Literature review and robotic management of a rare case of primary retroperitoneal mucinous cystadenoma.

Primary retroperitoneal mucinous cystic tumors (PRMCT) are divided into 3 groups: benign, borderline malignancy, and malignant. We report a rare case of benign retroperitoneal mucinous cystadenoma of a 59-year-old Caucasian female who presented to our clinic with moderate intermittent left upper quadrant abdominal pain for several months, accompanied by early satiety, and unintentional weight loss of 10 pounds. An abdominal contrast-enhanced computed tomography (CT) scan indicated the presence of a 6.5 × 8.8 cm multilobulated mass in the left upper quadrant, characterized by a homogenous appearance with smooth margins. Upper endoscopic ultrasound and fine needle aspiration were performed. Cytology and histology results yielded rare inflammatory cells and debris with no cytological evidence of malignancy. The case was discussed at the hepatopancreatobiliary conference; the patient underwent a robotic resection of the mass with a gastric rim. Primary retroperitoneal mucinous cystadenomas are commonly managed by complete surgical excision. Robotic excision presents an alternative approach for handling this uncommon neoplastic lesion.

Associations Between Organizational Communication and Patients' Experience of Prolonged Emotional Impact Following Medical Errors.

BACKGROUND: The emotional impact of medical errors on patients may be long-lasting. Factors associated with prolonged emotional impacts are poorly understood. METHODS: The authors conducted a subanalysis of a 2017 survey (response rate 36.8% [2,536/6,891]) of US adults to assess emotional impact of medical error. Patients reporting a medical error were included if the error occurred ≥ 1 year prior. Duration of emotional impact was categorized into no/short-term impact (impact lasting < 1 month), prolonged impact (> 1 month), and especially prolonged impact (> 1 year). Based on their reported experience with communication about the error, patients' experience was categorized as consistent with national disclosure guidelines, contrary to guidelines, mixed, or neither. Multinomial regression was used to examine associations between patient factors, event characteristics, and organizational communication with prolonged emotional impact (> 1 month, > 1 year). RESULTS: Of all survey respondents, 17.8% (451/2,536) reported an error occurring ≥ 1 year prior. Of these, 51.2% (231/451) reported prolonged/especially prolonged emotional impact (30.8% prolonged, 20.4% especially prolonged). Factors associated with prolonged emotional impact included female gender (adjusted odds ratio 2.1 [95% confidence interval 1.5-2.9]); low socioeconomic status (SES; 1.7 [1.1-2.7]); physical impact (7.3 [4.3-12.3]); no organizational disclosure and no patient/family error reporting (1.5 [1.03-2.3]); communication contrary to guidelines (4.0 [2.1-7.5]); and mixed communication (2.2 [1.3-3.7]). The same factors were significantly associated with especially prolonged emotional impact (female, 1.7 [1.2-2.5]; low SES, 2.2 [1.3-3.6]; physical impact, 6.8 [3.8-12.5]; no disclosure/reporting, 1.9 [1.2-3.2]; communication contrary to guidelines, 4.6 [2.2-9.4]; mixed communication, 2.1 [1.1-3.9]). CONCLUSION: Prolonged emotional impact affected more than half of Americans self-reporting a medical error. Organizational failure to communicate according to disclosure guidelines after patient-perceived errors may exacerbate harm, particularly for patients at risk of health care disparities.

Targeting hyaluronic acid synthase-3 (HAS3) for the treatment of advanced renal cell carcinoma.

