Journal of the Royal College of Physicians of London
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J R Coll Physicians Lond · Mar 1995
ReviewMega-trials: methodological issues and clinical implications.
A recent development of the therapeutic trial has been the mega-trial: a large, simple randomised trial analysed on an 'intention to treat' basis. Mega-trials have advantages in terms of increased statistical power, but also raise several new questions of interpretation. In mega-trials, randomisation serves to achieve identical allocation groups in a situation where there is poor experimental control and a large measure of between-subject variation. ⋯ In this sense, mega-trials can be repeated but cannot be replicated. Basic science and clinical science both seek understanding at the level of the individual subject; but in a mega-trial, analysis is only meaningful at the group level. The non-scientific nature of mega-trials derives from their methodology, which dispenses with the scientific aim of maximum experimental control to remove or minimise bias, and instead uses randomisation to achieve an equal distribution of bias between groups.
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J R Coll Physicians Lond · Sep 1994
Potential impact upon community mortality rates of training citizens in cardiopulmonary resuscitation.
In order to estimate the impact of a community programme of training in cardiopulmonary resuscitation (CPR), we reviewed all adult deaths in the city of Cardiff (population 292,600) during a 13-week period. Of 701 deaths, 70 were cases of fatal out-of-hospital cardiac arrest due to heart disease, for whom it was felt that CPR might have been of value. Only 34 (48.6%) deaths were witnessed, and in 22 of them the witness did not start CPR. ⋯ We calculate that a community CPR training programme may, at best, reduce the community cardiac mortality rate by 7.5%, ie saving between 24 and 56 lives per 100,000 adult population per year; but more realistically, such a programme can only achieve a reduction of 0.4%, ie saving up to six lives per 100,000 per year. Although community CPR training programmes are likely to lead to only a modest reduction in community cardiac mortality rates, because countrywide there are many deaths, the total of lives saved would be significant. Implementation of such programmes should be carefully evaluated.
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The use of 'do not resuscitate' (DNR) orders in hospitals has been the subject of considerable comment in both the medical and the lay press. Guidelines have been produced to help make DNR decisions but, as yet, there have been no published accounts of these in practice. We have used audit to accounts of these in practice. ⋯ This led to early consultant involvement in making decisions in 55 of 80 patients (69%) who were assessed as DNR at the time of death or discharge, documentation of reasons for DNR in all 55 of these and documentation of discussion with nurses in 49 (89%). Consultants agreed with DNR decisions made by their juniors in 31 of 34 cases (91%) and changed 'for CPR' decisions to DNR in 24 of 108 (22%). We have demonstrated that audit is an appropriate way to change and develop practice in sensitive areas such as this.