Jarvik J G, Maravilla K R, Haynor D R, Levitz M, Deyo R A
Department of Radiology, School of Medicine, University of Washington, Seattle 98195, USA.
Radiology. 1997 Aug;204(2):447-54. doi: 10.1148/radiology.204.2.9240534.
To demonstrate the feasibility of a randomized trial to compare rapid magnetic resonance (MR) imaging with plain radiography as the initial imaging study in patients with low back pain, to test measures of the decision-making process and patient outcomes, and to offer a model for using randomized clinical trials to evaluate diagnostic tests.
The authors randomly selected 62 patients with low back pain to undergo either rapid MR imaging or plain radiography. The authors measured functional status, satisfaction, and general health status at baseline and at 3 months. The modified Roland scale was the primary outcome measure. In addition, the authors examined diagnostic and therapeutic decision making and resources used by each group.
There were no statistically significant differences between the two patient groups with respect to outcome (Roland score: MR imaging = 12.5, radiography = 12.1). MR imaging provided more useful information to clinicians and resulted in greater patient reassurance.
Randomly selecting patients to undergo imaging examinations and measuring outcomes is feasible; however, a larger, multicenter study is necessary to determine whether rapid MR imaging is a cost-effective replacement for plain radiography in patients with low back pain.
证明一项随机试验的可行性,该试验旨在比较快速磁共振成像(MR)与普通X线摄影作为腰痛患者初始影像学检查的效果,测试决策过程和患者预后的指标,并提供一个使用随机临床试验来评估诊断测试的模型。
作者随机选择62例腰痛患者,分别接受快速MR成像或普通X线摄影检查。作者在基线和3个月时测量了患者的功能状态、满意度和总体健康状况。改良罗兰量表是主要的结局指标。此外,作者还研究了每组的诊断和治疗决策以及所使用的资源。
两组患者在结局方面(罗兰评分:MR成像组 = 12.5,X线摄影组 = 12.1)无统计学显著差异。MR成像为临床医生提供了更多有用信息,并使患者更安心。
随机选择患者进行影像学检查并测量结局是可行的;然而,需要进行更大规模的多中心研究,以确定快速MR成像是否是腰痛患者普通X线摄影的经济有效替代方法。