Abstract
Introduction
Osteomyelitis is an increasing burden on the society especially due to the emergence of multiple drug-resistant organisms. The lack of a central registry that prospectively collects data on patient risk factors, laboratory test results, treatment modalities, serological analysis results, and outcomes has hampered the research effort that could have improved and provided guidelines for treatments of bone infections. The current manuscript describes the lessons learned in setting up a multi-continent registry.
Materials and methods
This multicenter, international registry was conducted to prospectively collect essential patient, clinical, and surgical data with a 1-year follow-up period. Patients 18 years or older with confirmed S. aureus long bone infection through fracture fixation or arthroplasty who consented to participate in the study were included. The outcomes using the Short Form 36 Health Survey Questionnaire (version 2), Parker Mobility Score, and Katz Index of Independence in Activities of Daily Living were assessed at baseline and at 1 month, 6 months, and 12 months. Serological samples were collected at follow-ups.
Results
Contract negotiation with a large number of study sites was difficult; obtaining ethics approvals were time-consuming but straightforward. The initial patient recruitment was slow, leading to a reduction of target patient number from 400 to 300 and extension of enrollment period. Finally, 292 eligible patients were recruited by 18 study sites (in 10 countries of 4 continents, Asia, North and South America, and Central Europe). Logistical and language barriers were overcome by employing courier service and local monitoring personnel.
Conclusions
Multicenter registry is useful for collecting a large number of cases for analysis. A well-defined data collection practice is important for data quality but challenging to coordinate with the large number of study sites.
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References
Rubin RJ, Harrington CA, Poon A, Dietrich K, Greene JA, Moiduddin A (1999) The economic impact of Staphylococcus aureus infection in New York City hospitals. Emerg Infect Dis 5(1):9–17. https://doi.org/10.3201/eid0501.990102
Calhoun JH, Manring MM, Shirtliff M (2009) Osteomyelitis of the long bones. Semin Plast Surg 23(2):59–72. https://doi.org/10.1055/s-0029-1214158
Anderson DJ, Arduino JM, Reed SD, Sexton DJ, Kaye KS, Grussemeyer CA, Peter SA, Hardy C, Choi YI, Friedman JY, Fowler VG Jr (2010) Variation in the type and frequency of postoperative invasive Staphylococcus aureus infections according to type of surgical procedure. Infect Control Hosp Epidemiol 31(7):701–709. https://doi.org/10.1086/653205
Kremers HM, Nwojo ME, Ransom JE, Wood-Wentz CM, Melton LJ 3rd, Huddleston PM 3rd (2015) Trends in the epidemiology of osteomyelitis: a population-based study, 1969 to 2009. J Bone Joint Surg Am 97(10):837–845. https://doi.org/10.2106/jbjs.N.01350
Foster TJ (2005) Immune evasion by staphylococci. Nat Rev Microbiol 3(12):948–958. https://doi.org/10.1038/nrmicro1289
Anderson DJ, Kaye KS, Chen LF, Schmader KE, Choi Y, Sloane R, Sexton DJ (2009) Clinical and financial outcomes due to methicillin resistant Staphylococcus aureus surgical site infection: a multi-center matched outcomes study. PLoS ONE One 4(12):e8305. https://doi.org/10.1371/journal.pone.0008305
Murillo O, Grau I, Lora-Tamayo J, Junyent J, Ribera A, Tubau F, Ariza J, Pallares R (2015) The changing epidemiology of bacteraemic osteoarticular infections in the early 21st century. Clin Microbiol Infect 21(3):254–258. https://doi.org/10.1016/j.cmi.2014.09.007
Perry KI, Hanssen AD (2017) Orthopaedic infection: prevention and diagnosis. J Am Acad Orthop Surg 25(Suppl 1):S4–S6. https://doi.org/10.5435/jaaos-d-16-00634
Chambers HF, Deleo FR (2009) Waves of resistance: Staphylococcus aureus in the antibiotic era. Nat Rev Microbiol 7(9):629–641. https://doi.org/10.1038/nrmicro2200
Planet PJ (2017) Life After USA300: the rise and fall of a superbug. J Infect Dis 215 (suppl_1):S71–s77. https://doi.org/10.1093/infdis/jiw444
Humphreys H, Becker K, Dohmen PM, Petrosillo N, Spencer M, van Rijen M, Fordos A, Pujol M, Dubouix A, Garau J (2016) Staphylococcus aureus and surgical site infections: benefits of screening and decolonization before surgery. J Hosp Infect 94(3):295–304. https://doi.org/10.1016/j.jhin.2016.06.011
