Abstract
BACKGROUND: Breast cancer (BC) management in China faces significant challenges, particularly in terms of standardizing diagnosis and treatment protocols across various healthcare settings. The implementation of a quality control (QC) indicator system offers a potential solution to improve treatment consistency and outcomes. This study evaluated the impact of a QC indicator system on the standardization of neoadjuvant and adjuvant therapies for BC. METHODS: A QC system was developed by an expert panel in alignment with China's 2022 guidelines. A comparative study was conducted between Jiangsu Cancer Hospital (experimental, implementing PDCA-cycle management) and Nantong Tumor Hospital (control, routine practices). Key indicators included cTNM staging completeness, chemotherapy record standardization, and rational anti-tumor drug use. Additionally, clinical outcomes, patient-reported outcomes (PROs), and treatment adherence were assessed, alongside qualitative data derived from clinical records. RESULTS: After the QC system was implemented, Jiangsu Cancer Hospital demonstrated significant improvements: cTNM staging completeness increased from 92.5% to 98.08%, chemotherapy record standardization improved by 66.65%, and rational drug use rose from 78% to 87.5% (all P<0.05). In contrast, no significant improvements were observed in the control hospital. The clinical outcomes and patient-reported symptoms also demonstrated favorable trends in the intervention hospital. Qualitative data revealed facilitators such as clearer treatment protocols and improved coordination, while challenges included increased documentation workload. CONCLUSIONS: The QC system effectively enhanced the standardization of neoadjuvant and adjuvant therapies for breast cancer, with improvements in clinical management and rational drug use. These results offer a scalable model for improving breast cancer management quality in other regions and institutions. Further research, including multi-center studies with extended follow-up, is recommended to validate these findings and explore the long-term impact of QC interventions on patient outcomes.