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QUALITY ASSURANCE FOR RADICAL CYSTECTOMY MORBIDITY AND MORTALITY
Vol. 179, No. 4, Supplement, Saturday, May 17, 2008
THE JOURNAL OF UROLOGY®
7
Surgical Apgar Scoring Methodology Allocated points per category Intraoperative variables 0 1 2 3 Estimated blood loss (cc) > 1,500 1001–1,500 601–1000 Lowest heart rate (beats/min) > 85 76–85 66–75 56–65 Lowest mean arterial pressure < 40 40–54 55–69 (mmHg) Total score is the sum of the points in all three categories during surgery
3
4 ---- -----
RESULTS: The surgical Apgar score was significantly associated with adverse events (n=40, 25.8%) (p=0.0003). Eleven RI WKH VXEMHFWV ZLWK D VFRUH H[SHULHQFHG D PDMRU complication or death while 26 (25.7%) of 101 subjects with an intermediate score of 5-7 experienced a complication. Conversely, 3 (8.3%) of the 36 subjects with a score of 8 or greater experienced a PDMRU FRPSOLFDWLRQ RU GHDWK UHODWLYH ULVN EHWZHHQ VXUJLFDO$SJDU DQG &, S )HPDOHJHQGHU$6$FODVV FRURQDU\ DUWHU\ GLVHDVH YROXPH RI LQWUDYHQRXV ÀXLG DGPLQLVWHUHG DQGLQWUDRSHUDWLYHEORRGWUDQVIXVLRQZHUHDOVRIRXQGWREHVLJQL¿FDQW predictors of postoperative complications or death (p<0.05). CONCLUSIONS: The surgical Apgar score predicts postoperative complications and death in patients undergoing radical cystectomy. This objective, easily administered predictive tool allows system-based measures to improve outcomes and may aid in selection of intensity of postoperative care. Further research is needed to determine if inclusion of additional perioperative factors would improve this model. Source of Funding: None
6 THE EFFECTS OF CYSTECTOMY PROVIDER VOLUME ON POSTOPERATIVE AND OVERALL MORTALITY IN A PUBLICLY FUNDED HEALTH CARE SYSTEM Girish S Kulkarni*, Peter C Austin, David R Urbach, Andreas Laupacis, Neil E Fleshner. Toronto, ON, Canada. INTRODUCTION AND OBJECTIVE: Hospital and surgeon volume are often used as proxy measures of quality of care for radical cystectomy. Studies published to date have primarily originated from privately funded health care systems and have focused on post-operative mortality rates. We assessed the effect of provider cystectomy volume on both postoperative and overall mortality in a publicly funded health care setting. METHODS: Patients undergoing cystectomy in Ontario, &DQDGDEHWZHHQ ZHUHLGHQWL¿HGYLDWKH&DQDGLDQ,QVWLWXWH for Health Information Discharge Abstract Database, a population-based administrative database of all inpatient hospital admissions. The effects of hospital volume and surgeon volume on postoperative mortality rates (ie death within 30 days of cystectomy or prior to discharge) were assessed with multilevel, random effects logistic regression models. Analyses were adjusted for patient factors including age, sex, socioeconomic status, comorbidity and admission urgency. The effects of hospital volume and surgeon volume on overall survival were assessed XVLQJ&R[SURSRUWLRQDOKD]DUGVPRGHOVGHVLJQHGWRDFFRXQWIRUSDWLHQW clustering within hospital or surgeons, respectively. In addition to patient factors, overall survival analyses were adjusted for tumor characteristics extracted from cystectomy pathology reports gathered via linkage to the Ontario Cancer Registry. 5(68/76 2I F\VWHFWRP\SDWLHQWVLGHQWL¿HG experienced a postoperative death and 2230 (67.7%) died overall. Pathology reports were available for 2535 (77%) of these patients. 1HLWKHU KRVSLWDO YROXPH 25 &, S QRU VXUJHRQYROXPH 25 &, S ZHUHVLJQL¿FDQWO\ associated with postoperative cystectomy mortality. However, both KRVSLWDOYROXPH +5IRUF\VWHFWRP\LQFUHDVH &, p=0.015) and surgeon volume (HR for 10 cystectomy increase: 0.85, &, S ZHUHVLJQL¿FDQWO\DVVRFLDWHGZLWKRYHUDOO survival. CONCLUSIONS: In a publicly funded health care system, SURYLGHU YROXPH ZDV QRW VLJQL¿FDQWO\ DVVRFLDWHG ZLWK SRVWRSHUDWLYH mortality. High volume providers, however, experienced improved overall mortality rates compared to low volume providers. Future research should focus on the underlying process measures that contribute to the RYHUDOOPRUWDOLW\EHQH¿WRIKLJKYROXPHSURYLGHUV Source of Funding: Canadian Institutes of Health Research.
