averaged IBI-EDA dynamics, but only the measures of covariance produced reliable and unbiased estimates of the interindividual distribution of IBI-EDA coupling. We conclude that the extraction of phasic response patterns during continuous and unrestricted experimental situations may considerably facilitate psychophysiological research.     

Culture and Disability in Sexuality Studies: A Methodological and Content Review of Literature

Disabilities impact individuals across all demographic groups, resulting in multiculturalism within the culture of disability. Several years ago researchers within the area of disabilities studies noted a tendency to overlook the cultural heterogeneity within their samples of individuals with disabilities and called for greater awareness. It is unclear to what degree research psychologists as well as other disciplines have heeded the call to adopt a cultural lens when studying populations with disabilities. A methodological and content review of sexuality and disability studies was conducted to evaluate how researchers are conceptualizing and presenting cultural data. Recent articles in four leading disability journals from 2002 to 2006 were reviewed, yielding 54 studies and over 11,000 participants. The content analysis found tremendous inconsistency in the collection style and reporting of cultural information (e.g. gender, race, ethnicity, socio-economic status, sexual orientation). Results indicate ethnic minorities may continue to be under-recruited and understudied in the disability and sexuality literature.     

利用MALDI-TOFMS进行恶性肿瘤血清蛋白组学研究方法的建立

目的:建立一套稳定的利用MALDI-TOF MS进行恶性肿瘤血清蛋白质组学分析方法。方法:通过对血清样品采集、保存条件的优化,标准蛋白质的选择,样品的前处理和上样分析等多种条件的优化,确定各个相关参数的选择。结果:经实验条件的比较与优化发现,血液样本采集1 h后经2000 g离心分离血清,分装成若干份,冻存于-80℃冰箱备用,样本前处理方法参照说明书进行;质谱分析条件为应用线性模式,采集范围800-10,000Da,利用多点采集的方法,8点采集,累加至400shots,保存备用。结论:通过优化实验条件,初步建立了利用MALDI-TOF MS进行血清蛋白质组学分析的一整套研究方法,生物质谱分析结果的整体稳定性和重复性可满足统计学和临床医学实验室分析要求。     

食管癌中心灶多点取材检测细胞DNA含量的临床意义

作者采用癌灶多点取材法，对食管癌患考癌细胞ＤＮＡ含量进行了分析。结果表明，患者癌细胞ＤＮＡ异倍体和多异倍体检出率和随机一点取材法相比，分别增加了５０％和３．５倍。用该取材法还可以检测患者的ＤＮＡ倍体异质性和ＤＮＡ干系的分布情况。     

Additional information from parental questionnaires and pharmacy records for registration of birth defects

EUROCAT Northern Netherlands registers children born with a birth defect in the Northern Netherlands. Data used to be collected via a notification form, which is filled out by the notifier and, if necessary, completed by the general practitioner. To increase the amount of information, EUROCAT started using new methodology in July 1997. The new procedure consists of three additional steps. Firstly, a parental questionnaire with 43 questions concerning pregnancy and medical history is sent to the parents. Also, the pharmacist is approached to provide information on the drugs that were dispensed to the mother in the period from three months before until the end of the pregnancy. The last step is a telephone interview with the mother. In this study the old and new method are compared with respect to response, quality and quantity of the data. Of the 198 parental questionnaires included in this study, 179 (90.4%) were returned. The pharmacists returned 173 out of 179 requests for information (96.6%). The parental information is more complete for ethnicity and serum screening. The quality of the drug exposure data is much better using the new methodology. The general practitioner's input is still necessary for specification and verification of the diagnosis.     

四维超声心动图成像方法学探讨（下）——方法学要点及局限性

我院开展四维超声心动图临床应用研究以来,在145例患者进行不同心脏结构的三维超声图像重建中获得了一些体会和经验。本文将在研究过程中出现的应用方法学问题及现阶段还存在的技术局限性进行探讨。     

一种泛导分析:广义相空间分析及其在乳腺肿瘤细胞形态学非线性研究中的应用——QMSOS的PHASE功能模块

本文介绍一种泛导分析法:广义相空间及其在乳腺良恶性肿瘤细胞形态学的非线性分析中的应用。结果表明,乳腺恶性肿瘤细胞的形态学变化的复杂性远大于乳腺良性肿瘤细胞,同时也提示一种新型的诊断法的有效性,这种方法是基于一个细胞群体及其形态演变的过程而不是传统的基于对单个细胞的识别。