The Impact of Chemotherapy-Related Cognitive Impairment on Social Roles and Well-Being in Breast Cancer Survivors.

PURPOSE: To explore the impact of disruptions in information processing (DIPs) on social roles, well-being, and quality of life (QOL) in breast cancer survivors after chemotherapy. PARTICIPANTS & SETTING: Experiences of DIPs were explored in eight breast cancer survivors aged 53-70 years, 12-60 months post-treatment, referred from a National Cancer Institute-designated cancer center and a nonprofit breast cancer support organization from January 6 to August 31, 2020. METHODOLOGIC APPROACH: This study used a mixed-methods approach. Participants journaled and answered questionnaires sent via mail that asked them about changes in their cognition, QOL, and social roles. Qualitative data were thematically analyzed using constant comparative analysis, and questionnaire scores were compared with qualitative data. FINDINGS: Journals revealed problems with functioning in occupational roles and increased stress, anxiety, and frustration. Women with more DIPs tended to have lower role satisfaction and QOL. Greater role satisfaction was associated with higher QOL and social role participation. IMPLICATIONS FOR NURSING: Mitigating the effects of DIPs on social function may allow women to continue in important roles, which has the potential to affect QOL.

Patient-Reported Bowel, Urinary, and Sexual Outcomes After Laparoscopic-Assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial (ALaCart).

OBJECTIVE: The aim of this study was to compare patient-reported urinary, bowel, and sexual functioning of ALaCaRT Trial participants randomized to open or laparoscopic surgery for rectal cancer. SUMMARY BACKGROUND DATA: The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established. METHODS: Participants completed QLQ-CR29 at baseline, 3, and 12 months post-surgery. Additionally, women completed Rosen's Female Sexual Functioning Index (FSFI). Men completed the International Index of Erectile Function (IIEF) and QLQ-PR25. We compared the proportions of participants in each group who experienced moderate/severe symptoms/dysfunction at each time-point and compared mean difference scores from baseline to 12 months between groups. All analyses were intention-to-treat. Sexual functioning analyses included only the participants who expressed sexual interest at baseline. RESULTS: Baseline PRO compliance of 475 randomized participants was 88%. At 12 months, a lower proportion of open surgery participants experienced moderate-severe fecal incontinence and sore skin, compared to Laparoscopic participants, and a lower proportion of men randomized to open surgery experienced moderate-severe urinary symptoms. There were no differences at 3 months for bowel or urinary symptoms. Sexual functioning among sexually interested participants was similar between groups at 3 and 12 months; however, a lower proportion of women reported moderate to severe sexual dissatisfaction at 3 months in the open as compared to the laparoscopic group, (Rebecca.mercieca@sydney.edu.au., 95% CI 0.03-0.39). DISCUSSION: Despite the slightly lower proportions of open surgery participants self-reporting moderate-severe symptoms for 3 of 16 urinary/bowel domains, and lack of differences in sexual domains, it remains difficult to recommend one surgical approach over another for rectal resection.

Influenza vaccination for hospital Employees: A 3-year success-story of a flu-pod drive-thru at a Veterans affairs medical center.

The Advisory Committee on Immunization Practices recommends all healthcare practitioners and hospital staff receive an annual influenza vaccination. Many challenges were noted in achieving this goal; especially during the last 2 influenza seasons throughout the COVID-19 pandemic. Over the past 3 years our institution has implemented a Drive-Thru fixed Point of Distribution (POD) event for this purpose. Drive-Thru PODs can be a safe and effective strategy for employee vaccination during a pandemic.

Challenging NICE guidelines on parathyroid surgery.

