Which Benefits Can Justify Risks in Research?

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs.

Pantry clients and Supplemental Nutrition Assistance Program-Education practitioners' perspectives on factors influencing healthy eating policy, system and environmental interventions in food pantries.

The Supplemental Nutrition Assistance Program-Education identified food pantries as a targeted setting for policy, system, and environmental (PSE) interventions to promote healthy eating among households who rely on pantries to supplement their food needs. The present study sought to identify factors influencing capacity and readiness to implement healthy eating PSE interventions in food pantries. Qualitative interviews were conducted via zoom with twenty-six community residents with experience receiving SNAP benefits and twelve SNAP-Ed staff in rural and urban counties in Ohio to identify themes and indicators related to community/organisational capacity and readiness to implement healthy eating PSE interventions in food pantries. Themes and related indicators generated based on inductive and deductive coding of interview transcripts were prioritised and weighted by eleven community nutrition experts during a virtual consensus conference. Five themes emerged; expert-derived weights (scaled low, 0 to high, 1) reflect the perceived importance of each to implementation of healthy eating PSE interventions in food pantries: food pantry capacity and logistics [0⋅252], networks and relationships [0⋅228], community nutrition practitioner capacity [0⋅212], food pantry user characteristics [0⋅156], and stigma and stereotypes [0⋅1⋅52]. Overall, seventeen indicators were identified reflecting these themes. Successful and sustained PSE interventions at food pantries will require a tailored approach that considers food pantries' capacity, needs and opportunities within the community, and capacity of community nutrition practitioners. The themes and indicators identified provide guidance for responsive PSE approaches in food pantries that meet communities where they are.

Raising concerns on questionable ethics approvals - a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection.

BACKGROUND: The practice of clinical research is strictly regulated by law. During submission and review processes, compliance of such research with the laws enforced in the country where it was conducted is not always correctly filled in by the authors or verified by the editors. Here, we report a case of a single institution for which one may find hundreds of publications with seemingly relevant ethical concerns, along with 10 months of follow-up through contacts with the editors of these articles. We thus argue for a stricter control of ethical authorization by scientific editors and we call on publishers to cooperate to this end. METHODS: We present an investigation of the ethics and legal aspects of 456 studies published by the IHU-MI (Institut Hospitalo-Universitaire Méditerranée Infection) in Marseille, France. RESULTS: We identified a wide range of issues with the stated research authorization and ethics of the published studies with respect to the Institutional Review Board and the approval presented. Among the studies investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) did not even contain a reference to the ethics approval number while they present research on human beings. We thus contacted the journals that published these articles and provide their responses to our concerns. It should be noted that, since our investigation and reporting to journals, PLOS has issued expressions of concerns for several publications we analyze here. CONCLUSION: This case presents an investigation of the veracity of ethical approval, and more than 10 months of follow-up by independent researchers. We call for stricter control and cooperation in handling of these cases, including editorial requirement to upload ethical approval documents, guidelines from COPE to address such ethical concerns, and transparent editorial policies and timelines to answer such concerns. All supplementary materials are available.

Mass spectrometry quantitation of immunosuppressive drugs in clinical specimens using online solid-phase extraction and accurate-mass full scan-single ion monitoring.

Introduction: Therapeutic drug monitoring (TDM) of immunosuppressants is essential for optimal care of transplant patients. Immunoassays and liquid chromatography-mass spectrometry (LC-MS) are the most commonly used methods for TDM. However, immunoassays can suffer from interference from heterophile antibodies and structurally similar drugs and metabolites. Additionally, nominal-mass LC-MS assays can be difficult to optimize and are limited in the number of detectable compounds. Objectives: The aim of this study was to implement a mass spectrometry-based test for immunosuppressant TDM using online solid-phase extraction (SPE) and accurate-mass full scan-single ion monitoring (FS-SIM) data acquisition mode. Methods: LC-MS analysis was performed on a TLX-2 multi-channel HPLC with a Q-Exactive Plus mass spectrometer. TurboFlow online SPE was used for sample clean up. The accurate-mass MS was set to positive electrospray ionization mode with FS-SIM for quantitation of tacrolimus, sirolimus, everolimus, and cyclosporine A. MS2 fragmentation pattern was used for compound confirmation. Results: The method was validated in terms of precision, analytical bias, limit of quantitation, linearity, carryover, sample stability, and interference. Quantitation of tacrolimus, sirolimus, everolimus, and cyclosporine A correlated well with results from an independent reference laboratory (r = 0.926-0.984). Conclusions: Accurate-mass FS-SIM can be successfully utilized for immunosuppressant TDM with good correlation with results generated by standard methods. TurboFlow online SPE allows for a simple "protein crash and shoot" sample preparation protocol. Compared to traditional MRM, analyte quantitation by FS-SIM facilitates a streamlined assay optimization process.

