Thresholds in PROMIS Scores Anchored to Subsequent Unscheduled Health Service Use Among People Diagnosed With Cancer.

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.

Study protocol: Exploring the use of Family Health Histories in the African American community to reduce health disparities in Flint, Michigan.

Background: Health disparities are costly and preventable differences in disease progression that disproportionately affect minority communities such as African Americans. Practices to reduce health disparities can be rooted in prevention, particularly through screening tools. Family Health History tools are preventative screening mechanisms meant to explore family history to better understand how an individual's health can potentially be predicted or impacted. These tools are underutilized in the African American community. Contributions to this underutilization include a lack of cultural tailoring in the tools, a lack of health literacy in community members, and a lack of effective health communication. The Family Health History Study will create a culturally appropriate Family Health History toolkit to increase family health history utilization and ultimately decrease health disparities. Methods: The proposed sample will be composed of 195 African American adults ages 18 + who live in Genesee County, Michigan. The study consists of two phases: the development phase and the randomized pilot study phase. The goal of the development phase (n = 95) is to explore how Family Health History toolkits can be modified to better serve the African American community using a community based participatory research approach and to create a culturally tailored family health history toolkit. In the pilot study phase, 100 participants will be randomized to the culturally tailored toolkit or the current standard Family Health History toolkit. Outcomes will include feasibility and acceptability of the intervention. Discussion: This study will result in a culturally appropriate Family Health History tool that is co-developed with community members that can be utilized by African American adults to better understand their family health histories. Trial registration: Clinicaltrials.gov: NCT05358964 Date: May 5, 2022.

A framework for testing non-inferiority in a three-arm, sequential, multiple assignment randomized trial.

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.

The effects of osteopathic manipulative treatment on pain and disability in patients with chronic low back pain: a single-blinded randomized controlled trial.

CONTEXT: The evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak by systematic reviews, because it is generally based on low-quality studies. Consequently, there is a need for more randomized controlled trials (RCTs) with a low risk of bias. OBJECTIVES: The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic LBP. METHODS: A single-blinded, crossover, RCT was conducted at a university-based health system. Participants were adults, 21-65 years old, with nonspecific LBP. Eligible participants (n=80) were randomized to two trial arms: an immediate OMT intervention group and a delayed OMT (waiting period) group. The intervention consisted of three to four OMT sessions over 4-6 weeks, after which the participants switched (crossed-over) groups. The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values. RESULTS: Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively. After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported. CONCLUSIONS: OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.

Predictors of persistence of post-chemotherapy symptoms among survivors of solid tumor cancers.

CONTEXT: Late or residual symptoms diminish quality of life for many cancer survivors after completion of treatment. OBJECTIVES: Examine risk factors associated with persisting symptom burden after chemotherapy and the lack of symptom improvement over time. METHODS: Survivors who completed curative-intent chemotherapy within two years for solid tumors were enrolled into a symptom management trial. There were 375 survivors with two or more comorbid conditions or one comorbid condition and elevated depressive symptoms (pre-defined risk factors in the trial design) who received interventions and 71 survivors without these risk factors who did not receive interventions. For all survivors, symptoms were assessed at intake, 4, and 13 weeks and categorized as mild, moderate, or severe based on the interference with daily life. The probabilities of moderate or severe symptoms and symptom improvement were analyzed using generalized mixed-effects models in relation to comorbidity, depressive symptoms, age, sex, race/ethnicity, employment, time since chemotherapy completion, and physical function. Multiple symptoms were treated as nested within the survivor. RESULTS: Moderate or severe symptoms at baseline and the lack of improvement over time were associated with younger age and lower physical function over and above a greater number of comorbidities and elevated severity of depressive symptoms. CONCLUSION: Risk factors identified in this research (younger age, lower physical function, greater comorbidity, and higher depressive symptoms) can be used to allocate resources for post-treatment symptom management for cancer survivors in order to relieve symptoms that do not necessarily resolve with time.

Recruitment of older adults from long-term care settings for a longitudinal clinical trial.

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.

Perinatal HIV exposure and infection and caregiver depressive symptoms.

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.

In utero/peripartum antiretroviral therapy exposure and mental health outcomes at 8-18 years old: A longitudinal comparative study of children with perinatally acquired HIV, children perinatally HIV exposed but uninfected, and children unexposed uninfected from Uganda.

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.

Social determinants of health, psychological distress, and caregiver burden among informal cancer caregivers of cancer survivors during treatment.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION NUMBER: NCT03743415 www.clinicaltrials.gov.

