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• W3023323669 abstract "We read with interest the article entitled “The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria” by Parvizi et al [[1]Parvizi J. Tan T.L. Goswami K. Higuera C. Della Valle C. Chen A.F. et al.The 2018 definition of periprosthetic Hip and knee infection: an evidence-based and validated criteria.J Arthroplasty. 2018; 33: 1309-1314.e2Abstract Full Text Full Text PDF PubMed Scopus (563) Google Scholar]. Our group includes pathologists with subspecialty expertise in hemostasis and thrombosis testing and orthopedic surgeons; we are especially interested in the proposed use of D-dimer in modified scoring criteria for diagnosis of periprosthetic joint infection. We believe that there are several issues with including D-dimer in the proposed modified scoring criteria. First, the article refers to serum D-dimer; however, the commonly used clinical laboratory assays we are aware of measure D-dimer in patient plasma [[2]Longstaff C. Adcock D. Olson J.D. Jennings I. Kitchen S. Mutch N. et al.Harmonisation of D-dimer - a call for action.Thromb Res. 2016; 137: 219-220Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar]. Next, the criteria were developed from data contributed by 3 different academic medical centers [[1]Parvizi J. Tan T.L. Goswami K. Higuera C. Della Valle C. Chen A.F. et al.The 2018 definition of periprosthetic Hip and knee infection: an evidence-based and validated criteria.J Arthroplasty. 2018; 33: 1309-1314.e2Abstract Full Text Full Text PDF PubMed Scopus (563) Google Scholar]. Given the variety of D-dimer assay kits that are currently commercially available, it is likely that different centers are using different assays, but the type and laboratory performance characteristics of the assay used in each center are not clearly stated in the article [[3]Lippi G. Tripodi A. Simundic A.M. Favaloro E.J. International survey on D-dimer test reporting: a call for standardization.Semin Thromb Hemost. 2015; 41: 287-293Crossref PubMed Scopus (37) Google Scholar,[4]Olson J.D. Cunningham M.T. Higgins R.A. Eby C.S. Brandt J.T. D-dimer: simple test, tough problems.Arch Pathol Lab Med. 2013; 137: 1030-1038Crossref PubMed Scopus (42) Google Scholar]. D-dimer assays are not well standardized and the variability among kits may impact whether any individual kit may be used in the proposed criteria. We have seen an example of assay variability making certain D-dimer assays inappropriate for use in the HERDOO2 clinical decision rule, which is designed to identify women with first unprovoked VTE who are at low risk of VTE recurrence and could discontinue anticoagulant therapy [[5]Rodger M.A. Le Gal G. Langlois N.J. Gin B. Mallick R. Giulivi A. et al.HERDOO2 clinical decision rule to guide duration of anticoagulation in women with unprovoked venous thromboembolism. Can I use any d-Dimer?.Thromb Res. 2018; 169: 82-86Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar]. If a laboratory does not know which D-dimer kit was used to create the proposed periprosthetic joint infection criteria, it will not be able to determine whether its D-dimer result can be used in the criteria for clinical decision-making. A clarification of the D-dimer assays used by the participating institution will be helpful to the readers. It is also likely that if a laboratory or practice would like to adopt these criteria, some validation or verification of the local D-dimer assay for this specific indication may be needed. Second, D-dimer may be reported in several different unit magnitudes (eg, ng/mL, μg/L, and others) and there are 2 different unit types (fibrinogen equivalent units [FEU] and D-dimer units [D-DU]) [[3]Lippi G. Tripodi A. Simundic A.M. Favaloro E.J. International survey on D-dimer test reporting: a call for standardization.Semin Thromb Hemost. 2015; 41: 287-293Crossref PubMed Scopus (37) Google Scholar,[4]Olson J.D. Cunningham M.T. Higgins R.A. Eby C.S. Brandt J.T. D-dimer: simple test, tough problems.Arch Pathol Lab Med. 2013; 137: 1030-1038Crossref PubMed Scopus (42) Google Scholar]. The unit magnitude and type must be included with numeric D-dimer results to allow laboratories to properly interpret and compare the result; however, the D-dimer values included in the article only describe the unit magnitude (ng/mL) [[1]Parvizi J. Tan T.L. Goswami K. Higuera C. Della Valle C. Chen A.F. et al.The 2018 definition of periprosthetic Hip and knee infection: an evidence-based and validated criteria.J Arthroplasty. 2018; 33: 1309-1314.e2Abstract Full Text Full Text PDF PubMed Scopus (563) Google Scholar]. For example, if the proposed threshold for D-dimer as presented by Parvizi et al is 860 ng/mL D-DU, applying this 860 ng/mL D-DU cutoff to a D-dimer result measured in FEU will give false-positive results. The mathematical relationship between the unit types indicates that approximately 2 ng/mL FEU is equal to 1 ng/mL DDU; therefore, a cutoff of 860 ng/mL D-DU would be equivalent to a threshold of 1720 ng/mL FEU. If the proposed threshold represents ng/mL FEU, then applying an 860 ng/mL FEU threshold to results measured in D-DU will give false-negative results (given that the equivalent threshold in D-DU is 430 ng/mL D-DU). Inadequate communication of the specific D-dimer assays appropriate for use in these criteria and of the D-dimer unit type will prevent laboratories from being able to provide appropriate D-dimer testing needed for adoption of these criteria in clinical practice. Furthermore, the observed contribution of D-dimer to the proposed criteria