Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
REVIEWS Standards for Thoracic Surgical Oncology in a Single-Payer Healthcare System Sudhir Sundaresan, MD, Bernard Langer, MD, Tom Oliver, BA, Farrah Schwartz, MA, Melissa Brouwers, PhD, Hartley Stern, MD, and the Expert Panel on Thoracic Surgical Oncology* The Ottawa Hospital, Ottawa; Cancer Care Ontario, Toronto; Program in Evidence-Based Care, McMaster University, Hamilton; and Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada Through systematic literature review and a consensusbased 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. (Ann Thorac Surg 2007;84:693–701) © 2007 by The Society of Thoracic Surgeons O Patients The patients are described as those who have cancer and who require thoracic surgical oncology services for lung or esophageal carcinoma in a single-payer healthcare system. Methods Evidence Search and Literature Search Strategy The literature was systematically searched for published reports addressing the optimum delivery of thoracic surgical care for patients with lung or esophageal carcinoma. Published sources included the medical databases MEDLINE (OVID, 1990 through December 2004), EMBASE (OVID, 1990 through December 2004), the Cochrane Library (OVID, Issue 4, 2004), the Canadian Medical Association Infobase, and the National Guideline Clearinghouse, as well as abstracts published in the proceedings of the meetings of the American Society of Clinical Oncology (1997–2004) and the American Society for Therapeutic Radiology and Oncology (1992–2003). Article bibliographies and personal files were also searched for evidence relevant to this report. Unpublished sources were sought by contacting the Ontario heads of surgical oncology in each region, conducting a web search of Canadian provincial and national thoracic surgery associations, American and European thoracic organizations, and through direct contact with leaders in the field. *See Appendix for the members of the Expert Panel on Thoracic Surgical Oncology. Study Selection Criteria Address correspondence to Dr Sundaresan, c/o Tom Oliver, McMaster University, 1280 Main St W, DTC, 3rd Floor, Hamilton, Ontario, L8S 4L8, Canada; e-mail: [email protected]. Reports were selected for inclusion in this systematic review of the evidence if they reported information on organizational resources relating to improved outcomes © 2007 by The Society of Thoracic Surgeons Published by Elsevier Inc 0003-4975/07/$32.00 doi:10.1016/j.athoracsur.2007.03.069 REVIEWS ntario is the most populous province in Canada with a population of approximately 12 million people spread over more than 1 million square kilometers [1]. In Ontario, thoracic surgical oncology services are provided within a single-payer tax-based healthcare system in many university and community hospitals, both large and small. A comprehensive approach to the diagnosis and staging of patients is essential to establish correct diagnosis, to select those patients with apparently localized disease as candidates for potentially curative resection, and to correctly understand the prognosis. This is in addition to determining the need for additional (adjuvant) therapies, enrolling patients in clinical trials, and reaching any meaningful conclusions about the outcome of thoracic cancer care. Also, increasing evidence indicates that there is a survival benefit afforded by preoperative or postoperative adjuvant therapy for many surgically resected lung cancers [2]. Thus, there is a strong case associated with survival benefit for the patient to approaching these cancers from a multidisciplinary perspective with collaborative input and leadership from different specialists. There is a need for quality standards for thoracic cancer surgery to improve patient outcomes, especially with the increased volumes of thoracic surgery anticipated in the coming years due to a growing and aging population. The optimum method of organizing the delivery of thoracic surgical oncology care has not been well-established in the medical or organizational literature. 694 REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS Ann Thorac Surg 2007;84:693–701 Table 1. Reports of Differences in Surgical Practice Affecting Patient Outcomes Author, Year, Reference No. Resection Type High versus low surgical volume Treasure, 2005 [3] Lobectomy REVIEWS High volume Low volume High volume Low volume High volume Low volume High volume Low volume High volume Low volume High volume Low volume High volume Low volume ⬎ 47 ⬍ 15 ⬎ 17 ⬍7 ⬎6 ⬍2 ⬎ 31 ⬍ 22 NR NR ⬎ 20 ⬍2 ⱖ6 ⱕ5 2.5% 2.7% 5.0%a 6.1% 9.2%a 18.8% 0.9% 2.6% Lowera Higher 10.2% ⱖ 15.0% 0.0%a 22.0% High volume High volume High volume High volume Low volume NR NR NR NR ⬎ 20 ⬎ 20 ⬎ 20 ⬃ 58 ⬃ 22 NR NR NR NR 5.1% 5.2% 6.1% 5.5% 7.7% 3.0%a 5.3% 11.8% 20.2% ⬍ Experience ⬎ Experience ⬃ 23 Specialty Thoracic Cardiothoracic Birkmeyer 2003 [4] Lung NR NR Esophagectomy NR NR Hannan, 2002 [5] Lobectomy NR NR Bachman, 2002 [6] Esophageal NR NR Gillison, 2002 [7] Cardioesophageal NR NR Miller, 1997 [8] Esophagectomy NR NR Thoracic specialist compared with other surgeons Goodnev, 2005 [9] Lung Thoracic Cardiothoracic