Cooper L S, Chalmers T C, McCally M, Berrier J, Sacks H S
Technology Assessment Group, Harvard School of Public Health, Boston, MA 02115.
JAMA. 1988 Jun 10;259(22):3277-80.
To study the quality of early research on the clinical efficacy of diagnostic imaging with magnetic resonance, we assessed 54 evaluations published in the first four years after introduction of this modality using ten commonly accepted criteria of research methodology. The terms sensitivity, specificity, false-positive or false-negative, accuracy, and predictive values were used infrequently. Nineteen percent of the evaluations used three terms appropriately, 48% used one or two terms, and 33% used none. Data were presented appropriately for one or more of the five terms in 59% of evaluations. A "gold standard" comparison with the results of an independent procedure, such as surgical or autopsy findings, was presented in 22% of evaluations. Results of another imaging procedure were described in 63% of evaluations. Only one evaluation clearly described a prospective study design, although 11 evaluations apparently were planned in advance. Not one evaluation contained an appropriate statistical analysis of the distributions of quantitative readings, "blinded" image readers to diagnosis or other test results, measured observer error, or randomized the order of magnetic resonance imaging and other imaging procedures. We conclude that health care professionals paying for expensive innovative diagnostic technology should demand better research on diagnostic efficacy.
为研究关于磁共振成像临床疗效的早期研究质量，我们使用十条普遍认可的研究方法标准，评估了在引入该技术后的头四年发表的54项评估。敏感性、特异性、假阳性或假阴性、准确性以及预测值等术语很少被使用。19%的评估正确使用了三个术语，48%使用了一两个术语，33%未使用任何术语。59%的评估针对五个术语中的一个或多个进行了恰当的数据呈现。22%的评估给出了与独立程序（如手术或尸检结果）结果的“金标准”比较。63%的评估描述了另一种成像程序的结果。尽管有11项评估显然是提前计划好的，但只有一项评估明确描述了前瞻性研究设计。没有一项评估对定量读数的分布进行适当的统计分析，让图像读取者对诊断或其他测试结果“盲法”评估，测量观察者误差，或将磁共振成像及其他成像程序的顺序随机化。我们得出结论，为昂贵的创新诊断技术付费的医疗保健专业人员应要求对诊断疗效进行更好的研究。
