Dexamethasone Dose for COVID-19 in a Large U.S. Hospital Network From April 2020 to May 2023.

PURPOSE: While potential harm from high doses of systemic dexamethasone for clinical management of COVID-19 is an important concern, little is known about real world dexamethasone dosing in patients hospitalized with COVID-19 in the United States. METHODS: Descriptive study to assess dexamethasone daily dose in adults with COVID-19 in a large US hospital network, overall and by respiratory support requirements, extracted using semi- structured nursing notes. RESULTS: Of 332 430 hospitalizations with a COVID-19 diagnosis, 201 637 (60.7%) hospitalizations included dexamethasone administration. The mean age of recipients was 63 years, 53.0% were male, and 64.5% White. Median time from admission to dexamethasone administration was 0 day (interquartile range [IQR], 0-1 days) and median duration of use was 5 (IQR, 3-9) days. Almost 80% of hospitalizations received standard daily doses (≤ 6 mg daily), 12.7% moderately high daily doses (> 6- ≤ 10 mg daily), and 8.1% high (> 10- ≤ 20 mg daily) or very high daily dose (> 20 mg daily). Over 20% of COVID-19 hospitalizations requiring no oxygen or simple oxygen received high doses of systemic dexamethasone. CONCLUSIONS: Given the findings from the UK RECOVERY trial, and the general uncertainty around safety of higher dexamethasone doses in those requiring more intense respiratory support, standard daily dexamethasone doses of 6 mg or less for hospitalized COVID-19 requiring supplemental oxygen are recommended.

Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk.

PURPOSE: On August 20, 2020, the United States (U.S.) Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) along with labeling updates to inform the public about a small increased risk of non-melanoma skin cancer (NMSC) associated with hydrochlorothiazide (HCTZ) use. This study aims to assess whether the DSC impacted HCTZ use in the U.S. METHODS: We conducted a trend analysis in the Sentinel Distributed Database using national healthcare administrative data from January 2017 to November 2022. We identified two cohorts each month: An overall cohort of all enrollees and a skin cancer cohort of those with a history of NMSC. For each cohort, we plotted the monthly proportion of patients receiving HCTZ-containing products among those receiving any thiazide diuretics. We performed interrupted time series analyses to quantify the impact of the DSC on these monthly proportions. Secondary analyses were conducted on the proportion of HCTZ users among patients receiving any antihypertensives. RESULTS: In the overall cohort, the DSC was only associated with a statistically significant but clinically negligible trend change of monthly HCTZ proportion within this cohort (0.018%; 95% CI, 0.012%-0.025%). Similar results were observed in the skin cancer cohort. The secondary analysis found no significant level change or trend change in the monthly proportion of HCTZ use among antihypertensive users. CONCLUSIONS: We did not observe significant changes in HCTZ use following the DSC about its NMSC risk, among the overall population and those with a history of NMSC. Our findings were in accordance with the DSC recommendation.

Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States, Canada, and Denmark.

BACKGROUND: Following the mass recall of valsartan products with nitrosamine impurities in July 2018, the number of patients exposed to these products, the duration of exposure, and the potential for cancer remains unknown. Therefore, we assessed the extent and duration of use of valsartan products with a nitrosamine impurity in the United States, Canada, and Denmark. METHODS: We conducted a retrospective cohort study using administrative healthcare data from the US FDA Sentinel System, four Canadian provinces that contribute to the Canadian Network for Observational Drug Effect Studies (CNODES), and the Danish National Prescription Registry. Patients, 18 years and older between May 2012 and December 2020 with a valsartan dispensing were identified in each database. Patients were followed from the date of valsartan dispensing until discontinuation. We defined four valsartan exposure categories based on nitrosamine impurity status; recalled generic products with confirmed NDMA/NDEA levels (recalled-tested); recalled generic products that were not tested (recalled); non-recalled generic and non-recalled branded products. In Denmark, the recalled-tested category was not included due to absence of testing data. The proportion and duration of use of valsartan episodes stratified by nitrosamine-impurity status was calculated. RESULTS: We identified 3.3 and 2.8 million (United States) and 51.3 and 229 thousand (Canada) recalled-tested and recalled valsartan exposures. In Denmark, where valsartan exposure was generally low, there were 10 747 recalled exposures. Immediately after the recall notices were issued, there was increased rates of switching to a non-valsartan ARB. The mean duration of use of the recalled-tested products was 167 (±223.1) and 146 (±255.8) days in the United States and Canada respectively. For the recalled products, mean cumulative duration of use was 178 (±249.6), 269 (±397.3) and 166 (±251.0) days in the United States, Canada, and Denmark, respectively. CONCLUSION: In this cohort study, despite widespread use of recalled generic valsartan between 2012 and 2018, the duration of use was relatively short and probably did not pose an elevated risk of nitrosamine-induced cancer. However, since products with nitrosamine impurity could have been on the market over a 6-year period, patients exposed to these products for longer durations could have a potentially different risk of cancer.

