Adam M. Lukasiewicz

Orthopaedic Surgeons Receive the Most Industry Payments to Physicians but Large Disparities are Seen in Sunshine Act Data

BackgroundIndustry payments made to physicians by drug and device manufacturers or group purchasing organizations are now reported to the Centers for Medicare and Medicaid Services (CMS) as a part of the Physician Payments Sunshine Act. Initial reports from the program show that orthopaedic surgeons lead all physician specialties in total and average industry payments. However, before further discussion of these payments and their implications can take place, it remains to be seen whether these figures are a true reflection of the field of orthopaedic surgery in general, rather than the result of a few outlier physicians in the field. In addition, the nature and sources of these funds should be determined to better inform the national dialogue surrounding these payments.Questions/PurposesWe asked: (1) How do industry payments to orthopaedic surgeons compare with payments to physicians and surgeons in other fields, in terms of median payments and the Gini index of disparity? (2) How much do payments to the highest-receiving orthopaedic surgeons contribute to total payments? (3) What kind of industry payments are orthopaedic surgeons receiving? (4) How much do the highest-paying manufacturers contribute to total payments to orthopaedic surgeons?Materials and MethodsWe reviewed the most recent version of the CMS Sunshine Act Open Payments database released on December 19, 2014, containing data on payments made between August 1, 2013 and December 31, 2013. Data on total payments to individual physicians, physician specialty, the types of payments made, and the manufacturers making payments were reviewed. The Gini index of statistical dispersion was calculated for payments made to orthopaedic surgeons and compared with payments made to physicians and surgeons in all other medical specialties. A Gini index of 0 indicates complete equality of payments to everyone in the population, whereas an index of 1 indicates complete inequality, or all income going to one individual.ResultsA total of 15,376 orthopaedic surgeons receiving payments during the 5-month period were identified, accounting for USD 109,846,482. The median payment to orthopaedic surgeons receiving payments was USD 121 (interquartile range, USD 34–619). The top 10% of orthopaedic surgeons receiving payments (1538 surgeons) received at least USD 4160 and accounted for 95% of total payments. Royalties and patent licenses accounted for 69% of all industry payments to orthopaedic surgeons.ConclusionsEven as a relatively small specialty, orthopaedic surgeons received substantial payments from industry (more than USD 110 million) during the 5-month study period. Whether there is a true return of value from these payments remains to be seen; however, future ethical and policy discussions regarding industry payments to orthopaedic surgeons should take into account the large disparities in payments that are present and also the nature of the payments being made. It is possible that patients and policymakers may view industry payments to orthopaedic surgeons more positively in light of these new findings.Level of EvidenceLevel III, Economic and Decision Analysis.

Patient factors associated with 30-day morbidity, mortality, and length of stay after surgery for subdural hematoma: a study of the American College of Surgeons National Surgical Quality Improvement Program

