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PURPOSE: To establish thresholds in the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference, physical function, fatigue, and depression scores on the basis of their association with subsequent use of the emergency department (ED) or urgent care by people diagnosed with cancer. METHODS: Retrospective data from 952 people seen at Henry Ford Cancer and insured through the Health Alliance Plan were analyzed using generalized linear mixed-effects models. The log odds of ED or urgent care use during 14 or 30 days after each patient-reported outcome (PRO) assessment were related to PRO scores, while adjusting for comorbidity, sociodemographic, and tumor characteristics. RESULTS: Pain interference and physical function were associated with subsequent ED or urgent care visits, but fatigue and depression were not, and the results for 14- and 30-day visits were similar. Thresholds anchored in the likelihood of these visits differed according to cancer stage. For people with advanced cancer, a pain interference score of 60 or higher (odds ratio [OR] 3.75, [95% CI, 1.53 to 7.87]) and a physical function score lower than 40 (OR 2.94, [95% CI, 1.22 to 7.06]) produced the largest ORs with narrowest CIs for 30-day visits. For people with nonadvanced cancer, the thresholds of 65 for pain interference (OR 2.64, [95% CI, 1.40 to 5.01]) and 35 for physical function (OR 1.87, [95% CI, 1.01 to 3.45]) produced largest ORs with narrowest CIs for 30-day visits. CONCLUSION: These anchor-based thresholds in PROMIS scores can inform clinicians' actions with the goal of preventing ED or urgent care visits. PROMIS pain interference and physical function were related to emergency room or urgent care use. [ABSTRACT FROM AUTHOR]

Cumulative lifetime adversity and social support were investigated as determinants of psychosocial adjustment (esteem, distress, hopefulness, positive outlook/future aspirations, and sense of purpose) over 12 months in 6-10-years-old HIV-infected, HIV-exposed uninfected and HIV-unexposed uninfected children from Uganda. Each determinant and psychosocial adjustment indicator was self-reported using standardized questionnaires administered at baseline, 6, and 12 months. Linear mixed effects models were used to relate time-varying lifetime adversity and social support to psychosocial adjustment over 12 months. Regardless of HIV status, higher adversity predicted lower esteem (coefficient b = -2.98, 95% confidence interval (CI): [-4.62, -1.35]) and increased distress (b =3.96, 95% CI: [1.29, 6.62]) but was not associated with hopefulness, positive outlook or sense of purpose. Low social support predicted higher distress (b =9.05, 95% CI: [7.36, 10.73]), lower positive outlook (b = -10.56, 95% CI: [-2.34, -8.79]) and low sense of purpose (b = -9.90, 95% CI: [-11.44, -8.36]) over 12 months. Pragmatic interventions that enhance coping with adversity and provide emotional/instrumental support should be tested for effectiveness in promoting resilient psychosocial adjustment trajectory in vulnerable children.

Caregiver's and child's self-reported quality of life (QOL) was defined using standardized questionnaires in a sample (N = 277) of 6-10 years old HIV-infected, HIV-exposed uninfected, and HIV-unexposed uninfected children from Uganda. Psychosocial stress (acute stress and cumulative lifetime adversity) and physiologic stress (dysregulations across 13 biomarkers), perinatal HIV status, and their interaction were related to child QOL via general linear models. Lower child- and caregiver-reported psychosocial stress were dose-dependently associated with higher QOL (acute stress: mean difference coefficient b = 8.1-14.8, effect size [ES] = 0.46-0.83). Lower allostasis was dose-dependently associated with higher QOL (b = 6.1-9.7, ES = 0.34-0.54). Given low caregiver acute stress, QOL for HIV-infected was similar to HIV-uninfected children; however, given high caregiver acute stress, a QOL disadvantage (b = -7.8, 95% CI: -12.8, -2.8; ES = -0.73) was evident for HIV-infected versus uninfected children. Testing of caregiver stress reduction interventions is warranted to increase wellbeing in dependent children.

IntroductionInfection with HIV subtype A has been associated with poorer neurocognitive outcomes compared to HIV subtype D in Ugandan children not eligible for antiretroviral therapy (ART). In this study, we sought to determine whether subtype-specific differences are also observed among children receiving ART.Materials and methodsChildren were recruited from a clinical trial in which they were randomized to receive either lopinavir (LPV)- or non-nucleoside reverse transcriptase inhibitor (NNRTI)- based ART (NCT00978068). Age at initiation of ART ranged from six months to six years. HIV subtype was determined by PCR amplification and population sequencing of the pol region derived from peripheral blood mononuclear cell DNA, followed by application of the REGA and Recombinant Identification Programme algorithms. General cognition was assessed using the Kaufman Assessment Battery for Children (Second Edition), attention using the Test of Variables of Attention, and motor skills using the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition). Home environment was assessed using the Home Observation for the Measurement of the Environment (HOME). Age-adjusted test z-scores were entered into a regression model that adjusted for sex, socio-economic status score, HOME score, years of schooling, and ART treatment type.ResultsOne hundred and five children were tested; median (interquartile range) age was 7.05 years (6.30 to 8.44), CD4 count was 867.7 cells/mm3 (416.0 to 1203.5), and duration on ART was 4.03 years (3.55 to 4.23). Seventy-eight children had HIV subtype A and 27 had subtype D; the groups had comparable home and socio-economic status, except that there were more males among children infected with subtype A than D (64.7% vs. 35.3%, p = 0.02). There were no differences between the subtypes in general cognition (estimated mean difference: 0.20; 95% CI: -0.11 to 0.50); p = 0.21), attention (-0.18, 95% CI: -0.60 to 0.24, p = 0.41) and motor skills (1.60, 95% CI: -0.84 to 4.04, p = 0.20).ConclusionsOur results imply that ART may diminish the neurocognitive disadvantage seen in treatment-naïve HIV-infected children with subtype A.