BACKGROUND: Hyaluronic acid (HA) promotes cancer metastasis; however, the currently approved treatments do not target HA. Metastatic renal carcinoma (mRCC) is an incurable disease. Sorafenib (SF) is a modestly effective antiangiogenic drug for mRCC. Although only endothelial cells express known SF targets, SF is cytotoxic to RCC cells at concentrations higher than the pharmacological-dose (5-µM). Using patient cohorts, mRCC models, and SF combination with 4-methylumbelliferone (MU), we discovered an SF target in RCC cells and targeted it for treatment. METHODS: We analyzed HA-synthase (HAS1, HAS2, HAS3) expression in RCC cells and clinical (n = 129), TCGA-KIRC (n = 542), and TCGA-KIRP (n = 291) cohorts. We evaluated the efficacy of SF and SF plus MU combination in RCC cells, HAS3-transfectants, endothelial-RCC co-cultures, and xenografts. RESULTS: RCC cells showed increased HAS3 expression. In the clinical and TCGA-KIRC/TCGA-KIRP cohorts, higher HAS3 levels predicted metastasis and shorter survival. At > 10-µM dose, SF inhibited HAS3/HA-synthesis and RCC cell growth. However, at ≤ 5-µM dose SF in combination with MU inhibited HAS3/HA synthesis, growth of RCC cells and endothelial-RCC co-cultures, and induced apoptosis. The combination inhibited motility/invasion and an HA-signaling-related invasive-signature. We previously showed that MU inhibits SF inactivation in RCC cells. While HAS3-knockdown transfectants were sensitive to SF, ectopic-HAS3-expression induced resistance to the combination. In RCC models, the combination inhibited tumor growth and metastasis with little toxicity; however, ectopic-HAS3-expressing tumors were resistant. CONCLUSION: HAS3 is the first known target of SF in RCC cells. In combination with MU (human equivalent-dose, 0.6-1.1-g/day), SF targets HAS3 and effectively abrogates mRCC.

Development and testing of the Stakeholder Quality Improvement Perspectives Survey (SQuIPS).

BACKGROUND: To create a theory-informed survey that quality improvement (QI) teams can use to understand stakeholder perceptions of an intervention. METHOD: We created the survey then performed a cross-sectional survey of QI stakeholders of three QI projects. The projects sought to: (1) reduce unplanned extubations in a neonatal intensive care unit; (2) maintain normothermia during colorectal surgery and (3) reduce specimen processing errors for ambulatory gastroenterology procedures. We report frequencies of responses to survey items, results of exploratory factor analysis, and how QI team leaders used the results. RESULTS: Overall we received surveys from 319 out of 386 eligible stakeholders (83% response rate, range for the three QI projects 57%-86%). The QI teams found that the survey results confirmed existing concerns (eg, the intervention would not make work easier) and revealed unforeseen concerns such as lack of consensus about the overall purpose of the intervention and its importance. The results of our factor analysis indicate that one 7-item scale (Cronbach's alpha 0.9) can efficiently measure important aspects of stakeholder perceptions, and that two additional Likert-type items could add valuable information for leaders. Two QI team leaders made changes to their project based on survey responses that indicated the intervention made stakeholders' jobs harder, and that there was no consensus about the purpose of the intervention. CONCLUSIONS: The Stakeholder Quality Improvement Perspectives Survey was feasible for QI teams to use, and identified stakeholder perspectives about QI interventions that leaders used to alter their QI interventions to potentially increase the likelihood of stakeholder acceptance of the intervention.

Early Experience with Salvage Retzius-sparing Robotic-assisted Radical Prostatectomy: Oncologic and Functional Outcomes.

OBJECTIVE: To report on feasibility, safety, and continence outcomes using the Retzius-sparing approach in the salvage setting (sRS-RARP). MATERIALS AND METHODS: A total of 26 patients underwent robotic salvage prostatectomy at our institution from January 2012 to May 2020 by a single surgeon (RM). Twenty patients underwent sRS-RARP and 6 underwent the standard approach (sRARP). Pre-, intra-, and postoperative outcomes were compared between these groups with emphasis on continence and oncologic safety. RESULTS: Patients had comparable preoperative characteristics with no significant difference in age, race, prostate-specific antigen level, and Gleason score. Most patients underwent primary external beam radiation therapy (69.2%). Median time to biochemical failure was 7.9 years (IQR 6.1-13.4). sRS-RARP required less console time (141.5 vs 199.5.0 minutes, P = .008) and less blood loss (50.0 mL vs 100.0 mL, P = .045) compared to sRARP. Postoperative course was uneventful with a median hospital stay of 1 day. Median catheterization time was 14.0 days (IQR 11.5-17). Patients undergoing sRS-RARP had better immediate (25.0% vs 0.0%, P < .001), 3 month (80.0% vs 0%, P < .001), and 12 month continence rates (100% vs 44%, P = .0384) compared to sRARP patients. Likewise, median time to continence was significantly shorter for sRS-RARP patients (90.0 vs 270.0 days, P = .0095). Biochemical recurrence rate was 20.0% in the sRS-RARP group and 33.3% in the sRARP group (P = .60). CONCLUSION: Early experience suggests that sRS-RARP is feasible, oncologically safe, and may offer improved continence compared to the sRARP approach.