OBJECTIVE Surgery for subdural hematoma (SDH) is a commonly performed neurosurgical procedure. This study identifies patient characteristics associated with adverse outcomes and prolonged length of stay (LOS) in patients who underwent surgical treatment for SDH. METHODS All patients in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) who were treated via craniotomy or craniectomy for SDH between 2005 and 2012 were identified. Patient demographics, comorbidities, and 30-day outcomes were described. Multivariate regression was used to identify predictors of adverse events. RESULTS A total of 746 surgical procedures performed for SDH were identified and analyzed. Patients undergoing this procedure were 64% male with an average age (± SD) of 70.9 ± 14.1 years. The most common individual adverse events were death (17%) and intubation for more than 48 hours (19%). In total, 34% experienced a serious adverse event other than death, 8% of patients returned to the operating room (OR), and the average hospital LOS was 9.8 ± 9.9 days. In multivariate analysis, reduced mortality was associated with age less than 60 years (relative risk [RR] = 0.47, p = 0.017). Increased mortality was associated with gangrene (RR = 3.5, p = 0.044), ascites (RR = 3.00, p = 0.006), American Society of Anesthesiologists (ASA) Class 4 or higher (RR = 2.34, p = 0.002), coma (RR = 2.25, p < 0.001), and bleeding disorders (RR = 1.87, p = 0.003). Return to the OR was associated with pneumonia (RR = 3.86, p = 0.044), male sex (RR = 1.85, p = 0.015), and delirium (RR = 1.75, p = 0.016). Serious adverse events were associated with ventilator dependence preoperatively (RR = 1.86, p < 0.001), dialysis (RR = 1.44, p = 0.028), delirium (RR = 1.40, p = 0.005), ASA Class 4 or higher (RR = 1.36, p = 0.035), and male sex (RR = 1.29, p = 0.037). Similarly, LOS was increased in ventilator dependent patients by 1.56-fold (p = 0.002), in patients with ASA Class 4 or higher by 1.30-fold (p = 0.006), and in delirious patients by 1.29-fold (p = 0.008). CONCLUSIONS Adverse outcomes are common after surgery for SDH. In this study, 18% of the patients died within 30 days of surgery. Factors associated with adverse outcomes were identified. Patients and families should be counseled about the serious risks of morbidity and death associated with acute traumatic SDH requiring surgery.

Risk Factors for Blood Transfusion with Primary Posterior Lumbar Fusion.

Study Design. Retrospective cohort study. Objective. To identify factors associated with blood transfusion for primary posterior lumbar fusion surgery, and to identify associations between blood transfusion and other postoperative complications. Summary of Background Data. Blood transfusion is a relatively common occurrence for patients undergoing primary posterior lumbar fusion. There is limited information available describing which patients are at increased risk for blood transfusion, and the relationship between blood transfusion and short‐term postoperative outcomes is poorly characterized. Methods. The American College of Surgeons National Surgical Quality Improvement Program (ACS‐NSQIP) database was used to identify patients undergoing primary posterior lumbar fusion from 2011 to 2013. Multivariate analysis was used to find associations between patient characteristics and blood transfusion, along with associations between blood transfusion and postoperative outcomes. Results. Out of 4223 patients, 704 (16.7%) had a blood transfusion. Age 60 to 69 (relative risk [RR] 1.6), age greater than equal to 70 (RR 1.7), American Society of Anesthesiologists class greater than equal to 3 (RR 1.1), female sex (RR 1.1), pulmonary disease (RR 1.2), preoperative hematocrit less than 36.0 (RR 2.0), operative time greater than equal to 310 minutes (RR 2.9), 2 levels (RR 1.6), and 3 or more levels (RR 2.1) were independently associated with blood transfusion. Interbody fusion (RR 0.9) was associated with decreased rates of blood transfusion. Receiving a blood transfusion was significantly associated with any complication (RR 1.7), sepsis (RR 2.6), return to the operating room (RR 1.7), deep surgical site infection (RR 2.6), and pulmonary embolism (RR 5.1). Blood transfusion was also associated with an increase in postoperative length of stay of 1.4 days (P < 0.001). Conclusion. 1 in 6 patients received a blood transfusion while undergoing primary posterior lumbar fusion, and risk factors for these occurrences were characterized. Strategies to minimize blood loss might be considered in these patients to avoid the associated complications. Level of Evidence: 3

Timing of Complications After Spinal Fusion Surgery.