Vitamin D and Probability of Developmental Disorders among Perinatally HIV-Affected and Unaffected Ugandan Children.

We tested the hypothesis that vitamin D deficiency (VDD) is associated with higher developmental disorder probability in 604 children with perinatal HIV infection (CPHIV, n = 199), HIV exposed and uninfected (CHEU, n = 196), and HIV unexposed uninfected (CHUU, n = 201). Children at 6-18 years old and their adult caregivers were assessed at enrollment, 6, and 12-month follow-ups. Serum 25-hydroxyvitamin-D (25OHD) levels in children quantified per the NHANES protocol were used to define VD categories as VDD (25OHD < 20 ng/mL), VD insufficient (VDI, 20 ≤ 25OHD ≤ 25 ng/mL), and VD sufficient (VDS = reference group if 25OHD > 25 ng/mL). Perinatal HIV status per DNA polymerase chain reaction/HIV rapid diagnostic tests included: CPHIV, CHEU, and CHUU. Developmental stage was defined as pre-adolescent (age < 11) vs. adolescent (age ≥ 11) years. Caregiver responses to standardized questions from Behavioral Assessment System for Children, Third Edition (BASC-3), were used to calculate probability scores for four disorders, namely: autism (ASD), attention deficit & hyperactivity (ADHD), emotional behavioral disorder (EBD), functional impairment (FI), and resiliency at 0, 6 and 12 months. Multivariable longitudinal models estimated VD-associated standardized mean difference (SMD) and corresponding 95% confidence intervals (95% CI) in respective probability scores in Statistical Analysis Software (v.9.4). Baseline VDD vs. VDS predicted higher probability scores of moderate clinical importance for ASD, ADHD, EBD, and higher FI among pre-adolescents (SMD = 0.32 to 0.40, 95% CI: 0.00 to 0.74). VDD was not associated with resiliency or any developmental disorders among adolescents. VDD predicted higher developmental disorder and FI scores over 12 months in a developmental stage-dependent manner. This relationship requires further understanding to appropriately target future interventions.

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention.

PURPOSE: To examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention. BACKGROUND: The United States Preventive Services Task Force (USPSTF) currently recommends PPD prevention for pregnant people at risk of PPD (i.e., selective/indicated prevention). However, universal prevention may be more scalable, equitable, and cost-beneficial. DESIGN: Effectiveness of ROSE for preventing PPD among people at risk is known. To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD risk. We will enroll 2320 pregnant people, assess them with commonly available PPD risk prediction tools, randomize everyone to ROSE or enhanced care as usual, and assess ROSE as universal, selective, and indicated prevention in terms of: (1) effectiveness (PPD prevention and functioning), (2) cost-benefit, (3) equity (PPD cases prevented by universal prevention that would not be prevented under selective/indicated for minority vs. non-Hispanic white people), (4) quantitative and qualitative measures of scalability (from 98 agencies previously implementing ROSE), (5) ROSE mechanisms across risk levels. We will integrate results to outline pros and cons of the three prevention approaches (i.e., universal, selective, indicated). CONCLUSION: This will be the first trial to assess universal vs. selective/indicated PPD prevention. Trial design illustrates a novel, efficient way to make these comparisons. This trial, the largest PPD prevention trial to date, will examine scalability, an understudied area of implementation science.

Computer-based intervention for residents of domestic violence shelters with substance use: A randomized pilot study.

BACKGROUND: Intimate Partner Violence (IPV) is a significant public health problem often associated with serious mental health and physical health implications. Substance use disorders (SUDs) are one of the most common comorbidities among women with IPV, increasing risk of subsequent IPV. METHODS: The current study examined the feasibility, acceptability, and preliminary effectiveness of a brief computerized intervention to reduce alcohol and drug use among women with IPV. Fifty women with recent IPV and alcohol and drug use risk were recruited from domestic violence shelters and randomized to the experimental computerized intervention or to an attention and time control condition. The primary outcome was percent heavy drinking or drug using days in 3 month increments over the 6 months after leaving the shelter. Receipt of substance use services and IPV severity were evaluated as secondary outcomes. RESULTS: The computerized intervention was feasible and acceptable, with high (n = 20, 80%) completion rates, engagement with the intervention, and satisfaction scores. As expected in this pilot trial, there were no significant differences between conditions in percent heavy drinking/drug using days or receipt of substance use services and large individual differences in outcomes. For example, receipt of substance use services decreased by a mean of 0.05 times/day from the baseline to the 6-month time period in the control condition (range -1.00 to +0.55) and increased by a mean of 0.06 times/day in the intervention condition (range -0.13 to +0.89). There were large decreases in IPV severity over time in both conditions, but directions of differences favored the control condition for IPV severity. CONCLUSION: A computerized intervention to reduce the risk of alcohol/drug use and subsequent IPV is feasible and acceptable among residents of a domestic violence shelter. A fully powered trial is needed to conclusively evaluate outcomes.

