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• W2894442840 abstract "Through the leadership of The Society of Thoracic Surgeons (STS) Workforce on Research Development, the STS Research Center now offers three programs that facilitate outcomes research using the STS General Thoracic Surgery Database (GTSD): (1) the Access and Publications Program supports STS-sponsored projects with data analysis conducted at an STS-approved data analytic center, (2) the STS Task Force for Funded Research (TFR) helps STS investigators pursue extramural research funding for projects analyzing STS National Database data, and (3) the Participant User File (PUF) research program provides investigators with approved projects deidentified patient-level data files from the STS GTSD to be analyzed at their institution. A synopsis of the processes and goals of each program, in addition to 2017-based articles published or accepted in 2017 and works in progress, are outlined. Surgeons increasingly recognize the importance of having comprehensive clinical data from their specialty available for analysis and evaluation of clinical processes and outcomes. Yet, the quality of such investigations depends on the quality and representativeness of the data. STS GTSD continues to evolve to empower thoracic surgeons with the most comprehensive, reliable data set within their specialty. The STS Workforce on National Databases has continued to respond to the challenges and needs of our specialty and has worked tirelessly to improve the quality, granularity, and completeness of data entered into the GTSD. An important GTSD research milestone was recently accomplished under the auspices of the STS TFR. Specifically, investigators from one of the grants under TFR have successfully linked GTSD data with the Centers for Medicare and Medicaid Services (CMS) national databases to obtain longitudinal follow-up and resource utilization data on surgically treated lung cancer patients [1The Society of Thoracic Surgeons. STS Research Center. Longitudinal Follow-Up & Linked Registries. Available at https://www.sts.org/registries-research-center/sts-research-center/longitudinal-follow-linked-registries. Accessed August 6, 2018.Google Scholar, 2Fernandez F.G. Furnary A.P. Kosinski A.S. et al.Longitudinal follow-up of lung cancer resection from The Society of Thoracic Surgeons General Thoracic Surgery Database in patients 65 years and older.Ann Thorac Surg. 2016; 101: 2067-2076Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar]. This advancement in available GTSD-based data provides surgeons with the opportunity to move beyond 30-day outcomes and examine longitudinal outcomes within thoracic surgery [1The Society of Thoracic Surgeons. STS Research Center. Longitudinal Follow-Up & Linked Registries. Available at https://www.sts.org/registries-research-center/sts-research-center/longitudinal-follow-linked-registries. Accessed August 6, 2018.Google Scholar]. Although assessment of short-term outcomes remains essential, this linkage is particularly important in thoracic oncologic surgery, providing an opportunity to assess how perioperative decisions affect cancer-related outcomes. Other national data sets that include long-term outcomes frequently lack the level of operative and perioperative detail provided by the STS GTSD. An important overarching goal of the STS Workforce on Research Development is to continuously improve access to and use of the data collected in the STS national database for research purposes by surgeon participants. Creating additional pathways and improving existing processes for GTSD data requests has provided surgeon investigators with more opportunity and improved efficiency. In addition to the TFR mechanism, the STS currently offers sponsored outcomes research through the Access and Publications Task Force and the newer PUF research program. This review will outline the design, purpose, and processes associated with each program and provide an update on recent clinical studies generated from the STS GTSD through each of these task forces. The STS TFR (formerly the Task Force for Longitudinal Follow-up and Linked Registries) oversees research in which STS data are linked to additional data sources to provide complimentary data. The major limitation of the STS GTSD has been the absence of information regarding outcomes beyond the immediate postoperative period of 30 days or hospital discharge. Long-term survival is a critical outcome measure for oncologic surgery, including lung cancer surgery, the most frequent operation reported in the GTSD. Through a funded research initiative, long-term survival data have been obtained for a subset of lung cancer operations in the STS GTSD through