Publications

BACKGROUND: Insurance type has been reported to be an independent predictor of overall survival in lung cancer patients. We studied the effect of insurance type on patient outcomes after minimally invasive pulmonary lobectomy for lung cancer.

METHODS: We retrospectively analyzed 433 consecutive patients who underwent robotic-assisted pulmonary lobectomy by one surgeon during an 80-month period. Perioperative outcomes and intraoperative and postoperative complications were noted. Disposition at discharge after surgery (favorable, eg, transfer to home with self-care or with home health nursing and/or physical therapy, versus unfavorable, eg, long-term acute care or rehabilitation facility, hospice, or death) and 5-year overall survival (5-years OS) were also recorded. We used Pearson χ2, analysis of variance (ANOVA), and Kruskal-Wallis test to compare variables and Cox regression for survival analysis.

RESULTS: There were 107 patients (mean age 57.5 years) with private insurance, 118 (mean age 70.3 years) with public insurance (Medicare or Medicaid), 196 (mean age 71.8 year; P < .001) with combination insurance plans (Medicare plus a privately supplied supplemental), and 12 patients with no insurance (excluded owing to low sample size). There were more current smokers in the public insurance group, more former smokers in the combination insurance group, and more nonsmokers in the private insurance group (P = .03). There were more comorbidities in the public and combination insurance groups versus the private insurance group, including gastroesophageal reflux disease (P = .003), hypertension (P = .01), and hyperlipidemia (P < .001). The groups had no differences in tumor size or pathologic stage. There were higher numbers of intraoperative conversions to open lobectomy in the private and public insurance groups versus the combination insurance group (P = .001). Also, the private and combination insurance groups had more cases of favorable disposition at discharge after surgery compared with the public insurance group (P < .001). Multivariable regression analyses identified private insurance type as an independent predictor of favorable disposition at discharge (public versus private plan; odds ratio, 0.43; 95% confidence interval [CI], 0.22-0.85, P = .02) and 5-year OS (combination versus private plan; hazard ratio, 2.68; 95% CI, 1.26-5.67, P = .01; public versus private plan; HR, 2.84; 95% CI, 1.37-5.89; P = .01).

CONCLUSION: Although public or combination insurance type was associated with greater risk of all-cause mortality, and public insurance type was associated with less favorable disposition at discharge after surgery and overall conversion to open lobectomy, insurance type was not associated with increased intraoperative complications, hospital duration of stay, or in-hospital mortality after minimally invasive robotic-assisted pulmonary lobectomy.

INTRODUCTION: Microsurgical clipping and Endovascular coiling (EC) are both effective alternatives in the management of intracranial aneurysms. EC has been shown to be associated with the risk of recurrent aneurysm (RA) growth. Considering the minimally invasive nature of this procedure, the management of intracranial aneurysms has been skewed toward EC, especially in the developed world. In this scenario, there has been an upsurge of RAs after EC. Since the optimal management of these RAs has not been defined, they pose a unique challenge to the treating surgeons.

AIMS AND OBJECTIVES: The aim of this study is to elucidate the optimal management of RAs after EC.

MATERIALS AND METHODS: Medical records of all patients who underwent surgery for RAs were reviewed from the period January 2014 to March 2019. The demographic and angiographic patterns of the patients and operative techniques and complications were studied. The outcome was dichotomized into good and bad depending on the Glasgow outcome scale (GOS).

RESULTS: There were four cases of RAs operated in our institution between the above-mentioned period. There were varied differences between the initial coiling and time to recurrences. All four patients were operated under neuromonitoring. Three underwent clipping and one patient underwent clipping with bypass. All four patients had good outcome with a GOS of 5/5.

CONCLUSION: Operations for RAs constitute many technical challenges and require a lot of expertise. Such surgeries are recommended in high-volume centers, with sufficient experience in both clipping and cerebral bypass.

BACKGROUND: Primary orbital involvement is extremely rare in echinococcosis. We report a case of giant orbital hydatid cyst in a 15-year-old boy.

CASE DESCRIPTION: A 15-year-old boy presented with left-side proptosis and gradual painless vision loss. Computed tomography and magnetic resonance imaging revealed a giant multilocular cystic orbital lesion extending into subfrontal region. Surgical excision was done. Histopathology was suggestive of hydatid cyst. Postoperatively, an antiparasitic agent was administered for 3 months.