Depression among Underserved Rural and Urban Caregivers of Latinas with Breast Cancer.

Among Latino/as, informal caregiving duties are often deemed a family responsibility. Understanding psychological outcomes tied to caregivers of Latina breast cancer survivors is important to identify the impacts of cancer. Secondary analysis of baseline data collected in a randomized clinical trial (RCT) from 230 Latina breast cancer survivor-caregiver dyads. Characteristics of caregivers residing in rural/underserved and urban areas were compared using t- or chi-square tests. General linear models were used to analyze depressive symptoms in relation to residence, survivor-caregiver relationship, acculturation, obligation, reciprocity, and comorbidities. Urban residence was significantly associated with higher levels of depression controlling for survivor-caregiver relationship acculturation, obligation, reciprocity, and comorbidities. Mother caregivers had significantly higher levels of depression than other caregivers. Depression among Latino/a caregiver's providing care to an adult child is an important consideration as Latino/as are less likely to seek out/have access to mental health services than other groups.

Social Determinants of Health and Symptom Burden During Cancer Treatment.

BACKGROUND: Cancer survivors (defined as individuals from diagnosis to the end of life) in treatment experience multiple physical and psychological symptoms (e.g., fatigue, pain, depression, anxiety, disturbed sleep) that influence their well-being and treatment outcomes. Underrepresented cancer survivors may disproportionately experience greater symptom burden (number of symptoms, symptom severity, depression, anxiety). OBJECTIVES: The aim of this study was to examine the relationships of social determinants of health, including age, ethnicity, education, income and whether income meets the survivor's needs, neighborhood (rural vs. urban), access to healthcare (e.g., insurance), and social isolation, with symptom burden in cancer survivors. METHODS: This secondary analysis included baseline data from 400 cancer survivors of solid tumor cancers undergoing chemotherapy or targeted therapy who participated in a larger randomized trial of symptom management interventions. Symptom burden was measured by the Center for Epidemiological Studies-Depression scale for depression and Patient-Reported Outcomes Measurement Information System scores for anxiety and social isolation, summed severity index of 16 symptoms from the General Symptom Distress Scale, and the total number of symptoms. Self-reported comorbid conditions were measured using the Bayliss tool. General linear models were used to relate symptom measures (one at a time) to age, number of comorbid conditions, level of education, marital status, income meeting needs, and size of metropolitan neighborhood. Additional covariates included site of cancer, its treatment, and whether the cancer was metastatic. RESULTS: Non-Hispanic White survivors ( n = 191) were older and had more comorbid conditions, a higher proportion of metastatic cancers, and higher levels of education and income compared with Hispanic survivors ( n = 168) and non-Hispanic survivors of other races ( n = 41). Compared with the other two groups, Hispanic survivors had the lowest rate of health insurance availability, and non-Hispanic survivors of other races had the lowest social isolation. Age, number of comorbid conditions, and social isolation were significantly associated with number of symptoms, symptom severity, and depression. Age and social isolation were associated with anxiety. In addition, the symptom severity of non-Hispanic White survivors was lower than that of Hispanic survivors and non-Hispanic survivors of other races. DISCUSSION: These findings highlight the health disparities in symptom burden experienced among cancer survivors when considering their social determinants of health. Assessing these may help clinicians address health disparities in cancer care.

Beyond burnout: a four-year survey of osteopathic medical student mental health and the implications for the development of wellness and mental health programs.