Evaluation of Quality of Life and Levels of Depression, Anxiety and Stress in Patients Following Facial Trauma.

Background: Due to the anatomical intricacy of the region and the possibility of psychological as well as physical damage, maxillofacial injuries are unusual. Studies have shown that general psychological morbidity is more prevalent following maxillofacial trauma leading to post-traumatic stress disorder and behavioural changes at various times. Purpose: To evaluate the quality of life and levels of stress, depression and anxiety in patients following facial trauma. Methodology: Prospective research including 30 patients with maxillofacial injuries was conducted. Based on the requirements for inclusion and exclusion, these patients were included in the trial and were provided with psychological counselling and guidance from their time of admission till the follow-up period. The baseline levels of quality of life, depression, anxiety and stress symptoms were assessed at the time of presentation (T0), 1 month (T1) and 3 months (T2), using the Depression Anxiety Stress Scale-21 and World Health Organization Quality of Life-BREF questionnaire. Results: The levels of stress, anxiety and depression, as well as quality of life, did not differ significantly (p > 0.05). Conclusion: There is no correlation between maxillofacial trauma and levels of anxiety, depression, stress and quality of life if the subjects are exposed to psychotherapy and guidance.

Transparency, reproducibility, and replicability of pharmacoepidemiology studies in a distributed network environment.

PURPOSE: Our objective is to describe how the U.S. Food and Drug Administration (FDA)'s Sentinel System implements best practices to ensure trust in drug safety studies using real-world data from disparate sources. METHODS: We present a stepwise schematic for Sentinel's data harmonization, data quality check, query design and implementation, and reporting practices, and describe approaches to enhancing the transparency, reproducibility, and replicability of studies at each step. CONCLUSIONS: Each Sentinel data partner converts its source data into the Sentinel Common Data Model. The transformed data undergoes rigorous quality checks before it can be used for Sentinel queries. The Sentinel Common Data Model framework, data transformation codes for several data sources, and data quality assurance packages are publicly available. Designed to run against the Sentinel Common Data Model, Sentinel's querying system comprises a suite of pre-tested, parametrizable computer programs that allow users to perform sophisticated descriptive and inferential analysis without having to exchange individual-level data across sites. Detailed documentation of capabilities of the programs as well as the codes and information required to execute them are publicly available on the Sentinel website. Sentinel also provides public trainings and online resources to facilitate use of its data model and querying system. Its study specifications conform to established reporting frameworks aimed at facilitating reproducibility and replicability of real-world data studies. Reports from Sentinel queries and associated design and analytic specifications are available for download on the Sentinel website. Sentinel is an example of how real-world data can be used to generate regulatory-grade evidence at scale using a transparent, reproducible, and replicable process.

Validity of inpatient electronic health record-based measures of oxygen-related therapy in the United States: Lessons applicable for studying COVID-19 endpoints.

