An independent jury-based consensus conference model for the development of recommendations in medico-surgical practice.

BACKGROUND: There is an increasing demand for standardization in the choice of treatments for specific conditions, so-called personalized medicine. The task is far from trivial, because the perspectives from many stakeholders must be respected, including patients and health care providers, as well as payers or governments to better control costs while optimizing quality of care. One approach to provide widely accepted therapies is the consensus conference. METHODS: We describe a novel methodology to achieve consensus in controversial areas with the main goal to minimize biases. RESULTS: The principle of this approach relies on a clear distinction between those who provide the evidence (experts) and those who draw the final recommendations (the jury). The jury consists of individuals with sufficient background knowledge to cover the perspectives of all stakeholders' without being involved directly in the topic under evaluation. The organizing committee, the experts, and the jury interact within 3 phases: Preparation, the actual consensus conference, and deliberations. Each question is addressed by a panel of experts, leading to the proposition of recommendations at the conference meeting, which are challenged by the jury and the audience. Based on all available information, the jury finalizes the consensus recommendations, which are eventually published and made available to all. CONCLUSION: This novel model of consensus conference allows the construction of consensual, evidence-based, explicit recommendations for therapies in a process that may also identify issues for further research, eventually fostering progress in the field.

Early results after regionalization of thoracic surgical practice in a single-payer system.

BACKGROUND: Regionalization of the practice of thoracic surgery into designated centers was carried out in Ontario to manage volume, improve outcomes, and facilitate comprehensive care. This article describes the process used by Cancer Care Ontario (CCO) to regionalize thoracic surgery practice and reports early results. METHODS: A thoracic surgery standard was created by CCO, specifying criteria for level I (tertiary) and level II (secondary) thoracic surgery centers based on current volumes and projected population growth and referral patterns, and then implemented the standard using various incentives and disincentives. RESULTS: Before regionalization (2004), 46 hospitals performed thoracic surgical procedures compared with 13 level I and 2 level II centers in 2010. From 2007 to 2011, a mean $8.4 million was distributed annually to designated centers to fund a mean 625 additional thoracic operations annually. By 2009 to 2010, the number of esophagectomies performed at designated centers increased from 212 to 285 (89% being performed in designated centers). Correspondingly, the number of lung resections increased from 1,396 to 1,858 (94% being performed in designated centers). Median wait time for lung cancer resection did not change. Regionalization achieved a significant reduction in 30-day mortality after pneumonectomy (10.9%-5.6%; p = 0.03) but no change for esophagectomy (5.9%-5.8%; p = 0. 96) or lobectomy (2.2%-1.9%; p = 0. 37). CONCLUSIONS: Regionalization was challenging but feasible and was associated with reduced 30-day mortality after pneumonectomy. More data are required to evaluate other short- and long-term outcome measures to further validate benefits from regionalization.

Recommendations for liver transplantation for hepatocellular carcinoma: an international consensus conference report.

Although liver transplantation is a widely accepted treatment for hepatocellular carcinoma (HCC), much controversy remains and there is no generally accepted set of guidelines. An international consensus conference was held on Dec 2-4, 2010, in Zurich, Switzerland, with the aim of reviewing current practice regarding liver transplantation in patients with HCC and to develop internationally accepted statements and guidelines. The format of the conference was based on the Danish model. 19 working groups of experts prepared evidence-based reviews according to the Oxford classification, and drafted recommendations answering 19 specific questions. An independent jury of nine members was appointed to review these submissions and make final recommendations, after debates with the experts and audience at the conference. This report presents the final 37 statements and recommendations, covering assessment of candidates for liver transplantation, criteria for listing in cirrhotic and non-cirrhotic patients, role of tumour downstaging, management of patients on the waiting list, role of living donation, and post-transplant management.

Guideline for optimization of surgical and pathological quality performance for radical prostatectomy in prostate cancer management: evidentiary base.

