Analysis of adverse outcomes in the post-anesthesia care unit based on anesthesia liability data.

STUDY OBJECTIVE: The aim of this study is to provide a contemporary medicolegal analysis of claims brought against anesthesiologists in the United States for events occurring in the post-anesthesia care unit (PACU). DESIGN: In this retrospective analysis, we analyzed closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database. SETTING: Claims closed between January 1, 2010 and December 31, 2014 were included for analysis if the alleged damaging event occurred in a PACU and anesthesiology was named as the primary responsible service. PATIENTS: Forty-three claims were included for analysis. Data regarding ASA physical status and comorbidities were obtained, whenever available. Ages ranged from 18 to 94. Patients underwent a variety of surgical procedures. Severity of adverse outcomes ranged from temporary minor impairment to death. INTERVENTIONS: Patients receiving care in the PACU. MEASUREMENTS: Information gathered for this study includes patient demographic data, alleged injury type and severity, operating surgical specialty, contributing factors to the alleged damaging event, and case outcome. Some of these data were drawn directly from coded variables in the CRICO CBS database, and some were gathered by the authors from narrative case summaries. RESULTS: Settlement payments were made in 48.8% of claims. A greater proportion of claims involving death resulted in payment compared to cases involving other types of injury (69% vs 37%, p = 0.04). Respiratory injuries (32.6% of cases), nerve injuries (16.3%), and airway injuries (11.6%) were common. Missed or delayed diagnoses in the PACU were cited as contributing factors in 56.3% of cases resulting in the death of a patient. Of all claims in this series, 48.8% involved orthopedic surgery. CONCLUSIONS: The immediate post-operative period entails significant risk for serious complications, particularly respiratory injury and complications of airway management. Appropriate monitoring of patients by responsible providers in the PACU is crucial to timely diagnosis of potentially severe complications, as missed and delayed diagnoses were a factor in a number of the cases reviewed.

Efficacy of Tumor-Infiltrating Lymphocytes Combined with IFN-α in Chinese Resected Stage III Malignant Melanoma.

BACKGROUND: This study aims to explore the efficacy of tumor-infiltrating lymphocytes (TIL) along with interferon-α (IFN-α) to treat stage III malignant melanoma (MM) patients in China. METHODS: Between May 2010 and October 2014, 77 patients of stage III MM who underwent surgery were collected in this study. These patients were divided into two groups: patients who received TIL + IFN-α ± RetroNectin-activated cytokine-induced killer cells (R-CIK) in Arm 1 (n = 27) and IFN-α ± R-CIK in Arm 2 (n = 50) as adjuvant therapy. The primary endpoints were disease-free survival (DFS) time and DFS rates measured at time points of 1, 2, and 3 years. The secondary endpoints were overall survival (OS) rates measured at time points of 1, 2, 3, and 5 years as well as OS as evaluated by Kaplan-Meier. RESULTS: Our results indicated that the median DFS and OS in Arm 1 were significantly better than those in Arm 2. The data also demonstrated that DFS rate and OS rates in Arm 1 were significantly better than those in Arm 2 at all measured time points. CONCLUSION: Patients who undergo surgical excision of stage III MM appear to enjoy prolonged DFS and OS when treated with TIL + IFN-α compared to IFN-α alone.

Efficacy of RetroNectin-activated cytokine-induced killer cell therapy in the treatment of advanced hepatocelluar carcinoma.