CONTEXT: The mental health crisis in medicine cannot be explained by burnout alone. Physicians are not immune to this crisis and are known to have higher rates of suicide and depression than the general population. A high prevalence of mental health symptoms has been observed in early medical training. OBJECTIVES: This study was completed to characterize medical students' mental well-being and provide guidance for timely intervention. METHODS: An annual prospective, voluntary, anonymous, cross-sectional survey of medical students was completed over a 4-year period in medical school from 2016 to 2019. The survey was created based on standardized psychiatric screening tools assessing symptoms of depression, anxiety, burnout, and sleep problems. In each of those years, 1,257 (2016), 1,254 (2017), 1,221 (2018), and 1,220 (2019) enrolled students, respectively, were invited to participate. Data on students' mental health were analyzed in relation to their year of school separately for each survey year utilizing SAS 9.4. RESULTS: A total of 973 students in 2016, 889 students in 2017, 547 students in 2018, and 606 students in 2019 participated in the study. For depression and burnout subscales, an increase in symptom scores were observed every survey year (2016, 2017, 2018, and 2019) by the second or third year of medical school with a clinically significant effect size. Persistently high levels of anxiety were observed throughout medical school, with significant increases after the first year noted in the 2016 and 2017 surveys, but not in the 2018 or 2019 surveys. Similarly, significant changes in sleep disturbance were found in the 2016 and 2017 surveys, but not in 2018 or 2019. CONCLUSIONS: Symptoms of burnout, depression, and anxiety were observed throughout all four years of medical school, with increases starting after the first year. Early intervention is needed to support students' mental health and increase access to care and resources.

A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy.

CONTEXT: Many cancer survivors experience a lingering symptom burden after chemotherapy. OBJECTIVES: In this sequential multiple assignment randomized trial, we tested optimal sequencing of two evidence-based interventions for symptom management. METHODS: Survivors of solid tumors (N = 451) were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms. High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N = 282) or 12-week SMSH with eight weeks of Telephone Interpersonal Counseling (TIPC, N = 93) added during weeks one to eight. After four weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N = 30) or add TIPC (N = 31). Severity of depression and summed severity index of 17 other symptoms over weeks one to13 were compared between randomized groups and among three dynamic treatment regimes (DTRs): 1) SMSH for 12 weeks; 2) SMSH for 12 weeks with eight weeks of TIPC from week one; 3) SMSH for four weeks followed by SMSH+TIPC for eight weeks if no response to the SMSH alone on depression at week four. RESULTS: There were no main effects for randomized arms or DTRs, but there was a significant interaction of trial arm with baseline depression favoring SMSH alone during weeks one to four in the first randomization and SMSH+TIPC in the second randomization. CONCLUSION: The SMSH may represent a simple effective option for symptom management, adding TIPC only when there is no response to SMSH alone for people with elevated depression and multiple co-morbidities.

Growth differences by school-age and adolescence according to in utero and peripartum antiretroviral therapy exposure among Ugandan children.

In utero/peripartum antiretroviral (IPA) drug exposure in human immunodeficiency virus (HIV)-exposed children has established benefit for prevention of HIV mother-to-child-transmission but its association with height-for-age by adolescence is unknown. Hence we quantify IPA-associated growth differences at 6 to 18 years old among children with perinatally acquired HIV (CPHIV) infection and children HIV exposed but uninfected (CHEU) relative to children HIV unexposed and uninfected (CHUU). Cohort study. Kampala, Uganda. Two hundred thirty eight community controls and 490 children of women living with HIV born between 2000 and 2011 in a community were enrolled at 6 to 18 years of age and followed every 6 months for 1 year. Height-for-age determined at enrollment, 6 and 12 months after enrollment using the World Health Organization reference. IPA exposure was retrospectively determined from medical records and categorized as: no IPA, single-dose nevirapine with/without zidovudine (sdNVP ±â€…AZT), sdNVP + AZT + lamivudine, or combination antiretroviral therapy (cART). Mean differences (ß) with 95% confidence intervals (CIs) in height-for-age over 12 months were evaluated according to IPA exposure for CPHIV and CHEU and relative to CHUU using longitudinal linear mixed effects models adjusted for caregiver factors (sex, age, education, functioning in caregiving role, and lifetime adversity) in Statistical Analysis Software (v.9.4). Regardless of IPA type, CPHIV grew worse than CHUU by school-age/adolescence (ß = -0.30, 95% CI: -0.48, -0.11). Relative to CHUU height-for-age was similar for CHEU exposed to sdNVP ±â€…AZT (ß = -0.16, 95% CI: -0.46, 0.14) and for CHEU exposed to sdNVP + AZT + lamivudine (ß = 0.08, 95% CI: -0.20, 0.35). However, CHEU without any IPA exposure had lower height-for-age (ß = -0.27, 95% CI: -0.52, -0.00) whereas CHEU with cART exposure had greater height-for-age (ß = 0.41, 95% CI: 0.10, 0.71) in comparison with CHUU by 6 to 18 years old. Our findings suggest that CHEU may achieve height-for-age parity with CHUU by school-age and adolescent years- especially if provided benefit of effective cART in the peripartum period. However, CPHIV regardless of IPA exposure type and CHEU without IPA exposure remain at a disadvantage and will benefit from intervention to support their growth.