Upgrading on radical prostatectomy specimens of very low- and low-risk prostate cancer patients on active surveillance: A population-level analysis.

INTRODUCTION: A proportion of prostate cancer (PCa) patients initially managed with active surveillance (AS) are upgraded to a higher Gleason score (GS) at the time of radical prostatectomy (RP). Our objective was to determine predictors of upgrading on RP specimens using a national database. METHODS: The Surveillance, Epidemiology, and End Results Prostate with Watchful Waiting database was used to identify AS patients diagnosed with very low- or low-risk PCa who underwent delayed RP between 2010 and 2015. The primary outcome was upgrading to GS 7 disease or worse. Logistic regression analyses were used to evaluate demographic and oncological predictors of upgrading on final specimen. RESULTS: A total of 3775 men underwent RP after a period of AS, 3541 (93.8%) of whom were cT2a; 792 (21.0%) patients were upgraded on RP specimen, with 85.4%, 10.6%, and 3.4% upgraded to GS 7(3+4), 7(4+3), and 8 diseases, respectively. On multivariable analysis, higher prostate-specific antigen (PSA) at diagnosis (5-10 vs. 0-2 ng/ml, odd ratio [OR] 2.59, p<0.001) and percent core involvement (80-100% vs. 0-20%, OR 2.52, p=0.003) were significant predictors of upgrading on final RP specimen, whereas higher socioeconomic status predicted lower odds of upgrading (highest vs. lowest quartile OR 0.75, p=0.013). CONCLUSIONS: Higher baseline PSA and percent positive cores involvement are associated with significantly increased risk of upgrading on RP after AS, whereas higher socioeconomic status predicts lower odds of such events. These results may help identify patients at increased risk of adverse pathology on final specimen who may benefit from earlier definitive treatment.

Long-Term Impacts Faced by Patients and Families After Harmful Healthcare Events.

BACKGROUND: Patients and families report experiencing a multitude of harms from medical errors resulting in physical, emotional, and financial hardships. Little is known about the duration and nature of these harms and the type of support needed to promote patient and family healing after such events. We sought to describe the long-term impacts (LTIs) reported by patients and family members who experienced harmful medical events 5 or more years ago. METHODS: We performed a content analysis on 32 interviews originally conducted with 72 patients or family members about their views of the factors contributing to their self-reported harmful event. Interviews selected occurred 5 or more years after the harmful event and were grouped by time since event, 5 to 9 years (22 interviews) or 10 or more years (10 interviews) for analysis. We analyzed these interviews targeting spontaneous references of ongoing impacts experienced by the participants. RESULTS: Participants collectively described the following four LTIs: psychological, social/behavioral, physical, and financial. Most cited psychological impacts with half-reporting ongoing anger and vivid memories. More than half reported ongoing physical impacts and one-third experienced ongoing financial impacts. Long-term social and behavioral impacts such as alterations in lifestyle, self-identity, and healthcare seeking behaviors were the most highly reported. CONCLUSIONS: These patients and families experienced many profound LTIs after their harmful medical event. For some, these impacts evolved into secondary harms ongoing 10 years and more after the event. Our results draw attention to the persistent impacts patients and families may experience long after harmful events and the need for future research to understand and support affected patients and families.

Association of open communication and the emotional and behavioural impact of medical error on patients and families: state-wide cross-sectional survey.

