Results from a Real-World Multicenter Analysis of 482 Patients with Chronic Lymphocytic Leukemia Treated with Ibrutinib: A Look at Racial Differences.

BACKGROUND: Despite recent approvals of lifesaving treatments for chronic lymphocytic leukemia (CLL), real-world data on the tolerability of the Bruton tyrosine kinase inhibitor ibrutinib for CLL treatment are lacking, especially in Black patients. OBJECTIVE: To expand upon a previously reported retrospective chart review of ibrutinib-treated patients with CLL to increase the number of sites and the enrollment period in first-line (1L) and relapsed/refractory (R/R) settings with a subanalysis based on ethnicity. PATIENTS AND METHODS: Adults with CLL who initiated ibrutinib treatment from five centers were followed for ≥ 6 months. RESULTS: We identified 482 patients with CLL [405 White (153 1L, 252 R/R), 37 Black (17 1L, 20 R/R), 40 other/unidentified]. At baseline, 58.5% of all patients (68.8% of Black patients) had hypertension. At a median follow-up of 28.2 months, 31.1% of patients overall discontinued ibrutinib, 16.2% due to adverse events (12.2% 1L, 18.8% R/R). Overall, 46.0% of patients experienced ≥ 1 dose hold (40.2% 1L, 49.8% R/R), and 28.8% of patients experienced ≥ 1 dose reduction (24.9% 1L, 31.4% R/R). Among Black patients, ibrutinib was discontinued in 24.3% of patients (17.6% 1L, 30.0% R/R), 8.1% due to disease progression and 5.4% due to adverse events; 40.5% of patients experienced ≥ 1 dose hold (35.3% 1L, 45.0% R/R), and 32.4% of patients experienced ≥ 1 dose reduction (23.5% 1L, 40.0% R/R). CONCLUSIONS: Toxicity and disease progression were the most common reasons for ibrutinib discontinuations in the overall population and among Black patients, respectively. Encouraging research participation of underrepresented patient groups will help clinicians better understand treatment outcomes.

Ibrutinib, a Bruton tyrosine kinase inhibitor, is an approved oral targeted therapy for the treatment of chronic lymphocytic leukemia (CLL). Patients treated with ibrutinib can experience side effects (referred to as adverse events) and may need to reduce the drug dose (referred to as dose reductions) or stop treatment (referred to as discontinuations) for a variety of reasons. A previous study showed that patients who were treated with ibrutinib experienced frequent dose reductions and discontinuations. This study described dose reductions and discontinuations in a larger patient population treated with ibrutinib and also described outcomes in Black patients. Patients with CLL treated with ibrutinib were identified from five medical centers and were followed for a minimum of 6 months. Patients experienced frequent dose reductions and discontinuations in routine clinical practice. The most common cause of discontinuations was adverse events in the overall patient population and disease progression in the Black patient population. Black patients treated with ibrutinib had similar rates of dose reductions and discontinuations as the overall patient population. Rates of dose reductions and discontinuations for patients with CLL treated with ibrutinib were higher in this real-world study than in clinical trials.

COVID-19-Related Emergency Department Visits Among Undocumented Patients in Los Angeles County.

Undocumented immigrants may be vulnerable to poor COVID-19 outcomes, but also may be less likely to seek medical care. To our knowledge, there have not been any investigations of potential COVID-19 disparities by immigration status. We analyzed emergency department (ED) visit data from March 20, 2020 to September 30, 2020 among patients in a safety-net hospital in Los Angeles County (n=30,023). We compared the probability of COVID-19-related ED visits between undocumented immigrants and Medi-Cal patients. We also examined differences in these comparisons over time. Undocumented patients had higher odds of COVID-19-related ED visits than Medi-Cal patients (OR: 1.41, 95% CI: 1.24-1.60) for all months in the study period except September. Even in the earliest days of the pandemic, undocumented patients were more likely than Medi-Cal patients to have a COVID-19-related ED visit. Additional analyses suggest this was likely because of higher COVID-19 exposure rather than differences in ED utilization.

Psychiatric Admissions Among Undocumented Immigrants at an Urban County Hospital.

