Background African American (AA) men in the general US population are more than twice as likely to die of prostate cancer (PC) compared with non‐Hispanic white (NHW) men. The authors hypothesized that receiving care through the Veterans Affairs (VA) health system, an equal‐access medical system, would attenuate this disparity. Methods A longitudinal, centralized database of >20 million veterans was used to assemble a cohort of 60,035 men (18,201 AA men [30.3%] and 41,834 NHW men [69.7%]) who were diagnosed with PC between 2000 and 2015. Results AA men were more likely to live in regions with a lower median income ($40,871 for AA men vs $48,125 for NHW men; P < .001) and lower high school graduation rates (83% for AA men vs 88% for NHW men; P < .001). At the time of diagnosis, AA men were younger (median age, 63.0 years vs 66.0 years; P < .001) and had a higher prostate‐specific antigen level (median, 6.7 ng/mL vs 6.2 ng/mL; P < .001), but were less likely to have Gleason score 8 to 10 disease (18.8% among AA men vs 19.7% among NHW men; P < .001), a clinical T classification ≥3 (2.2% vs 2.9%; P < .001), or distant metastatic disease (2.7% vs 3.1%; P = 0.01). The 10‐year PC‐specific mortality rate was slightly lower for AA men (4.4% vs 5.1%; P = .005), which was confirmed in multivariable competing‐risk analysis (subdistribution hazard ratio, 0.85; 95% CI, 0.78‐0.93; P < .001). Conclusions AA men diagnosed with PC in the VA health system do not appear to present with more advanced disease or experience worse outcomes compared with NHW men, in contrast to national trends, suggesting that access to care is an important determinant of racial equity.
IMPORTANCEResearchers often analyze cancer registry data to assess for differences in survival among cancer treatments. However, the retrospective, nonrandomized design of these analyses raises questions about study validity.OBJECTIVE To examine the extent to which comparative effectiveness analyses using observational cancer registry data produce results concordant with those of randomized clinical trials. DESIGN, SETTING, AND PARTICIPANTSIn this comparative effectiveness study, a total of 141 randomized clinical trials referenced in the National Comprehensive Cancer Network Clinical Practice Guidelines for 8 common solid tumor types were identified. Data on participants within the National Cancer Database (NCDB) diagnosed between 2004 and 2014, matching the eligibility criteria of the randomized clinical trial, were obtained. The present study was conducted from August 1, 2017, to September 10, 2019. The trials included 85 118 patients, and the corresponding NCDB analyses included 1 344 536 patients. Three Cox proportional hazards regression models were used to determine hazard ratios (HRs) for overall survival, including univariable, multivariable, and propensity score-adjusted models. Multivariable and propensity score analyses controlled for potential confounders, including demographic, comorbidity, clinical, treatment, and tumor-related variables. MAIN OUTCOMES AND MEASURESThe main outcome was concordance between the results of randomized clinical trials and observational cancer registry data. Hazard ratios with an NCDB analysis were considered concordant if the NDCB HR fell within the 95% CI of the randomized clinical trial HR. An NCDB analysis was considered concordant if both the NCDB and clinical trial P values for survival were nonsignificant (P Ն .05) or if they were both significant (P < .05) with survival favoring the same treatment arm in the NCDB and in the randomized clinical trial. RESULTSAnalyses using the NCDB-produced HRs for survival were concordant with those of 141 randomized clinical trials in 79 univariable analyses (56%), 98 multivariable analyses (70%), and 90 propensity score models (64%). The NCDB analyses produced P values concordant with randomized clinical trials in 58 univariable analyses (41%), 65 multivariable analyses (46%), and 63 propensity score models (45%). No clinical trial characteristics were associated with concordance between NCDB analyses and randomized clinical trials, including disease site, type of clinical intervention, or severity of cancer. CONCLUSIONS AND RELEVANCEThe findings of this study suggest that comparative effectiveness research using cancer registry data often produces survival outcomes discordant with those of (continued)
