Food Insecurity and Experiences of Discrimination Among Caregivers of Hospitalized Children.

BACKGROUND AND OBJECTIVES: Pediatric hospitals are adopting strategies to address food insecurity (FI), a stigmatizing condition, among families with children. We hypothesized that parents and other caregivers ("caregivers") from households with FI or marginal food security (MFS) are more likely to experience discrimination during their child's hospitalization. METHODS: We analyzed data from 319 caregivers of children admitted to an urban, academic children's hospital and randomly assigned to the control arm of the double-blind randomized controlled CommunityRx-Hunger trial (November 2020 to June 2022, NCT R01MD012630). Household food security in the 30 days before admission and discrimination during hospitalization were measured with the US Household Food Security Survey and the Discrimination in Medical Settings Scale, respectively. We used logistic regression to model the relationship between food security status and discrimination, adjusting for gender, race, ethnicity, income, and partner status. RESULTS: Most participants were African American or Black (81.5%), female (94.7%), and the parent of the hospitalized child (93.7%). FI and MFS were prevalent (25.1% and 15.1%, respectively). Experiences of discrimination during a child's hospitalization were prevalent (51.9%). Caregivers with FI had higher odds than caregivers with food security of experiencing discrimination (adjusted odds ratio = 2.0, 95% confidence interval 1.1-3.6, P = .03); MFS was not significantly associated with discrimination (P = .25). Compared with food secure caregivers, those with FI had higher odds of 5 of 7 experiences of discrimination assessed. CONCLUSIONS: Among parents and other caregivers, household FI is associated with experiences of discrimination during a child's hospitalization.

CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials.

BACKGROUND: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago's South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers. METHODS AND FINDINGS: CommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in the first 12 months than originally projected for in-person enrollment. DISCUSSION: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. TRIAL REGISTRATION: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).

Social Risk and Smoking Among Women Smokers Early in the COVID-19 Pandemic: The Role of Mental Health.

Background: We examined patterns of smoking in relation to health-related socioeconomic vulnerability (HRSV) among U.S. women early in the pandemic and whether mental health symptoms mediated these relationships. Materials and Methods: Data were obtained from the April 2020 National U.S. Women's Health COVID-19 Study (N = 3200). Among current smokers, adjusted odds of increased smoking since the start of the pandemic (vs. same or less) by incident and worsening HRSVs were modeled. Structural equation modeling was used to assess anxiety, depression, and traumatic stress symptoms as mediators of the relationship between six HRSVs (food insecurity; housing, utilities, and transportation difficulties; interpersonal violence; financial strain) and increased smoking early in the pandemic. Results: Nearly half (48%) of current smokers reported increased smoking since the pandemic started. Odds of increased smoking were higher among women with incident financial strain (aOR = 2.0, 95% CI 1.2-3.3), incident food insecurity (aOR = 2.9, 95% CI 1.7-5.1), any worsening HRSV (aOR = 2.2, 95% CI 1.5-3.0), and worsening food insecurity (aOR = 1.9, 95% CI 1.3-3.0). Anxiety symptoms were a significant, partial mediator of the relationship between increased smoking and any worsening HRSVs (proportion mediated = 0.17, p = 0.001) and worsening food insecurity (0.19, p = 0.023), specifically. Depression symptoms were a significant, partial mediator of the relationship between increased smoking and any worsening HRSVs (0.15, p = 0.004) and incident financial strain (0.19, p = 0.034). Traumatic stress was not a significant mediator of any tested relationship. Conclusions: Anxiety and depression symptoms partially explain the relationship between rising socioeconomic vulnerability and increased smoking among women early in the pandemic. Addressing HRSVs and mental health may help reduce increased smoking during a public health crisis.

Perceived Appropriateness of Assessing for Health-related Socioeconomic Risks Among Adult Patients with Cancer.