Pre-analytical sample handling standardization for reliable measurement of metabolites and lipids in LC-MS-based clinical research.

The emerging disciplines of lipidomics and metabolomics show great potential for the discovery of diagnostic biomarkers, but appropriate pre-analytical sample-handling procedures are critical because several analytes are prone to ex vivo distortions during sample collection. To test how the intermediate storage temperature and storage period of plasma samples from K3EDTA whole-blood collection tubes affect analyte concentrations, we assessed samples from non-fasting healthy volunteers (n = 9) for a broad spectrum of metabolites, including lipids and lipid mediators, using a well-established LC-MS-based platform. We used a fold change-based approach as a relative measure of analyte stability to evaluate 489 analytes, employing a combination of targeted LC-MS/MS and LC-HRMS screening. The concentrations of many analytes were found to be reliable, often justifying less strict sample handling; however, certain analytes were unstable, supporting the need for meticulous processing. We make four data-driven recommendations for sample-handling protocols with varying degrees of stringency, based on the maximum number of analytes and the feasibility of routine clinical implementation. These protocols also enable the simple evaluation of biomarker candidates based on their analyte-specific vulnerability to ex vivo distortions. In summary, pre-analytical sample handling has a major effect on the suitability of certain metabolites as biomarkers, including several lipids and lipid mediators. Our sample-handling recommendations will increase the reliability and quality of samples when such metabolites are necessary for routine clinical diagnosis.

Patients' and primary carers' views on clozapine treatment for schizophrenia: A cross-sectional study in Qatar.

Subjective views of clozapine treatment among patients with schizophrenia in the Middle East and North African MENA Region have not previously been assessed. Globally, few studies have assessed the views of carers to clozapine treatment. We conducted a cross-sectional survey, using a clinician administered structured interview, of patients with schizophrenia/schizoaffective disorder prescribed clozapine in Qatar, and their primary carers. Participants were asked to rate clozapine against prior their antipsychotic treatment in terms of specific benefits and side effects. Forty-two patients and 33 carers participated in the study. Of the patients, two thirds were male, approximately half were Qatari and the mean age was 33.9 years. Patients and carers rated clozapine as superior to prior antipsychotic treatment on all 7 potential benefits inquired about. The greatest perceived benefit was improved mood. Patients rated clozapine as less likely to cause extrapyramidal side effects but more likely to cause 18 other potential side effects compared to prior antipsychotic treatment, with the greatest difference being for nocturnal salivation, increased appetite, and constipation. Nearly half of patients (48 %) and two thirds of carers (64 %) stated that they would have preferred to start clozapine earlier in their illness. Sixty percent of patients and 37 % of carers regarded the information that they had received from health professionals on clozapine as inadequate. Less than half of patients and approximately-two thirds of carers had adequate knowledge of haematological monitoring for clozapine. Generally, there were significantly positive correlation between patients and carers regarding the overall side effects of clozapine treatment. Likewise, improvement in hearing voices paranoid thoughts correlated with improved quality of life. In summary, the results show that patients and carers appreciate the benefits of clozapine despite its side effects being problematic. The results support clozapine being offered earlier in treatment and services providing more information on clozapine to patients and carers.

Assessment of patients' satisfaction with the postanesthesia care unit service at University Hospital in Al Khobar, KSA.