linkage to the CMS Medicare database [2Fernandez F.G. Furnary A.P. Kosinski A.S. et al.Longitudinal follow-up of lung cancer resection from The Society of Thoracic Surgeons General Thoracic Surgery Database in patients 65 years and older.Ann Thorac Surg. 2016; 101: 2067-2076Abstract Full Text Full Text PDF PubMed Scopus (34) Google Scholar] The CMS database was selected because it was the most feasible of the available data sources for this project and linkage algorithms had already been established to STS data. This approach limits the analysis to individuals aged 65 years and older with Medicare insurance. Ongoing STS initiatives are examining mechanisms to provide long-term survival information for all patients in the STS database. Creation of this STS-CMS–linked data has permitted examination of longitudinal outcome studies with the database that were previously not feasible. These studies will enhance the rich data already captured in the GTSD and should inform clinical care in lung cancer surgery for years to come. One such study was published in 2017 and is reviewed in this report. Several others have been presented at national meetings and have or will be published in 2018. The care of the clinical stage III non-small cell lung cancer with suspected or confirmed mediastinal lymph node metastases (cIII-N2) is extremely variable in the United States. The role of surgery in these patients is controversial, partly because of variability in short-term and long-term outcomes. This study [3Boffa D. Fernandez F.G. Kim S. et al.Surgically managed clinical stage IIIA-clinical N2 lung cancer in The Society of Thoracic Surgeons Database.Ann Thorac Surg. 2017; 104: 395-403Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar] aimed to characterize the management of such patients in the STS GTSD. All patients who underwent operations for cIIIA-N2 lung cancer between 2002 and 2012 were examined. The subset of patients aged older than 65 years linked to Medicare data was further analyzed for long-term survival outcomes. Of 3,319 surgically managed cIIIA-N2 patients who were identified, 1,784 (54%) were treated with upfront surgical intervention (treatment naïve) and another 1,535 (46%) first received induction therapy. A positron emission tomography scan or computed tomography scan, or both, was documented in 93% of patients as preoperative staging. In addition, 51% of patients were coded in the STS-GTSD as having undergone invasive mediastinal staging before the operation, with mediastinoscopy, endobronchial ultrasound, endoscopic ultrasound, or thoracoscopy. Nodal overstaging (cN2 found to be pathologic N0/N1) was observed in 43% of upfront surgery patients. The most frequent operation was a lobectomy, which was performed in 69% of patients. A pneumonectomy was performed in only 11%. The operative mortality rate, defined as death in-hospital or within 30 days of the operation, was similar between patients treated with upfront surgery (1.9%) and induction therapy (2.5%, p = .2583). The 30-day and 90-day mortality rates for STS-CMS–linked patients stratified by procedure are shown in Figure 1. A high mortality rate for pneumonectomy was observed. The unadjusted Kaplan-Meier estimate of 5-year survival was 35% in patients treated with induction therapy and then surgical intervention and was 36% in patients treated with upfront surgery. This study demonstrates that surgeons participating in the STS database achieve excellent short-term and long-term results treating cIIIA-N2 lung cancer. As noted, most patients undergo lobectomy, and one cannot extrapolate such results to pneumonectomy. However, prevalent overstaging was observed in the database. Furthermore, avoidance of the administration of induction therapy suggest either an “overcoding” of false positives on imaging studies or variable compliance to current treatment guidelines for the management of cIIIA-N2 lung cancer. Therefore, this study emphasizes that increased efforts are needed to improve clinical stage determination and guideline compliance in the GTSD for this cohort of patients with locally advanced lung cancers. There are several recently completed and ongoing studies using the STS-CMS–linked lung cancer surgery data set. Risk models for long-term survival after lung cancer surgery and the effect of operative complications have been developed and published in 2018 [4Onaitis M.W. Furnary A.P. Kosinski A.S. et al.Prediction of long-term survival after lung cancer surgery for elderly patients in The Society of Thoracic Surgeons General Thoracic Surgery Database.Ann Thorac Surg. 2018; 105: 309-316Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar, 5Fernandez F.G. Kosinski A.S. Furnary A.P. et