BACKGROUND: The objective is to provide surgical and pathological guidelines for radical prostatectomy (RP) with or without concurrent pelvic lymph node dissection (PLND) to achieve optimal benefit for patients, with minimal risk of harm. METHODS: For surgical questions, a literature search of MEDLINE, EMBASE and the Cochrane database was performed. A literature search for the pathological questions was not conducted since the protocol for invasive carcinomas of the prostate gland developed by the College of American Pathologists (CAP) was endorsed. Urologists and pathologists were consulted for their assessment of the surgical and pathological recommendations. RESULTS: Limited high-quality evidence from 95 primary studies was available and, therefore, the expert panel developed recommendations on the basis of a consensus of the expert opinion of the working group and through a consultation with urologists and pathologists. In addition to the CAP protocol, some technical recommendations related to the handling and processing of the specimen were made. CONCLUSION: Radical prostatectomy is recommended for the surgical treatment of prostate cancer, depending on a patient's preoperative risk profile. The panel unanimously determined that the goals for RP are to attain a positive margin rate of <25% for pT2 disease, a mortality rate of <1%, rates of rectal injury of <1% and blood transfusion rates of <10% in non-anemic patients. Standard PLND should be mandatory in high-risk patients, should be recommended for intermediate-risk patients and should be optional for low-risk patients. The quality and effectiveness of this treatment and of subsequent patient care depend on good management, effective communication and reporting between surgeons and pathologists working together as part of a multidisciplinary team. The complete guideline document is posted on the Cancer Care Ontario website (www.cancercare.on.ca); search in their Toolbox, Quality Guidelines & Standards, Clinical Program category under "surgery."

Guideline for optimization of colorectal cancer surgery and pathology.

BACKGROUND AND OBJECTIVES: There is evidence of gaps in care for colorectal cancer surgery related to obtaining negative resection margins and lymph node assessment. Recommendations on the surgical and pathological management of curable colon and rectal cancer were developed. METHODS: A systematic review on colorectal resection margins and lymph nodes was conducted. This evidence, combined with evidence from existing guidelines and expert consensus, was used to develop recommendations. The draft guideline was reviewed by an expert panel and was externally reviewed by practitioners in Ontario, Canada. RESULTS: The search of the recent literature identified 107 articles pertinent to resection margins and lymph node assessment. The majority of the evidence was of poor quality. Of the 63 practitioners who reviewed the guideline, 97% agreed with the draft recommendations and 92% thought that the report should be approved as a practice guideline. CONCLUSIONS: Achieving optimized performance concerning margin status and lymph node assessment requires the coordinated efforts of surgeons and pathologists, as well as other medical professionals. Focus should be on ensuring that colorectal cancers are resected with negative (R0) margins and that an adequate number of lymph nodes are assessed to allow for accurate decision making relating to prognosis and adjuvant therapy.

Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: a pooled analysis of two randomized trials.

PURPOSE: Adjuvant systemic chemotherapy administered after surgical resection of colorectal cancer metastases may reduce the risk of recurrence and improve survival, but its benefit has never been demonstrated. Two phase III trials (Fédération Francophone de Cancérologie Digestive [FFCD] Trial 9002 and the European Organisation for Research and Treatment of Cancer/National Cancer Institute of Canada Clinical Trials Group/Gruppo Italiano di Valutazione Interventi in Oncologia [ENG] trial) used a similar design and showed a trend favoring adjuvant chemotherapy, but both had to close prematurely because of slow accrual, thus lacking the statistical power to demonstrate the predefined difference in survival. We report here a pooled analysis based on individual data from these two trials. PATIENTS AND METHODS: After complete resection of colorectal liver or lung metastases, patients were randomly assigned to chemotherapy (CT arm; fluorouracil [FU] 400 mg/m(2) administered intravenously [IV] once daily plus dl-leucovorin 200 mg/m(2) [FFCD] x 5 days or FU 370 mg/m(2) plus l-leucovorin 100 mg/m(2) IV x 5 days [ENG] for six cycles at 28-day intervals) or to surgery alone (S arm). RESULTS: A total of 278 patients (CT, n = 138; S, n = 140) were included in the pooled analysis. Median progression-free survival was 27.9 months in the CT arm as compared with 18.8 months in the S arm (hazard ratio = 1.32; 95% CI, 1.00 to 1.76; P = .058). Median overall survival was 62.2 months in the CT arm compared with 47.3 months in the S arm (hazard ratio = 1.32; 95% CI, 0.95 to 1.82; P = .095). Adjuvant chemotherapy was independently associated with both progression-free survival and overall survival in multivariable analysis. CONCLUSION: This pooled analysis shows a marginal statistical significance in favor of adjuvant chemotherapy with an FU bolus-based regimen after complete resection of colorectal cancer metastases.

