John Wayne Clinical Research Lecture: New Avenues for Uplifting the Global Quality of Care in Surgical Oncology.

Health care equality is an idealistic goal that is difficult to achieve. However, uplifting the quality of care in surgery for cancer is achievable through several means, the most important of which is training of surgeons through properly structured training programs. However, such programs vary greatly, and no uniformity of curriculum exists throughout the world. On the other hand, several avenues are available for uplifting the quality of care through education and dissemination of knowledge at an individual level, an institutional level, a national level, and an international level. Efforts to uplift the quality of surgical care at an individual level can be by direct delivery of care or by dissemination of knowledge and experiences through personal interactions, lectures, and published works. Conferences, webinars, and travel grants are effective means offered by several institutions and national professional organizations. At an international level, however, much more can be done. For example, in the specialty of head and neck surgery, the International Federation of Head and Neck Oncologic Societies (IFHNOS) has done extraordinary work through world congresses, world tour programs, master courses on operative techniques, and its most impactful program, the Global On Line Fellowship in head and neck surgery and oncology. The programs offered by IFHNOS have had a huge impact on the quality of surgical care for head and neck cancer worldwide. This prototype can be used in many other specialties of surgical oncology to uplift the quality of care globally.

Global On Line Fellowship in head and neck surgery and oncology.

The International Federation of Head and Neck Oncologic Societies and Memorial Sloan Kettering Cancer Center in New York have partnered to create the Global On Line Fellowship program, a postgraduate fellowship training opportunity for candidates all around the world who are not able to get on-site fellowship training at centers of excellence. This article delineates the successes, challenges, and future goals for the program.

Distant metastasis of salivary gland cancer: Incidence, management, and outcomes.

BACKGROUND: Distant metastases (DMs) are the primary cause of treatment failure in patients with salivary gland carcinoma. There is no consensus on the standard treatment. METHODS: Patients with DMs were identified from an institutional database of 884 patients with salivary gland cancer who underwent resection of the primary tumor between 1985 and 2015. Survival outcomes for patients with DMs were determined with the Kaplan-Meier method. Univariate and multivariate analyses were performed to identify factors associated with DM. RESULTS: Of the 884 patients identified, 137 (15%) developed DMs during follow-up. Most of the primary tumors (n = 77 [56%]) were located in a major salivary gland. At clinical presentation, 53% of the tumors were classified as T3 or T4, and 32% had clinical node metastases. The median time to DM was 20.3 months. The factors associated with shorter distant recurrence-free survival were male sex, high-risk tumor histology, and advanced pathological T and N classifications. Patients with bone metastases had a lower survival rate than patients with lung metastases. The total number of DMs in a patient was inversely associated with survival. Patients who underwent surgical resection of DMs had a significantly higher 5-year rate of metastatic disease-specific survival than patients who underwent observation or nonsurgical treatment (44%, 29%, and 19%, respectively; P = .003). CONCLUSIONS: In patients with DMs of salivary gland carcinoma, survival is negatively associated with high-grade histology, bone DMs, and the total number of DMs. Metastasectomy can help to lengthen disease-free survival.

Cost-effectiveness analysis of papillary thyroid cancer surveillance.

BACKGROUND: The recent overdiagnosis of subclinical, low-risk papillary thyroid cancer (PTC) coincides with a growing national interest in cost-effective health care practices. The aim of this study was to measure the relative cost-effectiveness of disease surveillance of low-risk PTC patients versus intermediate- and high-risk patients in accordance with American Thyroid Association risk categories. METHODS: Two thousand nine hundred thirty-two patients who underwent thyroidectomy for differentiated thyroid cancer between 2000 and 2010 were identified from the institutional database; 1845 patients were excluded because they had non-PTC cancer, underwent less than total thyroidectomy, had a secondary cancer, or had <36 months of follow-up. In total, 1087 were included for analysis. The numbers of postoperative blood tests, imaging scans and biopsies, clinician office visits, and recurrence events were recorded for the first 36 months of follow-up. Costs of surveillance were determined with the Physician Fee Schedule and Clinical Lab Fee Schedule of the Centers for Medicare and Medicaid Services. RESULTS: The median age was 44 years (range, 7-83 years). In the first 36 months after thyroidectomy, there were 3, 44, and 22 recurrences (0.8%, 7.8%, and 13.4%) in the low-, intermediate-, and high-risk categories, respectively. The cost of surveillance for each recurrence detected was US $147,819, US $22,434, and US $20,680, respectively. CONCLUSIONS: The cost to detect a recurrence in a low-risk patient is more than 6 and 7 times greater than the cost for intermediate- and high-risk PTC patients. It is difficult to justify this allocation of resources to the surveillance of low-risk patients. Surveillance strategies for the low-risk group should, therefore, be restructured.