al.Differential effects of operative complications on survival after surgery for primary lung cancer.J Thorac Cardiovasc Surg. 2018; 155: 1254-1264Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar]. The comparative effectiveness of operative approach (minimally invasive vs thoracotomy) and extent of resection (sublobar resection vs lobectomy) has also been investigated. In addition, the penetration, completeness, and representativeness of the GTSD for lobectomy and correlation between program short-term and long-term performance for lung cancer surgery have been examined. Reports from these studies are forthcoming. Finally, the CMS data will be used to examine cost and resource utilization along the continuum of care associated with lung cancer surgery. The traditional pathway for pursuit of STS-sponsored research is through the Access and Publications program. Investigator proposals are reviewed by the Access and Publication Task Force, and approved projects are developed and analyzed at the STS-approved data analytic center, which is currently the Duke Clinical Research Institute. Three GTSD studies resulting from Access and Publication program were published in 2017, two on lung and one on esophageal surgery [6Durheim M.T. Kim S. Gulack B.C. et al.Mortality and respiratory failure after thoracoscopic lung biopsy for interstitial lung disease.Ann Thorac Surg. 2017; 104: 465-470Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar, 7Shroyer A.L. Quin J.A. Grau-Sepulveda M.V. et al.Geographic variations in lung cancer lobectomy outcomes: the General Thoracic Surgery Database.Ann Thorac Surg. 2017; 104: 1650-1655Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar, 8Towe C.W. Gulack B.C. Kim S. et al.Restrictive transfusion practices after esophagectomy are associated with improved outcome: a review of The Society of Thoracic Surgeons General Thoracic Database.Ann Surg. 2018; 267: 886-891Google Scholar]. The reports deal with questions important to our practice yet incompletely elucidated and discussed. During a 2-year interval that ended in 2011, the thoracic database collected information on patients with interstitial lung disease undergoing lung biopsy. Before that date, the database did not list specific diagnoses, whereas after 2011, the reporting of lung biopsies became optional. This narrow window provided an opportunity to study the outcome of elective lung biopsy in patients admitted on the day of the operation [6Durheim M.T. Kim S. Gulack B.C. et al.Mortality and respiratory failure after thoracoscopic lung biopsy for interstitial lung disease.Ann Thorac Surg. 2017; 104: 465-470Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar]. There were 3,085 procedures between 2009 and 2014, with 3,022 occurring between 2009 and 2011 and only 63 when reporting of these procedures was voluntary from 2012 to 2014. The study group had a median diffusion capacity of the lung for carbon monoxide (Dlco) of 53%, a median age of 60 years, and 47% were former smokers. The incidence of death during hospitalization or within 30 days was 1.4% compared with a rate of 1.2% in wedge resection for lung cancer observed in a propensity-matched analysis from the STS database [9Linden P.A. D’Amico T.A. Perry Y. et al.Quantifying the safety benefits of wedge resection: a Society of Thoracic Surgery Database propensity-matched analysis.Ann Thorac Surg. 2014; 98: 1705-1711Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar]. The incidence of respiratory failure, measured only between 2012 and 2014, was 4.8% (3 of 63 patients). A multivariable analysis identified pulmonary hypertension (odds ratio, 5.39), preoperative steroids, Dlco, and forced expired volume in 1 second as risk factors for the composite of operative mortality or respiratory failure. A Dlco below 40% raised the risk of either outcome sevenfold. Often the limitations of such a database study are more obvious to surgeons than its value in clinical practice. The authors pointed to the difficult task of separating risk of disease from risk of procedure, in particular because interstitial lung disease consists of heterogeneous conditions. Despite the shortcoming, in the absence of better data that may never be available, the results suggest measuring pulmonary artery pressure to help determine risk before lung biopsy, to consider the importance of biopsy in patients on steroids or with a low Dlco, and to perhaps substitute alternative means of diagnosis when all three risk factors are unfavorable. Unfortunately, the analysis did not include patients undergoing nonelective lung biopsy, although their data may be of even greater importance when considering the risk and benefit of lung biopsy in hospitalized patients. After