Meyr Andrew J, Singh Salil, Zhang Xinmin, Khilko Natalya, Mukherjee Abir, Sheridan Michael J, Khurana Jasvir S
Department of Podiatric Surgery, Temple University School of Podiatric Medicine, Philadelphia, PA 19107, USA.
J Foot Ankle Surg. 2011 Nov-Dec;50(6):663-7. doi: 10.1053/j.jfas.2011.08.005. Epub 2011 Sep 9.
Bone biopsy is often referred to as the reference standard for the diagnosis of diabetic foot osteomyelitis (OM), and it also serves as an important interventional tool with respect to diabetic foot infections and limb salvage. However, the phrase bone biopsy lacks a standardized definition, and the statistical reliability of the pathologic diagnosis has not been previously examined. The objective of the present study was to quantify the reliability of the histopathologic analysis of bone with respect to the diagnosis of diabetic foot OM. Four pathologists, kept unaware of the previous pathology reports and specific patient clinical characteristics, retrospectively reviewed 39 consecutive tissue specimens and were informed only that it was "a specimen of bone taken from a diabetic foot to evaluate for OM." As a primary outcome measure, the pathologists were asked to make 1 of 3 possible diagnoses: (1) no evidence of OM, (2) no definitive findings of OM, but cannot rule it out, or (3) findings consistent with OM. There was complete agreement among all 4 pathologists with respect to the primary diagnosis in 13 (33.33%) of the 39 specimens, with a corresponding kappa coefficient of 0.31. A situation of clinically significant disagreement, or in which at least 1 pathologist diagnosed "no evidence of OM," but at least 1 other pathologist diagnosed "findings consistent with OM," occurred in 16 (41.03%) of the specimens. These results indicate agreement below the level of a "reference standard" and emphasize the need for a more comprehensive diagnostic protocol for diabetic foot OM.
骨活检通常被视为诊断糖尿病足骨髓炎（OM）的参考标准，并且在糖尿病足感染和肢体挽救方面也是一种重要的干预工具。然而，“骨活检”这一术语缺乏标准化定义，且病理诊断的统计可靠性此前尚未得到检验。本研究的目的是量化骨组织病理学分析在诊断糖尿病足OM方面的可靠性。四位病理学家在不知晓先前病理报告和患者具体临床特征的情况下，回顾性审查了39份连续的组织标本，且仅被告知这是“一份取自糖尿病足用于评估OM的骨标本”。作为主要结局指标，要求病理学家做出三种可能诊断中的一种：（1）无OM证据；（2）无OM的确切发现，但不能排除；或（3）与OM相符的发现。在39份标本中的13份（33.33%）中，所有四位病理学家在主要诊断方面完全一致，相应的kappa系数为0.31。在16份（41.03%）标本中出现了具有临床意义的分歧情况，即至少有一位病理学家诊断为“无OM证据”，但至少有另一位病理学家诊断为“与OM相符的发现”。这些结果表明一致性低于“参考标准”水平，并强调需要针对糖尿病足OM制定更全面的诊断方案。
