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A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: The current NSQIP Surgical Risk Calculator does not adequately estimate risk among patients with clinical stage I non–small cell lung cancer.
Major finding: The NSQIP risk calculator significantly underestimated serious complication risk in operative patients (16.6% actual risk vs. 8.8% predicted) and did not adequately stratify risk between surgical and stereotactic body radiation therapy (SBRT) patients.
Data source: Researchers retrospectively assessed 279 NSCLC stage I lung cancer patients who underwent surgery vs. 206 patients who underwent SBRT from 2009 to 2012.
Disclosures: The study was supported by grants from the National Institutes of Health. The authors had no relevant financial disclosures.