a report of the STS National Cardiac Database that showed differences in risk-adjusted mortality after isolated coronary artery bypass graft surgery among the four major United States Census regions (Northeast, Midwest, South, and West), ranging from 1.63% to 2.25% [10Quin J.A. Sheng S. O’Brien S.M. Welke K.F. Grover F.L. Shroyer A.L. Regional variation in patient risk factors and mortality after coronary artery bypass grafting.Ann Thorac Surg. 2011; 92: 1277-1282Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar], a similar investigation was begun examining lobectomy in the GTSD. Shroyer and associates [7Shroyer A.L. Quin J.A. Grau-Sepulveda M.V. et al.Geographic variations in lung cancer lobectomy outcomes: the General Thoracic Surgery Database.Ann Thorac Surg. 2017; 104: 1650-1655Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar] reviewed 39,078 lobectomies for lung cancer, compared with 504,608 bypass grafts, and found no differences in operative mortality or major perioperative morbidity across regions (Table 1). The proportion of high-risk cases was lower in one region (range, 15.9% to 19.9%). Differences in the proportion of surgeons with fewer than 7 cases per year (range among regions, 39.8% to 56.3%) and proportions of hospitals with fewer than 17 cases per year (range 38.8% to 47.8%) were not significant. Disease severity and transfusion rates were also comparable. Given the current state of the GTSD of low case numbers and event rates for the examined procedure, a lack of substantial difference between regions is not entirely surprising. The addition of a more event-prone but also more uncommon resection, such as pneumonectomy, would not have changed the result of this study with certainty. Once again, the exclusion of procedures performed by general, pediatric, or oncologic surgeons with limited thoracic specialty training prevents our database from describing the realities of national practice in general thoracic surgery.Table 1Unadjusted and Adjusted Odds Ratios Across Regions for Operative Mortality and Major Morbidity of Pulmonary Lobectomy for Lung Cancer in The Society of Thoracic Surgeons General Thoracic Surgery Database Demonstrate No Significant DifferencesReprinted from Shroyer and colleagues 7Shroyer A.L. Quin J.A. Grau-Sepulveda M.V. et al.Geographic variations in lung cancer lobectomy outcomes: the General Thoracic Surgery Database.Ann Thorac Surg. 2017; 104: 1650-1655Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar with permission from The Society of Thoracic Surgeons.RegionUnadjusted OR (95% CI)p ValueaWald χ2 test.Adjusted OR (95% CI)p ValueaWald χ2 test.Operative mortality0.6030.761 Northeast1.00 (reference)1.00 (reference) South1.17 (0.90–1.51)1.02 (0.80–1.31) Midwest1.15 (0.83–1.59)0.96 (0.73–1.26) West1.16 (0.89–1.53)1.13 (0.86–1.48)Major morbidity0.0070.600 Northeast1.00 (reference)1.00 (reference) South1.21 (1.03–1.43)1.03 (0.87–1.22) Midwest1.30 (1.08–1.57)1.09 (0.91–1.31) West1.00 (0.83–1.21)(0.78–1.18)CI = confidence interval; OR = odds ratio.a Wald χ2 test. Open table in a new tab CI = confidence interval; OR = odds ratio. Studies of blood transfusion and perioperative outcomes in the STS database have been limited and circumspect because of the difficulty in assessing cause and effect. In one of the first such studies from the general thoracic database, preoperative hemoglobin, intraoperative and postoperative rates of red blood cell transfusion, and other preoperative and perioperative factors were analyzed in a cohort of 7,137 patients undergoing elective open or minimally invasive esophagectomy for cancer between 2008 and 2014 [8Towe C.W. Gulack B.C. Kim S. et al.Restrictive transfusion practices after esophagectomy are associated with improved outcome: a review of The Society of Thoracic Surgeons General Thoracic Database.Ann Surg. 2018; 267: 886-891Google Scholar]. To describe center-specific variation in transfusion practice, the authors created a transfusion model using a random intercept logistic regression, adjusting for patient-specific risk factors. A ratio of the observed-to-expected (O/E) transfusion rate was calculated for each of 182 centers. The unadjusted transfusion rate was 23% overall, 10% during, and 17% after the operation, with some patients receiving transfusion during both intervals. Factors associated with perioperative transfusion in the entire patient population were low preoperative hemoglobin, high American Association of Anesthesiologists Physical Status Classification, low creatinine clearance, and open versus minimally invasive esophagectomy. The institution-specific analysis of variation classified 7.1% of centers as having lower-than-expected and 8.7% higher-than-expected