Department of Orthopaedic Surgery, Hospital Cochin, Paris, France.
Clin Orthop Relat Res. 2013 Mar;471(3):905-14. doi: 10.1007/s11999-012-2544-8.
Biopsies of musculoskeletal tumors lead to alterations in treatment in almost 20% of cases. Control charts are useful to ensure that a process is operating at a predetermined level of performance, although their use has not been demonstrated in assessing the adequacy of musculoskeletal biopsies.
QUESTIONS/PURPOSES: We therefore (1) assessed the incidence of and the reasons for inadequate musculoskeletal biopsies when following guidelines for performing the procedure; and (2) implemented a process control chart, the CUSUM test, to monitor the proportion of inadequate biopsies.
We prospectively studied 116 incisional biopsies. The biopsy was performed according to 10 rules to (1) minimize contamination in the tissues surrounding the tumor; and (2) improve accuracy. A frozen section was systematically performed to confirm that a representative specimen was obtained. Procedures were considered inadequate if: (1) another biopsy was necessary; (2) the biopsy tract was not appropriately placed; and (3) the treatment provided based on the diagnosis from the biopsy was not appropriate.
Five (4.3%) of the 116 incisional biopsy procedures were considered failures. Three patients required a second repeat open biopsy and two were considered to receive inappropriate treatment. No alarm was raised by the control chart and the performance was deemed adequate over the monitoring period.
The proportion of inadequate musculoskeletal open biopsies performed at a referral center was low. Using a statistical process control method to monitor the failures provided a continuous measure of the performance.
肌肉骨骼肿瘤的活检会导致近 20%的病例治疗方案发生改变。尽管控制图在评估肌肉骨骼活检的充分性方面尚未得到证实,但它们对于确保过程在预定的性能水平上运行是有用的。
问题/目的:因此,我们(1)评估了在遵循进行该程序的指南时,肌肉骨骼活检不充分的发生率和原因;以及(2)实施了过程控制图,CUSUM 检验,以监测不充分活检的比例。
我们前瞻性研究了 116 例切开活检。根据 10 条规则进行活检,以(1)最大限度地减少肿瘤周围组织的污染;以及(2)提高准确性。系统地进行冰冻切片以确认获得了有代表性的标本。如果出现以下情况,则认为手术不充分:(1)需要再次进行活检;(2)活检通道未正确放置;以及(3)基于活检诊断提供的治疗不合适。
116 例切开活检中有 5 例(4.3%)被认为是失败的。3 名患者需要再次进行开放性重复活检,2 名患者被认为接受了不适当的治疗。控制图未发出警报,并且在监测期间认为性能是充分的。
在转诊中心进行的肌肉骨骼开放性活检不充分的比例较低。使用统计过程控制方法来监测失败情况提供了对性能的连续衡量。