General Martin-Ucar, 2004 [10] Lung Thoracic Cardiothoracic Silvestri, 1998 [11] Lobectomy Thoracic General Pneumonectomy Thoracic General Learning curve for esophageal survey Sutton, 1998 [12] Esophagectomy NR a Comparison Volume per Year 30-Day Mortality (%) NR NR Length of Stay (days) Morbidity Overall Survival NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR Longera Shorter 15% 15% NR NR NR NR NR NR NR 11.8 11.6 11.5 14.9 NR NR NR NR NR NR NR NR NR NR NR NR 31% 32% NR NR NR NR Highera Lower NR NR NR NR Indicates statistically significant differences at p ⬍ 0.05; all other comparisons were either not statistically compared or were not reported. NR ⫽ not reported. for patients undergoing cancer-related thoracic surgery. Patient-related outcomes of interest include tumor response, local disease control, survival, adverse events, or quality of life. Practice guidelines, meta-analyses, or systematic reviews related to the research question were also eligible for inclusion in the systematic review of the evidence. Articles were excluded from the systematic review of the evidence if they reported information on thoracic surgeries for tumors in locations other than the lung or esophagus, if they were published or developed prior to 1990, or if they were in a language other than English, or a combination of these. Results A total of thirty-two studies [3–34] and six organizational reports were identified [35– 40]. Results relating to surgical, hospital, or organizational characteristics affecting patient outcomes are presented in Tables 1, 2, and 3. Characteristics Report Overall, the quality of the evidence identified was modest. No randomized controlled trials were identified in the search of the literature, and reports based on discharge data from hospital, regional, or national databases were primarily retrospective. One challenge to interpreting and applying the evidence findings is that the reported outcomes are confounded by interdependent factors that can affect causality. Factors such as differences in referral practices, patient characteristics, disease characteristics, surgical complexity, surgical or hospital volume, presence or absence of a multidisciplinary team can all interact to influence outcomes. Where available, data that are adjusted for potentially confounding factors are reported. Thirty-day mortality or in-hospital mortality was commonly reported. However, reporting of other outcomes such as length of stay, morbidity, or overall survival was inconsistent and incomplete. Most of the reports investigated whether surgical or hospital volume affected pa- Ann Thorac Surg 2007;84:693–701 REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS 695 Table 2. Reports of Differences in Hospital Volume or Type Affecting Patient Outcomes Resection Type No. of Hospitals High versus low hospital volume Hannan, 2002 [5] Lobectomy Bachman, 2002 [6] Urbach, 2004 [13] Finlayson, 2003 [14] 15 134 Esophageal resection Esophagectomy NR NR 47 Total Lung resection 47 Total Esophagectomy 40 603 37 512 37 512 Lobectomy Pneumonectomy Finlayson, 2003 [15] Lung resection Christian, 2003 [16] Esophagectomy Dimick, 2003 [17] Esophagectomy Dimick, 2003 [18] Esophageal resection Esophageal resection Esophagectomy NR NR NR NR NR NR van Meerbeeck, 2002 [21] Birkmeyer, 2001 [22] Lung resection Kuo, 2001 [23] Esophagectomy van Lanschot, 2001 [24] Dimick, 2001 [25] Esophagectomy Bach, 2001 [26] Lung resection Swisher, 2000 [27] Esophagectomy 6 138 204 162 31 618 79 1806 79 944 NR NR NR NR 3 61 757 928 3 39 2 34 101 Total Khuri, 1999 [28] Lung resection 107 Total Begg, 1998 [29] Esophagectomy NR NR NR NR Dimick, 2003 [19] Birkmeyer, 2003 [20] Lobectomy Pneumonectomy Esophagectomy Esophagectomy Pneumonectomy Patti, 1998 [30] Esophagectomy Romano, 1992 [31] Lung resection a 5 196 NR NR Volume 30-Day Mortality (%) Length of Stay ⬎ 168 ⬍ 38 High Low ⬎ 8.8 ⬍ 8.8 ⬎ 8.8 ⬍ 8.8 ⬎ 9.0 ⬍ 4.0 ⬎ 37 ⬍ 19 ⬎ 37 ⬍ 19 ⬎ 41 ⬍8 ⱖ 10 ⬍3 ⬎6 ⱕ6 ⬎ 16 ⬍3 ⬎ 8.5 ⬍ 8.5 ⬎ 19 ⬍2 ⬎ 19 ⬍2 ⬎ 19 ⬍2 ⱖ 35 ⬍5 High Low 28 1.1 ⬎ 20 ⱕ 10 ⬎ 15 ⱕ3 ⬎ 66 ⬍9 ⱖ5 ⬍5 14–44 ⱕ5 ⱖ 11 ⱕ5 ⱖ 11 ⱕ5 ⬎ 30 ⱕ5 ⬎ 24 ⬍9 0.9%a 3.1% Lower Higher 10.9% 15.6% 3.5%a 4.9% 6.5%a 15.0% 3.5 4.3 8.9 10.6 ⱕ 4.9% ⱖ 6.9% Lowera Higher NR NR 3.7%a 11.8% 2.5%a 15.4% 8.1%a 23.1% 4.2%a 6.4% 10.6%a 17.0% 3.5% 6.9% 5.9%a 15.8% 2.5%a 9.2% 4.9%a 12.1% 2.7%a 16.0% 3.0%a 6.0% 3.0%a 12.2% 5.2% 7.1% 3.4%a 17.3% 10.7% 13.8% 6% 17% 9.2% 14.2% NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR ⬎ 20 days ⫽ 20%a ⬎ 20 days ⫽ 28% NR NR NR NR NR NR NR NR NR NR NR NR 13 daysa 15 days NR NR 11 daysa 19 days NR NR 14.7 daysa 17.7 days NR NR NR NR NR NR 22 days 22 days NR NR Morbidity NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR 39%a 48% NR NR ⬍ In HV hospitals NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR Indicates statistically significant differences at p ⬍ 0.05; all other comparisons were either not statistically compared or were not reported. NR ⫽ not reported. Overall Survival NR NR NR NR NR NR NR NR NR NR NR NR NR NR 6.6 5.4 NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR NR 33%** 44% NR NR NR NR NR NR NR NR NR NR NR NR REVIEWS Author, Year, Reference No. 696 REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS Ann Thorac Surg 2007;84:693–701 Table 3. Reports of Hospital Type Affecting Patient Outcomes Author, Year, Reference No. Organization Hospital type affecting patient outcomes Mine, 2000 [32] Specialist centre District hospital Dimick, 2004 [33] Teaching hospital Nonteaching Tanaka, 1994 [34] Teaching Large 400⫹ beds Med. 150–399 beds Small ⬍150 beds a Volume NR NR Mixed Mixed NR NR NR NR Resection Type No. of Patients Esophageal 53 60 NR NR NR NR NR NR Esophageal Lung 30-day Mortality (%) % With Prolonged Length of Stay 5.6% 12.5% 7.7% 10.2% Lowera Higher Higher Higher NR NR 26.5% 23.1% NR NR NR NR Morbidity Overall Survival (Years) NR NR NR NR NR NR NR NR 63% 62% (1 year) NR NR NR NR NR NR Indicates statistically significant differences at p ⬍ 0.05; all other comparisons were either not statistically compared or were not reported. NR ⫽ not reported. REVIEWS tient outcomes, but there were no common criteria across reports as to what constituted high volume or low volume, and the data on volumes were reported in a variable manner. In light of the variation in volume categorization, a volume cut-off was not established for this data set. Where multiple volumes were reported within a given study, reviewers extracted data that compared the highest volume data with the lowest volume data. Where the data were categorized in a dichotomous manner by the studies, those values were added to the data tables as reported. Although not ideal, those decisions were made with the underlying rationale that extreme volume differences would better inform the outcomes of interest, and in the case of dichotomous volume outcomes, a volume cut-off would result in undue amounts of missing data. lower for patients treated by a thoracic surgeon compared with a general surgeon, but that difference was not statistically significant. One study [10] reported no significant differences in patient outcomes with the introduction of a thoracic surgeon compared historically with cardiothoracic surgeons; however an increase in surgical volume, complex procedures, and operations on elderly patients was reported. One article investigating the role of an individual surgeon’s experience over time in relation to patient outcomes reported that as the level of experience increased, improvements in the patient’s outcomes were observed. Significant reductions in single-lung operating time, blood loss, transfusion requirements, hospital stay, and an increased yield of lymph nodes was noted [12]. Twenty-one reports with 27 evaluations [5, 6, 13–31] compared differences in patient outcomes by hospital volume (Table 2), and three reports [32–34] compared differences in hospital type that were identified in the systematic review of the literature (Table 3). As seen in Table 2, the range in volume comparison across the 21 reports is quite large for both lung and esophageal resections. In every instance, however, 30day mortality was reported to be lower in higher volume centers when compared with lower volume centers. The difference in 30-day mortality was reported to be statistically significant in 16 of 27 comparisons [5, 13, 14, 16, 18 –20, 22–27, 29]. Length of stay was reported in 5 of 21 studies. In four of five studies, length of stay was significantly shorter for patients treated at high-volume centers. Two studies reported lower morbidity in the higher-volume centers [16, 19], and one study reported a significant difference in overall survival for patients treated in a high-volume center [26]. As seen in Table 3, although the numbers were small, a retrospective comparison of an esophageal surgery center with a district hospital performing similar operations [32] reported no significant differences in 30-day mortality or in 1-year overall survival. In two studies, HOSPITAL CRITERIA. Ten reports comparing patient outcomes by surgeon volume [3– 8], surgeon specialty [9 –11], or individual surgical experience [12] were identified in the systematic review of the literature and are presented in Table 1. Although the cut-offs for high versus low volume were arbitrarily chosen, of the six reports that compared patient outcomes by high-surgeon volume versus lowsurgeon volume, three reports had significantly lower 30-day mortality for those patients who were treated by surgeons with higher yearly volume than those with lower surgical volumes [4, 6, 8]. Thirty-day mortality ranged from 0% to 22% in those studies. One study also reported a significant overall survival advantage for patients treated by high-volume surgeons as compared with low-volume surgeons [6]. The remaining three studies did not report any significant differences between volume groups [3, 5, 7]. Of the three studies comparing thoracic surgeons to cardiothoracic or general surgeons, one study reported significantly less 30-day mortality for patients undergoing lobectomy when treated by a thoracic surgeon as compared with a general surgeon [11]. For patients undergoing pneumonectomy, the mortality rate was 8% SURGEON CRITERIA. outcomes from teaching hospitals were retrospectively compared with nonteaching hospitals [33, 34]. One of