transfusion rates, whereas 84% of centers had an as-expected transfusion rate. The risk-adjusted transfusion rate varied 9.9-fold between centers (Fig 2). Higher-volume institutions transfused less often, whereas United States region, rural/urban status, proportion of minimally invasive esophagectomies, or teaching status had no effect on transfusion. Establishing the relationship between transfusion and operative death was more complex. The association of the O/E transfusion ratio with mortality required an O/E ratio for perioperative mortality for each institution. A trend toward higher mortality with an increased O/E transfusion rate was found that persisted when adjusted for center volume of cases. Institutions with lower-than-expected transfusion rates had a lower risk-adjusted operative mortality than those with higher-than-expected transfusion rates. Further, when adjusting for institutional volume, the Pearson correlation was similar to the unadjusted analysis. From these observations, the authors concluded that lower transfusion rates are associated with lower mortality, independent of center volume. Several points in the discussion of this provocative study merit comment. The authors suspect that concern about the gastric conduit and absence of transfusion guidelines are causes for the high overall transfusion rate compared with lung cancer. However, the frequent observation of preoperative anemia after neoadjuvant therapy administered for locally advanced esophageal cancer provides an equally intuitive explanation. Neoadjuvant therapy also explains why minimally invasive esophagectomy has lower transfusion rates. The first STS database study discussed above showed a higher rate of open esophagectomy among these patients. Finally, the use of the term “restrictive” when related to the practice of transfusion implies principled restraint based on center-specific norms, a circumstance not studied here. In reality, whereas one center without restrictive use may simply have fewer occasions to administer a transfusion due to lower blood loss, another center might adhere to a strict transfusion policy but administer more transfusions more often due to higher blood loss, perhaps due to more patients with locally advanced esophageal cancer. The authors took a first step into a complex, important, and so far insufficiently explored aspect of our practice. The PUF program is the latest innovative program that allows participants to submit research proposals based on data in the STS GTSD [11The Society of Thoracic Surgeons. STS Research Center. Participant User File Research Program. Available at https://www.sts.org/registries-research-center/sts-research-center/participant-user-file-research-program. Accessed August 6, 2018.Google Scholar]. After a robust STS Research Center and PUF Task Force review process of submitted proposals focused on feasibility and scientific merit of the research, participants with approved projects receive patient-level, deidentified data from the STS GTSD pertinent to their project to be analyzed at the investigator’s own institution. This provides a unique opportunity for the participant to have more autonomy in the review and analysis of the data. The review process, while rigorous, is designed to avoid overlap in projects, ensure that the requesting institution has the resources to provide a meticulous and thorough analysis, and to help facilitate project development and execution commensurate with the expectations of the STS. The review committee will provide feedback on the initial proposal and assist with abstract and manuscript reviews before their respective submissions. This program circumvents some of the inherent delays seen previously with data requests and allows qualified surgical investigators more enhanced independence in development and implementation of STS data projects. Although just over a year in existence, the PUF program has resulted in nine approved proposals so far that are in varying stages of development. The first STS GTSD–approved PUF project was presented at the STS 2018 meeting and is currently in press. Stanifer and colleagues [12Stanifer B.P. Andrei A.C. Liu M. et al.Short term outcomes of tracheal resection in The Society of Thoracic Surgeons Database.Ann Thorac Surg. 2018 Sept 18; ([in press accepted manuscript].)Google Scholar] recently presented one of the first projects originating from the PUF program involving analysis of tracheal resections at the STS 54th Annual Meeting in Fort Lauderdale, FL. Between 2002 and 2016, 1,617 tracheal resections were performed at 107 centers participating in the GTSD. Interestingly, a small number of centers performed most of the resections, with 50% of