Cancer treatment can trigger or exacerbate health-related socioeconomic risks (HRSR; food/housing insecurity, transportation/utilities difficulties, and interpersonal violence). The American Cancer Society and National Cancer Institute recommend HRSR screening and referral, but little research has examined the perceptions of patients with cancer on the appropriateness of HRSR screening in healthcare settings. We examined whether HRSR status, desire for assistance with HRSRs, and sociodemographic and health care-related factors were associated with perceived appropriateness of HRSR screening in health care settings and comfort with HRSR documentation in electronic health records (EHR). A convenience sample of adult patients with cancer at two outpatient clinics completed self-administered surveys. We used χ 2 and Fisher exact tests to test for significant associations. The sample included 154 patients (72% female, 90% ages 45 years or older). Thirty-six percent reported ≥1 HRSRs and 27% desired assistance with HRSRs. Overall, 80% thought it was appropriate to assess for HRSRs in health care settings. The distributions of HRSR status and sociodemographic characteristics were similar among people who perceived screening to be appropriate and those who did not. Participants who perceived screening as appropriate were three times as likely to report prior experience with HRSR screening (31% vs. 10%, P = 0.01). Moreover, 60% felt comfortable having HRSRs documented in the EHR. Comfort with EHR documentation of HRSRs was significantly higher among patients desiring assistance with HRSRs (78%) compared with those who did not (53%, P < 0.01). While initiatives for HRSR screening are likely to be seen by patients with cancer as appropriate, concerns may remain over electronic documentation of HRSRs. Significance: National organizations recommend addressing HRSRs such as food/housing insecurity, transportation/utilities difficulties, and interpersonal violence among patients with cancer. In our study, most patients with cancer perceived screening for HRSRs in clinical settings as appropriate. Meanwhile, concerns may remain over the documentation of HRSRs in EHRs.

Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care.

Background: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). CommunityRx-Hunger is a double-blind randomized controlled trial (RCT) that enrolls caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT that enrolls caregivers of community-residing people with dementia. Clinical trials that enroll caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify and track caregivers. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the CommunityRx protocols from in-person to remote operations. This study describes the novel methods used to iterate existing RCT protocols and factors contributing to their successful iteration. Methods: CommunityRx uses individual-level data to generate personalized community resource referrals for basic, health and caregiving needs. Our research program uses an asset-based, community-engaged approach including study-specific community advisory boards (CABs). In early 2020, both RCT protocols were pre-tested in-person. In March 2020, when pandemic conditions prohibited enrollment during clinical encounters, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Results: Enabled by engaged CABs and ARCTICS, both RCTs quickly adapted to remote operations. Designed before the pandemic, we had planned to launch both trials by March 2020 and complete enrollment by December 2021. The pandemic postponed launch until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in 12 months than originally projected in-person. Conclusions: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration to remote trial operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. Trial Status: Both studies are registered on ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999); CommunityRx for Caregivers (NCT04146545); My Diabetes My Community (NCT04970810).

Caregiving in a Pandemic: Health-Related Socioeconomic Vulnerabilities Among Women Caregivers Early in the COVID-19 Pandemic.

PURPOSE: Family and friends who provide regular care for a sick or dependent individual ("caregivers") are at increased risk of health-related socioeconomic vulnerabilities (HRSVs). This study examined pre-pandemic prevalence of and early pandemic changes in HRSVs among women caregivers compared with non-caregivers. METHODS: A cross-sectional survey was conducted in April 2020 (early pandemic) with 3,200 English-speaking US women aged 18 years or older, 30% of whom identified as caregivers. We modeled adjusted odds of self-reported HRSVs (financial strain, food/housing insecurity, interpersonal violence, transportation/utilities difficulties) before and changes during the early pandemic by caregiving status. Models were adjusted for age, race/ethnicity, marital status, education, income, number of people in household, number of children in household, physical and mental health, and number of comorbidities. RESULTS: Pre-pandemic, 63% of caregivers and 47% of non-caregivers reported 1 or more vulnerability (P <.01); food insecurity was most prevalent (48% of caregivers vs 33% of non-caregivers, P <.01). In the early pandemic, caregivers had higher odds than non-caregivers of financial strain, both incident (adjusted odds ratio [AOR] = 2.1; 95% CI, 1.6-2.7) and worsening (AOR = 2.0; 95% CI, 1.4-2.8); incident interpersonal violence (AOR = 2.0; 95% CI, 1.5-2.7); incident food insecurity (AOR = 1.6; 95% CI, 1.2-2.1); incident transportation difficulties (AOR = 1.9; 95% CI, 1.3-2.6); and incident housing insecurity (AOR = 1.6; 95% CI, 1.1-2.3). CONCLUSION: The coronavirus disease 2019 (COVID-19) pandemic increased risk of incident and worsening HRSVs for caregivers more than for non-caregivers. COVID-19 response and recovery efforts should target caregivers to reduce modifiable HRSVs and promote the health of caregivers and those who depend on them.Annals Online First article.