Objectives: The quality of health care is individually and subjectively reflected through patients' level of satisfaction, as well as the optimality and effectiveness of the provided postoperative pain management. The provision of postanesthesia care unit (PACU) service in hospitals has led to overall positive outcomes, in addition to the enhancement of patients' satisfaction with the provided pain management service. This study assessed patients' level of satisfaction with PACU service at a university hospital and discussed different factors that might have contributed to the level of satisfaction. Methods: A prospective cross-sectional study was carried out among patients after being discharged from PACU. The study took place at King Fahad Hospital of the University in Al Khobar, KSA between November 2021 and February 2022. The data were collected using a three-section predesigned questionnaire. Results: Two hundred patients were included in this study. Nearly all patients (95.5%) were satisfied with the provided pain management service. Almost all patients (99.5%) indicated that the PACU staff was courteous and professional during the entire pain management service. More patients complained about pain before using analgesia and this difference was statistically significant (Z = 8.642; p < 0.001). The satisfaction rate was significantly higher in the older age group (>45 years) (Z = 2.114; p = 0.035), in patients with American Society of Anesthesiology (ASA) 3 physical status (H = 13.130; p = 0.001), and those with a previous surgical history (Z = 2.139; p = 0.032). Conclusion: This study concluded that the level of patients' satisfaction with PACU service was high, and established a statistically significant association with age, ASA score, and previous surgical history. Healthcare providers should consider patient education and effective communication to increase patients' satisfaction level and improve the overall quality of care.

Method validation of multi-element panel in whole blood by inductively coupled plasma mass spectrometry (ICP-MS).

Background: Analytical methods to measure trace and toxic elements are essential to evaluate exposure and nutritional status. A ten-element panel was developed and validated for clinical testing in whole blood. Retrospective data analysis was conducted on patient samples performed at ARUP Laboratories. Methods: A method was developed and validated to quantify ten elements in whole blood by ICP-MS. Fifty microliters of sample were extracted with 950 µL of diluent containing 1 % ammonium hydroxide, 0.1 % Triton X-100, 1.75 % EDTA along with spiked internal standards. Four calibrators were used for each element and prepared in goat blood to match the patient specimen matrix. Samples were analyzed with an Agilent 7700 ICP-MS with a Cetac MVX 7100 µL Workstation autosampler. Results: The assay was linear for all elements with inter- and intra-assay imprecision less than or equal to 11% CV at the low end of the analytical measurement range (AMR) and less than or equal to 4% CV at the upper end of the AMR for all elements. Accuracy was checked with a minimum of 40 repeat patient samples, proficiency testing samples, and matrix-matched spikes. The linear slopes for the ten elements ranged from 0.94 to 1.03 with intercepts below the AMR and R2 ranging from 0.97 to 1.00. Conclusions: The multi-element panel was developed to analyze ten elements in whole blood to unify the sample preparation and increase batch run efficiency. The improved analytical method utilized matrix-matched calibrators for accurate quantification to meet regulatory requirements. The assay was validated according to guidelines for CLIA-certified clinical laboratories and was suitable for clinical testing to assess nutritional status and toxic exposure.

IRBs and the Protection-Inclusion Dilemma: Finding a Balance.

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including "vulnerable" groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.

STNM01, the RNA oligonucleotide targeting carbohydrate sulfotransferase 15, as second-line therapy for chemotherapy-refractory patients with unresectable pancreatic cancer: An open label, phase I/IIa trial.