resections occurring at only 9 centers. Overall 30-day mortality was 1% and was similar for malignant and benign indications (1.1% vs 1.5%, p = 0.10). Although no difference was reported in 30-day mortality between a cervical versus a thoracic approach, hospital readmission and overall complications were more common for resections performed through a thoracic approach, predominantly represented by an increase in pulmonary complications. Furthermore, high-volume centers (>4 cases/year) had a lower incidence of 30-day composite morbidity/mortality than low-volume centers (17% vs 27%, p < 0.001). This study highlights one of the ongoing challenges of the GTSD to attempt to capture details surrounding procedures performed less frequently within thoracic surgery. Although there remains a focus on providing comprehensive data on pulmonary and esophageal resections, providing surgeons with adequate data regarding many other thoracic procedures performed less commonly across the United States is also important. If the database is going to be used for low-volume procedures, then there is still a requisite need for detail that is pertinent to the disease process and procedure that could result in actionable intervention. In response to these needs, the newer version of the GTSD will have a tracheal surgery module that expands the data fields to include more perioperative and procedural details. Given finite resources, this remains a difficult balance to provide comprehensive data on common procedures while including pertinent data regarding thoracic procedures performed less often. The ProvenCare Lung Collaborative is designed to be a structured, systematic, evidence-based model of lung cancer care delivery [13Katlic M.R. Facktor M.A. Berry S.A. McKinley K.E. Bothe Jr., A. Steele Jr., G.D. ProvenCare lung cancer: a multi-institutional improvement collaborative.CA Cancer J Clin. 2011; 61: 382-396Crossref PubMed Scopus (41) Google Scholar]. This model of care proposed by the American College of Surgeons Commission on Cancer will use STS data as a control for a multiinstitutional pilot study of ProvenCare methods. This pilot will provide preliminary data on the efficacy of ProvenCare protocols and potentially set the stage for broader national trials implementing ProvenCare methods. GTSD data were recently been used to characterize trends in the adoption of robotic techniques for lobectomy. From these data, surgeons will be stratified by their relative experience with robotic lobectomy and their outcomes compared based on this level of experience. These data will help characterize the learning curve associated with robotic techniques and help guide surgeons in their choice of operative approach for lobectomy. There are three ongoing PUF analyses related to evaluation of esophageal cancer and esophageal resection. Using GTSD data from 2012 to the present, one proposal will examine patient characteristics and perioperative and intraoperative factors associated with lymph node yield during esophagectomy. Further analysis will attempt to assess whether the extent of lymphadenectomy is associated with postoperative complications or whether a more extensive lymph node count affects length of stay, intensive care unit admission, and discharge status. Another study is also analyzing GTSD data to define clinical factors associated with the development of chylothorax after esophagectomy. This will illustrate the incidence of chylothorax after esophagectomy in this cohort and attempt to identify alterable factors that might be associated with development of chylothorax postoperatively. Still, in a separate proposal, investigators are examining the effect of body mass index on surgical approach and postoperative outcomes after esophagectomy for esophageal cancer. This study will also attempt to examine how body mass index may affect variability in preoperative staging methods and selection of treatment modality with versus without induction therapy. The STS remains attentive to the ever changing needs of the practicing surgeon for better and more useful data. In addition to the challenges mentioned previously, expanding participation in the GTSD continues to be a priority for the STS. Increasing participation will likely require a multifaceted approach but certainly includes improving the quality of data provided and improving access to the data. Ultimately, the goal would be to approach the participation rate of the cardiac STS database of more than 90%." @default.
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• W2894442840 title "The Society of Thoracic Surgeons General Thoracic Surgery Database: 2018 Update on Research" @default.
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