Simple Summary: Obesity is a clear risk factor for future colorectal cancer (CRC), but its impact on mortality remains to be fully elucidated. Prior studies have had methodologic limitations, and key variables remain under-investigated. In this study of prospectively collected data from the Multiethnic Cohort, pre-diagnosis BMI trajectories were not associated with CRC-specific or all-cause mortality. Factors associated with mortality included African American race or Hawaiian ethnicity, smoking, and diabetes. Accounting for long-term BMI trajectories before diagnosis and other relevant factors demonstrates that obesity is not protective of mortality after CRC diagnosis. Background: Prior studies are inconclusive regarding the effect of obesity on mortality in persons with colorectal cancer (CRC). We sought to determine the association of pre-diagnosis body mass index (BMI) trajectories on mortality after CRC diagnosis. Methods: Utilizing the Multiethnic Cohort, we included adults aged 18–75 between 1 January 1993 and 1 January 2019 with a diagnosis of CRC and at least three available BMIs. The primary exposure, BMI, was subjected to group-based trajectory modeling (GBTM). We evaluated all-cause and CRC-specific mortality, using Cox proportional hazard (PH) models. Results: Of 924 persons, the median age was 60 years, and 54% were female. There was no statistically significant association between pre-cancer BMI trajectory and either all-cause or cancer-specific mortality. In competing risk analysis, the risk of CRC-specific mortality was higher for African Americans (HR = 1.56, 95% CI [1.00–2.43], p = 0.048) and smokers (HR = 1.59, 95% CI [1.10–2.32], p = 0.015). Risk of all-cause mortality was higher for Hawaiian persons (HR = 2.85, 95% CI [1.31–6.21], p = 0.009) and persons with diabetes (HR = 1.83, 95% CI [1.08–3.10], p = 0.026). Conclusions: Pre-diagnosis BMI trajectories were not associated with mortality after CRC diagnosis, whereas race/ethnicity, diabetes, and smoking were associated with an increased risk of death. Our findings suggest the obesity paradox alone does not account for mortality after CRC diagnosis. [ABSTRACT FROM AUTHOR]

This study compared three ethnic/racial groups of informal cancer caregivers on social determinants of health and tested social determinants of health as predictors of psychological distress and caregiver burden. This study was a secondary analysis of baseline data of a sequential multiple assignment randomized trial (SMART) testing symptom management interventions with caregiver-survivor dyads. Caregivers completed baseline measures of social determinants of health (SDoH), functional limitations, psychological distress, and caregiver burden. Hispanic, non-Hispanic White, and non-Hispanic other races caregivers were compared on these variables. Multivariate tests of associations between SDoH and caregiver burden and psychological distress were conducted in structural equation modeling with caregiver burden and psychological distress as latent variables. Hispanic caregivers reported significantly higher caregiver burden, specifically for finances, family, and schedules. Caregiver burden was significantly predicted by having income barely or not meeting needs, being female, socially isolated, married, Hispanic, and having poor physical functioning. Significant predictors of caregivers' psychological distress: being female, being socially isolated, and having poor physical functioning. Hispanic caregivers experience significant challenges associated with caregiver burden, especially if they are female, socially isolated, and have poor physical functioning. Assessment of these SDoH is important in caregiver health to provide supportive care during caregiving. NCT03743415 . [ABSTRACT FROM AUTHOR]

Sequential multiple assignment randomized trial design is becoming increasingly used in the field of precision medicine. This design allows comparisons of sequences of adaptive interventions tailored to the individual patient. Superiority testing is usually the initial goal in order to determine which embedded adaptive intervention yields the best primary outcome on average. When direct superiority is not evident, yet an adaptive intervention poses other benefits, then non-inferiority testing is warranted. Non-inferiority testing in the sequential multiple assignment randomized trial setup is rather new and involves the specification of non-inferiority margin and other important assumptions that are often unverifiable internally. These challenges are not specific to sequential multiple assignment randomized trial and apply to two-arm non-inferiority trials that do not include a standard-of-care (or placebo) arm. To address some of these challenges, three-arm non-inferiority trials that include the standard-of-care arm are proposed. However, methods developed so far for three-arm non-inferiority trials are not sequential multiple assignment randomized trial-specific. This is because apart from embedded adaptive interventions, sequential multiple assignment randomized trial typically does not include a third standard-of-care arm. In this article, we consider a three-arm sequential multiple assignment randomized trial from an National Institutes of Health-funded study of symptom management strategies among people undergoing cancer treatment. Motivated by that example, we propose a novel data analytic method for non-inferiority testing in the framework of three-arm sequential multiple assignment randomized trial for the first time. Sample size and power considerations are discussed through extensive simulation studies to elucidate our method. [ABSTRACT FROM AUTHOR]

