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

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

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.

Unplanned return to the operating room is an important indicator of surgical quality and patient safety. It is associated with increased risks of postoperative complications, mortality, prolonged hospitalization, higher medical costs, and greater use of healthcare resources. In orthopaedic practice, patients may require unplanned repeat surgery because of postoperative infection, bleeding or haematoma, venous thromboembolism, implant-related complications, neurological deterioration, wound problems, or other adverse events. However, the reported rate of unplanned return to the operating room may be affected by incomplete case registration, underreporting, insufficient data verification, and the absence of systematic case review and continuous improvement mechanisms.This study aims to evaluate the effectiveness of a standardized closed-loop quality improvement programme for the management of unplanned return to the operating room in orthopaedics. The programme is based on a management framework of monitoring and reporting, analysis and feedback, and continuous improvement. It is intended to improve the completeness and accuracy of case reporting, strengthen hospital-level management processes, and potentially reduce adverse surgical outcomes.This is a multicentre, prospective, hospital-level cluster before-and-after quality improvement study. The unit of enrollment, intervention, and analysis is the participating hospital and its orthopaedic department. Approximately 20 to 30 secondary or tertiary public general or specialty hospitals in China will be included. Each participating hospital must have an independent orthopaedic ward and surgical team, an annual orthopaedic surgical volume of at least 2,000 procedures during each of the previous three years, and the information systems and management capacity required for case registration, data verification, and follow-up.Individual patients will not be recruited as research participants, and no patient will be assigned to a research treatment. The intervention is implemented at the hospital and orthopaedic department level. Only aggregated and de-identified hospital-level data will be collected. The head of the participating orthopaedic department, or an authorized departmental representative, will provide written informed consent for participation of the department.For this study, unplanned return to the operating room is defined as an unplanned repeat surgical procedure required after an orthopaedic operation. It includes an unplanned return to the operating room within 31 days after the original procedure, either during the same hospitalization or following readmission. It may include repeat orthopaedic surgery, surgery performed by another specialty, or an unplanned repeat operation performed at another medical institution. Procedures that were planned before the original operation as part of a staged surgical strategy are excluded.Before implementation of the intervention, participating hospitals will complete a baseline assessment of their existing management systems, reporting practices, information systems, orthopaedic surgical volume, unplanned return to the operating room, postoperative complications, mortality, length of hospital stay, and hospitalization costs. Historical data on unplanned return to the operating room and reporting practices will also be collected when available.After baseline assessment, participating orthopaedic departments will receive standardized training and establish a closed-loop management system. The intervention includes six core components.First, the definition and reporting criteria for unplanned return to the operating room will be standardized across participating hospitals.Second, each department will establish a non-punitive reporting mechanism that encourages healthcare professionals to report cases actively, accurately, and promptly, with an emphasis on learning from adverse events and improving care processes.Third, each participating orthopaedic department will appoint a designated coordinator responsible for case collection, registration, data verification, reporting, organization of case-review meetings, documentation, and follow-up of improvement actions.Fourth, cases will be registered monthly and verified using multiple data sources. These sources may include departmental case records, hospital adverse-event reporting systems, hospital discharge records, medical record databases, and surgical or anaesthesia information systems. The purpose of this verification is to identify missed cases and improve the completeness and accuracy of reporting.Fifth, participating departments will conduct regular department-wide case-review meetings. These meetings will review the causes of unplanned repeat surgery, identify weaknesses in diagnosis, treatment, perioperative management, communication, documentation, and organizational processes, and conduct root-cause analyses when appropriate.Sixth, departments will develop, implement, document, and follow up continuous quality improvement actions based on problems identified through case review and data analysis. Improvement actions may involve revision of clinical or management procedures, staff training, strengthening of perioperative assessment, improvement of case reporting, or optimization of multidisciplinary coordination.The closed-loop management programme will be implemented continuously after the initial training and system-establishment period. Monthly management activities will include case registration, data verification, reporting, case review, and follow-up of improvement actions. Adherence to the intervention will be assessed quarterly. Study outcomes will be evaluated every six months during the 36-month follow-up period.The primary outcomes include the underreporting rate or reporting accuracy of unplanned return to the operating room and hospital-level management quality indicators. Management quality indicators include the proportion of hospitals appointing a departmental coordinator, active reporting rate, completion rate of departmental case registration, data-verification rate, completion rate of case-review documentation, department-wide case-review rate, implementation rate of improvement actions, and completion rate of the overall closed-loop management process.Secondary outcomes include the overall rate of unplanned return to the operating room in orthopaedics; rates of common postoperative complications, including bleeding or haematoma, infection, venous thromboembolism, implant-related complications, drainage-related complications, and mortality; unplanned readmission; average length of hospital stay; hospitalization costs; and the causes and factors associated with unplanned return to the operating room and underreporting.The intervention does not alter patients' clinical treatment, require additional diagnostic tests, or involve additional therapeutic or invasive procedures. It is therefore considered a minimal-risk organizational and behavioral quality improvement intervention.

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