Study Design. Retrospective cohort study. Objective. To characterize the timing of complications after spinal fusion procedures. Summary of Background Data. Despite many publications on risk factors for complications after spine surgery, there are few publications on the timing at which such complications occur. Methods. Patients undergoing anterior cervical decompression and fusion (ACDF) or posterior lumbar fusion (PLF; with or without interbody) procedures during 2011–2013 were identified in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. For each of 8 different complications, the median time from surgery until complication was determined, along with the interquartile range and middle 80%. Results. A total of 12,067 patients undergoing ACDF and 11,807 patients undergoing PLF were identified. For ACDF, the median day of diagnosis (and interquartile range; middle 80%) for anemia requiring transfusion was 0 (0–1; 0–2), myocardial infarction 2 (1–5; 0–15), pneumonia 4 (2–9; 1–14), pulmonary embolism 5 (2–9; 1–10), deep vein thrombosis 10.5 (7–16.5; 5–21), sepsis 10.5 (4–18; 1–23), surgical site infection 13 (8–19; 5–25), and urinary tract infection 17 (8–22; 4–26). For PLF, the median day of diagnosis (and interquartile range; middle 80%) for anemia requiring transfusion was 0 (0–1; 0–2), myocardial infarction 2 (1–4; 1–8), pneumonia 4 (2–9; 1–17), pulmonary embolism 5 (3–11; 2–17), urinary tract infection 7 (4–14; 2–23), deep vein thrombosis 8 (5–16; 3–20), sepsis 9 (4–16; 2–22), and surgical site infection 17 (13–22; 9–27). Conclusion. These precisely described postoperative time periods enable heightened clinical awareness among spine surgeons. Spine surgeons should have the lowest threshold for testing for each complication during the time period of greatest risk. Authors, reviewers, and surgeons utilizing research on postoperative complications should carefully consider the impact that the duration of follow-up has on study results. Level of Evidence: 3

Spinal Fracture in Patients With Ankylosing Spondylitis: Cohort Definition, Distribution of Injuries, and Hospital Outcomes.

Study Design. A retrospective cohort. Objective. The aim of this study was to characterize spinal fractures in patients with ankylosing spondylitis. Summary of Background Data. Patients with ankylosing spondylitis are susceptible to fractures of the spinal column, even from minor trauma. However, the literature describing patients with ankylosing spondylitis and spinal fractures consists largely of case reports and small case series. The purpose of this study is to better characterize fractures of the ankylosed spine, including the patient population, locations of fracture, and outcomes in a large, nationally representative sample. Methods. All patients with diagnoses of both fracture of the spinal column and ankylosing spondylitis admitted between 2005 and 2011 were identified in the National Inpatient Sample (NIS). Patient demographics, fracture regions, and complications were characterized with descriptive statistics. The associations between injury characteristics and outcomes were assessed using Poisson regression. Results. A total of 939 patients with ankylosing spondylitis admitted with a spinal fracture were identified in NIS. The average age was 68.4 ± 14.7 years, and 85% of patients were male. Cervical fractures were the most common (53.0%), followed by thoracic (41.9%), lumbar (18.2%), and sacral (1.5%). Spinal cord injury was present in 27.5% of cervical fractures, 16.0% of thoracic fractures, and 21.1% of cases overall. Fractures involving more than 1 region of the spine occurred in 13.1% of patients. Patients were treated with fusion in 49.9% of cases. In-hospital adverse events occurred in 29.4% of patients, and 6.6% of patients died during their admission. Conclusion. More than 10% of patients had fractures in more than 1 region of the spine. There is a high risk of adverse events in this population, and 6.6% of patients died during their inpatient stay. These results provide clinicians with a better understanding of the distribution and the high morbidity and mortality of fractures in the ankylosed spine. Level of Evidence: 3

Delayed surgery after acute traumatic central cord syndrome is associated with reduced mortality.

Study Design. A retrospective study of surgically treated patients with acute traumatic central cord syndrome (ATCCS) from the National Trauma Data Bank Research Data Set. Objective. To determine the association of time to surgery, pre-existing comorbidities, and injury severity on mortality and adverse events in surgically treated patients with ATCCS. Summary of Background Data. Although earlier surgery has been shown to be beneficial for other spinal cord injuries, the literature is mixed regarding the appropriate timing of surgery after ATCCS. Traditionally, this older population has been treated with delayed surgery because medical optimization is often indicated preoperatively. Methods. Surgically treated patients with ATCCS in the National Trauma Data Bank Research Data Set from 2011 and 2012 were identified. Time to surgery, Charlson Comorbidity Index, and injury severity scores were tested for association with mortality, serious adverse events, and minor adverse events using multivariate logistic regression. Results. A total of 1060 patients with ATCCS met inclusion criteria. After controlling for pre-existing comorbidity and injury severity, delayed surgery was associated with a decreased odds of inpatient mortality (odds ratio = 0.81, P = 0.04), or a 19% decrease in odds of mortality with each 24-hour increase in time until surgery. The association of time to surgery with serious adverse events was not statistically significant (P = 0.09), whereas time to surgery was associated with increased odds of minor adverse events (odds ratio = 1.06, P < 0.001). Conclusion. Although the potential neurological effect of surgical timing for patients with ATCCS remains controversial, the decreased mortality with delayed surgery suggests that waiting to optimize general health and potentially allow for some spinal cord recovery in these patients may be advantageous. Level of Evidence: 3