CONCLUSIONS: Hydatic cyst should be kept in differential diagnosis of orbital cystic lesions, especially in pediatric population and endemic areas.

IMPORTANCE: Maintenance therapies are often considered as a therapeutic strategy in patients with lymphoma following autologous hematopoietic cell transplantation (auto-HCT) to mitigate the risk of disease relapse. With an evolving therapeutic landscape, where novel drugs are moving earlier in therapy lines, evidence relevant to contemporary practice is increasingly limited. The American Society for Blood and Marrow Transplantation (ASBMT), Center for International Blood and Marrow Transplant Research (CIBMTR), and European Society for Blood and Marrow Transplantation (EBMT) jointly convened an expert panel with diverse expertise and geographical representation to formulate consensus recommendations regarding the use of maintenance and/or consolidation therapies after auto-HCT in patients with lymphoma.

OBSERVATIONS: The RAND-modified Delphi method was used to generate consensus statements where at least 75% vote in favor of a recommendation was considered as consensus. The process included 3 online surveys moderated by an independent methodological expert to ensure anonymity and an in-person meeting. The panel recommended restricting the histologic categories covered in this project to Hodgkin lymphoma (HL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma. On completion of the voting process, the panel generated 22 consensus statements regarding post auto-HCT maintenance and/or consolidation therapies. The grade A recommendations included endorsement of: (1) brentuximab vedotin (BV) maintenance and/or consolidation in BV-naïve high-risk HL, (2) rituximab maintenance in MCL undergoing auto-HCT after first-line therapy, (3) rituximab maintenance in rituximab-naïve FL, and (4) No post auto-HCT maintenance was recommended in DLBCL. The panel also developed consensus statements for important real-world clinical scenarios, where randomized data are lacking to guide clinical practice.

CONCLUSIONS AND RELEVANCE: In the absence of contemporary evidence-based data, the panel found RAND-modified Delphi methodology effective in providing a rigorous framework for developing consensus recommendations for post auto-HCT maintenance and/or consolidation therapies in lymphoma.

Incisional hernias occur after abdominal organ transplantation with rates of 1.6 per cent to 18 per cent in kidney transplants (KTs) and 1.7 to 32.4 per cent in liver transplants (LTs). We hypothesized a difference in KT and LT outcomes in patients with and without repair of incisional hernias. We conducted a retrospective cohort study of abdominal transplants from 2012 through 2016. The difference across compared groups for continuous variables was assessed using the independent sample t test, and for binary variables, using the chi-squared test. A total of 1518 transplants were performed, including 1138 KTs and 380 LTs. There were 83 KT incisional hernias (67 repaired) and 59 LT incisional hernias (48 repaired). There was no difference between groups with regard to smoking, diabetes, age, BMI, days on dialysis (KTs), pretransplant Model for End-Stage Liver Disease (MELD) (LTs), cold ischemic time, graft survival, or recurrence rate by repair method. In the LT population, there was a statistically significant difference in days on the waitlist (P = 0.02), drain placement (P = 0.04), and cytomegalovirus (CMV) mismatch (P = 0.02). Patient survival was also statistically significant for KTs (P = 0.04) and LTs (P = 0.01). KT and LT patients who have their incisional hernias repaired have better overall survival, regardless of the repair technique.

