Statistical Reliability of Bone Biopsy for the Diagnosis of Diabetic Foot Osteomyelitis

Published:September 12, 2011DOI:


      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.

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        The Journal of Foot and Ankle SurgeryVol. 52Issue 5
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          I welcome the publication of the investigation alluded to by the authors of the preceding letter. We clearly have a lot to learn with respect to the diagnosis of diabetic foot osteomyelitis (OM), and their proposed histopathologic classification system could prove to be an important step forward. I will especially consider whether their investigation examined the ability of pathologists to determine the difference between osteomyelitic and nonosteomyelitic bone, or whether it examined only the difference among different forms of OM after the primary diagnosis had been established.
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      • Statistical Reliability of Bone Biopsy for the Diagnosis of Diabetic Foot Osteomyelitis
        The Journal of Foot and Ankle SurgeryVol. 52Issue 5
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          We would like to comment on an article by Meyr et al (1) and describe our experience with diabetic foot osteomyelitis (2). We recently published a histopathologic classification of osteomyelitis according to the cell groups present and the histopathologic changes in the bone samples analyzed (2). We have shown that with the use of a perfectly defined theoretical framework, the interpretation of the data observed in the bone biopsy is no longer subjective and the interobserver variability decreases.
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