BACKGROUND: National Institute of Clinical Excellence (NICE) recommend against routinely using Intra-Operative Parathyroid Hormone (IOPTH) for first-time parathyroid surgery due to its cost and minimal surgical benefit. The European Society of Endocrine Surgeons differ from this and recommends IOPTH with conflicting pre-operative or single imaging. NICE guidance acknowledged that this may change practice in larger centres. We devised a retrospective single-centre cohort study to analyse the impact of IOPTH on decision-making and cost-effectiveness. METHODOLOGY: First-time parathyroidectomy procedures for primary hyperparathyroidism were assessed between 2017 and 2019. Ultrasound (US) and Sestamibi with parathyroid single-photon emission with computed tomography (SPECT-CT) were compared with IOPTH. The contribution of IOPTH to cure and cost effectiveness ratio was calculated. RESULTS: 114 cases were included, with IOPTH performed in all cases, SPECT-CT in 112 and US in 108 cases. A cure rate of 99.1% (113/114) was achieved. 11.4% (13/114) of the cure rate was influenced by IOPTH (P 0.01), instigating further exploration when its levels didn't decrease. This included 7.1% (4/56) in the concordant-imaging cohort. IOPTH accuracy (96.5%) was significantly superior (P = 0.03) to both US (80%) and SPECT-CT (81%). Comparing the total costs for IOPTH testing over 2 years (£39,721) with 13 potential re-operative procedures in its absence (£63,536), a positive cost-effectiveness ratio of £1832 per re-operative procedure averted was achieved. CONCLUSION: Abandoning IOPTH in first-time parathyroid surgery is too ambitious when weighing the cost of re-operative surgery against cost savings obtained by using routine IOPTH to achieve an improved cure rate, even in concordant imaging.

Potential implications of new information concerning manganese Ohio community health effects studies.

Several epidemiology studies have been conducted in Ohio communities where industrial facilities with manganese emissions are located. New information not addressed in the published papers for this research has been disclosed by U.S. federal agencies pursuant to the Freedom of Information Act. This paper describes the newly available information, presents statistical analyses of the new summary data, and explores how this information potentially impacts the conclusions of the published research. Based on a statistical analysis of the newly available data, we found very few, and no consistent, statistical differences for various illnesses, self-reported symptoms, and neuropsychological/neuromotor test results between one community with a manganese emission source and a control town that were part of the initial research. Further, we determined that the distribution of total suspended particulate manganese air concentrations did not correlate with the distribution of the more biologically relevant respirable manganese concentrations when data from two communities with potential manganese emissions were combined. These results are important, particularly in determining whether the studies should influence regulatory reference values related to manganese. We recommend that the full health effects data set associated with the published research be made available and re-evaluated to address the issues identified in this paper.

Treatment of glioblastoma with current oHSV variants reveals differences in efficacy and immune cell recruitment.

Oncolytic herpes simplex viruses (oHSVs) have demonstrated efficient lytic replication in human glioblastoma tumors using immunodeficient mouse models, but early-phase clinical trials have reported few complete responses. Potential reasons for the lack of efficacy are limited vector potency and the suppressive glioma tumor microenvironment (TME). Here we compare the oncolytic activity of two HSV-1 vectors, a KOS-strain derivative KG4:T124 and an F-strain derivative rQNestin34.5v.1, in the CT2A and GL261N4 murine syngeneic glioma models. rQNestin34.5v1 generally demonstrated a greater in vivo viral burden compared to KG4:T124. However, both vectors were rapidly cleared from CT2A tumors, while virus remained ensconced in GL261N4 tumors. Immunological evaluation revealed that the two vectors induced similar changes in immune cell recruitment to either tumor type at 2 days after infection. However, at 7 days after infection, the CT2A microenvironment displayed the phenotype of an untreated tumor, while GL261N4 tumors exhibited macrophage and CD4+/CD8+ T cell accumulation. Furthermore, the CT2A model was completely resistant to virus therapy, while in the GL261N4 model rQNestin34.5v1 treatment resulted in enhanced macrophage recruitment, impaired tumor progression, and long-term survival of a few animals. We conclude that prolonged intratumoral viral presence correlates with immune cell recruitment, and both are needed to enhance anti-tumor immunity.

MONARCC: a randomised phase II study of panitumumab monotherapy and panitumumab plus 5-fluorouracil as first-line therapy for RAS and BRAF wildtype metastatic colorectal cancer: a study by the Australasian Gastrointestinal Trials Group (AGITG).