INTRODUCTION: During the COVID-19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ventilation (MV) and supplemental oxygen (O2) use are markers of severe illness in hospitalized COVID-19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O2 use during COVID-19 hospitalization in administrative data versus nursing documentation. METHODS: We identified 319 553 adult hospitalizations with a COVID-19 diagnosis, February 2020-October 2022, and extracted coded, administrative data for MV or O2. Separately, we developed classification rules for MV or O2 supplementation from semi-structured nursing documentation. We assessed MV and O2 supplementation in administrative data versus nursing documentation and calculated ordinal endpoints of decreasing COVID-19 disease severity. Nursing documentation was considered the gold standard in sensitivity and positive predictive value (PPV) analyses. RESULTS: In nursing documentation, the prevalence of MV and O2 supplementation among COVID-19 hospitalizations was 14% and 75%, respectively. The sensitivity of administrative data was 83% for MV and 41% for O2, with both PPVs above 91%. Concordance between sources was 97% for MV (κ = 0.85), and 54% for O2 (κ = 0.21). For ordinal endpoints, administrative data accurately identified intensive care and MV but underestimated hospitalizations with O2 requirements (42% vs. 18%). CONCLUSIONS: In comparison to nursing documentation, administrative data under-ascertained O2 supplementation but accurately estimated severe endpoints such as MV. Nursing documentation improved ascertainment of O2 among COVID-19 hospitalizations and can capture oxygen requirements in adults hospitalized with COVID-19 or other respiratory illnesses.

Vaccine Breakthrough Infections Among Healthcare Workers in a COVID-19-Designated Tertiary Care Government Hospital in Sikkim.

Introduction Since the emergence of the coronavirus disease 2019 (COVID-19) virus at the beginning of 2020, the world has gone through various waves of pandemics. The health care workers (HCWs) or the COVID warriors as they were termed were the first line of defense against the virus. They were armed with personal protective equipment and prophylactic doses of the COVID-19 vaccine. Despite these precautions, some of the HCWs still contracted the disease and a few others succumbed to it. The objective of this study was to estimate the prevalence of COVID-19 infections and vaccine breakthrough infections (BTIs) in HCWs after receiving the COVID-19 vaccine during the second wave of the pandemic. Methods This was a cross-sectional, hospital-based study conducted over a period of four months from September 2021 to December 2021 on HCWs aged 18 years and above working at the COVID-19-designated tertiary care government hospital in Sikkim. A structured coded questionnaire with no patient identifiers was used to gather details on demographics, vaccination history, breakthrough infection, and other social details. HCWs who had received at least one dose of the COVID-19 vaccine at the time of initiation of the study and were >18 years of age were included in this study. Results A total of 678 HCWs were screened, out of which 229 (33%) participants tested positive for COVID-19 and the rest of the participants (455; 67%) tested negative. COVID-19 infections and vaccine BTIs (COVID-19 infection >14 days after the second vaccination) were recorded and 137 (20%) respondents had a post-vaccination COVID-19 infection out of which 115 (18.5%) were BTI. The majority of the participants were females and of the age group of 26-35 years. The correlation of COVID-19 infections with the dose gap between vaccination, gender, age, profession, department, area posted during COVID duty, cycles of duty performed, hospitalization due to infection, influenza vaccination, and comorbidity was analyzed. Conclusion COVID-19 vaccines are disease-modifying and they decrease the severity of BTIs in HCWs. Pandemics and outbreaks cannot be predicted; therefore, it becomes very important to have healthy frontline workers who are constantly exposed to infectious agents. Monitoring of health and surveillance of infectious diseases among the HCWs should be encouraged.

Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the United States.

