The Quality of Diagnostic Studies in Periprosthetic Joint Infections: Can We Do Better?

BACKGROUND

The diagnosis of periprosthetic joint infections (PJIs) continues to be a subject of extensive debate. This is in part due to the lack of a single "gold standard" test, and the marked heterogeneity in the design of studies evaluating the accuracy of different diagnostic modalities. The goal of this review is to critically analyze the evidence cited by the proceedings of the 2013 International Consensus Meeting (ICM) on PJI with regards to the diagnosis of PJI.

METHODS

References from the Proceedings of the ICM on PJI related to PJI minor criteria were retrieved and manually reviewed. A total of 25 studies were analyzed using a Validated Quality Assessment of Diagnostic Accuracy Studies tool.

RESULTS

A large number of studies were determined to have a high risk of bias for flow and timing domains due to the large numbers of exclusions. Studies of synovial white blood cells count and polymorphonuclear neutrophils percentage suffered from threshold optimization and lack of internal validity. Furthermore, due to the lack of homogeneity across studies, index test and reference standard domains showed high risk of bias for white blood cell/polymorphonuclear neutrophil percentage and the utility histological analysis, respectively. Leukocyte esterase testing lacked standardization with regard to the strip reagent used, and the exclusion of bloody samples limited sample sizes.

CONCLUSION

The 2013 ICM minor criteria were based on studies with a low quality of evidence. As the committee continues to adjust these guidelines, they should encourage future studies with sound clinical design, patient selection, and testing procedures.