Background: The impact of stroma-targeting therapy on tumor immune suppression is largely unexplored. An RNA oligonucleotide, STNM01, has been shown to repress carbohydrate sulfotransferase 15 (CHST15) responsible for tumor proteoglycan synthesis and matrix remodeling. This phase I/IIa study aimed to evaluate the safety and efficacy of STNM01 in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). Methods: This was an open-label, dose-escalation study of STNM01 as second-line therapy in gemcitabine plus nab-paclitaxel-refractory PDAC. A cycle comprised three 2-weekly endoscopic ultrasound-guided locoregional injections of STNM01 at doses of 250, 1,000, 2,500, or 10,000 nM in combination with S-1 (80-120 mg twice a day for 14 days every 3 weeks). The primary outcome was the incidence of dose-liming toxicity (DLT). The secondary outcomes included overall survival (OS), tumor response, changes in tumor microenvironment on immunohistopathology, and safety (jRCT2031190055). Findings: A total of 22 patients were enrolled, and 3 cycles were repeated at maximum; no DLT was observed. The median OS was 7.8 months. The disease control rate was 77.3%; 1 patient showed complete disappearance of visible lesions in the pancreas and tumor-draining lymph nodes. Higher tumoral CHST15 expression was associated with poor CD3+ and CD8+ T cell infiltration at baseline. STNM01 led to a significant reduction in CHST15, and increased tumor-infiltrating CD3+ and CD8+ T cells in combination with S-1 at the end of cycle 1. Higher fold increase in CD3+ T cells correlated with longer OS. There were 8 grade 3 adverse events. Interpretation: Locoregional injection of STNM01 was well tolerated in patients with unresectable PDAC as combined second-line therapy. It prolonged survival by enhancing T cell infiltration in tumor microenvironment. Funding: The present study was supported by the Japan Agency for Medical Research and Development (AMED).

Analysis of road traffic injuries presented to the emergency department in the Eastern Province of Saudi Arabia: a hospital-based study.

The increasing incidence of road traffic injuries (RTIs) has contributed to the disability and death of millions of people on both a national and global level. This retrospective study was conducted at King Fahad University Hospital (KFUH), Khobar, Saudi Arabia, and included all patients who presented at the emergency department due to road traffic accidents (RTAs) between January 1st, 2022, and December 31st, 2022. Patient data was retrieved from the health information system at KFUH. Descriptive and inferential analysis were performed with several variables analyzed using multivariate logistic regression and factorial ANOVA (MANOVA). During this period, 921 patients were treated at the hospital's emergency department. Of these, 611 (66.3%) were men and 310 (33.7%) were women. The most frequently affected age group was 16-25, representing 427 (46.4%) cases. Most patients were Saudi citizens (837, 90.9%). Among the patients, 19 (2.1%) required surgical treatment within 24 hours of the RTA, and 29 (3.1%) were admitted to the surgical intensive care unit (SICU). There were eight fatalities, representing 0.9% of the cases. January had the highest number of RTAs (12.7%). Moreover, 463 individuals (50.3%) had some form of injury, the most common type being lacerations and abrasions (n=228, 24.8%). Upper limb fractures were the most frequent type of fracture, occurring in 73 cases (7.9%). Being male (P=0.001), non-Saudi (P=0.014), and experiencing accidents during June and July (P=0.002) were associated with an increased prevalence of injury. Mortality had a statistically significant relationship with different patient age groups (P=0.014), patient citizenship (P=0.005), and length of hospital stay (P<0.001).

Impact of a mobile integrated healthcare and community paramedicine program on improving medication adherence in patients with heart failure and chronic obstructive pulmonary disease after hospital discharge: A pilot study.

Background: The mobile integrated health-community paramedicine (MIH-CP) program affiliated with the University of Maryland Medical Center focuses on improving patient transitions from hospital to home by addressing both medical and social determinants of health. Until recently, only self-contained health systems could integrate inpatient and outpatient medication data. Without some means to track patients in transition, there is a significant risk of medication-related problems and errors. Objective: To evaluate the impact of the MIH-CP program on medication adherence among patients with congestive heart failure (CHF) and/or chronic obstructive pulmonary disease (COPD). Methods: This is a pilot observational study designed to compare adherence to drug regimens prescribed at hospital discharge (measured by the proportion of days covered [PDC]) between patients enrolled in the MIH-CP program and a propensity-matched control group. Propensity scores were calculated using 11 demographic, diagnostic, third-party payer, and patient care-associated variables. Discharge medication details were obtained from electronic medical records. PDC for each of the medications were calculated from pharmacy claims data. Results: Eighty-three patients were included in the study; forty-three patients were placed in the intervention group and 40 were propensity-matched controls. After adjusting for age, sex, and third-party payer, findings indicated that medication adherence was higher among patients enrolled in the MIH-CP program compared with control during the first 30 days post-discharge, specifically among patients diagnosed with CHF (8% difference in PDC, 95% confidence interval [CI], -0.12-0.28%) and COPD (14% difference, 95% CI, -0.15-0.43%), although neither result achieved statistical significance. The differences in medication adherence between patients who were enrolled and those who were not enrolled in the MIH-CP program diminished after 30 days post-discharge. Conclusion: This pilot study demonstrated a trend toward improved medication adherence among patients enrolled in the MIH-CP program. Future research involving a larger patient cohort will be required to confirm these preliminary findings.