BACKGROUND: Doublet chemotherapy in combination with a biologic agent has been a standard of care in patients with metastatic colorectal cancer for over a decade. The evidence for a "lighter" treatment approach is limited to mono-chemotherapy plus bevacizumab in the RAS unselected population. Anti-EGFR antibodies have activity as monotherapy or in combination with chemotherapy in RAS wildtype metastatic colorectal cancer; however their role in first-line treatment in combination with 5-fluorouracil monotherapy or when given alone has not been well studied. MONARCC aims to investigate this approach in an elderly population. METHODS/DESIGN: MONARCC is a prospective, open-label, multicentre, non-comparative randomised phase II trial. Eligible patients aged ≥70 with unresectable metastatic, untreated, RAS/BRAF wildtype metastatic colorectal cancer will be randomised 1:1 to receive panitumumab alone or panitumumab plus infusional 5-fluorouracil. RAS and BRAF analyses will be performed in local laboratories. Comprehensive Health Assessment and Limited Health Assessments will be performed at baseline and at 16 weeks, respectively, to assess frailty. The Patient Symptom Questionnaire and Overall Treatment Utility are to be undertaken at different timepoints to assess the impact of treatment-related toxicities and quality of life. Treatment will be delivered every 2 weeks until disease progression, unacceptable toxicity (as determined by treating clinician or patient), delay of treatment of more than 6 weeks, or withdrawal of consent. The primary end point is 6-month progression-free survival in both arms. Secondary end points include overall survival, time to treatment failure, objective tumour response rate as defined by RECIST v1.1 and safety (adverse events). Tertiary and correlative endpoints include the feasibility and utility of a comprehensive geriatric assessment, quality of life and biological substudies. DISCUSSION: MONARCC investigates the activity and tolerability of first-line panitumumab-based treatments with a view to expand on current treatment options while maximising progression-free and overall survival and quality of life in molecularly selected elderly patients with metastatic colorectal cancer. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry: ACTRN12618000233224 , prospectively registered 14 February 2018.

The Impact of COVID-19 on Surgical Education.

BACKGROUND: At the onset of social distancing, our general surgery residency transitioned its educational curriculum to an entirely virtual format with no gaps in conference offerings. The aim of this study is to examine the feasibility of our evolution to a virtual format and report program attitudes toward the changes. METHODS: On March 15, 2020, due to the coronavirus disease (COVID-19) our institution restricted mass gatherings. We immediately transitioned all lectures to a virtual platform. The cancellation of elective surgeries in April 2020 then created the need for augmented resident education opportunities. We responded by creating additional lectures and implementing a daily conference itinerary. To evaluate the success of the changes and inform the development of future curriculum, we surveyed residents and faculty regarding the changes. Classes and faculty answers were compared for perception of value of the online format. RESULTS: Pre-COVID-19, residency-wide educational offerings were concentrated to one half-day per week. Once restrictions were in place, our educational opportunities were expanded to a daily schedule and averaged 16.5 hours/week during April. Overall, 41/63 residents and 25/94 faculty completed the survey. The majority of residents reported an increased ability (56%) or similar ability (34.1%) to attend virtual conferences while 9.9% indicated a decrease. Faculty responses indicated similar effects (64% increased, 32% similar, 4% decreased). PGY-1 residents rated the changes negatively compared to other trainees and faculty. PGY-2 residents reported neutral views and all other trainees and faculty believed the changes positively affected educational value. Comments from PGY1 and 2 residents revealed they could not focus on virtual conferences as it was not "protected time" in a classroom and that they felt responsible for patient care during virtual lectures. A majority of both residents (61%) and faculty (84%) reported they would prefer to continue virtual conferences in the future. CONCLUSIONS: The necessity for adapting our academic offerings during the COVID-19 era has afforded our program the opportunity to recognize the feasibility of virtual platforms and expand our educational offerings. The majority of participants report stable to improved attendance and educational value. Virtual lectures should still be considered protected time in order to maximize the experience for junior residents.

Return to work following laparoscopic-assisted resection or open resection for rectal cancer: Findings from AlaCaRT-Australasian Laparoscopic Cancer of the Rectum Trial.