BACKGROUND: The first follow-on drug (Basaglar) of the originator insulin glargine (Lantus), a long-acting insulin for treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM), was approved in 2015 in the United States. Information on the uptake, user characteristics, and outcomes of follow-on insulin remains sparse. OBJECTIVE: To describe the utilization, user characteristics, and health outcomes of the follow-on insulin glargine and insulin glargine originators in a large, distributed network of primarily commercially insured patients in the United States. METHODS: We used health care claims data in the US Food and Drug Administration's Sentinel common data model format across 5 research partners in the Biologics & Biosimilars Collective Intelligence Consortium distributed research network. Sentinel analytic tools were used to identify adult users of insulin glargine between January 1, 2011, and February 28, 2021, and describe patient demographics, baseline clinical characteristics, and adverse health events among users of the originators and the follow-on drug, stratified by diabetes type. RESULTS: We identified 508,438 users of originator drugs and 63,199 users of the follow-on drug. The proportions of the follow-on drug users among total insulin glargine users were 9.1% (n = 7,070) for T1DM and 11.4% (n=56,129) for T2DM. Follow-on use rose from 8.2% in 2017 to 24.8% in 2020, accompanied by a steady decrease in the use of originator drugs. Demographics of the users of the originators and follow-on drug were similar among the T1DM and T2DM groups. Overall, follow-on users had poorer baseline health profile and higher proportions of episodes with adverse events in the follow-up. CONCLUSIONS: We found evidence of increased uptake of the follow-on drug relative to the originator products in the post-2016 period. The differences in the base-line clinical characteristics between users of the originator products and the follow-on drug and their relationship with health outcomes merit further research. DISCLOSURES: Sengwee Toh consults for Pfizer, Inc., and TriNetX, LLC. This study was funded by the BBCIC.

Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study.

OBJECTIVES: To examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled. DESIGN: Retrospective cohort study. SETTING: USA, Canadian administrative healthcare data, Danish National Prescription Registry and UK primary care electronic health records. PARTICIPANTS: Patients aged 18 years and older between January 2014 and December 2020. INTERVENTION: Valsartan, losartan and irbesartan. MAIN OUTCOME: Monthly percentages of individual ARB episodes, new users and switches to another ARB, ACE inhibitors (ACEI) or calcium channel blockers containing products. RESULTS: We identified 10.8, 3.2, 1.8 and 1.2 million ARB users in the USA, UK, Canada and Denmark, respectively. Overall proportions of valsartan, losartan and irbesartan use were 18.4%, 67.9% and 5.2% in the USA; 3.1%, 48.3% and 10.2% in the UK, 16.3%, 11.4% and 18.3% in Canada, 1%, 93.5% and 0.6% in Denmark. In July 2018, we observed an immediate steep decline in the proportion of valsartan use in the USA and Canada. A similar trend was observed in Denmark; however, the decline was only minimal. We observed no change in trends of ARB use in the UK. Accompanying the valsartan decline was an increase in switching to other ARBs in the USA, Canada and Denmark. There was a small increase in switching to ACEI relative to the valsartan-to-other-ARBs switch. We also observed increased switching from other affected ARBs, losartan and irbesartan, to other ARBs throughout 2019, in the USA and Canada, although the usage trends in the USA remained unchanged. CONCLUSION: The first recall notice for valsartan resulted in substantial decline in usage due to increased switching to other ARBs. Subsequent notices for losartan and irbesartan were also associated with increased switching around the time of the recall, however, overall usage trends remained unchanged.

Using the IMEDS distributed database for epidemiological studies in type 2 diabetes mellitus.

INTRODUCTION: This study aimed to assess data relevancy and data quality of the Innovation in Medical Evidence Development and Surveillance System Distributed Database (IMEDS-DD) for diabetes research and to evaluate comparability of its type 2 diabetes cohort to the general type 2 diabetes population. RESEARCH DESIGN AND METHODS: A retrospective study was conducted using the IMEDS-DD. Eligible members were adults with a medical encounter between April 1, 2018 and March 31, 2019 (index period). Type 2 diabetes and co-existing conditions were determined using all data available from April 1, 2016 to the most recent encounter within the index period. Type 2 diabetes patient characteristics, comorbidities and hemoglobin A1c (HbA1c) values were summarized and compared with those reported in national benchmarks and literature. RESULTS: Type 2 diabetes prevalence was 12.6% in the IMEDS-DD. Of 4 14 672 patients with type 2 diabetes, 52.8% were male, and the mean age was 65.0 (SD 13.3) years. Common comorbidities included hypertension (84.5%), hyperlipidemia (82.8%), obesity (45.3%), and cardiovascular disease (44.7%). Moderate-to-severe chronic kidney disease was observed in 20.2% patients. The most commonly used antihyperglycemic agents included metformin (35.7%), sulfonylureas (14.8%), and insulin (9.9%). Less than one-half (48.9%) had an HbA1c value recorded. These findings demonstrated the notable similarity in patient characteristics between type 2 diabetes populations identified within the IMEDS-DD and other large databases. CONCLUSIONS: Despite the limitations related to HbA1c data, our findings indicate that the IMEDS-DD contains robust information on key data elements to conduct pharmacoepidemiological studies in diabetes, including member demographic and clinical characteristics and health services utilization.