Creating a Practical Transformational Change Management Model for Novel Artificial Intelligence-Enabled Technology Implementation in the Operating Room.

Objective: To identify change management (CM) strategies for implementing novel artificial intelligence and similar novel technologies in operating rooms and create a new CM model for future trials and applications inspired by the abovementioned strategies and established models. Methods: Key phases of technology implementation were defined, and strategies for transformational CM were created and applied in a recent CM experience at our institution between October 15, 2020 and October 15, 2021. We appraised existing CM models and propose the newly created model. Results: The key phases of the technology implementation were as follows: (1) team assembly; (2) committee approvals; (3) CM; and (4) system installation and go-live. Key strategies were (1) assemble team with necessary expertise; (2) anticipate potential institutional cultural and regulatory hurdles; (3) add agility to project planning and execution; (4) accommodate institutional culture and regulations; (5) early clinical partner buy-in and stakeholder engagement; and (6) consistent communication, all of which contributed to the new CM model creation. Conclusion: Key CM strategies and a new CM model addressing the unique needs and characteristics of operating room novel technology implementation were identified and created. The new model may be customized and tested for individual institution and project's needs and characteristics.

Pathogenic variants of the GNAS gene introduce an abnormal amino acid sequence in the ß6 strand/α5 helix of Gsα, causing pseudohypoparathyroidism type 1A and pseudopseudohypoparathyroidism in two unrelated Japanese families.

Pseudohypoparathyroidism 1A (PHP1A) and pseudopseudohypoparathyroidism (PPHP) are caused by loss-of-function variants of GNAS, which encodes Gsα. We present two unrelated Japanese families with PHP1A and PPHP harboring unreported pathogenic variants of GNAS (c.1141delG, p.Asp381Thrfs*23 and c.1117delC, p.Arg373Alafs*31). These variants introduce abnormal amino acids in the ß6 strand/α5 helix of Gsα, which interact with G protein coupling receptor (GPCR). We conclude that these variants alter the association of Gsα with GPCR and cause PHP1A or PPHP.

Jordanian nurses' attitudes toward using electronic health records during COVID-19 pandemic.

Electronic health records (EHRs) have proven their effectiveness during the coronavirus disease (COVID-19) pandemic. However, successful implementation of EHRs requires assessing nurses' attitudes as they are considered the first line in providing direct care for patients. This study assessed Jordanian nurses' attitudes and examined factors that affect nurses' attitudes toward using EHRs. A cross-sectional, correlational design was used. A convenient sample of 130 nurses was recruited from three major public hospitals in Jordan. All Participants completed the Nurses' attitudes Towards Computerization (NATC) Questionnaire. The overall nurses' attitude was positive; the mean was 61.85 (SD = 10.97). Findings revealed no significant relationship between nurses' attitudes toward using EHRs and nurses' age, gender, education level, previous computer skills experience, years of work experience, and years of dealing with EHRs. However, the work unit was found to have a significant correlation with nurses' attitudes toward using EHRs. Therefore, nurse administrators should arrange for the conduct of educational workshops and continuous training programs considering the needs of the nurses.

Copy Number Variation Analysis Facilitates Identification of Genetic Causation in Patients with Congenital Anomalies of the Kidney and Urinary Tract.