Effect of acute postsurgical pain trajectories on 30-day and 1-year pain.

Untreated pain after surgery leads to poor patient satisfaction, longer hospital length of stay, lower health-related quality of life, and non-compliance with rehabilitation regimens. The aim of this study is to characterize the structure of acute pain trajectories during the postsurgical hospitalization period and quantify their association with pain at 30-days and 1-year after surgery. This cohort study included 2106 adult (≥18 years) surgical patients who consented to participate in the SATISFY-SOS registry (February 1, 2015 to September 30, 2017). Patients were excluded if they did not undergo invasive surgeries, were classified as outpatients, failed to complete follow up assessments at 30-days and 1-year following surgery, had greater than 4-days of inpatient stay, and/or recorded fewer than four pain scores during their acute hospitalization period. The primary exposure was the acute postsurgical pain trajectories identified by a machine learning-based latent class approach using patient-reported pain scores. Clinically meaningful pain (≥3 on a 0-10 scale) at 30-days and 1-year after surgery were the primary and secondary outcomes, respectively. Of the study participants (N = 2106), 59% were female, 91% were non-Hispanic White, and the mean (SD) age was 62 (13) years; 41% of patients underwent orthopedic surgery and 88% received general anesthesia. Four acute pain trajectory clusters were identified. Pain trajectories were significantly associated with clinically meaningful pain at 30-days (p = 0.007), but not at 1-year (p = 0.79) after surgery using covariate-adjusted logistic regression models. Compared to Cluster 1, the other clusters had lower statistically significant odds of having pain at 30-days after surgery (Cluster 2: [OR = 0.67, 95%CI (0.51-0.89)]; Cluster 3:[OR = 0.74, 95%CI (0.56-0.99)]; Cluster 4:[OR = 0.46, 95%CI (0.26-0.82)], all p<0.05). Patients in Cluster 1 had the highest cumulative likelihood of pain and pain intensity during the latter half of their acute hospitalization period (48-96 hours), potentially contributing to the higher odds of pain during the 30-day postsurgical period. Early identification and management of high-risk pain trajectories can help in ascertaining appropriate pain management interventions. Such interventions can mitigate the occurrence of long-term disabilities associated with pain.

Racial and Ethnic Disparities in Health-Related Socioeconomic Risks During the Early COVID-19 Pandemic: A National Survey of U.S. Women.

Background: Nearly half of U.S. women experienced new or worsening health-related socioeconomic risks (HRSRs) (food, housing, utilities and transportation difficulties, and interpersonal violence) early in the COVID-19 pandemic. We sought to examine racial/ethnic disparities in pandemic-related changes in HRSRs among women. Materials and Methods: We conducted a cross-sectional survey (04/2020) of 3200 women. Pre- and early pandemic HRSRs were described by race/ethnicity. Weighted, multivariable logistic regression models generated odds of incident and worsening HRSRs by race/ethnicity. Results: The majority of Black, East or Southeast (E/SE) Asian, and Hispanic women reported ≥1 prepandemic HRSR (51%-56% vs. 38% of White women, p < 0.001). By April 2020, 68% of Black, E/SE Asian, and Hispanic women and 55% of White women had ≥1 HRSR (p < 0.001). For most HRSRs, the odds of an incident or worsening condition were similar across racial/ethnic groups, except Black, E/SE Asian and Hispanic women had 2-3.6 times the odds of incident transportation difficulties compared with White women. E/SE Asian women also had higher odds of worsening transportation difficulties compared with White women (adjusted odds ratios = 2.5, 95% confidence interval 1.1-5.6). In the early pandemic, 1/19 Hispanic, 1/28 E/SE Asian, 1/36 Black and 1/100 White women had all 5 HRSRs (extreme health-related socioeconomic vulnerability). Conclusions: Prepandemic racial/ethnic disparities in HRSRs persisted and prevalence rates increased for all groups early in the pandemic. Disparities in transportation difficulties widened. White women were much less likely than others to experience extreme health-related socioeconomic vulnerability. An equitable COVID-19 response requires attention to persistent and widening racial/ethnic disparities in HRSRs among women.

