Br Med J. 1977 Nov 5;2(6096):1196-9. doi: 10.1136/bmj.2.6096.1196.
The degree of observer variation in recording 11 186 items of clinical data from 242 woman who presented complaining of a lump in the breast to a group of 10 surgeons was studied. Each women was interviewed and examined twice and the findings (of the two clinicians) compared. There was a wide range of variation among the observers. Variation in recording the presence or absence of axillary nodes was considerable (45%), as was that in sizing the primary lesion (55%). In 20% of cases the two assessments of primary lesion size differed by over 2 cm. In other respects the results were more encouraging; much variation could be eliminated by wording the proforma more clearly. Moreover, variation was not person-specific, so that these findings are probably reasonably representative. Any future trial of breast lesions should (a) design specific proformata, (b) define terminology, (c) make these definitions universally available, and (d) conduct observer variation studies before the start of the full trial.
研究了10位外科医生对242名主诉乳房肿块的女性记录的11186项临床数据的观察者变异程度。每位女性接受了两次访谈和检查,并对(两位临床医生的)检查结果进行了比较。观察者之间存在广泛的变异。记录腋窝淋巴结有无的变异相当大(45%),对原发病变大小的判断变异也很大(55%)。在20%的病例中,对原发病变大小的两次评估相差超过2厘米。在其他方面,结果更令人鼓舞;通过更清晰地措辞表格可以消除很多变异。此外,变异并非因人而异,因此这些结果可能具有合理的代表性。未来任何关于乳腺病变的试验都应(a)设计特定的表格,(b)定义术语,(c)使这些定义普遍可用,以及(d)在全面试验开始前进行观察者变异研究。