BACKGROUND: Maintaining employment for adults with cancer is important, however, little is known about the impact of surgery for rectal cancer on an individual's capacity to return to work (RTW). This study aimed to determine the impact of laparoscopic vs. open resection on RTW at 12 months. METHODS: Analyses were undertaken among participants randomized in the Australian Laparoscopic Cancer of the Rectum Trial (ALaCaRT), with work status available at baseline (presurgery), and 12 months. Multivariable logistic regression, adjusted for sociodemographic and clinical characteristics estimated the effect of surgery on RTW in any capacity, or return to preoperative work status at 12 months. RESULTS: About 228 of 449 (51%) surviving trial participants at 12 months completed work status questionnaires; mean age was 62 years, 66% males, 117 of these received laparoscopic resection (51%). Of 228, 120 were employed at baseline (90 full-time, 30 part-time). Overall RTW in 120 participants in paid work at baseline was 78% (84% laparoscopic, 70% open surgery). Those employed full-time were more likely to RTW at 12 months (OR, 3.55; 95% CI, 1.02-12.31). Those with distant metastases at baseline were less likely to RTW (OR, 0.07; 95% CI, <0.01-0.83). Laparoscopic surgery was associated with a higher rate of RTW but did not reach statistical significance (OR 2.88; 95% CI, 0.95-8.76). CONCLUSIONS: Full-time work presurgery and the presence of metastatic disease predicts RTW status at 12 months. A laparoscopic-assisted surgical approach to rectal cancer may facilitate more patients to RTW, however, larger sample sizes are likely needed to confirm this result.

Halting a SARS-CoV-2 outbreak in a US Veterans Affairs nursing home.

A Veterans Affairs long term care facility on Long Island New York was confronted with a COVID-19 outbreak in late March to Mid-April 2020. Faced with a dwindling supply of PPE, the Infection Control team distributed supplies saved for a possible Ebola outbreak. A COVID unit was created within the nursing home facilitating the geographic isolation of cases; universal testing of residents and employees allowed for the implementation of proper quarantine measures. It was a multidisciplinary team approach led by the Infection Control team that successfully contained this outbreak.

Faculty Emotional Intelligence Matters for Resident Education.

OBJECTIVE: This study aimed to determine the emotional intelligence (EI) of surgical faculty and evaluate its relationship with resident evaluations of faculty behaviors. DESIGN: This study retrospectively collected faculty EI scores as well as general surgery resident evaluations of faculty. Parametric and nonparametric tests were used for statistical analysis. SETTING: The study was conducted at the University of Texas Southwestern in the Department of Surgery in Dallas, Texas. This is an academic, tertiary care center. PARTICIPANTS: Surgical faculty members at a single institution in 2018 completed the Emotional Intelligence Appraisal, a 28-item, electronic assessment with possible scores ranging from zero to 100. Aggregate, anonymous resident evaluations of faculty members were collected from the program director's office. Faculty with fewer than 8 resident evaluations were excluded. RESULTS: In total, 59 faculty members participated (89%). The sample was mostly white (69.2%), male (63.5%), with an average of 47 ± 10 years of age, 12.2 ± 10 years in practice, and 44 ± 24 evaluations per faculty member. The group's mean EI score was 76 ± 7.7. Faculty EI scores were found to have a moderate, positive correlation with resident rotational evaluations of faculty (r(51) = 0.52, p < 0.001). Faculty EI scores did not significantly correlate with resident evaluations of faculty intraoperative behaviors. CONCLUSIONS: The results of this study suggest that a majority of our faculty are competent with regard to EI. Furthermore, faculty EI is an important factor in the clinical learning environment and correlates with resident rotational evaluations of teaching behaviors.

Incorporating ToxCast™ data into naphthalene human health risk assessment.