Development of communities of practice to facilitate quality improvement initiatives in surgical oncology.

BACKGROUND: The process of developing clinical guidelines and standards for cancer treatment and screening is well established in the Ontario health care system; however, the dissemination and implementation of such guidelines and standards are more recent undertakings. Traditional implementation strategies to improve surgical practice and the delivery of cancer care have not been consistently effective. There is a recognized need to develop integrated models that offer direct support for implementation strategies. Such a model should be feasible, adaptable, and open to evaluation across diverse surgical settings. DISCUSSION: Research suggests that successful implementation should consider tools and expertise from other disciplines. This article considers a community of practice (COP) model to provide a supportive infrastructure for quality improvements in cancer surgery. The COP model was adapted for cancer surgeons. It is supported by 5 enablers referred to as tools: communication system, project development support, access to data, access to evidence review, and accreditation with continued medical education and continued professional development. These tools need to be part of an infrastructure that is both provided and supported by a team of administrators and health care professionals, who have active roles and responsibilities. Therefore, the primary objective of this article is to describe our COP model in cancer surgery including the key success factors necessary for providing the infrastructure and tools. The secondary objective is to offer the integrated COP model as a basis for future research and the evaluation of various collaborative improvement projects. SUMMARY: Building on knowledge management concepts, we identified the 4 essential processes that should be targeted by implementation strategies. A common COP evaluation framework uses the outcomes of 4 knowledge conversion modes-organizational memory, social capital, innovation, and knowledge transfer-as proxies for actual provider and organizational behavior. Insights from different collaborative improvement projects described in a consistent way could inform future research and assist in the collation of systematic reviews on this topic.

Recurrent pyogenic cholangitis with hepatolithiasis--the role of surgical therapy in North America.

PURPOSE: To determine role of surgical intervention for Recurrent Pyogenic Cholangitis with hepatolithiasis at a North American hepatobiliary center. METHODS: Retrospective analysis of 42 patients presenting between 1986 and 2005. RESULTS: Mean age is 54.3 years (24-87). Twenty-seven patients (64%) underwent surgery, after unsuccessful endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous intervention in 19/27 patients. Surgical procedures were: 10 common bile duct explorations with choledochojejunostomy and a Hutson loop and 17 hepatectomies (10 with, 7 without Hutson loop). Liver resection was indicated for lobar atrophy or stones confined to single lobe. Operative mortality was zero; complication rates for hepatectomy and common bile duct exploration were comparable (35% vs. 30%). Median follow-up was 24 months (3-228). Of 21 patients with Hutson loops, only seven (33%) needed subsequent loop utilization, with three failures. At last follow-up, 4/27 (15%) surgical patients had stone-related symptoms requiring percutaneous intervention, compared to 4/11 (36%) surviving nonoperative patients. Cholangiocarcinoma was identified in 5/42 (12%) patients; four were unresectable and one was an incidental in-situ carcinoma in a resected specimen. CONCLUSION: Surgery is a valuable part of multidisciplinary management of recurrent pyogenic cholangitis with hepatolithiasis. Hepatectomy is a useful option for selected cases. Hutson loops are useful in some cases for managing stone recurrence. Cholangiocarcinoma risk is elevated in this disease.

Standards for thoracic surgical oncology in a single-payer healthcare system.

Through systematic literature review and a consensus-based approach from an expert panel, standards on the organization for delivering thoracic cancer surgery in a single-payer healthcare environment were developed. Thirty-two studies and six organizational reports were identified. Results from 32 studies showed a trend toward higher volumes and improved patient outcomes, and six consensus reports provided recommendations on thoracic care standards. Thoracic surgical oncology standards in a single-payer healthcare system were developed. The benefits associated with the implementation of thoracic cancer surgery standards should result in increased regionalization of care, improved processes of care, and better patient outcomes.

Recurrence after liver resection for hepatocellular carcinoma: risk factors, treatment, and outcomes.