BACKGROUND: How openly healthcare providers communicate after a medical error may influence long-term impacts. We sought to understand whether greater open communication is associated with fewer persisting emotional impacts, healthcare avoidance and loss of trust. METHODS: Cross-sectional 2018 recontact survey assessing experience with medical error in a 2017 random digit dial survey of Massachusetts residents. Two hundred and fifty-three respondents self-reported medical error. Respondents were similar to non-respondents in sociodemographics confirming minimal response bias. Time since error was categorised as <1, 1-2 or 3-6 years before interview. Open communication was measured with six questions assessing different communication elements. Persistent impacts included emotional (eg, sadness, anger), healthcare avoidance (specific providers or all medical care) and loss of trust in healthcare. Logistic regressions examined the association between open communication and long-term impacts. RESULTS: Of respondents self-reporting a medical error 3-6 years ago, 51% reported at least one current emotional impact; 57% reported avoiding doctor/facilities involved in error; 67% reported loss of trust. Open communication varied: 34% reported no communication and 24% reported ≥5 elements. Controlling for error severity, respondents reporting the most open communication had significantly lower odds of persisting sadness (OR=0.17, 95% CI 0.05 to 0.60, p=0.006), depression (OR=0.16, 95% CI 0.03 to 0.77, p=0.022) or feeling abandoned/betrayed (OR=0.10, 95% CI 0.02 to 0.48, p=0.004) compared with respondents reporting no communication. Open communication significantly predicted less doctor/facility avoidance, but was not associated with medical care avoidance or healthcare trust. CONCLUSIONS: Negative emotional impacts from medical error can persist for years. Open communication is associated with reduced emotional impacts and decreased avoidance of doctors/facilities involved in the error. Communication and resolution programmes could facilitate transparent conversations and reduce some of the negative impacts of medical error.

The Reliability of Intraoperative Assessment on Predicting Tumor Size, Myometrial Invasion, and Cervical Involvement in Patients With a Preoperative Diagnosis of Complex Atypical Hyperplasia or (Clinical Stage I) Endometrial Cancer: A Prospective Cohort Study.

OBJECTIVES: The objective of this study is to assess the reliability of intraoperative uterine assessment compared with the final pathologic evaluation in patients with endometrial cancer (EC) and whether assessment improves with experience. METHODS: After Institutional Review Board approval, a prospective cohort study of women surgically managed with biopsy-proven complex atypical hyperplasia (CAH) or EC between March 2015 and December 2016 was performed. Demographics, preoperative biopsy results, procedure, intraoperative and final pathologic evaluation of lesion size, myometrial invasion, and lower uterine segment/cervical involvement were abstracted. The agreement between the intraoperative and final pathologic evaluation of tumor involvement of the uterus was determined using the kappa statistic and the intraclass correlation coefficient. RESULTS: A total of 264 patients with a preoperative diagnosis of CAH or EC were included-71 (26.9%) with CAH and 193 (73.1%) with EC. The mean age was 62.6±11.5, and mean body mass index was 37.2±10.1. The majority of women were white (67%). A total of 227 (85.9%) patients underwent a laparoscopic or robotic hysterectomy, whereas 36 (13.6%) underwent an abdominal hysterectomy. 233 (88.3%) patients had EC and 21 (7.9%) patients had CAH on final pathology. There was a fair agreement between the intraoperative estimation of myometrial invasion (κ=0.37). A moderate agreement exists between the intraoperative estimation of lower uterine segment/cervical involvement (κ=0.57). There was a strong agreement between intraoperative tumor size assessment and the final path (intraclass correlation coefficient=0.74). The intraoperative correlation of tumor size was similar for the first half of the cohort (κ=0.50) and the second half (κ=0.46) chronologically. CONCLUSIONS: Despite only a fair correlation in the myometrial invasion, intraoperative assessment of cervical involvement and especially tumor size is more readily identified and overall accurate. Therefore, intraoperative evaluation is an additional tool to use when making the decision to proceed with surgical staging.

Radiocirurgia estereotáxica extracraniana (SBRT) para tumores de pulmão: experiência do INCA / [Extracranial stereotactic radiosurgery (SBRT) for lung tumors: INCA experience]