Revisiting chronic low back pain: evidence that it is not non-specific.

CONTEXT: There is a common symptom pattern with most chronic low back pain (CLBP), suggesting that there is a common underlying etiology, belying the term "nonspecific." Many studies of CLBP and its treatment have been conducted with the assumption of nonspecificity, and as a result, treatment has not been focused, thus there has not been a significant change in CLBP prevalence over the past several decades. It is the thesis of this study to show that there is an underlying, specific cause of CLBP and that the presumption that CLBP is nonspecific is misdirected. The lumbosacropelvic (LSP) region, including the sacroiliac joint (SIJ), is part of a neuromusculoskeletal (NMSK) feedback system, and it is proposed here that CLBP is the result of a change in the feedback (afferent) aspect in that system. OBJECTIVES: The objectives of this study are to show that CLBP presents as a pattern of symptoms that actually represents the final common pathway for a dysfunctional LSP joint system. Rather than being "nonspecific," the majority of CLBP has an underlying cause that is quite specific and predictable. METHODS: A total of 252 patients were seen for CLBP, 67% of whom were diagnosed with an SIJ dysfunction. The presence of pain was recorded from seven structures most closely associated with CLBP. The conditional probabilities of having each pain generator given a SIJ dysfunction and an SIJ dysfunction given the presence of the pain generator were estimated, and associations were analyzed utilizing chi-square tests. Phi coefficients and odds ratios were utilized to quantify the strength of the association. The multivariable logistic regression model was fit to relate the presence or absence of the SIJ dysfunction to the seven pain generators. RESULTS: The associations between SIJ dysfunction and each pain generator were statistically significant. Phi coefficients indicated moderate strengths of these bivariate associations. Iliolumbar ligament (ILL) and psoas muscle (PSM) were significant predictors of SIJ dysfunction in the multivariable model. CONCLUSIONS: Seven pain generators had a strong association with SIJ dysfunction. This empirical clinical evidence supports our hypothesis that LSP system dysfunction, as evidenced by SIJ dysfunction, is a common source of symptom patterning associated with CLBP and is most likely the causal element. This is evidence that most CLBP is not "nonspecific" but rather the result of changes made by the NMSK control system for the LSP region.

Patient Reported Outcomes and Unscheduled Health Services use During Oral Anti-Cancer Treatment.

CONTEXT: People on oral anti-cancer agents must self-manage their symptoms with less interaction with oncology providers compared to infusion treatments. Symptoms and physical function are key patient-reported outcomes (PROs) and may lead to unscheduled health services uses (urgent care and emergency department [ED] visits, hospitalizations), which in turn lead to increased health care costs. OBJECTIVES: To evaluate the prediction of unscheduled health services uses using age, sex, and comorbidity, then determine the extent to which PRO data (symptoms and functioning) improve that prediction. METHODS: This post-hoc exploratory analysis was based on data from the control group of a trial of medication adherence reminder and symptom self-management intervention for people starting a new oral anti-cancer agent (n = 117 analyzed). Severity and interference with daily life for 18 symptoms, physical function, and depressive symptoms were assessed at intake (oral agent start), and four, eight, and 12 weeks later. Unscheduled health services use during three four-week periods after the start of oral agents was analyzed using generalized mixed effects models in relation to age, sex, comorbidity, and PROs at the beginning of each time period. RESULTS: The summed severity index of 18 symptoms and physical function were significant predictors of hospitalizations in the four weeks following PRO assessment. The addition of PROs improved areas under the receiver operating characteristic curves to be over .70 in most time periods. CONCLUSION: Monitoring of PROs has the potential of reducing unscheduled health services use if supportive care interventions are deployed based on their levels.

Predictive validation of Ugandan infant eye-tracking test for memory of human faces.

We provide initial evidence that an eye-tracking based measure of infant attention and working memory (gaze preference for novel human faces) can predict aspects of neurocognitive performance years later among Ugandan children. 49 HIV-exposed/uninfected Ugandan children (22 boys, 27 girls) 6-12 months old were tested with the Mullen Scales of Early Learning and a modified Fagan Test of Infant Intelligence (FTII). Modified FTII measures pertaining to attention are correlated to the KABC-II Mental Processing Index (MPI) (rp = -0.40), p Cognitive assessments adapted to eye-tracking instrumentation can be useful to evaluate attention and working memory in HIV-affected children living in low- and middle-income countries.