Effect of Palliative Care Curriculum on Serious Illness Conversation Preparedness.

BACKGROUND: A shortage of palliative pare (PC) specialists underscores the necessity that all clinicians feel comfortable with serious illness conversations (SICs). OBJECTIVE: To assess the effect of an intensive PC curriculum with multiple teaching modalities on Internal Medicine residents' confidence with SICs and advance care planning documentation. METHODS: Twelve PC modules consisting of didactic lectures, role-playing, and online interactive modules were integrated as continuing education during academic year 2018-2019. Surveys were administered precurriculum and at 3 and 6 months postcurriculum to measure the primary outcome of increasing resident preparedness for SICs. A retrospective chart review was used to analyze secondary outcomes of advance care planning documentation for patients cared for by residents exposed to the curriculum versus residents from the previous year who received monthly didactic PC lectures. RESULTS: Postintervention surveys demonstrated statistically significant improvement in resident confidence. An increase in patient code status confirmation rates (odds ratio, 1.81; 95% confidence interval, 1.12-2.94; P = 0.02) and a decrease in PC consultation (odds ratio, 0.56; 95% confidence interval, 0.33-0.97; P = 0.04) was observed when compared with the previous year. CONCLUSION: Among residents, the incorporation of an intensive PC curriculum that uses multiple teaching modalities improves confidence in SICs, which we believe is integral to the practice of goal-concordant patient care.

Postpartum Atypical Posterior Reversible Encephalopathy Syndrome in a COVID-19 Patient - An Obstetric Emergency.

Encephalopathy in COVID-19 has been widely reported with several reports of posterior reversible encephalopathy syndrome (PRES) speculated to be due to an abrupt surge in blood pressure caused by coronavirus disease. Though peripartum posterior reversible encephalopathy syndrome is well recognized, its atypical variant with hemorrhage is uncommon. Peripartum atypical posterior reversible encephalopathy syndrome with COVID-19 requires early recognition and warrants dedicated inter-disciplinary management. We present a case of postpartum atypical posterior reversible encephalopathy syndrome with good maternal and fetal outcome. Our clinical and treatment approach with differential diagnosis are discussed in this hitherto unreported obstetric emergency with COVID-19.

Financial Hardship, Healthcare Utilization, and Health Among U.S. Cancer Survivors.

INTRODUCTION: This study examined associations of both medical and nonmedical financial hardships with healthcare utilization and self-rated health among cancer survivors. METHODS: The National Health Interview Survey (2013-2017) was used to identify cancer survivors (aged 18-64 years: n=4,939; aged ≥65 years: n=6,972). A total of 4 levels of medical financial hardship intensities were created with measures from material, psychological, and behavioral domains. A total of 5 levels of nonmedical financial hardship intensities were created with measures in food insecurity and worry about other economic needs (e.g., housing expenses). Generalized ordinal logistic regression examined associations between medical and nonmedical financial hardship intensities and emergency department visits, use of preventive services and cancer screenings, and self-rated health. All analyses were performed in 2019. RESULTS: In adjusted analyses, cancer survivors with higher medical financial hardship intensity (Level 4 vs Level 1; aged 18-64 years: 42% vs 26.2%, p<0.001; aged ≥65 years: 37.6% vs 24.3%, p=0.001) and higher nonmedical financial hardship intensity (Level 5 vs Level 1; aged 18-64 years: 37.2% vs 27.9%, p=0.011) had more emergency department visits. Moreover, cancer survivors with higher medical financial hardship intensity had lower influenza vaccine (Level 4 vs Level 1; aged 18-64 years: 45.6% vs 52.5%, p=0.036; aged ≥65 years: 64.6% vs 75.6%, p=0.008) and lower breast cancer screening levels (Level 4 vs Level 1; 46.8% vs 61.2%, p=0.001). Similar patterns were found between higher financial hardship intensities and worse self-rated health. CONCLUSIONS: Higher medical and nonmedical financial hardships are independently associated with more emergency department visits, lower receipt of some preventive services, and worse self-rated health in cancer survivors. With growing healthcare costs, unmet medical and nonmedical financial needs may worsen health disparities among cancer survivors.

