Clinical Outcomes of Immune Checkpoint Inhibitors in Unique Cohorts Underrepresented in Clinical Trials.

Regulatory approval of immune checkpoint inhibitors (ICIs) was based on results of large, randomized clinical trials, resulting in limited outcomes data in patient cohorts typically underrepresented in such trials. The objective of this study was to evaluate the efficacy and safety of ICIs in these unique patient cohorts. This is a multicenter, retrospective analysis of real-world data at six academic and community clinics in the United States from 1 January 2011 to 1 April 2018. Patients were included if they had received at least one cycle of ICI treatment. Unique patient cohorts included age > 75 years, non-White race, positive smoking history, ECOG performance status (PS) ≥ 2, BMI ≥ 30 kg/m2, autoimmune diseases (AIDs), chronic viral infections (CVI), extensive prior lines of therapy (LOTs), or >three metastatic sites. Immune-related adverse events (irAEs), overall survival (OS), and time to treatment failure were evaluated in the entire cohort and in NSCLC patients treated with PD-(L)1 monotherapy. Outcomes and their association with unique patient cohorts were compared on univariate analysis and multivariate analysis to those without a particular characteristic in the entire NSCLC PD-(L)1 monotherapy cohorts. In total, 1453 patients were included: 56.5%-smokers, 30.4%-non-White, 22.8%-elderly, 20.8%-ECOG PS ≥ 2, 15.7%-history of AIDs, and 4.7%-history of CVI. The common ICIs were nivolumab (37.1%) and pembrolizumab (22.2%). Black patients, compared to White patients, experienced fewer irAEs (OR 0.54, p < 0.001). An ECOG PS of ≥2 (HR = 2.01, p < 0.001) and an increased number of previous LOTs were associated with poor OS (the median OS of 26.2 vs. 16.2 vs. 9.6 months for one vs. two vs. three prior LOTs, p < 0.001). The above results were confirmed in anti-PD-(L)1 monotherapy non-small cell lung cancer patients (n = 384). Overall, ICIs were safe and efficacious in these typically underrepresented patient cohorts. We noted ECOG PS ≥ 2 and an increased prior LOTs were associated with poor ICI efficacy, and Black patients, compared to White patients, experienced fewer irAEs.

Environmental Health Needs Among Latinas in Cleaning Occupations: A Mixed Methods Approach.

In the U.S., approximately half of maids and housekeeping cleaners are Latino or Hispanic, while the vast majority are women (88.3%). This largely immigrant, underserved workforce faces complex factors, which may contribute to adverse health outcomes. To understand relevant barriers and challenges, this mixed-methods study explored the environmental health needs of a heterogeneous group of Latinas in New Jersey (NJ) who clean occupationally, and consisted of 3 focus groups (N = 15) with a cross-sectional survey (N = 9), both conducted in Spanish. Participants were recruited from community-based English as a Second Language classes in Hackensack, NJ. Analysis of focus group audio recordings included descriptive and in vivo coding followed by inductive coding to explore thematic analysis. The survey responses were evaluated using descriptive statistics. As per the survey results, the environmental health needs of this population include sore muscles, back problems, asthma, other respiratory issues, migraine or headache, and skin issues (rash, etc.). In the group discussions, the roles of genetics, food, and chemical exposures in cancer etiology were of great interest and a variety of opinions on the topic were explored. Both the focus group discussions and survey responses suggested that this population also faces barriers including lack of training, chemical exposures and inadequate personal protective equipment (PPE). These barriers are compounded by daily environmental exposures from personal home cleaning practices. The development of culturally- and linguistically-appropriate interventions are warranted to better protect the health of essential occupational cleaners who keep homes, businesses and schools clean.

Knowledge, attitudes and behaviors of Latinas in cleaning occupations in northern New Jersey: a cross-sectional mixed methods study.

BACKGROUND: In the United States, 88.3% of all 1,163,000 maids and housekeeping cleaners are female, and approximately half of them Latinas. Latinas are understudied and underrepresented in health research, particularly involving chemical exposure in cleaning practices, lack of job training, and inadequate access to personal protective equipment. The purpose of this study is twofold: 1) to examine the knowledge (via training experiences), attitudes and behaviors of a heterogeneous group of Latinas who clean occupationally and 2) to assess their cleaning practices at work and at home. METHODS: This mixed-method study consisted of two phases: 1) three focus groups to explore knowledge (via training experiences), attitudes, and behaviors regarding cleaning practices (N = 15) and 2) a 43-question cross-sectional survey. Focus group audio recordings were analyzed using descriptive and in vivo coding and then coded inductively to explore thematic analysis. Statistical analysis of the survey evaluated means, frequency and percentage for each of the responses. RESULTS: Participants (n = 9) were women (mean age = 48.78 and SD = 6.72) from South America (n = 5), Mexico (n = 1), El Salvador (n = 1) and Dominican Republic (n = 2). The mean length of time living in the US was 18.78 years and over half (55.6%) worked in the cleaning industry for 10 or more years. Findings from the three focus groups (n = 15) included that training in cleaning often occurred informally at a very young age at home. Participants reported cleaning in groups where tasks are rotated and/or shared. Most were the primary person cleaning at home, suggesting increased exposure. Gloves and masks were the most frequently used PPE, but use was not consistent. For participants who purchase their own products, driving factors included price, smell and efficacy. Some participants used products supplied or preferred by the employer. CONCLUSIONS: Latinas in cleaning occupations face a range of social and health barriers including lack of safety and health training, inadequate PPE and low literacy. To address these issues, the development of an intervention is warranted to provide training and resources for this critical population of essential workers.