Chronic inhalation of naphthalene causes nasal olfactory epithelial tumors in rats and benign lung adenomas in mice. The available human data do not establish an association between naphthalene and increased respiratory cancer risk. Therefore, cancer risk assessment of naphthalene in humans depends predominantly on experimental evidence from rodents. The United States Environmental Protection Agency's (US EPA) Toxicity Forecaster (ToxCast™) database contains data from 710 in vitro assays for naphthalene, the majority of which were conducted in human cells. Of these assays, only 18 were active for naphthalene, and all were in human liver cells. No assays were active in human bronchial epithelial cells. In our analysis, all of the active naphthalene ToxCast assay data were reviewed and used to: 1) determine naphthalene human inhalation concentrations corresponding to relevant activity concentrations for all active naphthalene assays, using a physiologically based pharmacokinetic (PBPK) model; and 2) evaluate the transcriptional responses for active assays in the context of consistency with the larger naphthalene data set and proposed modes of action (MoAs) for naphthalene toxicity and carcinogenicity. The transcriptional responses in liver cells largely reflect cellular activities related to oxidative stress and chronic inflammation. Overall, the results from our analysis of the active ToxCast assays for naphthalene are consistent with conclusions from our earlier weight-of-evidence evaluation for naphthalene carcinogenesis.

Select Choices in Benign Breast Disease: An Initiative of the American Society of Breast Surgeons for the American Board of Internal Medicine Choosing Wisely® Campaign.

BACKGROUND: Up to 50% of all women encounter benign breast problems. In contrast to breast cancer, high-level evidence is not available to guide treatment. Management is therefore largely based on individual physician experience/training. The American board of internal medicine (ABIM) initiated its Choosing Wisely® campaign to promote conversations between patients and physicians about challenging the use of tests or procedures which may not be necessary. The American society of breast surgeons (ASBrS) Patient safety and quality committee (PSQC) chose to participate in this campaign in regard to the management of benign breast disease. METHODS: The PSQC solicited initial candidate measures. PSQC surgeons represent a wide variety of practices. The resulting measures were ranked by modified Delphi appropriateness methodology in two rounds. The final list was approved by ASBrS and endorsed by the ABIM. RESULTS: The final five measures are as follows. (1) Don't routinely excise areas of pseuodoangiomatous stromal hyperplasia (PASH) of the breast in patients who are not having symptoms from it. (2) Don't routinely surgically excise biopsy-proven fibroadenomas that are < 2 cm. (3) Don't routinely operate for a breast abscess without an initial attempt to percutaneously aspirate. (4) Don't perform screening mammography in asymptomatic patients with normal exams who have less than a 5-years life expectancy. (5) Don't routinely drain nonpainful, fluid-filled cysts. CONCLUSIONS: The ASBrS Choosing Wisely® measures that address benign breast disease management are easily accessible to patients via the internet. Consensus was reached by PSQC regarding these recommendations. These measures provide guidance for shared decision-making.

Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy.

INTRODUCTION: Although end-stage renal disease (ESRD) and surrogate markers for renal dysfunction are frequently used as outcome markers for IgA nephropathy, the clinical course after reaching ESRD is not well documented. This study examined outcomes of progression to ESRD and age at death in a cohort of adults with IgA nephropathy with a long duration of follow-up. METHODS: Patient and kidney survival of 251 adult patients with IgA nephropathy from the southeastern United States diagnosed between January 1, 1976 and December 31, 2005 were analyzed. RESULTS: Median age at diagnosis was 36.9 years. Most patients were men (69%) and Caucasian (95%). Only 46% had an estimated glomerular filtration rate >60 ml/min per 1.73 m2 at diagnosis. Mean follow-up time from time of diagnostic biopsy to death or end of study was 19.3 years. Of 251 patients, 132 (53%) progressed to ESRD and 97 (39%) died. Life expectancy was reduced by 10.1 years, with a median observed age of death at 65.7 years and a median expected age at death of 75.8 years. Eighty-three percent of the deaths occurred after progression to ESRD. CONCLUSION: Life expectancy is substantially reduced for patients diagnosed with IgA nephropathy in the southeastern United States.

Benchmarking the American Society of Breast Surgeon Member Performance for More Than a Million Quality Measure-Patient Encounters.