Little is known about the inpatient mental health needs of undocumented immigrants in the United States. Based on existing literature, we hypothesized that undocumented patients would have fewer psychiatric admissions than documented patients. We reviewed 2019 inpatient admission data for Hispanic/Latino patients at an urban hospital. Patients were coded as undocumented or documented using insurance proxies. Multivariable logistic regression was used to report odds ratio of admission diagnoses of interest by documentation status. There were no significant differences in psychiatric admissions between undocumented patients (2.1%) and documented patients (2.8%) (p=.77). Compared with documented counterparts, undocumented patients were more likely to be admitted for alcohol-related disorders (AOR=1.59, 95%CI=1.31-1.93) but had lower proportions of admission for substance-related disorders, mood disorders, anxiety disorders, and suicide and intentional self-inflicted injury among others. Future studies should examine factors contributing to alcohol use disorder and barriers to accessing and using mental health care.

Changes in Acute ED Visits by Race/Ethnicity During the Early COVID-19 Pandemic.

Emergency department (ED) visits for conditions unrelated to the Coronavirus Disease 2019 (COVID-19) pandemic decreased during the early pandemic, raising concerns about critically ill patients forgoing care and increasing their risk of adverse outcomes. It is unclear if Hispanic and Black adults, who have a high prevalence of chronic conditions, sought medical assistance for acute emergencies during this time. This study used 2018-2020 ED visit data from the largest safety net hospital in Los Angeles County to estimate ED visit differences for cardiac emergencies, diabetic complications, and strokes, during the first societal lockdown among Black and Hispanic patients using time series analyses. Emergency department visits were lower than the expected levels during the first societal lockdown. However, after the lockdown ended, Black patients experienced a rebound in ED visits while visits for Hispanics remained depressed. Future research could identify barriers Hispanics experienced that contributed to prolonged ED avoidance.

Psychiatric Emergencies in Los Angeles County During, and After, Initial COVID-19 Societal Restrictions: An Interrupted Time-Series Analysis.

Emergency department (ED) visits for psychiatric care in the US reportedly declined during the COVID-19 pandemic. This work, however, does not control for strong temporal patterning in visits before the pandemic and does not examine a potential "rebound" in demand for psychiatric care following the relaxation of initial societal restrictions. Here, we examine COVID-19-related perturbations in psychiatric care during and after the 1st stage of societal restrictions in the largest safety-net hospital in Los Angeles. We retrieved psychiatric ED visit data (98,888 total over 156 weeks, Jan 2018 to Dec 2020) from Los Angeles County + USC Medical Center. We applied interrupted time series methods to identify and control for autocorrelation in psychiatric ED visits before examining their relation with the 1st stage of societal restrictions (i.e., March 13 to May 8, 2020), as well as the subsequent "rebound" period of relaxed restrictions (i.e., after May 8, 2020). Psychiatric ED visits fell by 78.13 per week (i.e., 12%) during the 1st stage of societal restrictions (SD = 23.99, p < 0.01). Reductions in ED visits for alcohol use, substance use, and (to a lesser extent) anxiety disorders accounted for the overall decline. After the 1st stage of societal restrictions, however, we observe no "rebound" above expected values in psychiatric ED visits overall (coef = - 16.89, SD = 20.58, p = 0.41) or by diagnostic subtype. This pattern of results does not support speculation that, at the population level, foregoing ED care during initial societal restrictions subsequently induced a psychiatric "pandemic" of urgent visits.

Emergency Department Utilization Among Undocumented Latino Patients During the COVID-19 Pandemic.

OBJECTIVE: To determine whether Latino undocumented immigrants had a steeper decline in Emergency Department (ED) utilization compared to Latino Medi-Cal patients in a Los Angeles safety-net hospital, March 13, 2020, to May 8, 2020. STUDY DESIGN: The data were extracted from patient medical records for ED visits at LAC + USC Medical Center from January 2018 to September 2020. We analyzed weekly ED encounters among undocumented Latino patients in the nine-week period after COVID was declared a national emergency. We applied time-series routines to identify and remove autocorrelation in ED encounters before examining its relation with the COVID-19 pandemic. We included Latino patients 18 years of age and older who were either on restricted or full-scope Medi-Cal (n = 230,195). RESULTS: All low-income Latino patients, regardless of immigration status, experienced a significant decline in ED utilization during the first nine weeks of the pandemic. Undocumented patients, however, experienced an even steeper decline. ED visits for this group fall below expected levels between March 13, 2020, and May 8, 2020 (coef. = - 38.67; 95% CI = - 71.71, - 5.63). When applied to the weekly mean of ED visits, this translates to a 10% reduction below expected levels in ED visits during this time period. CONCLUSION: Undocumented immigrants' health care utilization was influenced by external events that occurred early in the pandemic, such as strict stay-at-home orders and the public charge rule change. Health care institutions and local policy efforts could work to ensure that hospitals are safer spaces for undocumented immigrants to receive care without immigration concerns.