BACKGROUND: Tumor recurrence remains the major cause of death after curative resection for hepatocellular carcinoma (HCC). The purpose of this study was to identify risk factors for the recurrence of HCC and to examine long-term outcomes after resection. METHODS: From July 1992 to July 2004, 193 consecutive patients who underwent hepatic resection as primary therapy with curative intent for HCC were included in this single-center analysis. The perioperative mortality rate was 5%. Time to recurrence (disease-free survival) and overall survival were determined by Kaplan-Meier analysis. Demographic, tumor, and treatment characteristics were tested for their prognostic significance by univariate and multivariate analysis with the log-rank test and the Cox proportional hazards model, respectively. RESULTS: Median overall survival for the entire cohort was 71 +/- 11 months; disease-free survival was 34 months (range, 1-149 months). After a median follow-up time of 34 months, 98 patients (51%) experienced recurrent cancer; initial tumor recurrence was confined to the liver in 86 patients (88%). With the use of multivariate analysis, preoperative vascular invasion detected on radiologic imaging studies; postoperative vascular invasion found on pathologic assessment, and intermediate and poor tumor differentiation and tumor size and number were significant predictors of disease-free survival. Of the 98 patients who had tumor recurrence, 53 patients (54%) underwent additional therapy (ablation, 31 patients; re-resection, 11 patients; transarterial chemoembolization, 8 patients; liver transplantation, 3 patients) with improvement in survival. CONCLUSION: Despite recurrences in >50% of patients, long-term survival can be achieved after resection of HCC. Identification of risk factors, close follow-up evaluation, and early detection are mandatory because recurrences that are confined to the liver may be amenable to treatment with an additional survival benefit.

Role of volume outcome data in assuring quality in HPB surgery.

Many studies have shown an association between both surgeon and hospital operative procedure volumes and outcomes, particularly operative mortality. It is also recognized that volume is only one of a number of factors, including 1) surgeon training and experience, and 2) hospital resources, organization, and processes of care, which can also influence outcomes. The Surgical Oncology Program at Cancer Care Ontario has included hospital volumes in a set of standards for the conduct of major pancreatic cancer surgery, along with recommendations for surgeon training and hospital resources, organization, support services, and processes of care to encourage regionalization of major HPB surgery. Cooperation with these recommendations was encouraged by the public reporting of mortality data and by an educational program directed at both surgeons and senior administrators in Ontario hospitals with the support of the provincial health ministry. The provincial mortality rate from major pancreatic cancer surgery has decreased by more than 50% since the introduction of this program.

Influence of hospital characteristics on operative death and survival of patients after major cancer surgery in Ontario.

BACKGROUND: There is a lack of information from Canadian hospitals on the role of hospital characteristics such as procedure volume and teaching status on the survival of patients who undergo major cancer resection. Therefore, we chose to study these relationships using data from patients treated in Ontario hospitals. METHODS: We used the Ontario Cancer Registry from calendar years 1990-2000 to obtain data on patients who underwent surgery for breast, colon, lung or esophageal cancer or who underwent major liver surgery related to a cancer diagnosis between 1990 and 1995 in order to assess the influence of volume of procedures and teaching status of hospitals on in-hospital death rate and long-term survival. For each disease site and before observing patient outcomes data, volume cut-off points were selected to create volume groups with similar numbers of patients. Teaching hospitals were those directly affiliated with a medical school. Logistic regression and proportional hazards models were used to consider the clustering of data at the hospital level and to assess operative death and long-term survival. We also used 4 measures to gauge the degree of procedure regionalization across the province including (1) the number of hospitals performing a procedure; (2) the percentage of patients treated in teaching hospitals; (3) the percentage of rural patients treated in higher volume procedure hospitals; and (4) median distances travelled by patients to receive care. RESULTS: The number of patients in our cohorts who underwent resection of the breast, colon, lung, esophagus or liver was 14 346, 8398, 2698, 629 and 362, respectively. Surgery in a high-volume versus a low-volume hospital did not have a statistically significant influence on the odds of operative death for patients who underwent colon, liver, lung or esophageal cancer resection. The risk of long-term death was increased in low-volume versus high-volume hospitals for patients who underwent resection of the breast (hazard ratio [HR] 1.2, 95% confidence interval [95% CI] 1.0-1.4, p < 0.05), lung (HR 1.3, 95% CI 1.1-1.6, p < 0.01) and liver (HR 1.7, 95% CI 1.0-2.7, p = 0.04). There were no significant differences in the odds of operative (in-hospital) death or risk of long-term death among patients treated in teaching compared with nonteaching hospitals. There was more regionalization of liver, lung and esophageal operations versus breast and colon operations. CONCLUSIONS: Increased hospital procedure volume correlated with improved longterm survival for patients in Ontario who underwent some, but not all, cancer resections, whereas hospital teaching status had no significant impact on patient outcomes. Across the province, further regionalization of care may help improve the quality of some cancer procedures.