The present study aimed to investigate the efficacy of RetroNectin-activated cytokine-induced killer cell (R-CIK) therapy in advanced hepatocellular carcinoma patients as compared with conventional chemotherapy, a comparison that has not yet been thoroughly studied. From January 2010 to October 2013, 74 patients with an initial diagnosis of advanced hepatocelluar carcinoma were enrolled in the study. Patients were assigned to one of two treatment arms: patients in arm 1 (n=37) received R-CIK treatment as the first line therapy, whereas those in arm 2 (n=37) received chemotherapy as the first line treatment. The primary end point measured in this study was median overall survival (mOS). Median progression-free survival time (mPFS) and 1- and 2-year survival rates were recorded as secondary end points. Kaplan-Meier analysis was performed on all mOS and mPFS data, and treatment hazard ratios were established using the Cox proportional hazards model. The 1-year survival rate in treatment arm 1 was 42.47% vs. 24.89% in arm 2 (95% CI, 24.91-59.01% vs. 12.10-40.02%, P=0.066); the 2-year survival rates were 21.24 and 5.53% (95% CI, 4.60-45.86 vs. 0.46-21.06%, P=0.106) in arms 1 and 2, respectively; the mPFS in arm 1 was 4.37 vs. 3.90 (x2=0.182, P=0.670) in arm 2; and the mOS in arm 1 was 14.03 months vs. 9.46 months(x2=4.406, P=0.036) in arm 2. Calculations of univariate analyses of arm 1, R-CIK cycles ≥6, KPS >70, AFP ≤400 ng/ml, and findings of no vascular invasion and no extra-hepatic metastasis were potential predictive factors (P<0.05). Calculations from multivariate analyses similarly identified these factors as potentially having predictive value (P<0.05). The main adverse effects of R-CIK therapy included fever and headache pain. R-CIK treatment may prolong mOS in advanced hepatocellular carcinoma patients compared with conventional chemotherapy. Patients who underwent ≥6 cycles of R-CIK, had KPS scores >70, AFP ≤400 ng/ml, displayed no evidence of vascular invasion, and no extra-hepatic metastasis appeared to have longer survival times compared with other cohorts in the present study.

Efficacy of cytokine-induced killer cells in the treatment of elderly patients with metastatic pancreatic adenocarcinoma.

Currently, metastatic pancreatic cancer is associated with disappointing survival outcomes. This is largely due to a rapid progression of the disease and a precipitous deterioration in the health of affected individuals, especially elderly patients who are often unable to tolerate chemotherapy. The aim of this study was to evaluate the efficacy and safety of adoptive immunotherapy using cytokine-induced killer cells (CIK) as a first-line treatment for metastatic pancreatic cancer. Between December 2010 and June 2012 eight patients were enrolled in this study. All participants were elderly, suffering from metastatic pancreatic cancer, and unable to tolerate chemotherapy. All patients in this study received R-CIK therapy only as a first-line treatment. In the eight patients, 1 had complete response (CR), 5 had stable disease (SD) and 2 had progression disease (PD). Therefore, the overall response rate (ORR) was 12.5% (1/8) and the disease control rate (DCR) was 75.0% (6/8 patients). The 1-year survival rate was 37.5%, and the median overall survival time (mOS) was 13.04 months (95% CI: 5.9-20.2). The results indicated that no significant positive or negative predictive factors were identified by univariate analysis. The main adverse effect of R-CIK was fever and the side effect rate was 25.0% (2/8). Adoptive immunotherapy using R-CIK cells showed comparable OS to survival data seen in previous trials assessing conventional chemotherapies in elderly patients and the adverse effect is less pronounced.

Cost-utility analyses in spine care: a qualitative and systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: A systematic review was performed to identify US-based cost-utility analyses (CUA) studies in spine care and to critically evaluate the quality of the available literature. SUMMARY OF BACKGROUND DATA: There has been a recent trend in the United States toward increased publication of economic analyses in spine care. The cost-effectiveness of spine interventions and the quality of published literature is not well understood. METHODS: A MEDLINE search was conducted to identify cost analyses in spine care. Articles were excluded on the basis of the following criteria: nonspine care, nonoperative, non-US based, nonclinical, and not CUA. Of the 424 screened articles, 20 met inclusion criteria. Quality of studies was assessed using the Quality of Health Economic Studies instrument. RESULTS: Evidence for the cost-effectiveness of operative spinal intervention is varied. The majority of available studies report favorable cost-effectiveness ratios, however, a few studies suggest that certain operative interventions are not cost-effective. Average Quality of Health Economic Studies score of all included studies was 75.1 (60-93). The quality of evidence is variable and there are a number of weaknesses in the available literature, most significant of which is that few studies adopt a long-term time horizon or have sufficient follow-up (N = 3/20). High Quality of Health Economic Studies scoring studies were more likely to have sensitivity analysis (P = 0.016), societal cost perspective (P = 0.014), and a funding disclosure (P = 0.03). CONCLUSION: There is a small but rapidly growing body of US-based CUA in spine care. The quality of CUA evidence is variable but there are significant opportunities to strengthen future CUA studies in spine. This study highlights the need for more attention to CUA research and the quality of these studies in spine care.