We designed a phase I clinical trial of vaccinations with autologous glioma cells expressing transgene-derived interleukin-4 (IL-4), and treated one patient with a right temporal lobe recurrent glioblastoma. This 62-year-old man underwent craniotomy and partial tumor removal, at which time autologous tumor cells were obtained for vaccine preparation. After confirming the patient's cellular immune function by skin test, two cycles of vaccination with irradiated autologous glioma cells admixed with gene transfected fibroblasts were given intradermally. The patient demonstrated no evidence of allergic encephalitis throughout this course. Immunohistochemistry with biopsy samples taken from the vaccine sites demonstrated that the infiltration level of CD4, CD8 and CD1a positive cells increased proportionally to the amount of IL-4 produced at the each site, suggesting that there was local immune response induced at the vaccine site. While it is premature to assess effectiveness of the vaccine, this initial patient's course suggested a transient response to the vaccine, and he survived 10 months after treatment.
BACKGROUND:Comparative effectiveness research has a vital role in recent health reform and policies. Specialty training is one of these provider-side variables, and surgeons who were trained in different specialties may have different outcomes on performing the same procedure. OBJECTIVE: To investigate the impact of spine surgeon specialty (neurosurgery vs orthopedic surgery) on early perioperative outcome measures of elective anterior cervical diskectomy and fusion (ACDF) for degenerative spine diseases. METHODS: This was a retrospective, 1:1 propensity score-matched cohort study. In total, 21 211 patients were reviewed from the American College of Surgeons National Surgical Quality Improvement Program database. Propensity score matching and subgroup analysis were performed. RESULTS: In both groups (single-level/multilevel ACDF), patients operated on by neurosurgeons had longer operation time (133 vs 104 min/164 vs 138 min), shorter total hospital stay (24 vs 41 h/25 vs 46 h), and lower rates of return to operating room (0.7% vs 2.1%/0.6% vs 2.4%), nonhome discharge (1.2% vs 4.6%/1.0% vs 4.9%), discharge after postoperative day 1 (6.7% vs 11.9%/10.1% vs 18.9%), perioperative blood transfusion (0.4% vs 2.1%/0.6% vs 3.1%), and sepsis (0.2% vs 0.7%/0.1% vs 0.7%; P < .05). In the singlelevel ACDF group, patients operated on by neurosurgeons had lower readmission (1.9% vs 4.1%) and unplanned intubation rates (0.1% vs 1.1%; P < .05). Other outcome measures and mortality rates were similar among the 2 cohorts in both groups. CONCLUSION: Our analysis found significant differences in early perioperative outcomes of patients undergoing ACDF by neurosurgeons and orthopedic surgeons. These differences might have significant clinical and cost implications for patients, physicians, program directors, payers, and health systems.
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