Accuracy of administrative and clinical registry data in reporting postoperative complications after surgery for oral cavity squamous cell carcinoma.

BACKGROUND: The purpose of this study was to describe and compare how postoperative complications after oral cavity squamous cell carcinoma (SCC) surgery are reported in medical records, institutional billing claims, and national clinical registries. METHODS: The medical records of 355 previously untreated patients who underwent surgery for oral cavity SCC at our institution were retrospectively reviewed for postoperative complications. Information was compared with claims and National Surgical Quality Improvement Program (NSQIP) data. RESULTS: We identified 219 patients (62%) experiencing 544 complications (10% major). Billing claims identified 29% of these patients, 36% of overall complications, and 98% of major complications. Of overlapping patients, NSQIP identified 27% of patients, 33% of overall complications, and 100% of major complications noted on chart abstraction. CONCLUSION: The incidence of minor postoperative complications after oral cavity SCC surgery is relatively high. Both claims data and NSQIP accurately recorded major complications, but were suboptimal compared to chart abstraction in capturing minor complications.

Incidence and management of renal adverse events in patients with relapsed and/or refractory multiple myeloma treated with single-agent carfilzomib.

Patients with multiple myeloma (MM) frequently experience renal dysfunction owing to patient-specific risk factors, the pathophysiology of MM, and treatment-related adverse events. The presence of renal complications in patients with MM may be associated with advanced disease and is a negative prognostic factor for survival. Frequently these patients receive reduced or modified dosing regimens, which can result in under-dosing and may adversely affect treatment efficacy. Consequently, there is a need for effective therapies with favorable renal safety profiles. Carfilzomib is a selective proteasome inhibitor approved in the United States as a single agent for the treatment of relapsed and refractory MM. Safety studies have demonstrated that single-agent carfilzomib is well tolerated in patients with relapsed and/or refractory MM and concomitant renal dysfunction. This article reviews the etiology and incidence of renal adverse events in patients with MM, the renal safety profile of single-agent carfilzomib from four phase II studies in patients with relapsed and/or refractory MM, and the management of patients with MM who receive carfilzomib and are at risk for renal complications.

Hyperbaric oxygen therapy in necrotising soft tissue infections: a study of patients in the United States Nationwide Inpatient Sample.

PURPOSE: Necrotising soft tissue infection (NSTI) is a deadly disease associated with a significant risk of mortality and long-term disability from limb and tissue loss. The aim of this study was to determine the effect of hyperbaric oxygen (HBO(2)) therapy on mortality, complication rate, discharge status/location, hospital length of stay and inflation-adjusted hospitalisation cost in patients with NSTI. METHODS: This was a retrospective study of 45,913 patients in the Nationwide Inpatient Sample (NIS) from 1988 to 2009. RESULTS: A total of 405 patients received HBO(2) therapy. The patients with NSTI who received HBO(2) therapy had a lower mortality (4.5 vs. 9.4 %, p = 0.001). After adjusting for predictors and confounders, patients who received HBO(2) therapy had a statistically significantly lower risk of dying (odds ratio (OR) 0.49, 95 % confidence interval (CI) 0.29-0.83), higher hospitalisation cost (US$52,205 vs. US$45,464, p = 0.02) and longer length of stay (LOS) (14.3 days vs. 10.7 days, p < 0.001). CONCLUSIONS: This retrospective analysis of HBO(2) therapy in NSTI showed that despite the higher hospitalisation cost and longer length of stay, the statistically significant reduction in mortality supports the use of HBO(2) therapy in NSTI.

System dynamics to model the unintended consequences of denying payment for venous thromboembolism after total knee arthroplasty.

BACKGROUND: The Hospital Acquired Condition Strategy (HACS) denies payment for venous thromboembolism (VTE) after total knee arthroplasty (TKA). The intention is to reduce complications and associated costs, while improving the quality of care by mandating VTE prophylaxis. We applied a system dynamics model to estimate the impact of HACS on VTE rates, and potential unintended consequences such as increased rates of bleeding and infection and decreased access for patients who might benefit from TKA. METHODS AND FINDINGS: The system dynamics model uses a series of patient stocks including the number needing TKA, deemed ineligible, receiving TKA, and harmed due to surgical complication. The flow of patients between stocks is determined by a series of causal elements such as rates of exclusion, surgery and complications. The number of patients harmed due to VTE, bleeding or exclusion were modeled by year by comparing patient stocks that results in scenarios with and without HACS. The percentage of TKA patients experiencing VTE decreased approximately 3-fold with HACS. This decrease in VTE was offset by an increased rate of bleeding and infection. Moreover, results from the model suggest HACS could exclude 1.5% or half a million patients who might benefit from knee replacement through 2020. CONCLUSION: System dynamics modeling indicates HACS will have the intended consequence of reducing VTE rates. However, an unintended consequence of the policy might be increased potential harm resulting from over administration of prophylaxis, as well as exclusion of a large population of patients who might benefit from TKA.

