Development and challenges in setting up an international bone infection registry
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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.
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.
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.
KeywordsStaphylococcus aureus Bone infection registry Implant-related infection Registry development Prosthetic joint infection Fracture-related infection
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.
This study was funded by the AO Foundation via the AOTrauma clinical priority program “Bone Infection”.
Compliance with ethical standards
Conflict of interest
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.
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).
Informed consent was obtained from all individual participants included in the study.
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