Background: Congenital anomalies of the kidneys and urinary tract (CAKUT) are the most common cause of chronic kidney disease among children and adults younger than 30 yr. In our previous study, whole-exome sequencing (WES) identified a known monogenic cause of isolated or syndromic CAKUT in 13% of families with CAKUT. However, WES has limitations and detection of copy number variations (CNV) is technically challenging, and CNVs causative of CAKUT have previously been detected in up to 16% of cases. Objective: To detect CNVs causing CAKUT in this WES cohort and increase the diagnostic yield. Design setting and participants: We performed a genome-wide single nucleotide polymorphism (SNP)-based CNV analysis on the same CAKUT cohort for whom WES was previously conducted. Outcome measurements and statistical analysis: We evaluated and classified the CNVs using previously published predefined criteria. Results and limitations: In a cohort of 170 CAKUT families, we detected a pathogenic CNV known to cause CAKUT in nine families (5.29%, 9/170). There were no competing variants on genome-wide CNV analysis or WES analysis. In addition, we identified novel likely pathogenic CNVs that may cause a CAKUT phenotype in three of the 170 families (1.76%). Conclusions: CNV analysis in this cohort of 170 CAKUT families previously examined via WES increased the rate of diagnosis of genetic causes of CAKUT from 13% on WES to 18% on WES + CNV analysis combined. We also identified three candidate loci that may potentially cause CAKUT. Patient summary: We conducted a genetics study on families with congenital anomalies of the kidney and urinary tract (CAKUT). We identified gene mutations that can explain CAKUT symptoms in 5.29% of the families, which increased the percentage of genetic causes of CAKUT to 18% from a previous study, so roughly one in five of our patients with CAKUT had a genetic cause. These analyses can help patients with CAKUT and their families in identifying a possible genetic cause.

Knowledge, attitude, and practice towards basic life support among graduating class health science and medical students at Dilla University; a cross sectional study.

Introduction: Basic Life Support is a level of medical care Applied to victims of life-threatening illnesses and injuries before professional help is provided. This study aimed to assess the knowledge, attitude, and practice toward Basic Life support in Graduating class of health science and medical students at Dilla university referral hospital. Method: ology: A cross-sectional study was conducted on graduating class students of Dilla University, college of medicine and health science from September 10/2021 to December 13/2021. A total of 167 participants were selected by a systematic random sampling technique. A bi-variable and multi-variable logistic regression analysis were carried out. Result: Among the study participants, 95 (56.9%) and 86(51.5%) have good knowledge and good practice towards basic life support respectively. Being trained for basic life support and advanced life support, exposure with the person in need of basic life support were found more knowledgeable with odd ratio of [AOR = 13.8, 95% CI (6.3-30.1)], [AOR = 27.7, 95% CI (6.4-119)] and [AOR = 15.7, 95% CI (6.6-37.5)]. Learning anesthesia increases knowledge about basic life support nearly two times [AOR = 1.8, 95% CI (o.4-9.5)] when compared to medicine. Conclusion: The findings of this study suggest that nearly half of health science students in our hospital lack adequate knowledge and skills in BLS. Training on basic life support and advanced life support, learning in anesthesia and medicine departments, and exposure to the person in need of basic life support were significantly associated with high knowledge. To increase knowledge of BLS standardized Training and assessments are recommended.

Treatment quality and outcomes vary with hospital burden of uninsured and Medicaid patients with cancer in early non-small cell lung cancer.

