INTRODUCTION: The surgical Apgar score (SAS) can predict 30-day major complications or death after surgery. Studies have validated the score in different patient populations and suggest it should be used to objectively guide postoperative care. We aimed to see whether using the SAS in a decisive approach in a future randomised controlled trial (RCT) would be likely to demonstrate an effect on postoperative care and clinical outcome. METHODS: A total of 143 adults undergoing general/vascular surgery in 9 National Health Service hospitals were recruited to a pilot single blinded RCT and the data for 139 of these were analysed. Participants were randomised to a control group with standard postoperative care or to an intervention group with care influenced (but not mandated) by the SAS (decisive approach). The notional primary outcome was 30-day major complications or death. RESULTS:Incidence of major complications was similar in both groups (control: 20/69 [29%], intervention: 23/70 [33%], p=0.622). Immediate admissions to the critical care unit was higher in the intervention group, especially in the SAS 0-4 subgroup (4/6 vs 2/7) although this was not statistically significant (p=0.310). Validity was also confirmed in area under the curve (AUC) analysis (AUC: 0.77). CONCLUSIONS: This pilot study found that a future RCT to investigate the effect of using the SAS in a decisive approach may demonstrate a difference in postoperative care. However, significant changes to the design are needed if differences in clinical outcome are to be achieved reliably. These would include a wider array of postoperative interventions implemented using a quality improvement approach in a stepped wedge cluster design with blinded collection of outcome data.
RCT Entities:
INTRODUCTION: The surgical Apgar score (SAS) can predict 30-day major complications or death after surgery. Studies have validated the score in different patient populations and suggest it should be used to objectively guide postoperative care. We aimed to see whether using the SAS in a decisive approach in a future randomised controlled trial (RCT) would be likely to demonstrate an effect on postoperative care and clinical outcome. METHODS: A total of 143 adults undergoing general/vascular surgery in 9 National Health Service hospitals were recruited to a pilot single blinded RCT and the data for 139 of these were analysed. Participants were randomised to a control group with standard postoperative care or to an intervention group with care influenced (but not mandated) by the SAS (decisive approach). The notional primary outcome was 30-day major complications or death. RESULTS: Incidence of major complications was similar in both groups (control: 20/69 [29%], intervention: 23/70 [33%], p=0.622). Immediate admissions to the critical care unit was higher in the intervention group, especially in the SAS 0-4 subgroup (4/6 vs 2/7) although this was not statistically significant (p=0.310). Validity was also confirmed in area under the curve (AUC) analysis (AUC: 0.77). CONCLUSIONS: This pilot study found that a future RCT to investigate the effect of using the SAS in a decisive approach may demonstrate a difference in postoperative care. However, significant changes to the design are needed if differences in clinical outcome are to be achieved reliably. These would include a wider array of postoperative interventions implemented using a quality improvement approach in a stepped wedge cluster design with blinded collection of outcome data.
Authors: M Mura Assifi; John Lindenmeyer; Benjamin E Leiby; Zvi Grunwald; Ernest L Rosato; Eugene P Kennedy; Charles J Yeo; Adam C Berger Journal: J Gastrointest Surg Date: 2011-10-27 Impact factor: 3.452
Authors: Alex B Haynes; Scott E Regenbogen; Thomas G Weiser; Stuart R Lipsitz; Gerald Dziekan; William R Berry; Atul A Gawande Journal: Surgery Date: 2011-01-08 Impact factor: 3.982
Authors: Paul Q Reynolds; Neal W Sanders; Jonathan S Schildcrout; Nathaniel D Mercaldo; Paul J St Jacques Journal: Anesthesiology Date: 2011-06 Impact factor: 7.892
Authors: Israel Zighelboim; Nora Kizer; Nicholas P Taylor; Ashley S Case; Feng Gao; Premal H Thaker; Janet S Rader; L Stewart Massad; David G Mutch; Matthew A Powell Journal: Gynecol Oncol Date: 2009-12-16 Impact factor: 5.482
Authors: Lena Shah; Marlene Rojas; Oscar Mori; Carlos Zamudio; Jay S Kaufman; Larissa Otero; Eduardo Gotuzzo; Carlos Seas; Timothy F Brewer Journal: BMC Public Health Date: 2015-06-26 Impact factor: 3.295