Introdução: A radiocirurgia estereotáxica extracraniana (SBRT) para tumores de pulmão é o tratamento de escolha para pacientes com tumor de pulmão estádio inicial, não candidatos à cirurgia, bem como para oligometástases. Entretanto, essa técnica requer disponibilidade de equipamentos de alta tecnologia, além de capacitação profissional para sua implementação. Poucos são os relatos de experiência em serviços com atendimento exclusivo pelo Sistema Único de Saúde (SUS). Objetivos: Descrever o perfil dos pacientes tratados com a técnica de SBRT de pulmão no Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA). Métodos: Foram avaliados pacientes com diagnóstico de tumores de pulmão (primários ou metastáticos), tratados com a técnica SBRT no período de janeiro de 2015 a dezembro de 2018. Os dados foram obtidos pela pesquisa em prontuário eletrônico e físico, além de banco de dados do Sistema de Planejamento Eclipse® versão 13.6. Todos os tratamentos foram realizados no aparelho acelerador linear de fótons e elétrons, técnica modulada, verificação por IGRT, com aquisição de imagens por tomografia 4D. Resultados: Foram avaliados 912 pacientes com diagnóstico topográfico de tumores de pulmão, dos quais 46 realizaram SBRT. Os tipos histopatológicos identificados foram: adenocarcinoma (63%), carcinoma escamoso (CEC) (29%), sarcoma (2%), outras histologias (4%) e sem laudo (2%). Em relação à lateralidade, foram 26 lesões à esquerda, 18 à direita e 2 bilaterais. A distribuição em relação à árvore brônquica principal foi: 37 periféricos (77%), 9 centrais (19%) e 2 ultracentrais (4%). As doses utilizadas foram: 3x 18 Gy (50%), 5x 10 Gy (26%), 5x 6 Gy (13%) e outros diversos (11%). Conclusão: A realização de SBRT para tumores de pulmão vem crescendo nos últimos anos, confirmando a necessidade de maior número de equipamentos de alta tecnologia disponíveis no SUS e aumento da capacitação profissional para sua implementação. O perfil mais incidente de tratamentos no INCA é de homens com adenocarcinoma primário de pulmão esquerdo e localização periférica.

Introduction: Stereotactic body radiation therapy (SBRT) is the treatment of choice for patients with early stage non-surgical lung tumor as well as for oligo metastases. However, this technique requires the availability of high technology equipment and professional training for its implementation. There are few reports of experience in services with exclusive care by the Brazilian Unified Health System (SUS). Objectives: To describe the profile of patients treated with the lung SBRT technique at the National Cancer Institute José de Alencar Gomes da Silva (INCA). Methods: The patients with lung tumor (ICD 10 C34) diagnosis from January 2015 to December 2018 and treated with the SBRT technique were analyzed. Data were examined by electronic and physical medical records, as well as data from the Eclipse® Planning System database version 13.6. All treatments used a linear photon and electron accelerator, modulated technique, verification by IGRT, with image acquisition by 4D tomography. Results: We evaluated 912 patients with topographic diagnosis of lung tumors, of which 46 underwent SBRT. The identified histological types were: adenocarcinoma (63%), squamous carcinoma (29%), sarcoma (2%), other histologies (4%) and without report (2%). Regarding laterality, there were 26 left, 18 right and 2 bilateral lesions. Regarding the location in relation to the main bronchial tree: 37 were peripheral (77%), 9 were central (19%), 2 were ultra-central (4%). The most commonly used dose regimens were: 3x 18 Gy (50%), 5x 10 Gy (26%), 5x 6 Gy (13%) and others (11%), all procedures being performed on the Trilogy® Linear Accelerator. Conclusion: SBRT for lung tumors has been increasing in recent years. The most commonly observed treatment profile in this institution is men with primary left lung adenocarcinoma and peripheral location

Can Communication-And-Resolution Programs Achieve Their Potential? Five Key Questions.

Communication-and-resolution programs (CRPs) are intended to promote accountability, transparency, and learning after adverse events. In this article we address five key challenges to the programs' future success: implementation fidelity, the evidence base for CRPs and their link to patient safety, fair compensation of harmed patients, alignment of CRP design with participants' needs, and public policy on CRPs. While the field has arrived at an understanding of the core communication-and-resolution practices, limited adherence fuels skepticism that programs are meeting the needs of patients and families who have been injured by care or improving patient safety. Adherence to communication-and-resolution practices could be enhanced by adopting measures of CRP quality and implementing programs in a comprehensive, principled, and systematic manner. Of particular importance is offering fair compensation to patients in CRPs and supporting their right to attorney representation. There is evidence that the use of CRPs reduces liability costs, but research on other outcomes is limited. Additional research is especially needed on the links between CRPs and quality and on the programs' alignment with patients' and families' needs. By honoring principles of transparency, quality improvement, and patient and family empowerment, organizations can use their CRPs to help revitalize the medical profession.

