Methodological issues in the use of guidelines and audit to improve clinical effectiveness in breast cancer in one United Kingdom health region.

AIMS To develop a system to improve and monitor clinical performance in the management of breast cancer patients in one United Kingdom health region. DESIGN An observational study of the changes brought about by the introduction of new structures to influence clinical practice and monitor change. SETTING North Thames (East) Health region, comprising seven purchasing health authorities and 21 acute hospitals treating breast cancer. SUBJECTS The multi-disciplinary breast teams in 21 hospitals and an audit sample of 419 (28%) of the breast cancer patients diagnosed in 1992 in the region. INTERVENTIONS Evidence-based interventions for changing clinical practice: regional guidelines, senior clinicians acting as <>, audit of quality rather than cost of services, ownership of data by clinicians, confidential feed-back to participants and education. OUTCOME MEASURES Qualitative measures of organizational and behavioural change. Quantitative measures of clinical outcomes compared to guideline targets and to results from previous studies within this population. RESULTS Organizational changes included the involvement, participation of and feedback to 16 specialist surgeons and their multidisciplinary teams in 21 hospitals. Regional clinical guidelines were developed in 6 months and the dataset piloted within 9 months. The audit cycle was completed within 2 years. The pilot study led to prospective audit at the end of 2 years for all breast cancers in the region and a 15-fold increase in high quality clinical information for these patients. Changes in clinical practice between 1990 and 1992 were observed in the use of chemotherapy (up from 17-23%) and axillary surgery (up from 46-76%). CONCLUSIONS The approach used facilitated rapid change and found a balance between local involvement (essential for sustainability within a hospital setting) and regional standardization (essential for comparability across hospitals). The principles of the approach are generalized to other cancers and to other parts of the UK and abroad.