COVID-19 case counts and COVID-19 related Emergency Department visits: differences by immigration status, March-December 2020.

BACKGROUND: Undocumented immigrants face barriers to health care access, which may have been exacerbated during the early days of the COVID-19 pandemic. We test whether undocumented immigrants in Los Angeles County accessed COVID-19 related medical care by examining their Emergency Department (ED) patterns through high and low periods of COVID-19 infection. If undocumented immigrants were underutilizing or foregoing health care, we expect null or weaker associations between COVID-19 cases and COVID-19 related ED visits relative to Medi-Cal patients. METHODS: We analyzed all ED visits to the Los Angeles County + University of Southern California (LAC + USC) Medical Center between March - December 2020 (n = 85,387). We conducted logistic regressions with Los Angeles County weekly COVID-19 case counts as our main independent variable and an interaction between case counts and immigration status, stratified by age (over and under 65 years). RESULTS: We found that undocumented immigrants under 65 years old had a higher odds for a COVID-19 related ED visit compared to Medi-Cal patients and that both undocumented and Medi-Cal patients had higher odds of a COVID-19 related ED visit as COVID-19 cases in Los Angeles County increased. For patients over 65 years, Medi-Cal patients actually had a weaker association between ED visits and county COVID-19 counts; as COVID-19 case counts rose, the odds of a COVID-19 related ED visit increased for the undocumented patients. CONCLUSION: While the overall likelihood of undocumented patients having a COVID-19 related ED visit varies compared to Medi-Cal patients - for younger patients, the odds is higher; for older patients, the odds is lower - it does not appear that undocumented patients underutilized the ED during the early COVID-19 pandemic relative to Medi-Cal patients. The ED may be a viable source of contact for this high-risk population for future outreach.

Real-world ibrutinib dose reductions, holds and discontinuations in chronic lymphocytic leukemia.

Aim: A retrospective chart review of ibrutinib-treated patients with chronic lymphocytic leukemia (CLL) was conducted. Patients & methods: Adults with CLL who initiated ibrutinib were followed for ≥6 months (n = 180). Results: Twenty-five percent of first-line ibrutinib patients experienced ≥1 dose reduction, mainly due to adverse events (AEs; 79%). Treatment discontinuations and dose holds occurred in 20 and 34% of patients, respectively, most commonly due to AEs (73 and 74%). Approximately one-quarter of relapsed/refractory ibrutinib patients experienced ≥1 dose reduction, mainly due to AEs (88%). Treatment discontinuation and dose holds occurred in 40% of patients (58 and 76% due to AEs, respectively). Conclusion: Dose reductions, holds and discontinuations were frequent in patients with CLL receiving ibrutinib in routine clinical practice.

Lay abstract Chronic lymphocytic leukemia (CLL) is a cancer that develops from a type of white blood cells called 'B cells.' Ibrutinib is a targeted therapy that inhibits the activity of a protein called Bruton's tyrosine kinase, which plays a key role in CLL. Patients receiving ibrutinib treatment can experience side effects ('adverse events'). In addition, patients may need to reduce their drug dose ('dose reductions') or stop treatment ('discontinuations') for a variety of reasons. We reviewed patients' charts to describe dose reductions and discontinuations in ibrutinib-treated patients with CLL. Our results indicate that dose reductions and discontinuations were frequent in patients with CLL receiving ibrutinib in routine clinical practice, and that the most common reason was adverse events.

Severity of Inpatient Hospitalizations Among Undocumented Immigrants and Medi-Cal Patients in a Los Angeles, California, Hospital: 2019.

Objectives. To compare the severity of inpatient hospitalizations between undocumented immigrants and Medi-Cal patients in a large safety-net hospital in Los Angeles, California. Methods. We conducted a retrospective analysis of all 2019 inpatient stays at a Los Angeles hospital (n = 22 480), including patients of all races/ethnicities. We examined 3 measures by using insurance status to approximate immigration status: illness severity, length of hospital stay, and repeat hospitalizations. We calculated group differences between undocumented and Medi-Cal patients by using inverse probability weighted regression adjustment separately for patients aged 18 to 64 years and those aged 65 years and older. Results. Younger undocumented patients had less severe illness and shorter lengths of stay than their Medi-Cal counterparts. Older undocumented immigrants also had less severe illness, but had similar lengths of stay and were more likely to have repeated hospitalizations. Conclusions. While existing work suggests that undocumented immigrants could have more severe health care needs on account of their poorer access to medical care, we did not see clear health disadvantages among hospitalized undocumented immigrants, especially younger patients. There were fewer differences between undocumented and Medi-Cal patients who were older. (Am J Public Health. 2021;111(11):2019-2026. https://doi.org/10.2105/AJPH.2021.306485).