Patient-Provider Discussions About Out-of-Pocket Costs of Cancer Care in the U.S.

INTRODUCTION: Despite the importance of cost-related discussions in cancer care, little is known about the prevalence or drivers of these discussions in clinical practice. This study estimates the prevalence and examines the correlates of cancer survivors' discussions about out-of-pocket costs of cancer care with providers. METHODS: The 2016 and 2017 Medical Expenditure Panel Survey Experiences with Cancer Surveys were used to identify 1,550 survivors who responded to the question on discussion about out-of-pocket costs of cancer care. Multivariable multinomial logistic regression examined the correlates of discussions about out-of-pocket costs. Analyses were performed in 2019. RESULTS: Approximately one quarter of cancer survivors reported having discussed the out-of-pocket costs of cancer care. In multivariable analyses, respondents in the following categories were less likely to report no cost discussion than any cost discussion: black non-Hispanic/other race (RRR=0.67, 95% CI=0.45, 0.98; white non-Hispanic race as reference), no health insurance at diagnosis (RRR=0.51, 95% CI=0.27, 0.95; private health insurance as reference), and any experience of financial hardship (RRR=0.48, 95% CI=0.35, 0.66; no financial hardship as reference). CONCLUSIONS: Patient-reported discussions about out-of-pocket costs for cancer care are infrequent in the U.S. The findings highlight the needs to improve the understanding of the barriers and facilitators for effective discussions about out-of-pocket costs of cancer care.

Worry About Daily Financial Needs and Food Insecurity Among Cancer Survivors in the United States.

BACKGROUND: A cancer diagnosis can impose substantial medical financial burden on individuals and may limit their ability to work. However, less is known about worry for nonmedical financial needs and food insecurity among cancer survivors. METHODS: The National Health Interview Survey (2013-2017) was used to identify cancer survivors (age 18-39 years, n=771; age 40-64 years, n=4,269; age ≥65 years, n=7,101) and individuals without a cancer history (age 18-39 years, n=53,262; age 40-64 years, n=60,141; age ≥65 years, n=30,261). For both cancer survivors and the noncancer group, adjusted proportions were generated for (1) financial worry ("very/moderately/not worried") about retirement, standard of living, monthly bills, and housing costs; and (2) food insecurity ("often/sometimes/not true") regarding whether food would run out, the fact that food bought did not last, and the inability to afford balanced meals. Further adjusted analyses examined intensity measures ("severe/moderate/minor or none") of financial worry and food insecurity among cancer survivors only. RESULTS: Compared with individuals without a cancer history, cancer survivors aged 18 to 39 years reported consistently higher "very worried" levels regarding retirement (25.5% vs 16.9%; P<.001), standard of living (20.4% vs 12.9%; P<.001), monthly bills (14.9% vs 10.3%; P=.002), and housing costs (13.6% vs 8.9%; P=.001); and higher "often true" levels regarding worry about food running out (7.9% vs 4.6%; P=.004), food not lasting (7.6% vs 3.3%; P=.003), and being unable to afford balanced meals (6.3% vs 3.4%; P=.007). Findings were not as consistent for cancer survivors aged 40 to 64 years. In contrast, results were generally similar for adults aged ≥65 years with/without a cancer history. Among cancer survivors, 57.6% (age 18-39 years; P<.001), 51.9% (age 40-64 years; P<.001), and 23.8% (age ≥65 years; referent) reported severe/moderate financial worry intensity, and 27.0% (age 18-39 years; P<.001), 14.8% (age 40-64 years; P<.001), and 6.3% (age ≥65 years; referent) experienced severe/moderate food insecurity intensity. Lower income and higher comorbidities were generally associated with greater intensities of financial worry and food insecurity in all 3 age groups. CONCLUSIONS: Younger cancer survivors experience greater financial worry and food insecurity. In addition to coping with medical costs, cancer survivors with low income and multiple comorbidities struggle to pay for daily living needs, such as food, housing, and monthly bills.