Do insurance and race represent independent predictors of undergoing total shoulder arthroplasty? A secondary data analysis of 3529 patients.

HYPOTHESIS: Race and insurance status are independent predictors of the choice between total shoulder arthroplasty (TSA) and hemiarthroplasty (HA) of the shoulder joint. BACKGROUND: Current literature shows that ethnic and socioeconomic status may influence access to health care. However, no study has demonstrated whether insurance status and race are independent predictors that patients with glenohumeral osteoarthritis will undergo TSA. MATERIALS AND METHODS: Patients with primary International Classification of Diseases, 9th revision, Clinical Modification, procedure codes for TSA and HA were selected from the 1988 to 2007 United States Nationwide Inpatient Sample. Primary predictors were race (Caucasian, African American, Hispanic, other) and insurance status (private, Medicare, Medicaid, other). Multiple logistic regressions were used to determine whether insurance status and race were associated with the choice of procedure for patients presenting with glenohumeral osteoarthritis. RESULTS: The study included data for 3529 patients, of whom 2369 underwent TSA (67.1%) and the remaining 1160 (32.9%) underwent HA. Of patients treated using TSA, 29% were privately insured, 63.2% had Medicare, and 2.5% had Medicaid (P < .001), and 62.1% were Caucasian, 2.5% were African American, 2.46% were Hispanic, and 30.9% had other ethnicities (P < .001). DISCUSSION: Multiple logistic regression analysis found that privately insured patients and Medicare patients did not show statistically different odds of having TSA compared with patients within the Medicaid (reference category) or "other payment" categories, after adjustment for a variety of potential confounders. Caucasian patients also did not show statistically different chances of undergoing TSA compared with African Americans. CONCLUSIONS: We were unable to support statistical evidence that race and insurance status are independent factors associated with the choice of the surgical procedure in patients with glenohumeral osteoarthritis.

Cost and outcomes after cold and mixed adenotonsillectomy in children.

OBJECTIVE/HYPOTHESIS: To compare cold and mixed (electrocautery tonsillectomy with curettage adenoidectomy) adenotonsillectomies in children in terms of hospital medications' and materials' costs, surgical time, aspirated blood volume, and postoperative pain. STUDY DESIGN: Randomized clinical trial in community hospitals. METHODS: Seventy-two patients aged 3 to 12 years, undergoing adenotonsillectomy, were randomized in two groups through sealed envelopes that were opened just prior to the procedure. Surgical time and aspirated blood volume were measured by a staff nurse. Hospital medication and material costs were supplied by the hospital's accounting department. A validated facial pain scale was used from the day of surgery to the 10th postoperative day to quantify pain. RESULTS: Bicaudal t test showed that materials' cost was lower in the mixed technique. Surgical time and aspirated blood volume were also lower with the mixed technique. The postoperative pain was more intense in the cold technique on the day of surgery, but was more intense in the mixed technique from the 4th day to the 6th day. Linear regression showed a weak association between materials' cost and aspirated blood volume. CONCLUSIONS: Mixed technique reduces the costs of materials while offering the patient and the surgeon a safer and faster method to perform adenotonsillectomy, although it is slightly more painful than the cold technique in the latter part of the postoperative period.

Selection mechanisms underlying high impact biomedical research--a qualitative analysis and causal model.

