OBJECTIVE: To assess the effect of a single randomized clinical trial, the National Surgical Adjuvant Breast Project (NSABP) B-06, on the surgical management of breast cancer in women. DESIGN: Retrospective cohort study. SETTING:All hospitals in Ontario. PATIENTS: A consecutive sample of 37,447 women with breast cancer newly diagnosed from Jan. 1, 1980, to Dec. 31, 1989, linked to a surgical procedure record in the Ontario Cancer Registry. MAIN OUTCOME MEASURE: The most invasive surgical procedure used within 90 days of diagnosis. RESULTS:Unilateral breast-ablative surgery (BAS) was performed in 57.3% of the women and breast-conserving surgery (BCS) in 31.6%. The annual rate of BAS declined from 77.5% in 1980 to 44.2% in 1989 and the rate of BCS rose from 12.5% in 1980 to 43.5% in 1989. The decline was linear from 1980 to 1984 and then accelerated significantly in 1985 (p < 0.0001), after the results of the NSABP B-06 trial were published. CONCLUSION: One randomized clinical trial can have an immediate and profound effect on medical practice.
RCT Entities:
OBJECTIVE: To assess the effect of a single randomized clinical trial, the National Surgical Adjuvant Breast Project (NSABP) B-06, on the surgical management of breast cancer in women. DESIGN: Retrospective cohort study. SETTING: All hospitals in Ontario. PATIENTS: A consecutive sample of 37,447 women with breast cancer newly diagnosed from Jan. 1, 1980, to Dec. 31, 1989, linked to a surgical procedure record in the Ontario Cancer Registry. MAIN OUTCOME MEASURE: The most invasive surgical procedure used within 90 days of diagnosis. RESULTS: Unilateral breast-ablative surgery (BAS) was performed in 57.3% of the women and breast-conserving surgery (BCS) in 31.6%. The annual rate of BAS declined from 77.5% in 1980 to 44.2% in 1989 and the rate of BCS rose from 12.5% in 1980 to 43.5% in 1989. The decline was linear from 1980 to 1984 and then accelerated significantly in 1985 (p < 0.0001), after the results of the NSABP B-06 trial were published. CONCLUSION: One randomized clinical trial can have an immediate and profound effect on medical practice.
Authors: B Fisher; E Montague; C Redmond; B Barton; D Borland; E R Fisher; M Deutsch; G Schwarz; R Margolese; W Donegan; H Volk; C Konvolinka; B Gardner; I Cohn; G Lesnick; A B Cruz; W Lawrence; T Nealon; H Butcher; R Lawton Journal: Cancer Date: 1977-06 Impact factor: 6.860
Authors: U Veronesi; R Saccozzi; M Del Vecchio; A Banfi; C Clemente; M De Lena; G Gallus; M Greco; A Luini; E Marubini; G Muscolino; F Rilke; B Salvadori; A Zecchini; R Zucali Journal: N Engl J Med Date: 1981-07-02 Impact factor: 91.245
Authors: B Fisher; M Bauer; R Margolese; R Poisson; Y Pilch; C Redmond; E Fisher; N Wolmark; M Deutsch; E Montague Journal: N Engl J Med Date: 1985-03-14 Impact factor: 91.245