In utero/peripartum antiretroviral therapy (IPA) exposure type was examined in relationship to mental health symptoms among 577 children with perinatally acquired HIV (CPHIV), children perinatally HIV exposed but uninfected (CHEU), and children HIV unexposed uninfected (CHUU). IPA exposure was categorized for CPHIV and CHEU as none, single‐dose nevirapine with or without zidovudine (sdNVP±AZT), sdNVP+AZT+lamivudine (3TC), or combination antiretroviral therapy (cART). Anxiety and depressive symptoms were reported at baseline, 6‐, and 12‐month follow‐up per behavioral assessment system for children. Multivariable linear mixed models were used to estimate differences (b) with 95% confidence intervals (95% CI) for IPA exposure types versus CHEU without IPA exposure. Depressive and anxiety symptoms were lower in CHUU relative to CHEU and CPHIV but did not differ between CPHIV and CHEU. CHEU with sdNVP±AZT exposure had greater anxiety (b = 0.51, 95% CI: [0.06, 0.96]) and depressive symptoms (b = 0.48, 95% CI: [0.07, 0.89]) than CHEU without IPA exposure. CHEU with sdNVP+AZT+3TC exposure had higher anxiety (b = 0.0.45, 95% CI: [0.03, 0.86]) and depressive symptoms (b = 0.72, 95% CI: [0.27, 1.17]) versus CHEU without IPA exposure. Depressive and anxiety symptoms were not different for CHEU and CPHIV exposed to cART (b = 0.12–0.60, 95% CI: [−0.41, 1.30]) and CHEU and CHUU (b = −0.04 to 0.08, 95% CI: [−0.24, 0.29]) without IPA exposure. Among CHEU, peripartum sdNVP±AZT and sdNVP+AZT+3TC but not cART compared to no IPA exposure was associated with clinically important elevations in anxiety and depressive symptoms. Monitoring of mental health trajectory of HIV‐affected children considering IPA is needed to inform mental health interventions. Patient Contribution: Caregivers and their dependents provided consent for participation and collaborated with study team to identify mutually convenient times for protocol implementation. [ABSTRACT FROM AUTHOR]

Recruitment of residents for research from long‐term care settings is known to be difficult. The purpose of this study was to summarize the effectiveness and cost in terms of time and dollars of recruitment methods for a cluster‐randomized controlled clinical trial conducted in long‐term care settings. This study was a retrospective, exploratory, descriptive analysis of recruitment data. After recruitment of 15 independent and assisted living communities, residents at each site were recruited to participate in the study using combinations of 12 different recruitment methods. Recruitment methods, time spent screening, and enrollment data were collected. Recruitment data were analyzed at the levels of site, research staff member, and participant. Over the study period, 279 older adults were screened and 172 enrolled from the 15 sites. Many participants were cognitively impaired. Research staff spent 39–89 h recruiting at each site and utilized an average of four different recruitment methods per site. Introductions of participants by site contacts yielded the most consented participants compared to other recruitment methods. Sites that had a dedicated recruiter utilized more recruiting methods and enrolled more participants than those without a dedicated recruiter. The cost of recruiting averaged $1490 per site and $93–$258 per enrollee (mean $144, standard deviation $58), but was more costly in larger facilities. Recruitment of older adults from long‐term care communities requires multiple methods of recruitment, skilled recruitment staff, and trust with the staff and potential participants. [ABSTRACT FROM AUTHOR]

Survival is possible for children perinatally exposed to or infected by HIV in the post-combined antiretroviral therapy era and identifying factors affecting children's ability to thrive has public health significance. Caregiver mental health is one such factor to consider given its impact on child development, but previous work has not included a full complement of HIV exposure/infection groups within HIV-endemic settings. We compared depressive symptoms among caregivers of 3 groups of 6-10-year-olds in Uganda: children with perinatally acquired HIV infection (CPHIV, n = 102), children with perinatal HIV exposure, but no infection (CPHEU, n = 101), and children without perinatal HIV exposure or infection (CHUU, n = 103). The Hopkins Symptom Checklist was used to assess caregiver depressive symptoms. Generalized linear models were used to estimate group mean differences. Adjusted models included caregiver demographics, social support, and lifetime trauma. Depression symptoms were higher among CPHEU compared to CPHIV caregivers (model coefficient [B] = −3.5, 95%CI −5.3, −1.8). This finding was minimally attenuated following adjustment for covariates (B = −2.2, 95%CI −4.1, −0.4) and among biological mothers. At lower levels of social support and wealth, CPHEU caregivers reported higher levels of depression symptoms than CPHIV caregivers. Our findings point to unmet mental health needs among CPHEU caregivers. [ABSTRACT FROM AUTHOR]