BACKGROUND: Although scientific innovation has been a long-standing topic of interest for historians, philosophers and cognitive scientists, few studies in biomedical research have examined from researchers' perspectives how high impact publications are developed and why they are consistently produced by a small group of researchers. Our objective was therefore to interview a group of researchers with a track record of high impact publications to explore what mechanism they believe contribute to the generation of high impact publications. METHODOLOGY/PRINCIPAL FINDINGS: Researchers were located in universities all over the globe and interviews were conducted by phone. All interviews were transcribed using standard qualitative methods. A Grounded Theory approach was used to code each transcript, later aggregating concept and categories into overarching explanation model. The model was then translated into a System Dynamics mathematical model to represent its structure and behavior. Five emerging themes were found in our study. First, researchers used heuristics or rules of thumb that came naturally to them. Second, these heuristics were reinforced by positive feedback from their peers and mentors. Third, good communication skills allowed researchers to provide feedback to their peers, thus closing a positive feedback loop. Fourth, researchers exhibited a number of psychological attributes such as curiosity or open-mindedness that constantly motivated them, even when faced with discouraging situations. Fifth, the system is dominated by randomness and serendipity and is far from a linear and predictable environment. Some researchers, however, took advantage of this randomness by incorporating mechanisms that would allow them to benefit from random findings. The aggregation of these themes into a policy model represented the overall expected behavior of publications and their impact achieved by high impact researchers. CONCLUSIONS: The proposed selection mechanism provides insights that can be translated into research coaching programs as well as research policy models to optimize the introduction of high impact research at a broad scale among institutional and governmental agencies.

Identification of novel prognosticators of outcome in squamous cell carcinoma of the head and neck.

PURPOSE: The goal of this study was to identify chromosomal aberrations associated with poor outcome in patients with head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS: We assessed the global genomic composition of 82 HNSCCs from previously untreated patients with comparative genomic hybridization (CGH). The CGH data were subcategorized into individual cytogenetic bands. Only genomic aberrations occurring in more than 5% of cases were analyzed, and redundancies were eliminated. Each aberration was submitted to univariate analysis to assess its relationship with disease-specific survival (DSS). We used Monte Carlo simulations (MCS) to adjust P values for the log-rank approximate chi(2) statistics for each abnormality and further applied the Hochberg-Benjamini procedure to adjust the P values for multiple testing of the large number of abnormalities. We then submitted abnormalities whose univariate tests resulted in an adjusted P value of less than.15 together with significant demographic/clinical variables to stepwise Cox proportional hazards regression. We again verified and adjusted P values for the chi(2) approximation of the final model by MCS. RESULTS: CGH analysis revealed a recurrent pattern of chromosomal aberrations typical for HNSCC. Univariate analysis revealed 38 abnormalities that were correlated with DSS. After controlling for multiple comparisons and confounding effects of stage, five chromosomal aberrations were significantly associated with outcome, including amplification at 11q13, gain of 12q24, and losses at 5q11, 6q14, and 21q11 (MCS adjusted P =.0009 to P =.01). CONCLUSION: HNSCC contains a complex pattern of chromosomal aberrations. A sequential approach to control for multiple comparisons and effect of confounding variables allows the identification of clinically relevant aberrations. The significance of each individual abnormality merits further consideration.

Prospective functional voice assessment in patients undergoing thyroid surgery.

OBJECTIVE: To analyze voice function before and after thyroidectomy for patients with normal preoperative voice using a standardized multidimensional voice assessment protocol. SUMMARY BACKGROUND DATA: The natural history of post-thyroidectomy voice disturbances for patients with preserved laryngeal nerve function has not been systematically studied and characterized with the intent of using the data for postoperative voice rehabilitation. METHODS: During a prospective single-arm study, patients with normal voice underwent functional voice testing using a standardized voice grading scale and a battery of acoustic, aerodynamic, glottographic, and videostroboscopic tests before, 1 week after, and 3 months after thyroidectomy. Differences in observed sample means were evaluated using analysis of covariance or t test; categorical data was analyzed using the Fisher exact or chi-square test. RESULTS: Fifty-four patients were enrolled; 50 and 46 were evaluable at 1 week and 3 months, respectively. No patient developed recurrent laryngeal nerve injury; one had superior laryngeal nerve injury. Fifteen (30%) patients reported early subjective voice change and seven (14%) reported late (3-month) subjective voice change. Forty-two (84%) patients had significant objective change in at least one voice parameter. Six (12%) had significant alterations in more than three voice measures, of which four (67%) were symptomatic, whereas 25% with three or fewer objective changes had symptoms. Patients with persistent voice change at 3 months had an increased likelihood of multiple (more than three) early objective changes (43% vs. 7%). Early maximum phonational frequency range and vocal jitter changes from baseline were significantly associated with voice symptoms at 3 months. CONCLUSIONS: Early vocal symptoms are common following thyroidectomy and persist in 14% of patients. Multiple (more than three) objective voice changes correlate with early and late postoperative symptoms. Alterations in maximum phonational frequency range and vocal jitter predict late perceived vocal changes. Factors other than laryngeal nerve injury appear to alter post-thyroidectomy voice. The variability of patient symptoms underscores the importance of understanding the physiology of dysphonia.