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.     

护理本科生关爱能力调查分析

目的了解护理本科生关爱能力现状,为护理本科生关爱能力的培养提供依据。方法采用关爱能力评价表,对四川省4所医学院校579名护理本科生关爱能力进行问卷调查。结果护理本科生关爱能力评分为189.72±19.57,在各维度中耐心维度得分最高,勇气维度得分最低;不同性别、民族、是否独生子女关爱能力比较,差异无显著性意义（均P〉0.05）;四年级护理本科生关爱能力评分显著高于二、三年级（均P〈0.05）。结论护理本科生关爱能力仍需提高,建议从实践关爱和课程设置等方面提高护理本科生的关爱能力。     

Occupational injury and illness in the semiconductor manufacturing industry

Two thousand nine hundred and ninety-four reports of OSHA-reportable occupational injury or illness cases in 1984 from member companies of a national trade association of semiconductor manufacturing firms were analyzed. The 37 participating manufacturing facilities represented 16 companies employing over 95,000 persons, or approximately one-third of the U.S. work force for this industry in 1984. The annual incidence rate for all reportable injuries and illnesses was 2.7 per 100 full-time employees (FTE) for men and 3.7 per 100 FTE for women. Strains, sprains, or dislocations were the most frequently reported incidents (N = 956 [31.9%]), followed by cuts, lacerations, punctures, scratches, and abrasions (N = 445 [14.9%]), and chemical burns (N = 401 [13.4%]). Increased work-loss days per case were associated with manufacturing sites that did not have an employee health clinic on the premises, with custodial occupations, and with female gender.     

铰链式冠外附着体的结构强度分析

目的探讨铰链式冠外附着体设计的合理性.方法采用有限元应力分析的实验方法,分析铰链式冠外附着体阳性结构L形球体的应力分布情况,对其结构强度进行测试.结果在附着体阳性结构L形球体的转角处应力最大,应力值为321.847MPa.结论该铰链式附着体的结构强度符合临床设计要求.     

Factors leading to long-term hospitalization after laparoscopic appendectomy.

BACKGROUND: Randomized studies demonstrate that laparoscopic appendectomy yields better results compared with open techniques. We sought to identify factors that determine an extended hospital stay among patients undergoing laparoscopic appendectomy. METHODS: This was a prospective study including 669 patients undergoing laparoscopic appendectomy. We analyzed variables that can predict the length of hospital stay. RESULTS: Of 669 patients undergoing laparoscopic appendectomy, 141 stayed in the hospital for > or = 5 days (Group 1), and 97 stayed in the hospital for < or = 1 day after surgery (Group 2). The univariate analysis demonstrated that fever (P<0.0001), nausea and vomiting (P=0.060), leukocytosis (P<0.0001), gangrened or perforated intraoperative appearance of the appendix (P<0.0001), and appendix position behind the ileocecal junction (P<0.001) were related to a longer hospital stay. The multivariate analysis through logistical regression showed that the factors independently and significantly associated with an extended hospital stay were presurgical fever, appendix position behind the ileocecal junction, and intraoperative gangrened or perforated appearance of the appendix. CONCLUSION: Fever, appearance, and position of the appendix are factors related to an extended hospital stay.     

冠心病患者血糖与微量元素的相关性研究

为探讨冠心病患者血糖与微量元素的关系，用电感耦合等离子体原子发射光谱法测定了７８例冠心病患者的６种微量元素变化，并与血糖做相关分析．结果冠心病患者高血糖组与正常血糖组相比，血清铁、铅、镉显著增高，锌和铬显著降低，Ｐ＜００５或００１，铜无显著性差异；血糖与血清铁、铅呈显著性正相关，与血清铬、锌呈显著负相关，而与铜、镉相关不显著．表明部分微量元素的不平衡构成对冠心病的危险因子———高血糖的促发作用，调整人群中微量元素的不平衡状态，对减少冠心病及糖尿病的发生可能有利     

特发性甲状旁腺功能低下（附13例分析）

本文观察分析了13例特发性甲状旁腺功能低下患者、查PTH6例。患者血清中除有本病低血钙、高血磷的固有特征外，其它微量元素也有改变，如血清镁值减低。这与文献[1]的报道相符。碱性磷酸酶2例明显升高。磷廓清率S例降低。肾小管磷重吸收率5例升高。放免甲功：抗甲状腺微粒体2例升高。T细胞亚群1例低于正常值。本病有家族性，与遗传有关。     

A highly variable STR at the D12S391 locus

A total of 103 fragments in the STR D12S391 locus were sequenced. 24 different alleles were found which can be grouped into 12 allelic classes based on the total number of repeats. The structure of this compund STR consists of blocks of (AGAT) and (AGAC) repeats with a consensus structure (AGAT)_8–l7 (AGAC)_6–10 (AGAT)_0–1. Whereas shorter alleles only have (AGAT) repeats, > 225 bp alleles are more complex, having two motifs (AGAT) and (AGAC). Population data showed that this to be a highly polymorphic STR with a heterozygosity of 0.9. This fact together with its simple structure make this STR very suitable for forensic and genetic purposes.     

Mouthguards: difference in longitudinal dimensional stability between single- and double-laminated fabrication techniques

Abstract –  Though the use of mouthguards (MGs) has increased with the increase in sporting activities, little is known about the influence of their fabrication methods on longitudinal dimensional stability. The objective of this study was to compare the difference in the longitudinal dimensional stability between single and laminated MGs. Single-layer MGs were made from a 4.0 mm thick ethylene vinyl acetate (EVA) sheet and laminated MGs were made from two 2.0 mm thick sheets of EVA. MGs were kept in a 37°C water bath for 60 h, equivalent to the time period of 3-months inter-oral use. MG deformation was analyzed by measuring designated points on the MG border using a profile projector (J-12, Nikon Inc., Tokyo, Japan) before and after the water immersion. A finite-element model was also created to examine the time course of stress accumulation during the sheet forming process using Finite Element software. Longitudinal deformation was smaller in the laminated MGs than in the single-layer MGs in the anterior area ( P  < 0.05). Finite element method (FEM) analysis also showed the largest stress accumulation in the anterior incisal area where deformations were mainly observed. Laminated double layer MGs have advantages over single-layer MGs in terms of longitudinal stability due to lower stress accumulation during the fabrication process.