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.     

经前后路联合手术治疗L5S1椎体结核

目的 探讨一期经前路病灶清除后路植骨内固定治疗L5S1椎体结核的临床疗效.方法 对40例L5S1椎体结核患者,采用一期经前路病灶清除椎体间植骨加后路椎弓根螺钉内固定植骨融合治疗.结果 所有患者随访6～24个月,35例植骨融合良好,5例融合欠佳;有1例出现尿路感染.结论 一期经前路病灶清除椎体间植骨加后路椎弓根螺钉内固定椎板植骨治疗L5S1椎体结核能在彻底清除病灶的前提下保证脊柱的稳定性,提高植骨块的融合率和缩短患者卧床时间.     

腰椎后路非融合固定系统的临床应用

复习腰椎后路非融合固定系统的设计原理、临床应用及治疗效果等相关文献,与传统的脊柱融合术相比,应用非融合系统可获得很好的疗效,并可以减少邻近节段退变的发生率。     

同时应用融合和非融合技术治疗创伤性腰椎间盘损伤(附4例临床病例报道及文献复习)

目的观察同时应用融合及非融合技术治疗腰椎间盘损伤的远期疗效,对照该术式与非手术治疗的远期疗效。方法对4例由于急性外伤引起的L4/L5及L5/S1椎间盘损伤患者进行影像学评价。根据生物力学稳定性对病变节段分别采用融合和非融合技术。手术全部经前路腹膜外切口。L5/S1采用椎间融合(自体髂骨 cage植入),L4/L5采用人工椎间盘植入。术后随访4年,摄术后X线正侧位、动力位片,术后2年MRI检查,SF36问卷调查。同期8例患者采用非手术治疗作为对照。结果术后6、12、24、36及48个月X线片显示,融合节段正侧位椎体间无移位,全部患者均有明显的骨性融合。非融合节段人工椎间盘假体位置良好,术后2年MRI显示有正常活动。同期8例非手术治疗患者5例缓解,3例因症状加重实施手术。结论前路融合技术可以有效稳定椎节,缓解腰椎不稳所致的疼痛。人工腰椎间盘植入可以有效地维持放射学稳定性,但不能完全替代正常椎间盘的功能。     

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.