Background: Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) has comparable fusion rates and outcomes to the open approach, though many surgeons avoid the technique due to an initial learning curve. No current studies have examined the learning curve of MI-TLIF with respect to fluoroscopy time and exposure. Our objective with this retrospective review was to therefore use a repeatable mathematical model to evaluate the learning curve of MI-TLIF with a focus on fluoroscopy time and exposure. Methods: We conducted a retrospective review of single level, primary fusions performed by a single surgeon during his initial experience with minimally invasive spine surgery. Chronologic case number was plotted against variables of interest, and learning was identified as the point at which the instantaneous rate of change of a curve fit to the data set equaled the average rate of change of the data set. Results: One hundred nine cases were reviewed. Proficiency in operative time was achieved at 38 cases with the first 38 requiring a median of 137 minutes compared to 104 minutes for the latter 71 cases (P , .0001). Mastery of fluoroscopy use occurred at case 51. The median fluoroscopy time for the first 51 cases was 2.8 minutes, which dropped to 2.1 minutes for cases 52 to 109 (P , .0001). The complication rate plateaued after 43 cases, with 3 of 11 total complications occurring in the latter 76 cases. Conclusions: Our results demonstrate the most gradual learning occurred with respect to fluoroscopy time and exposure, and operative time improved the quickest. Level of Evidence: IV. Clinical Relevance: These findings may guide spine surgeon education and training in minimally invasive techniques, and help determine safe case loads for radiation exposure during the initial learning phase of the technique. The model used to identify the learning curve can also be applied to several fields and surgical techniques.
BackgroundPopulation‐based studies demonstrate that Black men in the United States have an increased risk of death from prostate cancer. Determinants of racial disparities are multifactorial, including socioeconomic and biologic factors.MethodsThe authors conducted a pooled analysis of patients derived from 152 centers within the Veterans Health Administration. The cohort included men who had nonmetastatic prostate diagnosed between 2001 and 2015 and received definitive radiation therapy. The primary endpoint was prostate cancer‐specific mortality (PCSM). Secondary endpoints included all‐cause mortality (ACM) and the time from a prostate‐specific antigen level ≥4 ng/mL to biopsy and radiation therapy. A Cox regression model was performed to adjust for differences between clinical parameters.ResultsAmong the 31,131 patients included in the cohort, 9584 (30.8%) were Black. The 10‐year cumulative incidence of death from prostate cancer was lower in Black men compared with White men (4.0% vs 4.8%; P = .004). In a competing risk model, Black race was associated with a decreased risk of PCSM (subdistribution hazard ratio, 0.79; 95% CI, 0.69‐0.92; P = .002). Similarly, the 10‐year cumulative incidence of death from any cause was lower in Black men (27.6% vs 31.8%; P < .001). In multivariable analysis, Black men had a 10% decreased risk of ACM (hazard ratio, 0.90; 95% CI, 0.85‐0.95; P < .001).ConclusionsThe current results indicate relatively lower PCSM and ACM among Black men who were included in a large Veterans Health Administration cohort and received radiation therapy as primary treatment for nonmetastatic prostate cancer. There is an ongoing need to continue to understand and mitigate the factors associated with disparities in health care outcomes.
Key Points Question Is nivolumab-ipilimumab combination therapy cost-effective as first-line treatment for patients with advanced non–small cell lung cancer compared with platinum-doublet chemotherapy? Findings In this economic evaluation of the cost-effectiveness of nivolumab-ipilimumab combination therapy, a Markov model was designed to simulate patients with advanced non–small cell lung cancer who were receiving either nivolumab-ipilimumab combination therapy or platinum-doublet chemotherapy. In this model, nivolumab-ipilimumab combination therapy was not found to be cost-effective at a willingness-to-pay threshold of $100 000 per quality-adjusted life-year, with an incremental cost-effectiveness ratio of $401 700 per quality-adjusted life-year compared with chemotherapy. Meaning The findings suggest that first-line treatment with nivolumab-ipilimumab combination therapy is not cost-effective at current prices despite clinical trial data indicating that this therapy increases overall survival among patients with advanced non–small cell lung cancer.
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