Quality councils as health system performance and accountability mechanisms: the Cancer Quality Council of Ontario experience.

Recent national and provincial reviews on the status of healthcare in Canada have recommended the establishment of quality councils to guide quality improvement efforts. The emergence of quality councils, such as the Health Quality Council of Alberta, the Saskatchewan Health Quality Council, the Cancer Quality Council of Ontario and the Health Council of Canada, reflect new but largely unscrutinized models for improving quality of care. We discuss the varying mandates of these new quality councils, their fit with evolving governance and accountability structures and the credibility and legitimacy of their role as perceived by other health system organizations. To further illustrate these issues, we present insiders' perspectives on the Cancer Quality Council of Ontario's activities over its first three years, including the initial agenda, critical success factors and the nature of evolving relationships with other organizations in Ontario's healthcare system. While current Canadian quality councils represent an eclectic mix of methods for achieving improvements in quality of care, it is not entirely clear how quality councils will stimulate sustained and significant improvements in quality of care where other models have failed. However, these new Canadian quality councils represent natural experiments in motion from which much needs to be learned.

Survival after hepatic resection for colorectal metastases: a 10-year experience.

BACKGROUND: Metastatic colorectal cancer is a major cause of cancer death in North America. Hepatic resection offers the potential for cure in selected patients. We report the long-term outcomes of patients who underwent hepatic resection for colorectal metastases over a 10-year period at a single hepatobiliary surgical oncology center. METHODS: All patients who underwent liver resection for metastatic colorectal cancer between 1992 and 2002 were identified. Data were retrospectively obtained through chart review. Major outcome variables were disease-free survival and overall survival. Risk factors for disease recurrence and mortality were identified by multivariate analysis by using the Cox proportional hazard method. RESULTS: A total of 423 hepatectomies were performed for metastatic colorectal cancer. Most operations (n = 276; 65%) were major (four or more segments) hepatectomies. Perioperative morbidity occurred in 74 (17%) patients. There were seven (1.6%) perioperative deaths. The disease-free survival at 1, 5, and 10 years was 64%, 27%, and 22%, respectively. The overall survival at 1, 5, and 10 years was 93%, 47%, and 28%, respectively. Multivariate analysis identified four negative predictive factors for overall survival (hazard ratio; 95% confidence interval): a positive surgical margin (2.9; 1.5-5.3), large metastases (>5 cm; 1.5; 1.1-2.0), multiple metastases (1.4; 1.1-1.9), and age >60 years (1.4; 1.1-1.9). CONCLUSIONS: Hepatic resection for metastatic colorectal cancer is safe and provides good long-term overall survival rates of 47% at 5 years and 28% at 10 years. An aggressive approach is justified by the low operative mortality rate and good long-term survival, even in individuals with multiple bilobar metastases.

Surgical resection of hepatic and pulmonary metastases from colorectal carcinoma.