Breath analysis in gastrointestinal graft-versus-host disease after allogeneic hematopoietic cell transplantation.

Volatile organic compounds (VOCs) are generated during pathologic processes, and their assessment can be used to diagnose and monitor a variety of diseases. Given the role of the microbiome in graft-versus-host disease (GVHD), we hypothesized that microorganisms producing volatile metabolites may alter VOCs expelled in breath in patients with gastrointestinal (GI) GVHD. In this pilot study, exhaled breath samples were obtained from 19 patients with grade 2 to 4 acute GI GVHD, 10 patients with no GVHD at day 100, and 10 healthy control subjects; the samples were analyzed by using mass spectrometry. Overall, nine (47%) patients had grade 2 GVHD, eight (42%) patients had grade 3 GVHD, and two (11%) patients had grade 4 GVHD; 26% had upper GI, 21% had lower GI, and 53% had both upper and lower GI manifestations. Stepwise canonical discriminant analysis identified 5 VOCs distinguishing patients with and without GI GVHD: 2-propanol, acetaldehyde, dimethyl sulfide, isoprene, and 1-decene (Wilks' Λ, 0.43; F statistic, 6.08; P = .001). The model correctly classified 89% (17 of 19) and 90% (9 of 10) of patients with and without GI GVHD, respectively. Breath analysis is a feasible and promising noninvasive method to detect acute GI GVHD. Further study of serial breath analysis and the gut microbiome in a larger cohort are ongoing to validate these findings.

Manipulating Protein-Protein Interactions in Nonribosomal Peptide Synthetase Type II Peptidyl Carrier Proteins.

In an effort to elucidate and engineer interactions in type II nonribosomal peptide synthetases, we analyzed biomolecular recognition between the essential peptidyl carrier proteins and adenylation domains using nuclear magnetic resonance (NMR) spectroscopy, molecular dynamics, and mutational studies. Three peptidyl carrier proteins, PigG, PltL, and RedO, in addition to their cognate adenylation domains, PigI, PltF, and RedM, were investigated for their cross-species activity. Of the three peptidyl carrier proteins, only PigG showed substantial cross-pathway activity. Characterization of the novel NMR solution structure of holo-PigG and molecular dynamics simulations of holo-PltL and holo-PigG revealed differences in structures and dynamics of these carrier proteins. NMR titration experiments revealed perturbations of the chemical shifts of the loop 1 residues of these peptidyl carrier proteins upon their interaction with the adenylation domain. These experiments revealed a key region for the protein-protein interaction. Mutational studies supported the role of loop 1 in molecular recognition, as mutations to this region of the peptidyl carrier proteins significantly modulated their activities.

Comparative Effectiveness of Busulfan and Fludarabine versus Fludarabine and 400 cGy Total Body Irradiation Conditioning Regimens for Acute Myeloid Leukemia/Myelodysplastic Syndrome.

Allogeneic hematopoietic cell transplantation conditioning regimen intensity has varied for patients with acute myeloid leukemia and myelodysplastic syndrome. A comparative effectiveness analysis was performed to assess outcomes of busulfan and fludarabine (BuFlu) versus those of fludarabine and 400 cGy total body irradiation (FluTBI) conditioning. Thirty-three subjects received BuFlu and 38 received FluTBI. The BuFlu group received more red blood cell transfusions (P = .02) and had a longer time to platelet recovery (P = .004). There were no differences between the regimens regarding incidence of acute or chronic graft-versus-host disease (GVHD), quality of life, or 2-year outcome estimates for relapse (48; 95% confidence interval [CI], 30 to 64 and 50; 95% CI, 33 to 65), nonrelapse mortality (29; 95% CI, 14 to 45 and 29; 95% CI, 15 to 44), relapse-free survival (27; 95% CI, 13 to 43 and 29; 95% CI, 16 to 44), and overall survival (35; 95% CI, 19 to 51; and 37; 95% CI, 22 to 52), respectively. These comparable outcomes have implications for health care resource utilization. Future prospective investigation comparing these regimens with larger patient cohorts and additional strategies to prevent relapse and limit toxicities as well as cost-effectiveness analyses are warranted.