Human T cell lymphotropic virus type 1 (HTLV1)-associated adult T cell leukemia/lymphoma (ATLL) is an aggressive malignant disorder. Intensive conventional chemotherapy regimens and autologous hematopoietic cell transplantation (HCT) have failed to improve outcomes in ATLL. Allogeneic HCT (allo-HCT) is commonly offered as front-line consolidation despite lack of randomized controlled trials. We performed a comprehensive search of the medical literature using PubMed/Medline, EMBASE, and Cochrane reviews on September 10, 2018. We extracted data on clinical outcomes related to benefits (complete response [CR], overall survival [OS], and progression-free survival [PFS]) and harms (relapse and nonrelapse mortality [NRM]), independently by 2 authors. Our search strategy identified a total of 801 references. Nineteen studies (n = 2446 patients) were included in the systematic review; however, only 18 studies (n = 1767 patients) were included in the meta-analysis. Reduced intensity conditioning regimens were more commonly prescribed (52%). Bone marrow (50%) and peripheral blood (40%) were more frequently used as stem cell source. The pooled post-allografting CR, OS, and PFS rates were 73% (95% confidence interval [CI], 57% to 87%), 40% (95% CI, 33% to 46%), and 37% (95% CI, 27% to 48%), respectively. Pooled relapse and NRM rates were 36% (95% CI, 28% to 43%) and 29% (95% CI, 21% to 37%), respectively. The heterogeneity among the included studies was generally high. These results support the use of allo-HCT as an effective treatment for patients with ATLL, yielding pooled OS rates of 40%, but relapse still occurs in over one-third of cases. Future studies should evaluate strategies to help reduce relapse in patients with ATLL undergoing allo-HCT.

IMPORTANCE: The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.

OBJECTIVES: To determine how often the FDA has authorized novel interventions based on non-RCTs and to assess whether there is an association of the magnitude of treatment effects with FDA requirements for additional testing in randomized clinical trials (RCTs).

DATA SOURCES: Overall, 606 drug applications for the Breakthrough Therapy designation from its inception in January 2012 were downloaded from the FDA website in January 2017 and August 2018, and 71 medical device applications for the Humanitarian Device Exemption from its inception in June 1996 were downloaded in August 2017.

STUDY SELECTION: Approved applications based on non-RCTs were included; RCTs, studies with insufficient information, duplicates, and safety data were excluded.

DATA EXTRACTION AND SYNTHESIS: Data were extracted by 2 independent investigators. A statistical association of the magnitude of estimated effect (expressed as an odds ratio) with FDA requests for RCTs was assessed. The data were also meta-analyzed to evaluate the differences in odds ratios between applications that required further testing and those that did not. The results are reported according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.

MAIN OUTCOMES AND MEASURES: Disease, laboratory, and patient-related outcomes, including disease response or patient survival, were considered.

RESULTS: Among 677 drug and medical device applications, 68 (10.0%) were approved by the FDA based on non-RCTs. Estimates of effects were larger when no further RCTs were required (mean natural logarithm of the odds ratios, 2.18 vs 1.12; odds ratios, 8.85 vs 3.06; P = .03). The meta-analysis results confirmed these findings: estimated effects were approximately 2.5-fold higher for treatments or devices that were approved based on non-RCTs than for treatments or devices for which further testing in RCTs was required (6.30 [95% CI, 4.38-9.06] vs 2.46 [95% CI, 1.70-3.56]; P < .001). Overall, 9 of 677 total applications (1.3%) that were approved on the basis of non-RCTs had relative risks of 10 or greater and 12 (1.7%) had relative risks of 5 or greater. No clear threshold above which the FDA approved interventions based on the magnitude of estimated effect alone was detected.

CONCLUSIONS AND RELEVANCE: In this study, estimated magnitudes of effect were larger among studies for which the FDA did not require RCTs compared with studies for which it did. There was no clear threshold of treatment effect above which no RCTs were requested.

OBJECTIVE: To determine if perception of mistreatment and severity in each of the professional videotaped vignettes was similar between participants of differing professional status (Ob/Gyn attending physicians, resident physicians, and medical students), previous mistreatment status, ethnic minority status, and gender.

METHODS: Three video vignettes were filmed portraying possible medical student mistreatment during an obstetrics and gynecology clerkship. Prior to watching the videos, all participants were asked to complete a questionnaire related to their prior experience with mistreatment as a medical student along with other demographic details. After viewing each video, participants were asked to rate the video as representing mistreatment (yes/no) and, if yes, the severity of medical student mistreatment.

RESULTS: Eight attending physicians, ten resident physicians, and ten medical students participated in this study. Professional status, previous mistreatment status, ethnic minority status, and gender did not affect how participants perceived mistreatment or the severity of the video vignettes. Fifty percent (14/28) of participants reported previous mistreatment as a medical student, all of which occurred during their third year of medical school.

CONCLUSION: Medical students, resident physicians, and attending physicians generally agreed which video vignettes represented medical student mistreatment and the level of severity of the event.