Reveles KR, Duhon BM, Moore RJ, Hand EO, Howell CK (2016) Epidemiology of methicillin-resistant Staphylococcus aureus diabetic foot infections in a large academic hospital: implications for antimicrobial stewardship. PLoS ONE One 11(8):e0161658. https://doi.org/10.1371/journal.pone.0161658
Banerjee S, Argaez C (2017) CADTH rapid response reports. In: Topical antibiotics for infection prevention: a review of the clinical effectiveness and guidelines. Canadian Agency for Drugs and Technologies in Health Copyright (c) 2017 Canadian Agency for Drugs and Technologies in Health, Ottawa (ON)
Meyer E, Schroder C, Gastmeier P, Geffers C (2014) The reduction of nosocomial MRSA infection in Germany: an analysis of data from the Hospital Infection Surveillance System (KISS) between 2007 and 2012. Dtsch Arztebl Int 111(19):331–336. https://doi.org/10.3238/arztebl.2014.0331
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42(2):377–381. https://doi.org/10.1016/j.jbi.2008.08.010
Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V (2011) Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. AmJ Epidemiol 173(6):676–682
Ware JE Jr, Kosinski M, Dewey JE (2001) How to score-version 2 of the SF-36 Health Survey (Standard & Acute Forms), 3rd edn. QualityMetric Incorporated, Lincoln, p 02865
Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br 75(5):797–798
Katz S, Downs TD, Cash HR, Grotz RC (1970) Progress in development of the index of ADL. Gerontologist 10(1):20–30
Katz S (1983) Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am GeriatrSoc 31(12):721–727
Acknowledgements
The authors wish to thank Philip Buescher for his help and support with conduct of this study. We also wish to thank the numerous study coordinators, research associates and other study personnel, and the medical statisticians for their dedication and expertise. Last but not least, we would like to thank the study site principal investigators Drs Kjeld Søballe, Jorge Barla, Dirk Schaefer, Richard Buckley, Zhao Xie, James Stannard, Michael Suk, Volker Alt, Yi Liu, Bi Qing, Kiminori Yukata, Frankie Leung, Michael Blauth, Willem-Jan Metsemakers, Christoph Erichsen, Mario Morgenstern, Michael Nerlich, and Irvin Oh, who made this very complex project possible.
Funding
This study was funded by the AO Foundation via the AOTrauma clinical priority program “Bone Infection”.
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Stephen Kates has received multiple research grants from both governmental (NIH and AHRQ) and private sources (AO Foundation and PCORI). Severine Hurni and Maio Chen declare that they have no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The ethics committees (reference number) consulted were: Regionshuset, Viborg, Denmark (#1-10-72-18-13), Ethic Commission at Hospital Italiano, Buenos Aires, Agentina (#2288), Ethic Commission beider Basel, Switzerland (#EK 353/12), Conjoint Health Research Ethics Board, University of Calgary, Canada (#REB13-0179), Ethics Committee of the First Affiliated Hospital of Third Military Medical University, ChonQing, China (#Keyang-2014(8)), University of Missouri–Columbia Health Sciences Institutional Review Board, USA (#1205478), Geisinger Institutional Review Board, Danville, Pennsylvania, USA (#2014-0313), Ethics Committee University Giessen, Germany (#94/13), Zunyi Medical University Ethics Committee (no reference number), Ethics Committee of Zhejiang Provincial People's Hospital, China (#2013KY064), Ethics Committee of the Hamawaki Orthopedics Hospital, Hiroshima, Japan (no reference number), Institutional Review Soard of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster, Hong Kong (#UW 13-179), Ethics Committee of the Medical University Innsbruck, Austria (#UN4927), Medical Ethics Commission UZ KU Leuven/Onderzoek, Leuven, Belgium (#S57451), Ethik-Kommission der Bayerischen Landesärztekammer, Munich, Germany (#12121), Ethics Commission, University Regensburg, Regensburg, Germany (#14-102-0321), Virginia Commonwealth University IRB Panel, Richmond, VA, USA (#HM20006017), Unity Health System IRB, Rochester, NY, USA (#419), and University of Rochester Research Subjects Review Board (RSRB00043910).
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Informed consent was obtained from all individual participants included in the study.
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Kates, S.L., Hurni, S. & Chen, M.S. Development and challenges in setting up an international bone infection registry. Arch Orthop Trauma Surg 140, 741–749 (2020). https://doi.org/10.1007/s00402-019-03303-7
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DOI: https://doi.org/10.1007/s00402-019-03303-7