医学学术英语u1tb文章.docVIP

In 1955, during the dawn of the modern era of randomized clinical trials, Thomas Chalmers and his colleagues published a remarkable paper.1 It was then and probably remains one of the most detailed reports of clinical trials ever published: it begins with a Table of Contents and runs on to a further 71 pages of small type. It is a model of how randomized trials should be reported, reflecting Marc Daniels call for better reporting of clinical trials five years earlier,2 and anticipating by over four decades the reporting standards agreed and promulgated by the CONSORT Group.3 Tom Chalmers and his colleagues described the eligibility criteria of participants clearly, and their random allocation (with concealment of the next participants assignment) into their 2?×?2 factorial trials,4 thus permitting comparisons of two regimens per trial. The similarity between treatment groups in respect of 34 other variables that might affect patient prognosis was confirmed. Experimental and control regimens were precisely defined, and compliance with them was closely monitored and reinforced. All patients were accounted for at the end of the trials. Analyses were clearly described and transparent. The ‘external validity’ of the trial results was tested by comparison with another, independent control group of patients. Finally, late effects of the treatment regimens were assessed in a 10-year follow-up study. I first came across this report in 1959. Although I failed to appreciate many of its methodological strategies and strengths at that time, it changed my career. I was a final-year medical student on a medical ward, where a teenager with ‘infectious hepatitis’ (now called ‘Type-A hepatitis’) was admitted to my care. He presented with severe malaise, an enlarged and tender liver, and a colourful demonstration of deranged bilirubin metabolism that made me the envy of my fellow clerks. However, after a few days of total bed rest his spirits and energy returned and he asked me to let