Bertillon和Gompertz效应对临床试验结果的影响
Incidence of the Bertillon and Gompertz effects on the outcome of clinical trials
摘要：
医疗试验的报告提供了关于病人健康状况的非常详细的信息。相比之下，关于人口因素，通常只提供极少的数据。然而，其中一些因素可能会对总体死亡率产生显著影响，从而改变试验的结果和结论。本文重点讨论其中两个变量。第一个是婚姻状况;这种效应，将被称为贝蒂隆效应，可能会改变死亡率超过100%。第二个是最老患者的年龄;由于Gompertz定律的指数性质，最老年龄组年龄分布的变化可能对死亡总数产生巨大影响。可以看出，单靠随机化很难解决这些问题。然而，制定适当的补救措施是容易的。首先，应记录两个研究组患者的婚姻状况以及65岁以上患者的年龄分布。然后，由于这些数据并基于Bertillon和Gompertz定律，可以进行适当的校正。这种修正将显著提高试验结论的可靠性和准确性，特别是对于包括大比例老年受试者的试验。
英文摘要：
The accounts of medical trials provide very detailed information about the patients' health conditions. In contrast, only minimal data are usually given about demographic factors. Yet, some of these factors can have a notable impact on the overall death rate, thereby changing the outcome and conclusions of the trial. This paper focuses on two of these variables. The first is marital status; this effect, which will be referred to as the Bertillon effect, may change death rates by over 100%. The second is the age of the oldest patients; because of the exponential nature of Gompertz's law, changes in the distribution of ages in the oldest age group can have dramatic consequences on the overall number of deaths. It will be seen that randomization alone can hardly take care of these problems. Appropriate remedies are easy to formulate however. First, the marital status of patients as well as the age distribution of those over 65 should be documented for both study groups. Then, thanks to these data and based on the Bertillon and Gompertz laws, it will become possible to perform appropriate corrections. Such corrections will notably improve the reliability and accuracy of the trial's conclusions, especially for trials which include a large proportion of elderly subjects.
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