QUALITY ASSURANCE FOR RADICAL CYSTECTOMY MORBIDITY AND MORTALITY Venu Chalasani*, Mazen Abdelhady, Larry Stitt, Jonathan I Izawa. London, ON, Canada. INTRODUCTION AND OBJECTIVE: There is an increasing need for measurements of quality assurance in surgical procedures. Surgical audits may have increased importance when outcomes can be compared and individual surgeons receive feedback and have the opportunity to improve their outcomes in an expeditious fashion. CUSUM (Cumulative Summation) is one method for quality assurance WKDWKDVUHFHQWO\EHHQDGDSWHGWRWKHPHGLFDO¿HOGDVLWFDQEHXVHGWR monitor any binary surgical outcomes on an ongoing basis. The aim of WKLVVWXG\ZDVWRXWLOL]H&8680FKDUWVIRUTXDOLW\DVVXUDQFHLQUDGLFDO cystectomies. METHODS: CUSUM charts were generated from prospectively FROOHFWHGGDWDIRUWKH¿UVWUDGLFDOF\VWHFWRPLHVGRQHE\DVLQJOH surgeon from July 2001 to September 2007. Overall survival (OS) and GLVHDVHVSHFL¿FVXUYLYDO '66 ZHUHHVWLPDWHGXVLQJWKH.DSODQ0HLHU DFWXDULDOPHWKRGRORJ\DQGVWUDWL¿HGE\SDWKRORJLFVWDJHWRGHPRQVWUDWH survival outcomes. Based upon a literature review, the following alerts were set (acceptable and unacceptable rates) for these binary outcomes: death 0.3-4%, ileus 2-18%, ureteral-ileal anastomotic leak 0.3-1%, wound dehiscence 3.7-9%, pulmonary embolism 0.4-2%, and rectal injury 0.3-1%. RESULTS: The median follow-up was 16 months. There were 12, 12, 41, 26, 25, and 34 patients with pTis, pT1, pT2, pT3, pT4, and pN+ disease, respectively. Thirteen patients underwent neoadjuvant chemotherapy and 29 patient received adjuvant chemotherapy. Ten patients underwent prior pelvic radiotherapy. The 5-year OS for
8 DOES PRACTICE REFLECT THE EVIDENCE? LYMPH NODE DISSECTION WITH RADICAL PROSTATECTOMY: RESULTS FROM THE SEARCH DATABASE Charles D Scales*, Martha K Terris, William J Aronson, Joseph C Presti, Christopher J Kane, Christopher L Amling, Tracey L Krupski, Stephen J Freedland. Durham, NC, Augusta, GA, Los Angeles, CA, Palo Alto, CA, San Diego, CA, and Birmingham, AL. INTRODUCTION AND OBJECTIVE: Evidence-based practice is a rising force in urology. However, evidence levels in urology are generally low, and how urologists practice in the face of such uncertainty is unknown. Controversy exists as to whether lymph node dissection (LND) at the time of radical prostatectomy (RP) impacts biochemical IDLOXUHUDWHV*LYHQWKLVFRQWH[WZHVRXJKWWRFKDUDFWHUL]HWKHSUDFWLFH of LND with RP in an equal-access setting. 0(7+2'6 :HXWLOL]HGWKH6WUDWHJLF(TXDO$FFHVV5HJLRQDO Cancer Hospital (SEARCH) database to identify men undergoing RP from 1994 - 2007 with complete information on preoperative PSA, biopsy Gleason score, and clinical stage as well as demographic variables. The primary outcome was performance of LND at the time of RP. Men ZHUH ULVNVWUDWL¿HG DFFRUGLQJ WR WKH '¶$PLFR FODVVL¿FDWLRQ :H XVHG multivariable regression to identify characteristics associated with LND, controlling for patient characteristics and time period.