Estimated Ventricular Size, Asthma Severity, and Exacerbations: The Severe Asthma Research Program III Cohort.

BACKGROUND: Relative enlargement of the pulmonary artery (PA) on chest CT imaging is associated with respiratory exacerbations in patients with COPD or cystic fibrosis. We sought to determine whether similar findings were present in patients with asthma and whether these findings were explained by differences in ventricular size. METHODS: We measured the PA and aorta diameters in 233 individuals from the Severe Asthma Research Program III cohort. We also estimated right, left, and total epicardial cardiac ventricular volume indices (eERVVI, eELVVI, and eETVVI, respectively). Associations between the cardiac and PA measures (PA-to-aorta [PA/A] ratio, eERVVI-to-eELVVI [eRV/eLV] ratio, eERVVI, eELVVI, eETVVI) and clinical measures of asthma severity were assessed by Pearson correlation, and associations with asthma severity and exacerbation rate were evaluated by multivariable linear and zero-inflated negative binomial regression. RESULTS: Asthma severity was associated with smaller ventricular volumes. For example, those with severe asthma had 36.1 mL/m2 smaller eETVVI than healthy control subjects (P = .003) and 14.1 mL/m2 smaller eETVVI than those with mild/moderate disease (P = .011). Smaller ventricular volumes were also associated with a higher rate of asthma exacerbations, both retrospectively and prospectively. For example, those with an eETVVI less than the median had a 57% higher rate of exacerbations during follow-up than those with eETVVI greater than the median (P = .020). Neither PA/A nor eRV/eLV was associated with asthma severity or exacerbations. CONCLUSIONS: In patients with asthma, smaller cardiac ventricular size may be associated with more severe disease and a higher rate of asthma exacerbations. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01761630; URL: www.clinicaltrials.gov.

Equipoise in Appropriate Initial Volume Resuscitation for Patients in Septic Shock With Heart Failure: Results of a Multicenter Clinician Survey.

PURPOSE: International clinical practice guidelines call for initial volume resuscitation of at least 30 mL/kg body weight for patients with sepsis-induced hypotension or shock. Although not considered in the guidelines, preexisting cardiac dysfunction may be an important factor clinicians weigh in deciding the quantity of volume resuscitation for patients with septic shock. METHODS: We conducted a multicenter survey of clinicians who routinely treat patients with sepsis to evaluate their beliefs, behaviors, knowledge, and perceived structural barriers regarding initial volume resuscitation for patients with sepsis and concomitant heart failure with reduced ejection fraction (HFrEF) <40%. Initial volume resuscitation preferences were captured as ordinal values, and additional testing for volume resuscitation preferences was performed using McNemar and Wilcoxon signed rank tests as indicated. Univariable logistic regression models were used to identify significant predictors of ≥30 mL/kg fluid administration. RESULTS: A total of 317 clinicians at 9 US hospitals completed the survey (response rate 47.3%). Most respondents were specialists in either internal medicine or emergency medicine. Substantial heterogeneity was found regarding sepsis resuscitation preferences for patients with concomitant HFrEF. The belief that patients with septic shock and HFrEF should be exempt from current sepsis bundle initiatives was shared by 39.4% of respondents. A minimum fluid challenge of ∼30 mL/kg or more was deemed appropriate in septic shock by only 56.4% of respondents for patients with concomitant HFrEF, compared to 89.1% of respondents for patients without HFrEF (P < .01). Emergency medicine physicians were most likely to feel that <30 mL/kg was most appropriate in patients with septic shock and HFrEF. CONCLUSIONS: Clinical equipoise exists regarding initial volume resuscitation for patients with sepsis-induced hypotension or shock and concomitant HFrEF. Future studies and clinical practice guidelines should explicitly address resuscitation in this subpopulation.

