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 «opinion leaders», 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.