Periprosthetic joint infection development of a core outcome set

Aims
Periprosthetic joint infection (PJI) is a devastating complication of arthroplasty, with substantial morbidity, mortality, and healthcare costs. Despite advances in diagnosis and treatment, inconsistencies in outcome reporting have hindered evidence synthesis, limiting progress in understanding and management. This study aimed to develop a core outcome set (COS) for PJI to standardize outcome reporting in the literature.

Methods
A two-stage modified Delphi process was conducted to establish consensus across a range of domains. Stage 1 involved the identification of core outcomes in PJI research by an international expert panel. A patient group was also consulted to ensure that the domains were relevant to patient priorities. Stage 2 included a broader group of 55 stakeholders in an online consensus process to finalize the COS. Quantitative and qualitative data were collated to redefine the outcomes throughout the Delphi process.

Results
Following the modified two-stage Delphi process, a high level of consensus was achieved for all outcomes. The final COS included 23 outcomes across the following four domains: patient demographics and baseline characteristics; infection characteristics; surgical and treatment details; and outcomes and follow-up.

Conclusion
The developed COS provides a standardized framework for reporting outcomes in PJI research. By addressing variability and inconsistency in the literature, this COS aims to enhance comparability across studies, support robust evidence synthesis, and ultimately guide clinical decision-making.

Contributors

Ian W. Kennedy, Fares S. Haddad, COS PJI Group : Matthew P. Abdel, Donald S. Garbuz, Vanya Grant, R. M. D Meek, Carsten Perka, Chloe E. H Scott, Bryan D. Springer, Sam Oussedik, Micheal R. Whitehouse

Publication

Journal: Society of Bone & Joint Surgery
Volume: 107-B No.4
Issue:
Pages: -
Year: 2025
DOI: 10.1302/0301-620X.107B4.BJJ-2024-1727

Further Study Information

Current Stage: Completed
Date: August 2024 - January 2025
Funding source(s): None


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Periprosthetic Joint Infection

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Non-surgical, Surgery

Stakeholders Involved

- Clinical experts
- Journal editors
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process

An editorial was published by the authors, appraising the current literature and identifying gaps in current research methodologies. A core group of PJI experts and patients will be established to determine the core outcomes set (COS) for a Delphi process. A Delphi process will be undertaken with a range of key stakeholders, including clinicians and researchers, through online surveys. The level of agreement for accepting outcomes will be set at 75%. Qualitative feedback will also be collected during the process. If additional outcomes, or amendments to the existing outcomes, are recommended by two or more participants these will go forward to the subsequent Delphi rounds. All responses will be anonymous. A summary of the quantitative feedback will be shared anonymously to participants at the end of each round of the Delphi process.

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