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.     

Shoulder instability: impact of glenohumeral arthrotomography on treatment

We used arthrotomography to study the glenoid labrum in 114 patients. Sixty-nine of the patients had anatomic instability of the shoulder (including recurrent dislocation and subluxation of the shoulder), and 45 patients had functional instability of the shoulder (denoted by chronic pain, clicking of the joint, and the sensation that an unstable condition exists without the objective signs of it). Labral tears were revealed arthrotomographically in 86% of the patients with anatomic instability, while only 40% of the patients with functional instability had labral abnormalities, and these were primarily of minor severity. Fifty-six patients (44 of whom had anatomic instability; 12, functional instability) required surgery. The surgical findings were correlated with the arthrotomographic findings, and no false-positive results were revealed. However, arthrotomography demonstrated only part of the pathologic condition of two patients. These results confirm that there is a strong correlation between labral pathologic conditions and anatomic instability of the shoulder. Arthrotomographic studies have a great impact on the selection of therapy in cases of both anatomic and functional instability of the shoulder.     

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.