Hemodynamic Profiles of Shock in Patients With COVID-19.

Patients with serious COVID infections develop shock frequently. To characterize the hemodynamic profile of this cohort, 156 patients with COVID pneumonia and shock requiring vasopressors had interpretable echocardiography with measurement of ejection fraction (EF) by Simpson's rule and stroke volume (SV) by Doppler. RV systolic pressure (RVSP) was estimated from the tricuspid regurgitation peak velocity. Patients were divided into groups with low or preserved EF (EFL or EFP, cutoff ≤45%), and low or normal cardiac index (CIL or CIN, cutoff ≤2.2 L/min/m2). Mean age was 67 ± 12.0, EF 59.5 ± 12.9, and CI 2.40 ± 0.86. A minority of patients had depressed EF (EFLCIL, n = 15, EFLCIN, n = 8); of those with preserved EF, less than half had low CI (EFPCIL, n = 55, EFPCIN, n = 73). Overall hospital mortality was 73%. Mortality was highest in the EFLCIL group (87%), but the difference between groups was not significant (p = 0.68 by ANOVA). High PEEP correlated with low CI in the EFPCIL group (r = 0.44, p = 0.04). In conclusion, this study reports the prevalence of shock characterized by EF and CI in patients with COVID-19. COVID-induced shock had a cardiogenic profile (EFLCIL) in 9.6% of patients, reflecting the impact of COVID-19 on myocardial function. Low CI despite preservation of EF and the correlation with PEEP suggests underfilling of the LV in this subset; these patients might benefit from additional volume. Hemodynamic assessment of COVID patients with shock with definition of subgroups may allow therapy to be tailored to the underlying causes of the hemodynamic abnormalities.

Implementing a Review Process to Facilitate and Prioritize COVID-19 Research: Staying One Step Ahead of the Pandemic.

The first coronavirus disease 2019 (COVID-19) patient in the state of New Jersey (NJ) was admitted on March 2, 2020. With the number of hospitalized patients increasing exponentially in the following days and no established treatment approaches, research was to play a significant role in this fight. To facilitate review of all COVID-19 research proposals in a large health care network in NJ, we established the COVID-19 Research Review Committee (RRC) and implemented a peer-review process prior to the Institutional Review Board submission. The RRC was tasked with processing, soliciting, reviewing, and prioritizing research proposals and was comprised of a multidisciplinary group of reviewers. Within a 9-week period, three network-wide requests for proposals were released with 238 proposals submitted and 93 approved, an approval rate of 39%. The establishment of the RRC helped ensure scientific merit, better utilization of resources, collaborations across disciplines and network hospitals, and compliance with applicable regulatory and ethical standard.

Persistence of symptoms and quality of life at 35 days after hospitalization for COVID-19 infection.

BACKGROUND: Characterizing the prevalence and persistence of symptoms associated with COVID-19 infection following hospitalization and their impact is essential to planning post-acute community-based clinical services. This study seeks to identify persistent COVID-19 symptoms in patients 35 days post-hospitalization and their impact on quality of life, health, physical, mental, and psychosocial function. METHODS AND FINDINGS: This prospective cohort study used the PROMIS® Instruments to identify symptoms and quality of life parameters in consecutively enrolled patients between March 22 and April 16, 2020, in New Jersey. The 183 patients (median age 57 years; 61.5% male, 54.1% white) reported persistent symptoms at 35 days, including fatigue (55.0%), dyspnea (45.3%), muscular pain (51%), associated with a lower odds rating general health (41.5%, OR 0.093 [95% CI: 0.026, 0.329], p = 0.0002), quality of life (39.8%; OR 0.116 [95% CI: 0.038, 0.364], p = 0.0002), physical health (38.7%, OR 0.055 [95% CI: 0.016, 0.193], p <0.0001), mental health (43.7%, OR 0.093 [95% CI: 0.021, 0.418], p = 0.0019) and social active role (38.7%, OR 0.095 [95% CI: 0.031, 0.291], p<0.0001), as very good/excellent, particularly adults aged 65 to 75 years (OR 8·666 [95% CI: 2·216, 33·884], p = 0·0019). CONCLUSIONS: COVID-19 symptoms commonly persist to 35 days, impacting quality of life, health, physical and mental function. Early post-acute evaluation of symptoms and their impact on function is necessary to plan community-based services.