The effect of the publication of a major clinical trial in a high impact journal on clinical practise: the ORACLE Trial experience Sara Kenyon * , David J. Taylor Objective To estimate the short term effect of the publication of a major clinical trial on clinical practise. Design Questionnaire survey of clinical practise. Setting UK. Population All maternity units in the UK. Method A self-administered questionnaire completed by lead consultants on delivery suite of maternity units. Main outcome measures Changes in antibiotic prescription. Results Within six months of publication, approximately 50% of maternity units had changed their guidelines for the care of women with preterm prelabour rupture of the fetal membranes. Conclusion Publication of a major clinical trial does impact on clinical practise but the impact is heterogeneous in terms of time and consistency. INTRODUCTION There is widespread recognition of the need to improve the effectiveness of the implementation of research findings into clinical practise because of the continuing gap between research findings and clinical practise and the need to demonstrate that public investment in research results in better patient care and outcomes. In order to promote the uptake of research findings, it is necessary to identify the potential barriers to implementation and to develop strat- egies to overcome them. Specific interventions that have been used to promote research-based practise include using clinical guidelines, computerised decision support systems, educational programmes, communicating research findings to clinicians and patients and developing strategies for organisational change 1 . We report here the short term effect of the publication of a major trial results in a high impact clinical journal. This study reports the impact on reported clinical practise of the publication of a MRC funded, large, international pragmatic perinatal randomised controlled trial— ORACLE. The trial tested the hypothesis that the treatment of women under 37 weeks of gestation in either spontaneous preterm labour (SPL) or with preterm prelabour ruptured membranes (pPROM) with broad spectrum antibiotics (co-amoxiclav and erythromycin) prolonged pregnancy and improved neonatal mortality and morbidity. The trial randomised 11,155 women from 161 maternity units (135 within the UK). The trial began in July 1994 and completed recruitment in May 2000. The results were published in the Lancet in March 2001 2,3 . A total of 6295 women with spontaneous preterm labour were randomly assigned to 250 mg erythromycin, 325 mg co-amoxiclav, both antibiotics or neither. The results showed that neither of the antibiotics was associated with any improvement in neonatal mortality or morbidity. A total of 4826 women with preterm prelabour ruptured membranes were randomly assigned the same treatments. Results showed that the prescription of erythromycin to women with singleton pregnancies resulted in statistically significant reductions in composite primary outcome (neo- natal death, chronic lung disease, abnormal cerebral ultra- sound scans prior to discharge from hospital). Both antibiotics prolonged pregnancy but the prescription of erythromycin to women was associated reductions in neo- natal morbidity. An unexpected finding was that the pre- scription of co-amoxiclav was associated with an increase in neonatal necrotising enterocolitis. METHODS In September 2001, six months after publication of trial results, a self-administered questionnaire was sent to the lead consultant for delivery suite in maternity units with 24 hour obstetric service in England, Wales, Scotland and Northern Ireland to ascertain the short term impact of the ORACLE Trial results. A reminder was sent three weeks BJOG: an International Journal of Obstetrics and Gynaecology December 2002, Vol. 109, pp. 1341–1343 D RCOG 2002 BJOG: an International Journal of Obstetrics and Gynaecology PII:S1470-0328(02)02980-4 www.bjog-elsevier.com Obstetrics and Gynaecology, Leicester Royal Infirmary, P.O. Box 65, Leicester, UK * Correspondence: S. Kenyon, Obstetrics and Gynaecology, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary, P.O. Box 65, Leicester LE2 7LX, UK.