Structure-Based Design of MptpB Inhibitors That Reduce Multidrug-Resistant Mycobacterium tuberculosis Survival and Infection Burden in Vivo.

Mycobacterium tuberculosis protein-tyrosine-phosphatase B (MptpB) is a secreted virulence factor that subverts antimicrobial activity in the host. We report here the structure-based design of selective MptpB inhibitors that reduce survival of multidrug-resistant tuberculosis strains in macrophages and enhance killing efficacy by first-line antibiotics. Monotherapy with an orally bioavailable MptpB inhibitor reduces infection burden in acute and chronic guinea pig models and improves the overall pathology. Our findings provide a new paradigm for tuberculosis treatment.

A Multi-Stakeholder Consensus-Driven Research Agenda for Better Understanding and Supporting the Emotional Impact of Harmful Events on Patients and Families.

BACKGROUND: The nature and consequences of patient and family emotional harm stemming from preventable medical error, such as losing a loved one or surviving serious medical injury, is poorly understood. Patients and families, clinicians, social scientists, lawyers, and foundation/policy leaders were brought together to establish research priorities for this issue. METHODS: A one-day conference of diverse stakeholder groups to establish a consensus-driven research agenda focused on (1) priorities for research on the short-term and long-term emotional impact of harmful events on patients and families, (2) barriers and enablers to conducting such research, and (3) actionable steps toward better supporting harmed patients and families now. RESULTS: Stakeholders discussed patient and family experiences after serious harmful events, including profound isolation, psychological distress, damaging aspects of medical culture, health care aversion, and negative effects on communities. Stakeholder groups reached consensus, defining four research priorities: (1) Establish conceptual framework and patient-centered taxonomy of harm and healing; (2) Describe epidemiology of emotional harm; (3) Determine how to make emotional harm and long-term impacts visible to health care organizations and society at large; and (4) Develop and implement best practices for emotional support of patients and families. The group also created a strategy for overcoming research barriers and actionable "Do Now" approaches to improve the patient and family experience while research is ongoing. CONCLUSION: Emotional and other long-term impacts of harmful events can have profound consequences for patients and families. Stakeholders designed a path forward to inform approaches that better support harmed patients and families, with both immediately actionable and longer-term research strategies.

Does Obesity Affect Pathologic Agreement of Initial and Final Tumor Grade of Disease in Endometrial Cancer Patients?

OBJECTIVES: The objectives of this study were to compare preoperative and postoperative tumor grade to determine if surgical staging decisions for endometrial cancer based on preoperative biopsy are feasible and whether obesity affects the agreement. METHODS: A retrospective cohort study of women with endometrial cancer between January 2010 and December 2011 was performed. Demographics, stage of final pathology, biopsy method, preoperative and postoperative tissue grade, and histology were abstracted and stratified by patient body mass index (obese ≥30 kg/m and nonobese <30 kg/m). Patients with incomplete records or uterine sarcoma were excluded. The agreement between preoperative and postoperative tumor grade for all patients and in obese and nonobese patients was determined using weighted κ statistics. RESULTS: Four hindered forty-five patients were included: 161 nonobese patients and 284 obese patients. The proportion of preoperative sampling via office biopsy and dilation and curettage was similar in each cohort. Overall, the agreement between preoperative and postoperative pathology was only fair (weighted κ = 0.21). Stratified by body mass index, the agreement between preoperative and postoperative grade remains fair in obese and slight in nonobese patients (weighted κ = 0.21 and 0.19, respectively). Substantial increases in tumor grade from preoperative to postoperative pathologic specimens occurred in both cohorts. CONCLUSIONS: Obesity does not appear to significantly alter the correlation between preoperative biopsy and final tumor grade. With only fair correlation between preoperative and postoperative pathologic evaluation, utilization of preoperative biopsy pathology results as a triage tool for surgical staging should be avoided. However, the discordance between preoperative and postoperative pathology in favor of a higher grade on final pathology in both groups may cause some surgeons to favor staging.

