Anesthesia-Related Closed Claims in Free-Standing Ambulatory Surgery Centers.

BACKGROUND: As higher acuity procedures continue to move from hospital-based operating rooms (HORs) to free-standing ambulatory surgery centers (ASCs), concerns for patient safety remain high. We conducted a contemporary, descriptive analysis of anesthesia-related liability closed claims to understand risks to patient safety in the free-standing ASC setting, compared to HORs. METHODS: Free-standing ASC and HOR closed claims between 2015 and 2022 from The Doctors Company that involved an anesthesia provider responsible for the claim were included. We compared the coded data of 212 free-standing ASC claims with 268 HOR claims in terms of severity of injury, major injuries, allegations, comorbidities, contributing factors, and financial value of the claim. RESULTS: Free-standing ASC claims accounted for almost half of all anesthesia-related cases (44%, 212 of 480). Claims with high severity of injury were less frequent in free-standing ASCs (22%) compared to HORs (34%; P = .004). The most common types of injuries in both free-standing ASCs and HORs were dental injury (17% vs 17%) and nerve damage (14% vs 11%). No difference in frequency was noted for types of injuries between claims from free-standing ASCs versus HORs--except that burns appeared more frequently in free-standing ASC claims than in HORs (6% vs 2%; P = .015). Claims with alleged improper management of anesthesia occurred less frequently among free-standing ASC claims than HOR claims (17% vs 29%; P = .01), as well as positioning-related injury (3% vs 8%; P = .025). No difference was seen in frequency of claims regarding alleged improper performance of anesthesia procedures between free-standing ASCs and HORs (25% vs 19%; P = .072). Technical performance of procedures (ie, intubation and nerve block) was the most common contributing factor among free-standing ASC (74%) and HOR (74%) claims. Free-standing ASC claims also had a higher frequency of communication issues between provider and patient/family versus HOR claims (20% vs 10%; P = .004). Most claims were not associated with major comorbidities; however, cardiovascular disease was less prevalent in free-standing ASC claims versus HOR claims (3% vs 11%; P = .002). The mean ± standard deviation total of expenses and payments was lower among free-standing ASC claims ($167,000 ± $295,000) than HOR claims ($332,000 ± $775,000; P = .002). CONCLUSIONS: This analysis of medical malpractice claims may indicate higher-than-expected patient and procedural complexity in free-standing ASCs, presenting patient safety concerns and opportunities for improvement. Ambulatory anesthesia practices should consider improving safety culture and communication with families while ensuring that providers have up-to-date training and resources to safely perform routine anesthesia procedures.

Comparative Genomic Profiling of Second Breast Cancers following First Ipsilateral Hormone Receptor-Positive Breast Cancers.

PURPOSE: We compared the mutational profile of second breast cancers (SBC) following first ipislateral hormone receptor-positive breast cancers of patient-matched tumors to distinguish new primaries from true recurrences. EXPERIMENTAL DESIGN: Targeted next-generation sequencing using the Oncomine Tumor Mutation Load Assay. Variants were filtered according to their allele frequency ≥ 5%, read count ≥ 5X, and genomic effect and annotation. Whole genome comparative genomic hybridization array (CGH) was also performed to evaluate clonality. RESULTS: Among the 131 eligible patients, 96 paired first breast cancer (FBC) and SBC were successfully sequenced and analyzed. Unshared variants specific to the FBC and SBC were identified in 71.9% and 61.5%, respectively. Paired samples exhibited similar frequency of gene variants, median number of variants per sample, and variant allele frequency of the reported variants except for GATA3. Among the 30 most frequent gene alterations, ARIDIA, NSD2, and SETD2 had statistically significant discordance rates in paired samples. Seventeen paired samples (17.7%) exhibited common variants and were considered true recurrences; these patients had a trend for less favorable survival outcomes. Among the 8 patients with available tissue for CGH analysis and considered new primaries by comparison of the mutation profiles, 4 patients had clonally related tumors. CONCLUSIONS: Patient-matched FBC and SBC analysis revealed that only a minority of patients exhibited common gene variants between the first and second tumor. Further analysis using larger cohorts, preferably using single-cell analyses to account for clonality, might better select patients with true recurrences and thereby better inform the decision-making process.