BACKGROUND: Patients with hepatic and pulmonary metastases from colorectal cancer (CRC) may benefit from aggressive surgical therapy. We examined the longterm outcomes of patients who underwent both lung and liver resections for colorectal metastases over a 10-year period. STUDY DESIGN: Four hundred twenty-three hepatectomies were performed for metastatic CRC between 1992 and 2002 at two university-affiliated hospitals. Patients who underwent both lung and liver resections for metastatic CRC were studied. Demographic, perioperative, and survival data were evaluated by retrospective chart review. Disease-free survival (DFS) and overall survival (OS) were evaluated by Kaplan-Meier analysis and survival curves were compared using the log-rank test. RESULTS: Thirty-nine patients underwent both lung and liver resections for metastatic CRC. Eleven patients (28%) underwent staged liver and lung metastasectomy from synchronously identified metastases. Twenty-eight patients (72%) underwent sequential metastasectomy because of recurrent disease. The median disease-free and overall survivals after initial metastasectomy were 19.8 and 87 months, respectively. Serial metastasectomy was common in this patient population. The mean number of metastasectomies performed was 2.6 per patient (range 1 to 4). There was no difference in overall survival for patients with synchronous versus metachronous presentation of liver and lung metastases (p=0.45). The site of first recurrence after initial metastasectomy was, most commonly, the lung (n=19, 49%), followed by the liver (n=8, 21%). Nineteen patients (49%) underwent subsequent resections for recurrences. Seven patients (18%) underwent 2 or more liver resections for recurrent disease, and 12 (31%) underwent multiple lung resections. CONCLUSIONS: An aggressive multidisciplinary surgical approach should be undertaken for recurrent CRC metastases. In selected patients, serial metastasectomy for recurrent metastatic disease is safe and results in excellent longterm survival after CRC resection.

Predictors of failure after pancreaticoduodenectomy for ampullary carcinoma.

BACKGROUND: Complete resection offers the only potential cure for ampullary carcinoma. We analyzed factors that contribute to treatment failure and survival in patients who underwent pancreaticoduodenectomy for ampullary carcinoma. STUDY DESIGN: We retrospectively reviewed all patients who underwent pancreaticoduodenectomy between August 1994 and August 2003 for ampullary carcinoma. Demographic, clinical, and pathologic data were collected. Chi-square analysis was used for categorical data and the t-test was used for continuous variables. Kaplan-Meier analyses were compared using the log-rank test to examine patient survival. RESULTS: Forty-three patients (24 men) aged 63.7 +/- 11.4 years (standard deviation) were followed for a mean of 23.9 months (median 660 days, range 18 to 2,249 days). Jaundice (n = 33) and weight loss (n = 13) were the most common presenting symptoms. Stage (p < 0.01) and degree of differentiation (p < 0.029) were significant predictors of failure by univariate analysis. But only stage (p < 0.04) was a significant predictor by multivariate analysis. Further analysis revealed that nodal status (p < 0.001), but not tumor grade, was a significant predictor of treatment failure. Neither demographic nor clinical variables were significant predictors. Five-year overall and disease-free survival rates were 67.4% and 51.4%, respectively. Both metastases and disease recurrence had significant impact on patient survival. CONCLUSIONS: Tumor stage is associated with treatment failure after pancreaticoduodenectomy for ampullary carcinoma and may identify candidates for adjuvant therapy. Because an aggressive surgical approach can be adopted safely with the best chance for cure, we recommend that pancreaticoduodenectomy be offered to all patients with ampullary tumors when malignancy or dysplasia is in question.

Development of prostate cancer quality indicators: a modified Delphi approach.

OBJECTIVES: There is evidence of variation in both the processes and outcomes of prostate cancer care, resulting in possible harm to patients and increased costs to the health system. Care could be improved by first identifying critical, measurable indicators that correlate with quality of care. This work was conducted to develop indicators of prostate cancer care using a modified three-step Delphi approach. METHODS: A 17-member multidisciplinary panel reviewed potential indicators extracted from the medical literature through two consecutive rounds of rating followed by consensus discussion. The panel then prioritized the indicators selected in the previous two rounds. RESULTS: Of 31 possible indicators that emerged from 49 reviewed articles, 11 were prioritized by the panel as benchmarks for assessing the quality of surgical care for prostate cancer. The 11 indicators represent three levels of measurement (regional, hospital, individual provider) across several phases of care (diagnosis, surgery, pathology, and follow-up), as well as broad measures of outcomes. CONCLUSION: A systematic evidence- and consensus-based approach was used to develop quality indicators of prostate cancer care, with a focus on pre-, peri- and post-operative care as well as outcomes. Some of the indicators selected by the panel were also recommended by a similarly structured panel process. These indicators can be used by individual providers and organizations to monitor the quality of their services, and develop interventions to address any variations.