THE JOURNAL OF UROLOGY®
7
Surgical Apgar Scoring Methodology Allocated points per category Intraoperative variables 0 1 2 3 Estimated blood loss (cc) > 1,500 1001–1,500 601–1000 Lowest heart rate (beats/min) > 85 76–85 66–75 56–65 Lowest mean arterial pressure < 40 40–54 55–69 (mmHg) Total score is the sum of the points in all three categories during surgery
3
4 ---- -----
RESULTS: The surgical Apgar score was significantly associated with adverse events (n=40, 25.8%) (p=0.0003). Eleven RI WKH VXEMHFWV ZLWK D VFRUH H[SHULHQFHG D PDMRU complication or death while 26 (25.7%) of 101 subjects with an intermediate score of 5-7 experienced a complication. Conversely, 3 (8.3%) of the 36 subjects with a score of 8 or greater experienced a PDMRU FRPSOLFDWLRQ RU GHDWK UHODWLYH ULVN EHWZHHQ VXUJLFDO$SJDU DQG &, S )HPDOHJHQGHU$6$FODVV FRURQDU\ DUWHU\ GLVHDVH YROXPH RI LQWUDYHQRXV ÀXLG DGPLQLVWHUHG DQGLQWUDRSHUDWLYHEORRGWUDQVIXVLRQZHUHDOVRIRXQGWREHVLJQL¿FDQW predictors of postoperative complications or death (p<0.05). CONCLUSIONS: The surgical Apgar score predicts postoperative complications and death in patients undergoing radical cystectomy. This objective, easily administered predictive tool allows system-based measures to improve outcomes and may aid in selection of intensity of postoperative care. Further research is needed to determine if inclusion of additional perioperative factors would improve this model. Source of Funding: None
6 THE EFFECTS OF CYSTECTOMY PROVIDER VOLUME ON POSTOPERATIVE AND OVERALL MORTALITY IN A PUBLICLY FUNDED HEALTH CARE SYSTEM Girish S Kulkarni*, Peter C Austin, David R Urbach, Andreas Laupacis, Neil E Fleshner. Toronto, ON, Canada. INTRODUCTION AND OBJECTIVE: Hospital and surgeon volume are often used as proxy measures of quality of care for radical cystectomy. Studies published to date have primarily originated from privately funded health care systems and have focused on post-operative mortality rates. We assessed the effect of provider cystectomy volume on both postoperative and overall mortality in a publicly funded health care setting. METHODS: Patients undergoing cystectomy in Ontario, &DQDGDEHWZHHQ ZHUHLGHQWL¿HGYLDWKH&DQDGLDQ,QVWLWXWH for Health Information Discharge Abstract Database, a population-based administrative database of all inpatient hospital admissions. The effects of hospital volume and surgeon volume on postoperative mortality rates (ie death within 30 days of cystectomy or prior to discharge) were assessed with multilevel, random effects logistic regression models. Analyses were adjusted for patient factors including age, sex, socioeconomic status, comorbidity and admission urgency. The effects of hospital volume and surgeon volume on overall survival were assessed XVLQJ&R[SURSRUWLRQDOKD]DUGVPRGHOVGHVLJQHGWRDFFRXQWIRUSDWLHQW clustering within hospital or surgeons, respectively. In addition to patient factors, overall survival analyses were adjusted for tumor characteristics extracted from cystectomy pathology reports gathered via linkage to the Ontario Cancer Registry. 5(68/76 2I F\VWHFWRP\SDWLHQWVLGHQWL¿HG experienced a postoperative death and 2230 (67.7%) died overall. Pathology reports were available for 2535 (77%) of these patients. 1HLWKHU KRVSLWDO YROXPH 25 &, S QRU VXUJHRQYROXPH 25 &, S ZHUHVLJQL¿FDQWO\ associated with postoperative cystectomy mortality. However, both KRVSLWDOYROXPH +5IRUF\VWHFWRP\LQFUHDVH &, p=0.015) and surgeon volume (HR for 10 cystectomy increase: 0.85, &, S ZHUHVLJQL¿FDQWO\DVVRFLDWHGZLWKRYHUDOO survival. CONCLUSIONS: In a publicly funded health care system, SURYLGHU YROXPH ZDV QRW VLJQL¿FDQWO\ DVVRFLDWHG ZLWK SRVWRSHUDWLYH mortality. High volume providers, however, experienced improved overall mortality rates compared to low volume providers. Future research should focus on the underlying process measures that contribute to the RYHUDOOPRUWDOLW\EHQH¿WRIKLJKYROXPHSURYLGHUV Source of Funding: Canadian Institutes of Health Research.