The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.

STUDY OBJECTIVE: Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM. DESIGN: A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter. SETTING: 52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA. STUDY GROUP: 304 US-trained practicing anesthesiologists. INTERVENTIONS: The absence or presence of the EM during the simulation case. MEASUREMENTS: Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis. MAIN RESULTS: Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM. CONCLUSIONS: Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.

Risk factors and associated complications of acute kidney injury in adult patients undergoing a craniotomy.

OBJECTIVE: Understanding the risk factors and clinical outcomes associated with acute kidney injury (AKI) after craniotomy may help clinicians identify perioperative patients at risk for AKI and lead clinicians to institute preventive measures. The objective of this study was to identify risk factors associated with AKI after craniotomy and understand whether patients who develop AKI after craniotomy have worse clinical outcomes. PATIENTS AND METHODS: We performed a retrospective, propensity score matched cohort study consisting of 344 patients who developed an AKI or required renal dialysis post-operatively versus those who did not. An AKI was defined using a composite of two NSQIP variables: progressive renal insufficiency and acute renal failure. All data were derived from the American College of Surgeons National Safety Quality Improvement Program (ACS-NSQIP) between 2009-2017. RESULTS: Of the 50,691 patients who underwent a craniotomy, 202 developed post-operative AKI or required post-operative renal dialysis. Male gender, black race, age 65 and older, and a body mass index 30 or greater were associated with AKI. Patients with hypertension (OR [95 % CI] 4.41 [3.21-6.06]; p < 0.001), diabetes (OR [95 % CI] 3.5 [2.62-4.69]; p < 0.001), chronic obstructive pulmonary disease (OR [95 % CI] 2.27 [1.4-3.69]; p = 0.001), congestive heart failure (OR [95 % CI] 8.17 [4.29-15.58]; p < 0.001), chronic kidney disease (OR [95 % CI] 10.59 [6.09-18.41]; p < 0.001), bleeding disorder (OR [95 % CI] 3.83 [2.59-5.65]; p < 0.001), those who developed sepsis (OR [95 % CI] 4.63 [3.33-6.45]; p < 0.001), and emergent craniotomy (OR [95 % CI] 5.35 [4.05-7.06); p < 0.00) were more likely to develop AKI. The largest association between AKI after surgery was found in patients whose preoperative functional status was totally dependent in activities of daily living (OR [95 % CI] 5.93 [3.53-9.95]; p < 0.001). AKI was associated with a higher number of complications experienced by each patient (OR [95 % CI] 1.79 [1.4-2.3; p < 0.001]. Patients with higher ASA physical status were more likely to develop AKI, and mortality was significantly higher in the AKI cohort. There was a significant increase in the rates of returning to the operating room, failure to wean from the ventilator, unplanned intubations, number of complications, and length of stay between the two groups. AKI was also associated with a higher rate of perioperative pneumonia, venous thromboembolism, urinary tract infection, and sepsis. CONCLUSION: AKI is associated with significantly worse clinical outcomes after craniotomy. Perioperative strategies for prevention, management and supportive care of AKI for patients undergoing craniotomy may improve clinical outcomes.

Effect of intra-op morphine on children with OSA undergoing tonsillectomy.

OBJECTIVES: 1. To compare outcomes after tonsillectomy for pediatric patients with obstructive sleep apnea (OSA) given morphine intra-operatively and post operatively compared to those who were not - specifically Recovery Room (RR) time, length of stay (LOS), Emergency Department (ER) visits. STUDY DESIGN: Retrospective case series with chart review. SETTING: Tertiary care children's hospital. SUBJECTS AND METHODS: All children between 1 and 17 years old who had undergone tonsillectomy in a single institution from 2013 to 2016. Comparison between children who had received morphine intra-operatively was made for outcomes. RESULTS: 556 patients were included, 73 patients had morphine intraoperatively and 483 did not; these latter children were older (8.8 vs 6.5 years, P < 0.001), and had fewer episodes of obstructive apnea and hypopnea (AHI 4.47 vs 10.15, p = 0.003) than children who did not receive intra-op morphine. There were no differences in co-morbidities including asthma, whether they had a sleep study, time in the operating room, emergence time, RR time, airway complications, IMC/PICU admission for respiratory distress, ER visits, readmissions, bleeding or post-discharge nurse phone calls. There was a longer LOS (25.9 vs 21.4 h, P = 0.011) for the group receiving intra-op morphine. CONCLUSION: Children with OSA who receive intra-op morphine have a longer LOS suggesting that its use should be examined more closely in this population.