Factors Associated With Oncologist Discussions of the Costs of Genomic Testing and Related Treatments.

BACKGROUND: Use of genomic testing is increasing in the United States. Testing can be expensive, and not all tests and related treatments are covered by health insurance. Little is known about how often oncologists discuss costs of testing and treatment or about the factors associated with those discussions. METHODS: We identified 1220 oncologists who reported discussing genomic testing with their cancer patients from the 2017 National Survey of Precision Medicine in Cancer Treatment. Multivariable polytomous logistic regression analyses were used to assess associations between oncologist and practice characteristics and the frequency of cost discussions. All statistical tests were two-sided. RESULTS: Among oncologists who discussed genomic testing with patients, 50.0% reported often discussing the likely costs of testing and related treatments, 26.3% reported sometimes discussing costs, and 23.7% reported never or rarely discussing costs. In adjusted analyses, oncologists with training in genomic testing or working in practices with electronic medical record alerts for genomic tests were more likely to have cost discussions sometimes (odds ratio [OR] = 2.09, 95% confidence interval [CI] = 1.19 to 3.69) or often (OR = 2.22, 95% CI = 1.30 to 3.79), respectively, compared to rarely or never. Other factors statistically significantly associated with more frequent cost discussions included treating solid tumors (rather than only hematological cancers), using next-generation sequencing gene panel tests, having higher patient volume, and working in practices with higher percentages of patients insured by Medicaid, or self-paid or uninsured. CONCLUSIONS: Interventions targeting modifiable oncologist and practice factors, such as training in genomic testing and use of electronic medical record alerts, may help improve cost discussions about genomic testing and related treatments.

Has the Quality of Patient-Provider Communication About Survivorship Care Improved?

PURPOSE: The aim of the current study was to assess whether the quality of patient-provider communication on key elements of cancer survivorship care changed between 2011 and 2016. METHODS: Participating survivors completed the 2011 or 2016 Medical Expenditure Panel Survey Experiences with Cancer Surveys (N = 2,266). Participants reported whether any clinician ever discussed different aspects of survivorship care. Responses ranged from "Did not discuss at all" to "Discussed it with me in detail". Distributions of responses were compared among all respondents and only among those who had received cancer-directed treatment within 3 years of the survey. RESULTS: In 2011, the percentage of survivors who did not receive detailed instructions on follow-up care, late or long-term adverse effects, lifestyle recommendations, and emotional or social needs were 35.1% (95% CI, 31.9% to 38.4%), 54.2% (95% CI, 50.7% to 57.6%), 58.9% (95% CI, 55.3% to 62.5%), and 69.2% (95% CI, 65.9% to 72.3%), respectively, and the corresponding proportions for 2016 were 35.4% (95% CI, 31.9% to 37.8%), 55.5% (95% CI, 51.7% to 59.3%), 57.8% (95% CI, 54.2% to 61.2%), and 68.2% (95% CI, 64.3% to 71.8%), respectively. Findings were similar among recently treated respondents. Only 24% in 2011 and 22% in 2016 reported having detailed discussions about all four topics. In 2016, 47.6% of patients (95% CI, 43.8% to 51.4%) reported not having detailed discussions with their providers about a summary of their cancer treatments. CONCLUSION: Clear gaps in the quality of communication between survivors of cancer and providers persist. Our results highlight the need for continued efforts to improve communication between survivors of cancer and providers, including targeted interventions in key survivorship care areas.