may not hold when one accounts for the effects of D-dimer assay variability. In conclusion, the issues we identify in the use of D-dimer in proposed scoring criteria for periprosthetic joint infection presented by Parvizi et al result from a well-described root cause, namely the lack of standardization of D-dimer assays. D-dimer assays lack standardization in unit reporting and lack a common calibrator to standardize the varied assays in common clinical use; furthermore, D-dimer assays use over 20 different monoclonal antibodies of differing specificity, further contributing to differences in assay performance [[2]Longstaff C. Adcock D. Olson J.D. Jennings I. Kitchen S. Mutch N. et al.Harmonisation of D-dimer - a call for action.Thromb Res. 2016; 137: 219-220Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar,[3]Lippi G. Tripodi A. Simundic A.M. Favaloro E.J. International survey on D-dimer test reporting: a call for standardization.Semin Thromb Hemost. 2015; 41: 287-293Crossref PubMed Scopus (37) Google Scholar]. Until standardization of D-dimer assays improves, we will continue to see confusion in clinical use and reporting of D-dimer results. Due to lack of standardization, D-dimer assays are currently not interchangeable, and patient results obtained in different laboratories using different D-dimer assays cannot be compared or evaluated for trends. We reiterate that collaboration among regulatory bodies, professional organizations, and reagent manufacturers is necessary to improve standardization and use of D-dimer results and thus enhance the validity of research and subsequently improve patient outcomes [[6]Goodwin A.J. Higgins R.A. Moser K.A. Smock K.J. Chandler W.L. Kottke-Marchant K. et al.Issues surrounding age-adjusted d-dimer cutoffs that practicing physicians need to know when evaluating patients with suspected pulmonary embolism.Ann Intern Med. 2017; 166: 361-363Crossref PubMed Scopus (14) Google Scholar]. In light of the issues we have highlighted with D-dimer measurement, we find it concerning that the use of D-dimer for diagnosis of periprosthetic joint infection as proposed by Parvizi et al is mentioned in additional more recent publications, which show a similar lack of detail about the D-dimer assays used in the patients studied [[7]Shohat N. Tan T.L. Della Valle C.J. Calkins T.E. George J. Higuera C. et al.Development and validation of an evidence-based algorithm for diagnosing periprosthetic joint infection.J Arthroplasty. 2019; 34: 2730-2736.e1Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar,[8]Qin L. Li F. Gong X. Wang J. Huang W. Hu N. Combined measurement of D-dimer and C-reactive protein levels: highly accurate for diagnosing chronic periprosthetic joint infection.J Arthroplasty. 2020; 35: 229-234Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar]. There is a risk to patients for clinical and surgical mismanagement if D-dimer assays are used in the proposed periprosthetic joint infection criteria given the limitations we outline above. Download .pdf (.02 MB) Help with pdf files Conflict of Interest Statement for Pearson Download .docx (.02 MB) Help with docx files Conflict of Interest Statement for Chen Download .pdf (.26 MB) Help with pdf files Conflict of Interest Statement for Moser Download .pdf (.29 MB) Help with pdf files Conflict of Interest Statement for Smock Download .pdf (.03 MB) Help with pdf files Conflict of Interest Statement for Goodwin Download .pdf (.08 MB) Help with pdf files Conflict of Interest Statement for VanSandt Download .pdf (.27 MB) Help with pdf files Conflict of Interest Statement for Harris Download .pdf (.1 MB) Help with pdf files Conflict of Interest Statement for Olson Download .pdf (.2 MB) Help with pdf files Conflict of Interest Statement for Pham Download .pdf (.06 MB) Help with pdf files Conflict of Interest Statement for Volod Download .pdf (.31 MB) Help with pdf files Conflict of Interest Statement for Isom Download .pdf (.06 MB) Help with pdf files Conflict of Interest Statement for Pelt Download .pdf (.62 MB) Help with pdf files Conflict of Interest Statement for Unold The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated CriteriaThe Journal of ArthroplastyVol. 33Issue 5PreviewThe introduction of the Musculoskeletal Infection Society (MSIS) criteria for periprosthetic joint infection (PJI) in 2011 resulted in improvements in diagnostic confidence and research collaboration. The emergence of new diagnostic tests and the lessons we have learned from the past 7 years using the MSIS definition, prompted us to develop an evidence-based and validated updated version of the criteria. Full-Text PDF Reply to Letter to the Editor Regarding “The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria”The Journal of ArthroplastyVol. 35Issue 9PreviewWe thank you for the informative letter that raises several important issues regarding some of the subtleties involved in using d-dimer as a diagnostic test. The data presented by Moser et al [1] are extremely useful for the orthopedic community and should be taken into consideration when conducting research or using d-dimer in a clinical situation. . The d-dimer assay used in the current study was the HemosIL d-Dimer 500 kit on the ACL TOP instrument, measured on patient plasma. Results are reported in fibrinogen equivalent units (FEUs, ng/mL). Full-Text PDF" @default.
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• W3023323669 title "Letter to the Editor on “The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria”" @default.
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