Understanding breast cancer screening practices in Taiwan: a country with universal health care.

While the incidence of breast cancer (BC) has been relatively low in Asian countries, it has been rising rapidly in Taiwan. Within the last decade, it has replaced cervical cancer as the most diagnosed cancer site for women. Nevertheless, there is a paucity of studies reporting the attitudes and practices of breast cancer screening among Chinese women. The aim of this study is to assess Taiwanese women's knowledge of and attitudes toward BC screening and to identify potential factors that may influence screening behavior. The study population consisted of a sample of 434 Taiwanese women aged 40 and older. Despite access to universal health care for Taiwanese women and the fact that a majority of the women had heard of the breast cancer screening (mammogram, clinical breast exams, etc.), the actual utilization of these screening modalities was relatively low. In the current study, the majority of women had never had mammograms or ultrasound in the past 5 years. The number one most reported barriers were "no time, " "forgetfulness, " "too cumbersome, " and "laziness, " followed by the perception of no need to get screened. In addition, the results revealed several areas of misconceptions or incorrect information perceived by study participants. Based on the results from the regression analysis, significant predictors of obtaining repeated screening modalities included age, coverage for screening, barriers, self-efficacy, intention, family/friends diagnosed with breast cancer. The findings from the current study provide the potential to build evidence-based programs to effectively plan and implement policies in order to raise awareness in breast cancer and promote BC screening in order to optimize health outcomes for women affected by this disease.

Cardiovascular disease risk factors and diabetes in Asian Indians residing in Michigan.

Asian Indians are the largest Asian subgroup in the state of Michigan; however, data on the prevalence and correlates of cardiovascular disease for this group is limited. The sample consisted of 273 Asian Indians (AI) recruited through health fairs for surveys and blood tests throughout the state of Michigan. The prevalence of self-reported diabetes (20.1%) and elevated/abnormal glycated hemoglobin A1C levels (22.6%) exceeds the percentages of other ethnic groups reported in 2006-2008 Michigan Behavioral Risk Factor Survey. More than half of respondents had elevated body max index. The gender disparity in hypertension prevalence (50% for males vs. 19.3% for females) has not been observed in other similar studies and prevalence of male participants with hypertension also is higher than reported in other studies. In the multivariate analysis after adjusting demographic and access to health care factors, the results showed that the prevalence of metabolic syndrome increases among AI female participants but not among AI males. The data highlight the need for developing culturally-tailored interventions to effectively reduce multiple risk factors in this group.

Improving Breast Cancer Outcomes among Women in China: Practices, Knowledge, and Attitudes Related to Breast Cancer Screening.

Background. Breast cancer is a major public health issue and the most commonly diagnosed cancer for women worldwide. Despite lower incidence rates than those living in Western countries, breast cancer incidence among Chinese women has increased dramatically in the past 20 years. Nevertheless, there is a paucity of studies reporting the attitudes toward and practices of breast cancer screening among Chinese women. Methods. This cross-sectional study examined the practices, knowledge, and attitudes toward breast cancer screening (BCS) on a convenience sample of 400 Chinese women. Results. Among study participants, 75% of the women never had a mammogram and the top three barriers reported were low priority, feeling OK, and lack of awareness/knowledge toward breast cancer screening. The results from the logistic regression model showed increased self-efficacy; having performed monthly self-exams, and having had clinical breast exams in the past two years were significant correlates while demographic variables were not correlated with screening behaviors. Conclusion. The findings provide a foundation to better understand beliefs and practices of Chinese women toward BCS and highlight the critical need for general public, health professionals, and the health care system to work collaboratively toward improving the quality of breast cancer care in this population.