these [33] reported no significant differences between groups in an unadjusted analysis of 30-day mortality or length of stay. After adjusting for hospital volume, the risk of a prolonged length of stay was significantly higher in the nonteaching hospitals than in the teaching hospitals (odds ratio ⫽ 0.5; 95% confidence interval, 0.3– 0.8). In the other study [34], patients treated in teaching hospitals had significantly lower risks of death than those treated in small, medium, or large nonteaching hospitals; however, specific rates were not reported. There were no studies identified in the search of the literature that compared organizational criteria as they relate to improved patient outcomes after lung or esophageal resection. ORGANIZATIONAL CRITERIA. Environmental Scan Results Six practice organization documents [35– 40] were located through consultation and web search of published and unpublished literature. All of the practice organization documents were developed through expert consensus [35– 40]. The documents were generally consistent in their results. Most documents highlighted the importance of multidisciplinary collaboration as being vital to best patient care, including regular multidisciplinary rounds and established clinical leadership. Listed members of the multidisciplinary teams included representatives from thoracic surgery, respirology, anesthesia, medical oncology, radiation oncology, radiology, pathology, dedicated nursing, and palliative care. Most of the documents also discussed appropriate staffing levels for thoracic units. The two Canadian documents [35, 39] recognized the need for thoracic units to have affiliations with cancer centers as well as sufficient on-call coverage provided by thoracic surgeons. The documents also discussed the requirements for thoracic surgeons and agreed on the need for specialist training in thoracic surgery. The need for continuing medical education was also recognized as an important requirement for surgeons. Resources discussed in the practice organization documents included fully equipped operating rooms with protected operating room time, a dedicated thoracic ward and intensive care unit beds, specified volumes and diagnostic facilities, as well as appropriate institutional affiliations, organization of care, and quality monitoring. Human resource measurements included surgical caseload, multidisciplinary team members, and standards for number of resections per thoracic surgery unit per year. Comment Overall, the quality, quantity, and generalizability of the body of evidence on the optimum organization for the delivery of cancer-related thoracic surgery identified in the literature are limited. Studies of volume and outcome relationships as indicators of patient outcome contain an inherent risk of bias and potentially confounding co- REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS 697 interactions. There was also uneven reporting of outcomes across trials, and little consensus in the data as to what constitutes high or low volume. Notwithstanding these limitations, the results of the studies were consistent. Whether statistically significant or not, outcomes for patients were typically more favorable if they were treated by surgeons with higher volumes, surgeons with more experience, or by specialists in thoracic surgery. In terms of hospital criteria that might influence patient outcomes, treatment in higher volume hospitals and in specialist and teaching hospitals rather than general hospitals was generally associated with better patient outcomes. In none of these studies was there evidence of specific structural or process factors that might have been responsible for the volume-outcome relationship. The literature search identified no studies that compared organizational criteria as they relate to improved patient outcomes after lung or esophageal resection. The six practice organization documents identified in the search were also generally consistent in most aspects. The consensus panels or working groups generally recommended specialist training in thoracic surgery, practice in multidisciplinary treatment groups, protected operating room times, sufficient resources to perform the latest techniques with appropriate staffing, diagnostics, and postoperative care. Through a systematic review of the published and grey literature, and expert consensus opinion, thoracic cancer surgical standards were developed by an expert panel of thoracic surgeons, other medical specialists, hospital administrators, and planners. To facilitate document development, a smaller writing group (consisting of three senior surgeons and two research coordinators providing methodological support) was formed. The writing group met through teleconferences and in-person meetings and used e-mail as the main vehicle of communication. The full expert panel met on three occasions to discuss the draft produced by the writing group, come to a consensus, and give approval of the final draft. Over 100 practitioners and administrators across Ontario were also given the opportunity to provide comments and critique. Differences were resolved through consensus and