The quality of diagnostic studies used for the diagnostic criteria of periprosthetic joint infections.

Background: Although periprosthetic joint infection (PJI) is a serious complication following a total joint arthroplasty procedure, there remains uncertainty regarding the diagnosis of PJI due to the lack of a globally accepted, standardized definition. The goal of this review is to critically analyze the quality of the evidence used for the novel 2018 MSIS PJI definition and identify gaps and limitations with using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool.

Methods: References from the modified 2018 MSIS definition for PJI by Parvizi et al. were retrieved and manually reviewed. A total of 11 studies were assessed using a validated QUADAS-2 tool.

Results: Many included studies had an unclear or high risk of bias for the Index Test domain due to a lack of blinding and lack of prespecified thresholds. A majority of studies utilized Youden's J statistic to optimize the thresholds which may diminish external validity. Likewise, several studies were assessed to have an unclear and high risk of bias for the Flow and Timing domain primarily due to a lack of reporting and a large number of exclusions. Overall, there was a low risk of bias for the choice of reference standard, its conduct and interpretation, as well as for the Patient Selection domain.

Conclusion: Although the literature used for the MSIS 2018 PJI definition is fraught with potential sources of bias, there may be a trend toward an improvement in the quality of evidence when compared to the earlier definition of PJI.