Analysis of Delays to Surgery for Cervical Spinal Cord Injuries

Study Design. A retrospective study of surgically treated patients with cervical spinal cord injury (SCI) from the National Trauma Data Bank Research Data Set. Objective. To determine how time to surgery differs between SCI subtypes, where delays before surgery occur, and what factors are associated with delays. Summary of Background Data. Studies have shown that patients with cervical SCI undergoing surgery within 24 hours after injury have superior neurological outcomes to patients undergoing later surgery, with most evidence coming from the incomplete SCI subpopulation. Methods. Surgically treated patients with cervical SCI from 2011 and 2012 were identified in National Trauma Data Bank Research Data Set and divided into subpopulations of complete, central, and other incomplete SCIs. Relationships between surgical timing and patient and injury characteristics were analyzed using multivariate regression. Results. A total of 2636 patients with cervical SCI were identified: 803 with complete SCI, 950 with incomplete SCI, and 883 with central SCI. The average time to surgery was 51.1 hours for patients with complete SCI, 55.3 hours for patients with incomplete SCI, and 83.1 hours for patients with central SCI. Only 44% of patients with SCI underwent surgery within the first 24 hours after injury, including only 49% of patients with incomplete SCI. The vast majority of time between injury and surgery was after admission, rather than in the emergency department or in the field. Upper cervical SCIs and greater Charlson Comorbidity Index were associated with later surgery in all 3 SCI subpopulations. Conclusion. The majority of patients with SCI do not undergo surgery within the first 24 hours after injury, and the majority of delays occur after inpatient admission. Factors associated with these delays highlight areas of focus for expediting care in these patient populations. Level of Evidence: 4

ICD-9 diagnosis codes have poor sensitivity for identification of preexisting comorbidities in traumatic fracture patients: a study of the National Trauma Data Bank

BACKGROUND The use of large national databases for clinical research has increased recently in the field of trauma care as they allow study of rare events without the logistical difficulties of a prospective study. However, many of these databases use administrative billing codes, such as International Classification of Disease—9th Rev. (ICD-9) codes, to identify preexisting patient comorbidities. While the accuracy of these billing codes for research purposes has previously been called into question, this has not been studied in a trauma population. METHODS All patients with proximal tibia fractures in the 2011 and 2012 American College of Surgeons’ National Trauma Data Bank were reviewed. Rates of 12 individual comorbidities in this population were computed using both ICD-9 diagnosis codes and also National Trauma Data Bank chart-abstracted variables. The sensitivity was computed for ICD-9 coding of each comorbidity taking chart-abstracted data elements as criterion standard. With the use of multivariate logistic regression, controlling for age and Injury Severity Score (ISS), the odds ratio for mortality was computed for each comorbidity, using both ICD-9 diagnoses and chart-abstracted diagnoses. RESULTS A total of 32,441 patients with proximal tibia fractures were identified. The sensitivities of ICD-9 billing codes for the comorbidities analyzed ranged from 18.8% for previous myocardial infarction to 2.4% for alcoholism. In individual multivariate analyses of each comorbidity, there was a change in the statistical significance of the odds ratio for mortality for 6 of 12 comorbidities analyzed. CONCLUSION Researchers and those evaluating research in the field of trauma should carefully consider the accuracy of data elements in future studies, especially ICD-9–coded comorbidity diagnoses.

