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PubMed · 790878

Clinical trials in surgery.

F S Doran
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Abstract

Scientific knowledge is reliable because it has been built on accurate measurements. Clinical knowledge is not. The science of biometry was started in 1835 by the Belgian astronomer Adolphe Quetelet. In the last fifty years a precise set of rules have been invented for this science. The method is suitable for a wide range of problems in clinical medicine and as the result of its application in recent years a firm foundation has been laid upon which scientific clinical knowledge can be built. Surge-ns, particularly, have been slow to apply biometrical methods to their clinical problems; but a start has now been made. The outcome of a particular type of treatment is determined by a complex set of inter-acting factors. The basis of the appropriate biometrical method is the elimination of all bias in favour of one of the rival techniques being compared. If this precaution is taken the observed results of the trial can be fitted onto Quetelet's distribution graph, and the probability of the observed difference in the results being due to chance, and nothing else, can be measured mathematically. The accuracy of this measurement deteriorates the greater are the number of the patients who can not be found and examined at the end of the trial. To make this point two trials conducted by the author are used. In the trial designed to discover if postoperative deep vein thrombosis and pulmonary embolism could be prevented by electrically stimulating the patients legs during the operation there was no difficulty. All the patients were examined at the end of the trial, because it ended before any of the patients left the hospital. The trial to discover if the primary treatment of varicose veins ought to be by Fegan's sclerotherapy or by operation was the exact opposite. At the end of the first year of the two year trial 15% of the patients could not be traced. The results in these patients, therefore, was unknown. Because of this, elaborate mathematical calculations had to be made to try and reach a reliable conclusion to the trial. The loss of patients before the end of the trial is a very serious practical difficulty which besets all long-term clinical trials.

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Clinical Trials as TopicElectric StimulationFemaleHumansMalePostoperative ComplicationsPulmonary EmbolismSclerosing SolutionsSurgical Procedures, OperativeThrombophlebitisVaricose VeinsClinical TrialJournal Article

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F S Doran. 1976. Clinical trials in surgery.. https://pubmed.ncbi.nlm.nih.gov/790878/

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