the use of evidence for the standards document. Standards for Thoracic Surgical Oncology in a Single-Payer Healthcare System Please note that while the process of standards development was rigorous, according to grading conventions the evidence available to form the standards is of very low quality [41]. The standards presented below represent strong recommendations for practice. They are based on expert consensus opinion with primary consideration given to the perceived benefits for patients and the small likelihood of any harm arising from implementation of the standards. Surgeon Criteria Characteristics for surgeons undertaking the management of patients with thoracic cancer include: REVIEWS Ann Thorac Surg 2007;84:693–701 698 REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS ● Knowledgeable about thoracic cancer biology, behavior, and natural history. ● Well informed about appropriate investigation techniques, multidisciplinary treatment options, as well as postoperative management and the continuum of care. ● Skilled in modern techniques of surgery of the thoracic region. ● Experienced in the management of patients with thoracic diseases, specifically with the management of their complications, early and late. ● Committed to providing excellence in care to patients with thoracic diseases, specifically cancer patients, and to advancing knowledge in the field to improve patient outcomes. ● Committed to participating as a member of a multidisciplinary oncology team or to consult with such teams. ● Committed to participating in Cancer Care Ontario initiatives, particularly those of the Surgical Oncology Program or in the Program in Evidence-Based Care, or both, through membership in working groups, standing groups, or as active participants in external review and consultation processes. Training REVIEWS ● Surgeons should have formal training in programs such as the Royal College of Physicians and Surgeons of Canada programs in thoracic surgery, cardiothoracic surgery, or cardiovascular and thoracic surgery, or the American Board of Thoracic Surgery or other equivalent training recognized in Canada, and be certified and licensed to practice thoracic surgery in Canada. ● Surgeons should maintain expertise and competence through ongoing education in available Continuing Professional Development programs, such as the Maintenance of Certification program of the Royal College of Physicians and Surgeons of Canada or others. Practice Setting ● Level 1 tertiary care regional thoracic centers should be equipped to manage the full range of thoracic surgical care, as well as acting as the primary source to manage the most complex cases. To facilitate this goal, there should ideally be at least three thoracic surgeons on staff to provide intraoperative assistance and postoperative care, and weekend, holiday, and emergency coverage. X This number of surgeons is needed to provide the capacity for tertiary clinical care in addition to the other requirements and responsibilities of a multidisciplinary cancer care facility, including teaching, research, quality improvement, and program advancement. X A team approach is understood to improve the quality of surgery in complex cases and the judgment required to manage complications. Ann Thorac Surg 2007;84:693–701 ● In some regions, the population may not support a level 1 thoracic center. In these regions, a level 2, or secondary care unit, may be established to serve the basic thoracic surgery needs of the population. X Level 2 centers should have: X A minimum of one thoracic surgeon who performs routine thoracic procedures. X A formalized relationship with a level 1 tertiary center to which the thoracic surgeon may refer complex thoracic cases (eg, tracheal resections, major chest wall resections, and so forth). X Arrangements with surgical colleagues in those centers to provide support in the event of the thoracic surgeon’s absence. ● Hospitals not meeting level 1 or 2 thoracic surgery criteria should establish formal relationships with a level 1 or level 2 center to facilitate consultation and appropriate management and referral of patients with thoracic malignancies. For those hospitals where the geographic location, patient volume, or population catchments do not support level 1 or 2 status, the basic thoracic service needs may still be provided in that area through formal relationships with level 1 and 2 centers. Guided by the expertise of these centers, much of the initial and preoperative evaluation can be conducted at that hospital itself. The surgical care would require transferring the patient to the level 1 or 2 thoracic surgery unit. However, upon completion of the surgery, the patients can return to the originating center for ongoing care and follow-up as deemed appropriate and necessary by the multidisciplinary group at the level 1 or 2 center. Volume of Thoracic Surgery The standards of surgical volumes are not based on high-quality evidence, but rather on the consensus of an expert panel. Although a volume-outcome relationship was observed in the literature, the standards of volumes were primarily based on the established need for sufficient