Novel mode of action of c-kit tyrosine kinase inhibitors leading to NK cell-dependent antitumor effects.

Mutant isoforms of the KIT or PDGF receptors expressed by gastrointestinal stromal tumors (GISTs) are considered the therapeutic targets for STI571 (imatinib mesylate; Gleevec), a specific inhibitor of these tyrosine kinase receptors. Case reports of clinical efficacy of Gleevec in GISTs lacking the typical receptor mutations prompted a search for an alternate mode of action. Here we show that Gleevec can act on host DCs to promote NK cell activation. DC-mediated NK cell activation was triggered in vitro and in vivo by treatment of DCs with Gleevec as well as by a loss-of-function mutation of KIT. Therefore, tumors that are refractory to the antiproliferative effects of Gleevec in vitro responded to Gleevec in vivo in an NK cell-dependent manner. Longitudinal studies of Gleevec-treated GIST patients revealed a therapy-induced increase in IFN-gamma production by NK cells, correlating with an enhanced antitumor response. These data point to a novel mode of antitumor action for Gleevec.

A non-AUG-defined alternative open reading frame of the intestinal carboxyl esterase mRNA generates an epitope recognized by renal cell carcinoma-reactive tumor-infiltrating lymphocytes in situ.

A number of Ags recognized by tumor-reactive T cells have been characterized, including nonmutated gene products and a variety of epitopes shown to arise from either mutated or alternatively processed transcripts. Here, we report that the screening of a cDNA library with an HLA-B7-restricted renal cell carcinoma-reactive T cell clone derived from tumor-infiltrating lymphocytes (TILs) that were clonally amplified in vivo (as assessed by TCRBV complementarity determining region-3 length distribution analysis) resulted in the isolation of a nonamer encoded by an alternative open reading frame (ORF) (a +1 frameshift) of the intestinal carboxyl esterase gene. This peptide binds HLA-B*0702-presenting molecules as assessed in an immunofluorescence-based peptide binding assay using transfected T2 cells. Constitutive expression of this alternative ORF protein was observed in all transformed HLA-B7+ renal cell lines that were recognized in cytotoxicity assays by the TILs. The intestinal carboxyl esterase gene is transcribed in renal cell carcinoma tumors as well as in normal liver, intestinal, or renal tissues. Mutation of the natural ATG translation initiation site did not alter recognition, indicating that frameshifting (i.e., slippage of the ribosome forward) and recoding are not involved. In addition, a point mutation of the three AUG codons that may be used as alternative translation initiation sites in the +1 ORF did not abolish recognition, whereas mutation of an upstream ACG codon did, indicating that the latter codon initiates the translation of the alternative ORF. These results further extend the types of Ags that can be recognized by tumor-reactive TILs in situ (i.e., leading to clonal T cell expansion).

In situ T-cell responses in a primary regressive melanoma and subsequent metastases: a comparative analysis.

In an earlier study of the immune response in a patient with a cutaneous primary regressive melanoma, a T-cell-receptor diversity analysis demonstrated in situ amplification of certain lymphocytes. Two of them could be cloned and characterized as CD8+ HLA-class-l-restricted CTL with strong selective anti-tumor activity. Following a disease-free period of 3 years, the patient developed a gastric metastasis and subsequently (after an additional year) a metastasis in one axillary lymph node. Melanoma cell lines derived from the 2 secondary lesions have been established here. It was found that these metastatic cells have maintained expression of both HLA-class-I molecules and the peptidic antigen(s) recognized by the 2 clones amplified at the primary site. However, the corresponding T lymphocytes were either undetectable or poorly represented both in the gastric and in the axillary lesions. These results suggest that substantial alterations in the quality of T-cell infiltrates occurred during melanoma progression, despite an apparent stability in presentation of tumor-associated antigen(s) which initially triggered a positive rejection response.