Development of ovarian cancer surgery quality indicators using a modified Delphi approach.

OBJECTIVE: Little performance measurement has been undertaken in the area of oncology, particularly for surgery which is a pivotal event in the continuum of cancer care. This work was conducted to develop indicators of quality ovarian cancer surgery using a modified three-step Delphi approach. METHODS: A multidisciplinary panel, comprised of surgical and methodologic co-chairs, nine surgeons, one medical oncologist, one radiation oncologist, a nurse, and a pathologist, reviewed potential indicators extracted from the medical literature through two consecutive rounds of rating followed by consensus discussion. The panel then prioritized the indicators selected in the previous two rounds. RESULTS: Of 33 possible indicators that emerged from 41 selected articles, 14 were prioritized by the panel as benchmarks for assessing the quality of surgical care. The 14 indicators represent three levels of measurement (provincial/regional, hospital, individual provider) across several phases of care (diagnosis, surgery, pathology, and adjuvant therapy), as well as broad measures of access and outcomes. Some of the indicators selected by the panel were also recommended as standards of care by national initiatives in other countries. CONCLUSIONS: A systematic evidence- and consensus-based approach was used to develop quality indicators of ovarian cancer care, with a focus on pre-, peri-, and postoperative care as well as outcomes, that are applicable in any jurisdiction.

Transduodenal resection of peri-ampullary lesions.

Transduodenal resection (TDR) of lesions near the ampulla of Vater is an alternative to the Whipple pancreaticoduodenectomy. A retrospective analysis was performed to determine the long-term outcome and the utility of intraoperative frozen section examinations in aiding operative decision making in patients undergoing TDR. From 1992 to 2002, 19 patients with an average age of 64.2 years (range: 33-84 years) underwent a transduodenal resection of a peri-ampullary lesion; median follow-up was 47 months (range: 2-100 months). Pathology of the lesions was as follows: 11 with benign ampullary adenomas, including 4 with familial adenomatous polyposis (FAP); 7 with peri-ampullary adenocarcinomas; and 1 with a benign stricture. Survival for the entire cohort is 100%. In 12 cases an intraoperative frozen section was performed. The specificity and positive predictive value of the intraoperative histology were both 100%, and the sensitivity and negative predictive value were 57% and 38%, respectively. Three of the 4 patients with FAP have recurrent adenomatous change; 2 of the 7 with carcinoma have metastatic adenocarcinoma. Transduodenal resection of peri-ampullary lesions appears to be a safe alternative to radical resection for benign adenomas and selected carcinoma. Intraoperative frozen section assessment is recommended in cases of potential adenocarcinoma.

An aggressive surgical approach leads to improved survival in patients with gallbladder cancer: a 12-year study at a North American Center.

OBJECTIVE: To determine if an aggressive surgical approach, with an increase in R0 resections, has resulted in improved survival for patients with gallbladder cancer. SUMMARY BACKGROUND DATA: Many physicians express a relatively nihilistic approach to the treatment of gallbladder cancer; consensus among surgeons regarding the indications for a radical surgical approach has not been reached. METHODS: A retrospective review of all patients with gallbladder cancer admitted during the past 12 years was conducted. Ninety-nine patients were identified. Cases treated during the 12-year period 1990 to 2002 were divided into 2 time-period (TP) cohorts, those treated in the first 6 years (TP1, N = 35) and those treated in the last 6 years (TP2, N = 64). RESULTS: Disease stratification by stage and other demographic features were similar in the 2 time periods. An operation with curative intent was performed on 38 patients. Nine (26%) R0 resections were performed in TP1 and 24 (38%) in TP2. The number of liver resections, as well as the frequency of extrahepatic biliary resections, was greater in TP2 (P < 0.04). In both time periods, an R0 resection was associated with improved survival (P < 0.02 TP1, P < 0.0001 TP2). Overall survival of all patients in TP2 was significantly greater than in TP1 (P < 0.03), with a median survival of 9 months in TP1 and 17 months in TP2. The median 5-year survival in TP1 was 7%, and 35% in TP2. The surgical mortality rate for the entire cohort was 2%, with a 49% morbidity rate. CONCLUSIONS: A margin-negative, R0 resection leads to improved survival in patients with gallbladder cancer.