Myelopathy is associated with increased all-cause morbidity and mortality following anterior cervical discectomy and fusion: a study of 5256 patients in American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).

Study Design. Retrospective cohort. Objective. To evaluate whether myelopathy is associated with increased morbidity and mortality after anterior cervical discectomy and fusion (ACDF) compared with other indications for this procedure. Summary of Background Data. ACDF is the most common surgical procedure for the management of a spectrum of cervical spine pathologies. As a more advanced condition, myelopathy is generally thought to be associated with higher morbidity and mortality after this procedure, but there is limited evidence to support this supposition. The current study compares outcomes of ACDF procedures performed for myelopathy with those performed for other indications, controlling for other patient factors. Methods. Patients who underwent ACDF between 2010 and 2012 were identified in the American College of Surgeons National Surgical Quality Improvement Program database. Patients with myelopathy were identified by diagnosis codes for cervical myelopathy. Bivariate and multivariate logistic regressions were performed to compare 30-day adverse events and readmission between groups. Multivariate analyses controlled for patient and surgical characteristics. Results. A total of 5256 ACDF procedures met inclusion criteria, of which 1425 (27.3%) were performed for cervical myelopathy. Patients with myelopathy were older and were less healthy than patients without myelopathy. Multivariate analysis controlling for baseline patient characteristics found that patients with myelopathy were at significantly increased risk of any adverse event (odds ratio = 1.5), any severe adverse event (odds ratio = 1.8), and death (odds ratio = 8.9) compared with patients without myelopathy. Conclusion. After adjusting for baseline patient characteristics, not only were any adverse events and serious adverse events more common after ACDF for patients with myelopathy than for patients without myelopathy, but mortality was approximately 9 times more likely. It is important for surgical planning and patient counseling to keep this significant difference in mind for this common procedure that has different morbidities based on the pathology for which it is performed. Level of Evidence: 3

Overall Similar Infection Rates Reported in the Physician-reported Scoliosis Research Society Database and the Chart-abstracted American College of Surgeons National Surgical Quality Improvement Program Database.

Study Design. This is a retrospective cohort study. Objective. To compare the infection rates in the Scoliosis Research Society (SRS) morbidity and mortality database to those in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Summary of Background Data. Surgical databases have demonstrated value in orthopaedic surgery. However, few studies in the literature have used the SRS database relative to other available databases. To validate the surgeon-reported data of the SRS database, we compared the rate of postoperative infection in this database to that in the chart-abstracted ACS-NSQIP database. Methods. International Classification of Disease, ninth revision (ICD-9) codes were used to group patients from the 2012 and 2013 ACS-NSQIP database into groups corresponding to spinal deformity diagnoses delineated by SRS. Postoperative infection rates after surgical correction of these deformities compared with those reported in the 2012 and 2013 SRS database using &khgr;2 tests. Results. The overall rate of acute postoperative infection was slightly lower in the SRS database than in the ACS-NSQIP database (1.21% compared to 2.05% in ACS-NSQIP, a difference of only 0.84%, statistically significant, P < 0.001). The infection rates of most diagnoses did not differ; these included scoliosis (idiopathic <10 yr of age/congenital/neuromuscular/other scoliosis), spondylolisthesis (isthmic/dysplastic), and kyphosis (congenital and other). The only differences noted were in Scheuermann kyphosis (difference of 5.49%, P = 0.003), degenerative spondylolithesis (difference of 0.69%, P = 0.003), and idiopathic scoliosis in the age 10 to18 yr and adult age ranges (differences of 1.10% and 1.28%, P < 0.001 for both). Conclusion. Although some statistical differences were found in infection rates between the surgeon-reported SRS database and the chart-abstracted ACS-NSQIP database, these small differences likely reflect differences in surgical cases and data collection methods. This finding supports the validity of the surgeon-reported SRS morbidity and morality database. Level of Evidence: 3