Wheeler J G, Machin D, Campbell M J, Stephens R J, Bleehen N M, Girling D J
University of Southampton, Southampton General Hospital, UK.
Clin Oncol (R Coll Radiol). 1994;6(2):81-90. doi: 10.1016/s0936-6555(05)80109-8.
This paper investigates the influence on patient survival of an individual clinician's experience with a particular treatment regimen and the collective experience of the centre through which the patient is recruited to a particular clinical trial. Data were available from two series of randomized trials, one series in small cell and the other in non-small cell lung cancer, which were conducted by the Medical Research Council Lung Cancer Working Party. Successive small cell trials used the same chemotherapy regimen and successive non-small cell trials the same radiotherapy regimen. We found no evidence that either the degree of experience of individual clinicians with the regimen or the participation in terms of number of patients recruited to centres influenced patient survival. There is a strong suggestion, in non-small cell lung cancer that, as clinicians' experience with the regimen extended, they became increasingly likely to admit patients in poor condition to the trials. We stress how important it is to take account of patient prognostic characteristics in such an analysis, as we found that unadjusted comparisons suggested negative influences of increasing experience with the regimen. The implications for routine audit are self evident, in particular that it is not a substitute for the randomized controlled trial.
本文研究了个体临床医生对特定治疗方案的经验以及患者被招募参加特定临床试验的中心的集体经验对患者生存的影响。数据来自医学研究委员会肺癌工作组进行的两个系列随机试验,一个系列针对小细胞肺癌,另一个针对非小细胞肺癌。连续的小细胞试验使用相同的化疗方案,连续的非小细胞试验使用相同的放疗方案。我们没有发现证据表明个体临床医生对方案的经验程度或中心招募患者的数量会影响患者生存。在非小细胞肺癌中有一个强烈的迹象表明,随着临床医生对方案的经验增加,他们越来越有可能将病情较差的患者纳入试验。我们强调在这种分析中考虑患者预后特征是多么重要,因为我们发现未经调整的比较表明随着对方案经验的增加会产生负面影响。对常规审计的影响不言而喻,特别是它不能替代随机对照试验。