Will Improvements in Patient Experience With Care Impact Clinical and Quality of Care Outcomes?: A Systematic Review.

BACKGROUND: Patient experiences with health care have been widely used as benchmark indicators of quality for providers, health care practices, and health plans. OBJECTIVE: The objective of this study was to summarize the literature regarding the associations between Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient experiences and clinical and quality outcomes. RESEARCH DESIGN: A systematic review of the literature was completed using PubMed, Embase, and Cumulative Index to Nursing and Allied Health Literature on December 14, 2019. Separate searches were conducted to query terms identifying CAHPS surveys with clinical and quality outcomes of care. Two reviewers completed all components of the search process. STUDY SELECTION: Studies investigating associations between CAHPS composite ratings and health care sensitive clinical outcomes or quality measures of care were included in this review. Studies were excluded if they did not investigate patient experiences using CAHPS composite ratings or if CAHPS composites were not treated as the independent variable. RESULTS: Nineteen studies met inclusion criteria, 10 investigating associations of CAHPS composite ratings with clinical outcomes and 9 investigating these associations with quality measures. Patient-provider communication was the most studied CAHPS composite rating and was significantly associated with self-reported physical and mental health, frequency of emergency room visits and inpatient hospital stays, hospitalization length, and CAHPS personal physician global ratings. CONCLUSIONS: Ratings of patient experience with care may influence clinical and quality outcomes of care. However, key inconsistencies between studies affirm that more research is needed to solidify this conclusion and investigate how patient experiences differentially relate to outcomes for various patient groups.

Participatory decision-making for cancer care in a high-risk sample of low income Mexican-American breast cancer survivors: The role of acculturation.

BACKGROUND: Despite declining cancer incidence and mortality rates, Latina patients continue to have lower 5-year survival rates compared to their non-Hispanic white counterparts. Much of this difference has been attributed to lack of healthcare access and poorer quality of care. Research, however, has not considered the unique healthcare experiences of Latina patients. METHODS: Latina women with prior diagnoses of stage 0-III breast cancer were asked to complete a cross-sectional survey assessing several socio-demographic factors along with their experiences as cancer patients. Using a series of linear regression models in a sample of 68 Mexican-American breast cancer survivors, we examined the extent to which patients' ratings of provider interpersonal quality of care were associated with patients' overall healthcare quality, and how these associations varied by acculturation status. RESULTS: Findings for Latina women indicated that both participatory decision-making (PDM) (ß = 0.62, p < .0001) and trust (ß = 0.53, p = .02) were significantly associated with patients' ratings of healthcare quality. The interaction between acculturation and PDM further suggested that participating in the decision-making process mattered more for less acculturated than for more acculturated patients (ß = -0.51, p ≤ .01). CONCLUSIONS: The variation across low and high acculturated Latinas in their decision-making process introduces a unique challenge to health care providers. Further understanding the relationship between provider-patient experiences and ratings of overall healthcare quality is critical for ultimately improving health outcomes.

Diagnostic Accuracy of Two Food Insecurity Screeners Recommended for Use in Health Care Settings.

OBJECTIVES: To test the diagnostic accuracy of the American Academy of Pediatrics (AAP) recommended food insecurity screener. METHODS: We conducted prospective diagnostic accuracy studies between July and November 2016 in Chicago, Illinois. We recruited convenience samples of adults from adult and pediatric emergency departments (12-month recall study: n = 188; 30-day recall study: n = 154). A self-administered survey included the 6-item Household Food Security Screen (gold standard), the validated 2-item Hunger Vital Sign (HVS; often, sometimes, never response categories), and the 2-item AAP tool (yes-or-no response categories). RESULTS: Food insecurity was prevalent (12-month recall group: 46%; 30-day group: 39%). Sensitivity of the AAP tool using 12-month and 30-day recall was, respectively, 76% (95% confidence interval [CI] = 65%, 85%) and 72% (95% CI = 57%, 84%). The HVS sensitivity was significantly higher than the AAP tool (12-month: 94% [95% CI = 86%, 98%; P = .002]; 30-day: 92% [95% CI = 79%, 98%; P = .02]). CONCLUSIONS: The AAP tool missed nearly a quarter of food-insecure adults screened in the hospital; the HVS screening tool was more sensitive. Public health implications. Health care systems adopting food insecurity screening should optimize ease of administration and sensitivity of the screening tool.