Effectiveness of cyanoacrylate microbial sealant in the reduction of surgical site infection in gynecologic oncology procedures: A phase III single institution prospective randomized trial.

OBJECTIVES: Surgery is a cornerstone for patients with gynecologic malignancies. Surgical site infections (SSI) remain a source of post-operative morbidity. Consequences range from escalated costs, delay in adjuvant therapy, and increased morbidity. Our primary objective was to evaluate the effectiveness of a cyanoacrylate microbial sealant (CMS) to reduce post-operative SSI following laparotomy for suspected gynecologic malignancy. METHODS: Patients were randomized using a 1:1 allocation to receive either standard skin preparation or standard preparation with CMS and stratified by BMI. Patients were followed for 6weeks for SSI. Demographic data was collected through the EMR. Associations between SSI, use of CMS, and clinicopathologic factors were explored using descriptive statistics, chi-square and multivariate analysis. RESULTS: 300 patients underwent randomization. Median age of the cohort was 58. Arms were matched and there was no difference in rate of medical comorbidities. Mean BMI was 38.8kg/m2 in patients randomized to BMI≥30 and 26.3kg/m2 randomized to BMI<30. Surgical characteristics for the entire cohort: 66% malignancy, 91% clean-contaminated, 21% bowel surgery, 25% transfusion. Seventy-six (25%) patients developed a SSI: 43 patients (28%) treated with CMS, compared to 33 (21%) patients treated without CMS (p=0.18). Multivariate model demonstrated that BMI≥30 (p<0.005), surgery for malignancy (p=0.010), transfusion in the OR (p<0.001), and closure with staples (p=0.0005) were associated with post-operative SSI. CONCLUSIONS: Patients presenting to a gynecologic oncologist for surgery frequently present with multiple risk factors for SSI and laparotomy is complicated by surgical-site complications in up to 30% of cases. The addition of CMS alone does not appear to reduce risk of overall SSI. Additional risk-reducing strategies including use of antimicrobial agents and optimization of modifiable risk factors prior to surgery should be explored as pathways for reducing this significant post-operative morbidity.

Barriers of Pediatric Residents to Speaking Up About Patient Safety.

BACKGROUND AND OBJECTIVES: Medical errors are a leading cause of death in the United States. Effective communication and speaking up are crucial factors in patient safety initiatives. We examined the reasons reported by pediatric residents for not speaking up about safety events when they are observed in practice. We also tested a priori hypotheses of associations between categories of barriers to speaking up with perceptions of safety and teamwork culture. METHODS: Pediatric residents completed an anonymous electronic survey measuring safety and teamwork culture along with an open-ended question asking them to list the top 3 barriers to speaking up about patient safety concerns. Researchers independently coded the open-ended responses to identify themes, which were then categorized into a published framework. Data were collected in 2013 (response rate = 46%) and 2014 (response rate = 62%). RESULTS: The most common reported barriers to speaking up were as follows: perceived personal safety of speaking up (consequences, intimidation, and hierarchy concerns), individual barriers (communication skills and confidence), perceived efficacy of speaking up (feeling powerless), and contextual factors (high workload). Residents who reported barriers relating to efficacy of speaking up reported lower safety culture scores in 2013 and 2014. Residents who reported barriers related to safety reported lower teamwork culture scores in 2013. CONCLUSIONS: Pediatric residents reported individual barriers, personal safety concerns, lack of efficacy, and contextual factors as reasons to not speak up about patient safety. Concerns about the safety of speaking up and the efficacy of speaking up were correlated with teamwork and safety culture, respectively.

Resolving Malpractice Claims after Tort Reform: Experience in a Self-Insured Texas Public Academic Health System.

