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Biomedical subjects

C E Chilvers

Publications and source records attributed to C E Chilvers.

43 records · Page 3Linked to original sources

Improving the quality of data in randomized clinical trials: the COMPACT computer package. COMPACT Steering Committee.

One crucial component for a successful clinical trial is that the data gathered have a high level of reliability and completeness. This paper reviews some problems of data management and describes the computer package COMPACT which has been developed to deal with such problems. The package allows range and consistency checks and can monitor complex follow-up schedules. A unique feature of the package is a PROBLEMS file which has use both for identification of queries about the data and of patients with particular characteristics of interest. The ability to monitor drug dosages and to signal deviations from the protocol is of particular value. COMPACT has the syntax necessary to create a 'flat' file for transfer to statistical packages for analysis, and the variable description files for SAS, SPSS and MINITAB. The package is written in standard FORTRAN which enables transfer to different types of mini and micro computer systems.

Clinical Trials as Topic↗

Response to aminoglutethimide and cortisone acetate in advanced prostatic cancer.

Forty patients with metastatic adenocarcinoma of the prostate were evaluated for response to treatment with aminoglutethimide plus cortisone acetate. All had relapsed from or failed to respond to primary endocrine treatment with orchidectomy or stilboestrol. Nineteen patients (48%) showed subjective response, in most cases relief of bone pain. Side effects limited treatment in only 3 patients. We conclude that aminoglutethimide plus cortisone acetate is a useful addition to the treatment available for this difficult group of patients. The mechanism by which this treatment has a beneficial effect remains unclear.

Adenocarcinoma↗

A double-blind controlled crossover trial of an antigen-avoidance diet in atopic eczema.

20 out of 36 children (aged two to eight years) with atopic eczema completed a twelve-week, double-blind, controlled, crossover trial of an egg and cows' milk exclusion diet. During the first and third four-week periods, patients on an egg and cows' milk exclusion diet received a soya-based milk substitute (trial period) or an egg and cows' milk preparation (control period). Response was assessed in terms of eczema activity, number of areas affected, pruritus, sleeplessness, and antihistamine usage while on the two diets. During the middle period patients resumed their normal diet to minimise any carry-over effect. 14 patients responded more favourably to the antigen-avoidance diet than to the control diet, whereas only 1 responded more favourably to the control diet than the trial diet. Patients experienced more benefit during the first diet period than the second, whatever the nature of the diet. There was no correlation between a positive prick test to egg and cows' milk antigen and response to the trial diet.

Allergens↗