BACKGROUND: Nine breast cancer quality measures (QM) were selected by the American Society of Breast Surgeons (ASBrS) for the Centers for Medicare and Medicaid Services (CMS) Quality Payment Programs (QPP) and other performance improvement programs. We report member performance. STUDY DESIGN: Surgeons entered QM data into an electronic registry. For each QM, aggregate "performance met" (PM) was reported (median, range and percentiles) and benchmarks (target goals) were calculated by CMS methodology, specifically, the Achievable Benchmark of Care™ (ABC) method. RESULTS: A total of 1,286,011 QM encounters were captured from 2011-2015. For 7 QM, first and last PM rates were as follows: (1) needle biopsy (95.8, 98.5%), (2) specimen imaging (97.9, 98.8%), (3) specimen orientation (98.5, 98.3%), (4) sentinel node use (95.1, 93.4%), (5) antibiotic selection (98.0, 99.4%), (6) antibiotic duration (99.0, 99.8%), and (7) no surgical site infection (98.8, 98.9%); all p values < 0.001 for trends. Variability and reasons for noncompliance by surgeon for each QM were identified. The CMS-calculated target goals (ABC™ benchmarks) for PM for 6 QM were 100%, suggesting that not meeting performance is a "never should occur" event. CONCLUSIONS: Surgeons self-reported a large number of specialty-specific patient-measure encounters into a registry for self-assessment and participation in QPP. Despite high levels of performance demonstrated initially in 2011 with minimal subsequent change, the ASBrS concluded "perfect" performance was not a realistic goal for QPP. Thus, after review of our normative performance data, the ASBrS recommended different benchmarks than CMS for each QM.

Derivation of an occupational exposure level for manganese in welding fumes.

Exposure to high levels of manganese (Mn) in occupational settings is known to lead to adverse neurological effects. Since Mn is an essential nutrient, there are mechanisms that maintain its homeostatic control in the body, and there is some level of Mn in air that does not perturb Mn homeostasis. However, the Mn exposure concentrations at which no adverse effects are expected in occupational settings vary considerably across regulatory agencies. We set out to derive a Mn Occupational Exposure Level (OEL) for welders based on a review of studies that evaluated Mn exposure concentrations from welding fumes and: (1) neurological effects in welders; (2) levels of Mn in the brains of welders (via pallidal index [PI] estimated from magnetic resonance imaging [MRI]); (3) other biomarkers of Mn exposure in welders (i.e., blood and urine); and (4) Mn brain concentrations, PI, and corresponding neurological effects in non-human primates. Our analysis suggests uncertainty in quantifying dose-response associations for Mn from many of the occupational welding studies. The few welding studies that adequately estimate exposure suggest a possible OEL of 100-140µg/m3 for respirable Mn. This range is consistent with other epidemiology studies, studies of biomarkers of Mn exposure in welders, and with studies in non-human primates, though future studies could provide a stronger basis for deriving a Mn occupational guideline for welders.

The American Society of Breast Surgeons and Quality Payment Programs: Ranking, Defining, and Benchmarking More Than 1 Million Patient Quality Measure Encounters.

BACKGROUND: To identify and remediate gaps in the quality of surgical care, the American Society of Breast Surgeons (ASBrS) developed surgeon-specific quality measures (QMs), built a patient registry, and nominated itself to become a Center for Medicare and Medicaid Services (CMS) Qualified Clinical Data Registry (QCDR), thereby linking surgical performance to potential reimbursement and public reporting. This report provides a summary of the program development. METHODS: Using a modified Delphi process, more than 100 measures of care quality were ranked. In compliance with CMS rules, selected QMs were specified with inclusion, exclusion, and exception criteria, then incorporated into an electronic patient registry. After surgeons entered QM data into the registry, the ASBrS provided real-time peer performance comparisons. RESULTS: After ranking, 9 of 144 measures of quality were chosen, submitted, and subsequently accepted by CMS as a QCDR in 2014. The measures selected were diagnosis of cancer by needle biopsy, surgical-site infection, mastectomy reoperation rate, and appropriateness of specimen imaging, intraoperative specimen orientation, sentinel node use, hereditary assessment, antibiotic choice, and antibiotic duration. More than 1 million patient-measure encounters were captured from 2010 to 2015. Benchmarking functionality with peer performance comparison was successful. In 2016, the ASBrS provided public transparency on its website for the 2015 performance reported by our surgeon participants. CONCLUSIONS: In an effort to improve quality of care and to participate in CMS quality payment programs, the ASBrS defined QMs, tracked compliance, provided benchmarking, and reported breast-specific QMs to the public.