volumes to sustain dedicated services (eg, respirology, intensive care unit, physiotherapy, pathology, diagnostic imaging, and so forth), and a sufficient volume to support adequate coverage for full service units. These volumes were considered reasonable by the expert panel in light of the current distribution of thoracic surgery in the province, but it is recommended that these numbers be revisited as more data becomes available. ● The practice setting should have a sufficient volume of thoracic surgery to maintain the skills of surgeons in both complex cancer surgery and thoracic surgery. ● Surgical volumes in the range of 20 esophagectomy cases per unit per year and 150 anatomic pulmonary resections per unit per year should be considered targets for level 1 centers. ● Surgical volumes in the range of seven esophagectomy cases per unit per year and 50 anatomic pulmonary resections per unit per year should be considered targets for level 2 centers. ● The panel recognized that some regions may not have the population and cases to support the recommended target volumes, but could meet them as the predicted increase in cancer cases occurs. Hospital Criteria Important characteristics of the institution in which major thoracic cancer surgery would take place are: ● Commitment to high-quality, multidisciplinary thoracic cancer care. ● Commitment to providing or participating in an organizational structure to manage patients with these cancers through all phases of their care. ● Commitment to participate in activities that advance Cancer Care Ontario Provincial Cancer Plan (2004). ● Formal working relationship or association with a regional cancer center if a thoracic surgery unit is not located at the cancer center. Physical Resources and Collaborating Services The following physical resources and collaborating services are considered to be reasonable criteria that level 1 and 2 hospitals providing thoracic cancer surgery should be expected to meet in providing comprehensive acute care: ● Operating room available 24 hours per day, 7 days per week (24/7), with video capacity for bronchial and esophageal scopes, video-assisted thoracic surgery and laparoscopy, intraoperative fluoroscopy capacity, and frozen section available 24/7 for emergencies. ● An interventional radiology suite that has the capacity for needle biopsy of lung and chest masses and drainage of loculated pleural collections that is available 24/7 for emergencies, either onsite or at an on-call hospital. The capacity for embolization therapy for massive hemoptysis or prior to massive chest wall resections is essential for level 1 centers. ● Full spectrum of radiologic imaging, including roentgenogram and immediate portable roentgenogram access 24/7 for emergencies, esophageal contrast studies, computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and vascular imaging. ● For level 1 units, a dedicated thoracic surgical service with consolidated beds to ensure an appropriate level of nursing, physiotherapy, and respiratory therapy expertise. ● Specialized nursing care, including mechanical ventilation and invasive monitoring in a combination of intensive care unit and step-down beds sufficient to support the volume of patients treated. ● Affiliation with a regional cancer center with access to radiation therapy equipment and consultation from medical and radiation oncologists. ● Ambulatory endoscopy facility with access to surgeons, pulmonologists, and gastroenterologists. ● Onsite laboratory for pulmonary function tests and cardiac diagnostic assessment services, including echocardiography and nuclear imaging. REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS 699 ● Onsite rapid response laboratory (ie, biochemistry, hematology, transfusion, and microbiology) services sufficient to support operating room, intensive care unit, step-down, and ward requirements 24/7. ● Onsite or rapid access to pathology and cytology services sufficient to support operating room, endoscopy, and ambulatory services. Human Resources The human resources should include: ● Thoracic surgeons. ● Anesthesiologists skilled in thoracic anesthesia techniques. ● Other medical specialists including gastroenterologists, pulmonary medicine specialists, intensivists, a thoracic pathologist, and a radiologist with a subspecialty interest in diagnostic and interventional procedures of the chest. ● Allied professionals, including dedicated nurses; chest physiotherapists accessible 7 days a week; respiratory therapists available 24/7; dietary and nutritional, home care, social work, and pharmacy support; and access to a palliative care team. ● Formalized partnerships and access to oncology specialists including medical oncologists and radiation oncologists. ● Access to other consulting specialties as needed, such as infectious disease, cardiology, and neurology specialists. Organizational Criteria ● The successful management of patients with thoracic problems, particularly those with thoracic malignancies, by involving a multidisciplinary team approach with the use of standard diagnostic and treatment protocols and the involvement of a variety of surgical and