Objectives: Safety-net hospitals deliver a significant level of care to uninsured patients, Medicaid-enrolled patients, and other vulnerable patients. Little is known about the impact of safety-net hospital status on outcomes in non-small cell lung cancer. We aimed to compare treatment characteristics and outcomes between hospitals categorized according to their relative burden of uninsured or Medicaid-enrolled patients with non-small cell lung cancer. Methods: We queried the National Cancer Database for patients with clinical stage I and II non-small cell lung cancer presenting from 2004 to 2018. We categorized hospitals on the basis of their relative burden of uninsured or Medicaid-enrolled patients with non-small cell lung cancer into low-burden (<8.2%), medium-burden (8.2%-12.0%), high-burden (12.1%-16.8%), and highest burden (>16.8%) quartiles. We investigated the impact of care at these hospitals on outcomes while controlling for sociodemographic, clinical, and facility characteristics. Results: We identified 204,189 patients treated at 1286 facilities. There were 592 low-burden, 297 medium-burden, 219 high-burden, and 178 highest burden hospitals. Patients at highest burden hospitals were more likely to be younger, male, Black, and Hispanic (P < .01), and to reside in rural, low-income, and low-educated regions (P < .01). Patients at these facilities had a greater likelihood of not receiving surgery, undergoing an open procedure, undergoing a regional lymph node examination involving less than 10 lymph nodes, having a length of stay more than 4 days, and not receiving treatment (P < .05). Conclusions: Our results indicate reduced treatment quality and higher mortality in patients undergoing surgery for early non-small cell lung cancer at hospitals with an increased burden of uninsured or Medicaid-enrolled patients with non-small cell lung cancer. There is a need to raise the standard of care to improve outcomes in vulnerable populations.

HPV vaccination coverage for pediatric, adolescent and young adult patients receiving care in a childhood cancer survivor program.

Pediatric, adolescent and young adult patients undergoing cancer treatment and/or hematopoietic stem cell transplant are at increased risk for developing a secondary human papillomavirus (HPV)-associated malignancy. The objective of this study was to determine HPV vaccination coverage among individuals participating in a childhood cancer survivor program (CCSP). A retrospective cohort study was conducted among CCSP patients age 11-26 years attending a CCSP visit between 2014 and 2019. Survivors were age-, sex-, and race-matched 1:2 with controls without cancer. Data were abstracted from the electronic health record and state-based vaccination registry. Analysis was limited to Minnesota residents to minimize missing vaccination data. Survivorship care plans (SCPs) were reviewed for vaccine recommendations. 592 patients were included in the analyses (200 CCSP patients; 392 controls). By study design, mean age (18.4 years), race (72 % white), and sex (49 % female) were similar in the two groups. Among CCSP patients 22 % resided in a rural area compared to 3.8 % of controls. Vaccination coverage among CCSP patients was not statistically significantly different from controls [60.0 % vs 66.3 %, OR = 0.82, 95 % CI: (0.55, 1.23), p = 0.35]. Completion of 3 doses was not different between groups even though 3 doses is recommended for all CCSP patients regardless of age at initiation (28.5 % vs 30.1 %, p = 0.09). Only 8.0 % of SCPs recommended HPV vaccination. Although patients participating in a CCSP did not have significantly different HPV vaccination coverage compared to controls, HPV vaccination initiation and 3-dose series completion are still suboptimal in a patient population at high-risk of a secondary HPV-associated cancer.

Unresectable Intrahepatic Cholangiocarcinoma Treated with Radiation Segmentectomy/Lobectomy Using Yttrium 90-labeled Glass Microspheres.

Background: There is no curative treatment option for patients with unresectable intrahepatic, cholangiocarcinoma (IHC). The aim of this study was to evaluate the efficacy of; radiation segmentectomy/lobectomy using Y90-labeled glass microspheres in patients with; unresectable IHC. Methods: This IRB-approved, single-center study included, 16 patients (age: 67 ± 7.7 years) with IHC who received radiation segmentectomy or lobectomy, treatment using Y90-labeled glass microspheres between May 2009 and October 2019. Radiation, segmentectomy/lobectomy was defined as at least 190 Gy dose delivered into treated liver; volume. Results: The median OS from IHC diagnosis was 22.7 months (95% CI: 13.9-66.1) and from, radioembolization it was 7 months (95% CI: 4.33-54.17). Patients who did not receive, chemotherapy before the radioembolization had significantly longer median OS (26.8 vs. 5.9, months, P = 0.03). Four patients had >20 months survival after radioembolization, including 2, patients with survival of 42 and 54 months. There was no 30-day mortality and no severe, complications. Conclusion: Radiation segmentectomy/lobectomy is safe with minimal side effects. The median, OS of the study group is modest; however, 4 patients (25%) showed excellent survival. These results suggest a need for a larger study to define the IHC patient group who could, most benefit from this procedure.