A Comparison Between Recipients Receiving Matched Kidney and Those Receiving Mismatched Kidney from the Same Cadaver Donor

The optimal allocation of cadaveric kidneys for transplantation with reference to human leukocyte antigen (HLA) match and sharing these organs to a distant center remains controversial. The current analysis was performed using the United Network for Organ Sharing (UNOS) database for cadaveric kidney transplants (Tx) between 1988 and 1997. The graft survivals of zero-mismatch (matched) kidneys with the mate (mismatched) kidneys were compared. There were 2385 donors and 4770 Tx. Significant differences in recipient demographics between matched and mismatched Tx were: fewer African-American race (AA) in the matched group (9.0% vs. 21.9%), higher number of previous Tx (25.5% vs. 14.8%) and elevated mean cold ischemia time (24.0 vs. 22.2 h). Post-Tx dialysis requirements were similar (22.8% vs. 24.1%, p = 0.62) and matched kidneys had to travel more distance (920 vs. 232 miles). Using a Cox model, the matched group had a decreased relative hazard of graft failure of 23.0% (p = 0.0002) or 35% (p < 0.0001) with and without censoring for death. There was significantly better graft survival in the matched recipients in all pairs except AA (matched) and non-AA (mismatched). For older donors (> or = 50 years, n = 1508), the matched grafts survival was marginally significant (p =0.05). Matched kidneys have improved survival compared with the mismatched kidneys despite the longer distance traveled. The benefit of mismatched transplants was predominantly seen in non-AA.     

乳腺影像学报告及数据系统:超声良恶性病变鉴别诊断初探

1992年美国放射学会制定了乳腺影像学报告及数据系统(breast imaging reporting and data system,BI-RADS),2003年第四版修订时包括了超声诊断(BI-RADS-US)。本文旨在初步探讨BI-RADS-US对于乳腺良恶性病变鉴别诊断的能力。我们收集了2006年1月至2007年3月期间、获得病理诊断的乳腺占位性病变共69例72灶。均为女性,年龄14-83岁,平均41.6岁。首先根据一般的非BI-RADS标准,做出良恶性鉴别。然后用BI-RADS-US标准进行鉴别和分级(0-6级),其中2级和3级为良性和良性可能性大,4级为性质待定,5级为恶性可能性大。计算并比较上述两种方法的准确性、敏感性、特异性。结果在72病灶中,根据非BI-RADS标准,诊断为良性者40灶,符合病理诊断者38灶(95.0%),诊断为恶性者23灶,符合病理者18灶(78.3%);诊断为性质待定者9灶。根据BI-RADS-US标准和分级,2级和3级共有37灶,与病理结果符合者为36灶(97.2%);5级有31灶,与病理符合者为22灶(71.0%);4级有4灶。非BI-RADS和BI-RADS-US的准确性各为83.3%和81.9%(P=1.000),敏感性各为91.7%和95.8%(P=1.000),特异性各为79.2%和75.0%(P=0.754)。总之,第一版BI-RADS-US在乳腺良恶性病变鉴别诊断方面的初步应用表现出较高的敏感性,而与非BI-RADS方法比较则尚无明显差别。     

Discussing options between patients and health care professionals in genetic diagnosis: ethical and legal criteria

The specific characteristics of genetic data lead to ethical-legal conflicts in the framework of genetic diagnosis. Several international organisations, including UNESCO and the Council of Europe, have enacted rules referring to the use of genetic information. This paper discusses possible legal and ethical criteria that could be used in genetic testing.     

Statistical clues to postoperative blood loss: Moving averages applied to medical data

With the advent of computerized databases, medical data has become easy to accumulate; however, effective use of this data continues to pose significant problems. In other circumstances, smoothing algorithms have been used to uncover non-obvious correlations, trends and relationships in noisy data. We have applied four such algorithms to a large dataset of postoperative blood replacement in cardiopulmonary bypass patients. When applied to this dataset, one of the algorithms proved surprisingly effective. It confirmed several previously observed correlations, and also provided an additional series of counterintuitive and apparently unrelated associations. These associations have been explored in an accompanying paper.     

数据库技术新进展及其在医疗系统中的应用

论述了关系型数据库的革命性贡献与发展中的矛盾,实现医疗系统中的数据管理功能需要解决的问题,以及对临床数据输入系统的需求。     

Working‐correlation‐structure identification in generalized estimating equations

Selecting an appropriate working correlation structure is pertinent to clustered data analysis using generalized estimating equations (GEE) because an inappropriate choice will lead to inefficient parameter estimation. We investigate the well‐known criterion of QIC for selecting a working correlation structure, and have found that performance of the QIC is deteriorated by a term that is theoretically independent of the correlation structures but has to be estimated with an error. This leads us to propose a correlation information criterion (CIC) that substantially improves the QIC performance. Extensive simulation studies indicate that the CIC has remarkable improvement in selecting the correct correlation structures. We also illustrate our findings using a data set from the Madras Longitudinal Schizophrenia Study. Copyright © 2008 John Wiley & Sons, Ltd.     

Microformats: Three Proposed Standards for Solving the Need for Standard Data Presentation

The continuous glucose monitor market is just starting to develop. Current trends in the availability of diabetes information tools highlight the need for standard data presentation for continuous glucose monitors. These trends and their implications are discussed. This article proposes a set of standards for blood glucose data presentation. If device manufacturers adopt these standards, they will ensure that their continuous glucose monitors meet both the short-term and the long-term needs of users. This should increase the demand for these monitors and enable future device developments that appeal to a wider range of users.     

One‐ and two‐stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint

Phase II clinical trials are performed to investigate whether a novel treatment shows sufficient promise of efficacy to justify its evaluation in a subsequent definitive phase III trial, and they are often also used to select the dose to take forward. In this paper we discuss different design proposals for a phase II trial in which three active treatment doses and a placebo control are to be compared in terms of a single‐ordered categorical endpoint. The sample size requirements for one‐stage and two‐stage designs are derived, based on an approach similar to that of Dunnett. Detailed computations are prepared for an illustrative example concerning a study in stroke. Allowance for early stopping for futility is made. Simulations are used to verify that the specified type I error and power requirements are valid, despite certain approximations used in the derivation of sample size. The advantages and disadvantages of the different designs are discussed, and the scope for extending the approach to different forms of endpoint is considered. Copyright © 2008 John Wiley & Sons, Ltd.     

Measurement in clinical trials: A neglected issue for statisticians?

Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so‐called ‘responder analysis’, which may involve not only a loss of information through dichotomization, but also extravagant and unjustified causal inference regarding individual treatment effects at the patient level, and, increasingly, the use of the so‐called number needed to treat scale of measurement. Other problems involve inefficient use of baseline measurements, the use of covariates measured after the start of treatment, the interpretation of titrations and composite response measures. Many of these bad practices are becoming enshrined in the regulatory guidance to the pharmaceutical industry. We consider the losses involved in inappropriate measures and suggest that statisticians should pay more attention to this aspect of their work. Copyright © 2009 John Wiley & Sons, Ltd.