Unplanned Return to the Operating Room in Orthopaedics: Closed-Loop Quality Improvement Programme

This multicentre, prospective, before-and-after quality improvement study will evaluate a hospital-level closed-loop management programme for unplanned return to the operating room in orthopaedics. The unit of enrollment, intervention, and analysis is the participating hospital and its orthopaedic department. Approximately 20-30 secondary or tertiary public hospitals in China will be included. Individual patients will not be recruited as research participants, and only aggregated and de-identified hospital-level data will be collected.After baseline assessment and standardized training, participating orthopaedic departments will implement a closed-loop management programme comprising six core components: standardization of the definition of unplanned return to the operating room; establishment of a non-punitive reporting mechanism; appointment of a departmental coordinator; monthly case registration and multi-source data verification; regular department-wide case review and root-cause analysis; and development, implementation, and follow-up of continuous quality improvement actions.The primary outcomes include the underreporting rate or reporting accuracy and indicators of management quality, such as coordinator appointment, active reporting, case registration, data verification, case review, and completion of the closed-loop management process. Secondary outcomes include the rate of unplanned return to the operating room, common postoperative complications, mortality, unplanned readmission, length of hospital stay, and hospitalization costs. Intervention adherence will be assessed quarterly, and study outcomes will be evaluated every six months during the 36-month study period. The intervention will not alter patients' clinical treatment or require additional diagnostic or therapeutic procedures.

The unit of enrollment, intervention, and analysis is the participating hospital and its orthopaedic department. Individual patients are not recruited as research participants. Only aggregated and de-identified hospital-level data will be collected. 1.Inclusion Criteria: （1）A public secondary or tertiary general hospital or specialty hospital in China.（2）Has an independent orthopaedic ward and an established orthopaedic surgical team.（3）Has performed at least 2,000 orthopaedic surgical procedures per year during each of the previous three years.（4）Is willing to participate in the study and sign the study cooperation agreement.（5）The head of the orthopaedic department, or an authorized departmental representative, is willing to provide written informed consent on behalf of the participating department.（6）Has accessible hospital discharge records, surgical and anaesthesia information systems, and the information infrastructure required for data verification.（7）Is able to provide the required aggregated and de-identified study data and complete the scheduled follow-up assessments. 2.Exclusion Criteria: （1）Is currently conducting a similar quality improvement programme that may affect the evaluation of the study intervention.（2）Is unable to complete the required follow-up assessments or data reporting.（3）Experiences or is expected to experience major institutional restructuring during the study period that may substantially affect implementation of the intervention.