nonsurgical specialists. ● For level 1 units, a designated thoracic unit with identified leadership and accountability. ● A system of regular review of multidisciplinary patient management (eg, multidisciplinary clinics, clinical rounds, educational rounds, morbidity and mortality review, and formal ongoing outcome measurements and quality assurance) is essential for the achievement of optimal patient outcomes. ● Participation in regional and provincial integrated networks of care as outlined in the Cancer Care Ontario Provincial Cancer Plan (2004) to facilitate patient access, consultation, referral, quality improvement, and continuing professional development. ● Infrastructure support for participation, and the participation of patients in clinical research in thoracic care, both in local and national studies. In conclusion, the expert panel on thoracic surgical oncology created standards of practice for the delivery of thoracic surgical oncology as they pertain to the Ontario healthcare system, but also with applicability to other health single-payer tax-based healthcare systems as well. REVIEWS Ann Thorac Surg 2007;84:693–701 700 REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS The panel concluded that the benefits associated with the implementation of thoracic cancer surgery standards should result in increased regionalization, improved processes of care, and better patient outcomes. Because the optimum organization of thoracic surgical oncology services does not lend well to a structured investigation, there was little definitive evidence for the basis of the development of the standards of care. Thus, our strategy focused on transparent expert consensus opinion, a rigorous document development process, and an external review of practitioners and administrators across Ontario. The standards were developed to provide useful guidance to the regional planning authorities, hospital chief executive officers, cancer organizations, as well as surgeons and other practitioners in the planning of integrated cancer services, and are currently being implemented in Ontario, Canada. Work based on this systematic review and standards document was sponsored by Cancer Care Ontario, the Program in Evidence-Based Care, and the Ontario Ministry of Health and Long-Term Care. Ann Thorac Surg 2007;84:693–701 14. 15. 16. 17. 18. 19. 20. 21. 22. References REVIEWS 1. Government of Ontario (cited Oct 4, 2006). Toronto (Canada), 2006. Accessed from http://www.gov.on.ca/. 2. Smith W, Khuri FR. The care of the lung cancer patient in the 21st century: a new age. Semin Oncol 2004;31(2 Suppl 4):11–5. 3. Treasure T, Utley M, Bailey A. Assessment of whether in-hospital mortality for lobectomy is a useful standard for the quality of lung cancer surgery: retrospective study. BMJ 2003;327:73. 4. Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. New Engl J Med 2003;349:2117–27. 5. Hannan EL, Radzyner M, Rubin D, Dougherty J, Brennan MF. The influence of hospital and surgeon volume on in-hospital mortality for colectomy, gastrectomy, and lung lobectomy in patients with cancer. Surgery 2002;131:6 –15. 6. Bachmann MO, Alderson D, Edwards D, et al. Cohort study in South and West England of the influence of specialization on the management and outcome of patients with oesophageal and gastric cancers. Br J Surg 2002;89:914 –22. 7. Gillison EW, Powell J, McConkey CC, Spychal RT. Surgical workload and outcome after resection for carcinoma of the oesophagus and cardia. Br J Surg 2002;89:344 – 8. 8. Miller JD, Jain MK, de Gara CJ, Morgan D, Urschel JD. Effect of surgical experience on results of esophagectomy for esophageal carcinoma. J Surg Oncol 1997;65:20 –1. 9. Goodney PP, Lucas FL, Stukel TA, Birkmeyer JD. Surgeon specialty and operative mortality with lung resection. Ann Surg 2005;241:179 – 84. 10. Martin-Ucar AE, Waller DA, Atkins JL, Swinson D, O’Byrne KJ, Peake MD. The beneficial effects of specialist thoracic surgery on the resection rate for non-small-cell lung cancer. Lung Cancer 2004;46:227–32. 11. Silvestri GA, Handy J, Lackland D, Corley E, Reed CE. Specialists achieve better outcomes than generalists for lung cancer surgery. Chest 1998;114:675– 80. 12. Sutton DN, Wayman J, Griffin SM. Learning curve for oesophageal cancer surgery. Br J Surg 1998;85:1399 – 402. 13. Urbach DR, Baxter NN. Does it matter what a hospital is “high volume” for? Specificity of hospital volume-outcome 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. associations for surgical procedures: analysis of administrative data. BMJ 2004;328:737– 40. Finlayson EV, Birkmeyer JD. Effects of hospital volume on life expectancy after selected cancer operations in older adults: a decision analysis. J Am Coll Surg 2003;196:410 –7. Finlayson EV, Goodney PP, Birkmeyer JD. Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg 2003;138:721–75. Christian CK, Gustafson ML, Betensky RA, Daley J, Zinner MJ. The Leapfrog volume criteria may fall short in identifying high-quality surgical centers. Ann Surg 2003;238:447–55. Dimick JB, Pronovost PJ, Cowan JA Jr, Lipsett PA, Stanley JC, Upchurch GR Jr. Variation in postoperative complication rates after high-risk surgery in the United States. Surgery 2003;134:534 – 40. Dimick JB, Cowan JA Jr, Ailawadi G, Wainess RM, Upchurch GR Jr. National variation in operative mortality rates for esophageal resection and the need for quality improvement. Arch Surg 2003;138:1305–9. Dimick JB, Pronovost PJ, Cowan JA, Lipsett PA. Surgical volume and quality of care for esophageal resection: do high-volume hospitals have fewer complications? Ann Thorac Surg 2003;75:337– 41. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002;346:1128 –37. van Meerbeeck JP, Damhuis RA, Vos de Wael ML. High postoperative risk after pneumonectomy in elderly patients with right-sided lung cancer. Eur Respir J 2002;19:141–5. Birkmeyer JD, Finlayson EV, Birkmeyer CM. Volume standards for high-risk surgical procedures: potential benefits of the Leapfrog initiative. Surgery 2001;130:415–22. Kuo EY, Chang Y, Wright CD. Impact of hospital volume on clinical and economic outcomes for esophagectomy. Ann Thorac Surg 2001;72:1118 –24. van Lanschot JJ, Hulscher JB, Buskens CJ, Tilanus HW, ten Kate FJ, Obertop H. Hospital volume and hospital mortality for esophagectomy. Cancer 2001;91:1574 – 8. Dimick JB, Cattaneo SM, Lipsett PA, Pronovost PJ, Heitmiller RF. Hospital volume is related to clinical and economic outcomes of esophageal resection in Maryland. Ann Thorac Surg 2001;72:334 –9. Bach PB, Cramer LD, Schrag D, Downey RJ, Gelfand SE, Begg CB. The influence of hospital volume on survival after resection for lung cancer. New Eng J Med 2001;345:181– 8. Swisher SG, Deford L, Merriman KW, et al. Effect of operative volume on morbidity, mortality, and hospital use after esophagectomy for cancer. J Thorac Cardiovasc Surg 2000; 119:1126 –32. Khuri SF, Daley J, Henderson W, et al. Relation of surgical volume to outcome in eight common operations: results from the VA National Surgical Quality Improvement Program. Ann Surg 1999;230:414 –29. Begg CB, Cramer LD, Hoskins WJ, Brennan MF. Impact of hospital volume on operative mortality for major cancer surgery [see comment]. JAMA 1998;280:1747–51. Patti MG, Corvera CU, Glasgow RE, Way LW. A hospital’s annual rate of esophagectomy influences the operative mortality rate [see comment]. J Gastro Surg 1998;2:186 –92. Romano PS, Mark DH. Patient and hospital characteristics related to in-hospital mortality after lung cancer resection. Chest 1992;1:1332–7. Milne AA, Skinner J, Browning G. Centralisation of oesophageal cancer services; the view from the periphery [see comment]. J R Coll Surg Edinb 2000;45:164 –7. Dimick JB, Cowan JA Jr, Colletti LM, Upchurch GR Jr. Hospital teaching status and outcomes of complex surgical procedures in the United States. Arch Surg 2004;139:137. Tanaka H, Hiyama T, Hanai A, Fujimoto I. Interhospital differences in cancer survival: magnitude and trend in 19751987 in Osaka, Japan. Jpn J Cancer Res 1994;85:680 –5. 35. Darling GE, Maziak DE, Clifton JC, Finley RJ, Canadian Association of Thoracic Surgery. The practice of thoracic surgery in Canada. Can J Surg 2004;47:438 – 45. 36. Alberts WM, Bepler G, Hazelton T, Ruckdeschel JC, Williams JH Jr, American College of Chest Physicians. Lung cancer: practice organization. Chest. 2003;123(1 Suppl):332S–7S. 37. The Lung Cancer Working Party of the British Thoracic Society Standards of Care Committee. BTS Recommendations to respiratory physicians for organising the care of patients with lung cancer. Thorax 1998;53(Suppl 1):S1– 8. 38. The Leapfrog Group for Patient Safety. Evidence-based hospital referral. Apr 7, 2004 (cited Feb 5, 2005). Accessed from http://www.leapfroggroup.org/media/file/leapfrogevidence-based_hospital_referral_fact_sheet.pdf. 39. British Columbia Chest Surgery Association. British Columbia Programme of Thoracic Surgical Care, 2001. 40. The EACTS/ESTS Working Group on Structures in Thoracic Surgery. Structure of general thoracic surgery in Europe (document on the Internet). 2001 (cited Feb 5, 2005). Accessed from www.akh-wien.ac.at/herz-thorax-chirurgie/gts/proposal/ finaldocument.html. 41. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490. REVIEW SUNDARESAN ET AL THORACIC SURGICAL ONCOLOGY STANDARDS 701 Appendix Expert Panel on Thoracic Surgical Oncology Ian Macmillan, MD, Ontario Association of General Surgeons, St. Catharines, Ontario; John Dickie, MD, Peterborough Regional Health Centre, Peterborough, Ontario; Donna Maziak, MD, The Ottawa Hospital, Ottawa, Ontario; Peter Dixon, MD, Durham Regional Cancer Centre, Oshawa, Ontario; Brendan Mullen, MD, Mount Sinai Hospital, Toronto, Ontario; Bill Evans, MD, Juravinski Cancer Centre, Hamilton, Ontario; Kenneth Gehman, MD, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario; Narinder Paul, MD, University Health Network–Princess Margaret Hospital, Toronto, Ontario; Michael Humer, MD, Canadian Association of Thoracic Surgeons, Vancouver, British Columbia; Kevin Smith, MD, St. Joseph’s Healthcare, Hamilton, Ontario; Richard Inculet, MD, London Health Sciences Centre, London, Ontario; Donald Jones, MD, Credit Valley Hospital, Mississauga, Ontario; Shaf Keshavjee, MD, University of Toronto–Toronto General Hospital, Toronto, Ontario. REVIEWS Ann Thorac Surg 2007;84:693–701