QUALITY ASSURANCE FOR RADICAL CYSTECTOMY MORBIDITY AND MORTALITY Venu Chalasani*, Mazen Abdelhady, Larry Stitt, Jonathan I Izawa. London, ON, Canada. INTRODUCTION AND OBJECTIVE: There is an increasing need for measurements of quality assurance in surgical procedures. Surgical audits may have increased importance when outcomes can be compared and individual surgeons receive feedback and have the opportunity to improve their outcomes in an expeditious fashion. CUSUM (Cumulative Summation) is one method for quality assurance WKDWKDVUHFHQWO\EHHQDGDSWHGWRWKHPHGLFDO¿HOGDVLWFDQEHXVHGWR monitor any binary surgical outcomes on an ongoing basis. The aim of WKLVVWXG\ZDVWRXWLOL]H&8680FKDUWVIRUTXDOLW\DVVXUDQFHLQUDGLFDO cystectomies. METHODS: CUSUM charts were generated from prospectively FROOHFWHGGDWDIRUWKH¿UVWUDGLFDOF\VWHFWRPLHVGRQHE\DVLQJOH surgeon from July 2001 to September 2007. Overall survival (OS) and GLVHDVHVSHFL¿FVXUYLYDO '66 ZHUHHVWLPDWHGXVLQJWKH.DSODQ0HLHU DFWXDULDOPHWKRGRORJ\DQGVWUDWL¿HGE\SDWKRORJLFVWDJHWRGHPRQVWUDWH survival outcomes. Based upon a literature review, the following alerts were set (acceptable and unacceptable rates) for these binary outcomes: death 0.3-4%, ileus 2-18%, ureteral-ileal anastomotic leak 0.3-1%, wound dehiscence 3.7-9%, pulmonary embolism 0.4-2%, and rectal injury 0.3-1%. RESULTS: The median follow-up was 16 months. There were 12, 12, 41, 26, 25, and 34 patients with pTis, pT1, pT2, pT3, pT4, and pN+ disease, respectively. Thirteen patients underwent neoadjuvant chemotherapy and 29 patient received adjuvant chemotherapy. Ten patients underwent prior pelvic radiotherapy. The 5-year OS for
8 DOES PRACTICE REFLECT THE EVIDENCE? LYMPH NODE DISSECTION WITH RADICAL PROSTATECTOMY: RESULTS FROM THE SEARCH DATABASE Charles D Scales*, Martha K Terris, William J Aronson, Joseph C Presti, Christopher J Kane, Christopher L Amling, Tracey L Krupski, Stephen J Freedland. Durham, NC, Augusta, GA, Los Angeles, CA, Palo Alto, CA, San Diego, CA, and Birmingham, AL. INTRODUCTION AND OBJECTIVE: Evidence-based practice is a rising force in urology. However, evidence levels in urology are generally low, and how urologists practice in the face of such uncertainty is unknown. Controversy exists as to whether lymph node dissection (LND) at the time of radical prostatectomy (RP) impacts biochemical IDLOXUHUDWHV*LYHQWKLVFRQWH[WZHVRXJKWWRFKDUDFWHUL]HWKHSUDFWLFH of LND with RP in an equal-access setting. 0(7+2'6 :HXWLOL]HGWKH6WUDWHJLF(TXDO$FFHVV5HJLRQDO Cancer Hospital (SEARCH) database to identify men undergoing RP from 1994 - 2007 with complete information on preoperative PSA, biopsy Gleason score, and clinical stage as well as demographic variables. The primary outcome was performance of LND at the time of RP. Men ZHUH ULVNVWUDWL¿HG DFFRUGLQJ WR WKH '¶$PLFR FODVVL¿FDWLRQ :H XVHG multivariable regression to identify characteristics associated with LND, controlling for patient characteristics and time period.