OBJECTIVE: To describe the litigation experience in a state with strict tort reform of a large public university health system that has committed to transparency with patients and families in resolving medical errors. DATA SOURCES/STUDY SETTING: Secondary data collected from The University of Texas System, which self-insures approximately 6,000 physicians at six health campuses across the state. We obtained internal case management data for all medical malpractice claims closed during 1 year before and 6 recent years following the enactment of state tort reform legislation. STUDY DESIGN: We retrospectively reviewed information about malpractice claimants, malpractice claims, and the process and outcome of dispute resolution. DATA COLLECTION/EXTRACTION METHODS: We accessed an internal case management database, supplemented by both electronic and paper records compiled by the university's Office of General Counsel. PRINCIPAL FINDINGS: Closed claims dropped from 244 in 2001-2002 to an annual mean of 96 in 2009-2015, closures following lawsuits from 136 in 2001-2002 to an annual mean of 28 in 2009-2015, and paid claims from 60 in 2001 to an annual mean of 20 in 2009-2015. Patterns of resolution suggest efforts by the university to provide some compensation to injured patients in cases that were no longer economically viable for plaintiffs' lawyers to litigate. The percentage of payments relating to cases in which lawsuits had been filed decreased from 82 percent in 2001-2002 to 47 percent in 2009-2012 and again to 29 percent in 2012-2015, although most paid claimants were represented by attorneys. Unrepresented patients received payment in 13 cases closed in 2009-2012 (22 percent of payments; mean amount $60,566) and in 24 cases closed in 2012-2015 (41 percent of payments; mean amount $109,410). Even after tort reform, however, claims that resulted in payment remained slow to resolve, which was worsened for claimants subject to Medicare secondary payer rules. Strict confidentiality became a more common condition of settlement, although restrictions were subsequently relaxed in order to further transparency and improve patient safety. CONCLUSIONS: Malpractice litigation risk diminished substantially for a public university health system in Texas following legal changes that reduced rights to sue and available damages. Health systems operating in a low-tort environment should work with policy makers, plaintiffs' attorneys, and patient groups to assist unrepresented patients, facilitate early mediation, limit nondisclosure obligations following settlement, and expedite the resolution of Medicare liens.

IL-12 Expressing oncolytic herpes simplex virus promotes anti-tumor activity and immunologic control of metastatic ovarian cancer in mice.

BACKGROUND: Despite advances in surgical aggressiveness and conventional chemotherapy, ovarian cancer remains the most lethal cause of gynecologic cancer mortality; consequently there is a need for new therapeutic agents and innovative treatment paradigms for the treatment of ovarian cancer. Several studies have demonstrated that ovarian cancer is an immunogenic disease and immunotherapy represents a promising and novel approach that has not been completely evaluated in ovarian cancer. Our objective was to evaluate the anti-tumor activity of an oncolytic herpes simplex virus "armed" with murine interleukin-12 and its ability to elicit tumor-specific immune responses. We evaluated the ability of interleukin-12-expressing and control oncolytic herpes simplex virus to kill murine and human ovarian cancer cell lines in vitro. We also administered interleukin-12-expressing oncolytic herpes simplex virus to the peritoneal cavity of mice that had developed spontaneous, metastatic ovarian cancer and determined overall survival and tumor burden at 95 days. We used flow cytometry to quantify the tumor antigen-specific CD8+ T cell response in the omentum and peritoneal cavity. RESULTS: All ovarian cancer cell lines demonstrated susceptibility to oncolytic herpes simplex virus in vitro. Compared to controls, mice treated with interleukin-12-expressing oncolytic herpes simplex virus demonstrated a more robust tumor antigen-specific CD8+ T-cell immune response in the omentum (471.6 cells vs 33.1 cells; p = 0.02) and peritoneal cavity (962.3 cells vs 179.5 cells; p = 0.05). Compared to controls, mice treated with interleukin-12-expressing oncolytic herpes simplex virus were more likely to control ovarian cancer metastases (81.2 % vs 18.2 %; p = 0.008) and had a significantly longer overall survival (p = 0.02). Finally, five of 6 mice treated with interleukin-12-expressing oHSV had no evidence of metastatic tumor when euthanized at 6 months, compared to two of 4 mice treated with sterile phosphate buffer solution. CONCLUSION: Our pilot study demonstrates that an interleukin-12-expressing oncolytic herpes simplex virus effectively kills both murine and human ovarian cancer cell lines and promotes tumor antigen-specific CD8+ T-cell responses in the peritoneal cavity and omentum, leading to reduced peritoneal metastasis and improved survival in a mouse model.