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.     

Functional evaluation of sacral nerve root integrity. Report of a technique

We report our technique of direct stimulation of the sacral roots governing voiding by which the functional and anatomic integrity of these nerve roots can be assessed in patients with voiding dysfunction. The muscular responses to stimulation of each sacral root are described, as are the landmarks and approach used to achieve stimulation.     

The first t-test

The data with which Student illustrated the application of his famous distribution are examined from a number of aspects. Central to the discussion is the within-patient clinical trial at Kalamazoo whose results were published by Cushny and Peebles and misquoted by Student and Fisher. This trial is discussed from historical, pharmacological and statistical perspectives. Student's and Fisher's analyses and a more modern analysis by Preece are considered as is Cushny's and Peebles's interpretation. Brief biographies of the five physicians involved in running the trial are presented.     

The Excimer laser. II. Initial experiences with the Excimer laser in Lucerne]

In the period between September 1990 and July 1991, 35 patients (46 eyes) were treated with the Excimer Laser. In 25 patients (34 eyes), a Myopia-Laser-Shaping was performed, one patient was treated for both myopia and astigmatism. In eight patients (10 eyes) correction of astigmatism was carried out. Two patients with recurrent erosions and one patient with superficial scarring of the cornea were treated. The authors review their initial experience with the Excimer Laser. The decision to initiate treatment must not be undertaken lightly, because the possibility of serious complications may not be neglected. This method shows promise in selected patients with light to medium degrees of myopia. In cases of severe myopia, our experience is encouraging. Subjectively, the patients are satisfied with the results, which do not fall short of their expectations. Further research and clinical experience in this area is urgently required.     

环孢菌素A阻断人HL－60抗药性细胞于G_1期而诱导敏感细胞凋亡

进一步研究了抗三尖杉酯碱的ＨＬ－６０细胞（ＨＲ２０）抗细胞凋亡的机制及该抗性和抗药性的关系。结果表明，环孢菌素Ａ（ＣｓＡ）２０，１０μｇ·ｍｌ￣（－１）诱导ＨＬ－６０细胞发生凋亡，而阻断ＨＲ２０细胞于Ｇ＿１期，就不能诱导细胞发生凋亡。低浓度的ＣｓＡ明显增加柔红霉素在ＨＲ２０细胞内的积聚，其逆转抗药性作用与阻断细胞周期运行无关。ＣｓＡ１０μｇ·ｍｌ￣（－１）处理ＨＲ２０细胞，可引起５０ｋＤａ的蛋白质高度磷酸化。结果提示：环孢菌素Ａ阻断抗三尖杉酯碱的ＨＬ－６０细胞于Ｇ＿１期，而诱导敏感的ＨＬ－６０细胞发生凋亡，其阻断作用与抗药性无关     

Microsurgical anatomy of VII and VIII cranial nerves and related arteries in the cerebellopontine angle

Summary The relationships of VII and VIII cranial nerves and related arteries are reviewed in 26 preparations by microdissection techniques. These vessels may be grouped in large (AICA, PICA), medium (LA, SA, CSA, RPI) and small calibre (vasa nervorum, radicullar and medullar branches). The importance of these structures in acoustic neuroma surgery, vestibular neurectomy and cross-compression syndromes is discussed. Vascular loops and elongated arteries are normal structures present at birth.This work was supported by a grant from the AJ Roemmers Foundation