Advancing Patient Navigation for HIV: Evaluating Models of Care for Housing and Employment.

People with HIV face challenges securing housing and employment. Patient navigation is an effective intervention that can improve the receipt of these services, which have been linked to better health outcomes. The purpose of this study was to assess implementation of patient navigation in diverse delivery settings. We also evaluated the relationship between these services and health outcomes among participants. Twelve sites in the United States (N = 1,082) implemented navigation using single or multiple navigator interventions to improve housing, employment, viral suppression, and retention in care. Sites included health departments, health centers, and AIDS service organizations (ASO). Client-level data were used to model relationships of interest. Across the 12 sites, regardless of model, housing (odds ratio (OR) = 1.18, p < .001), employment (OR = 1.09, p < .001) and retention in care (OR 1.11, p = .007) improved significantly over time; however, viral suppression did not (OR = 1.04, p = .120). Regardless of model of care, patient navigation improved housing, employment, and retention in care. This study demonstrated that while navigation supports people with HIV in securing housing and employment, models using a more intensive format worked best in specific settings. While most studies focus on unimodal strategies, this study builds on the evidence by examining how navigation models can be delivered to reduce barriers to care.

Estimate of Increase in Colorectal Cancer Diagnoses with Expansion of Fecal Immunochemical Testing in an Urban Safety-Net Population.

BACKGROUND: Fecal immunochemical test (FIT) is less effective in detecting advanced adenomas (AA) than colonoscopy. Increase in FIT for colorectal cancer (CRC) screening may lead to an increased number of undetected AAs which may develop into future CRCs. AIM: We determined the potential impact of FIT expansion on missed AAs and future CRC diagnoses in an urban, tertiary-care, safety-net hospital. METHODS: CRC and AA diagnoses were identified in patients undergoing colonoscopy for average-risk CRC screening or positive FIT between 2017 and 2019 at Boston Medical Center. Poisson regression modeling was used to estimate the frequency of AAs per year by age group using data from 2017 to 2019, assuming average outpatient volume and proportion of screening colonoscopies. Total number of patients who received FIT was extrapolated from those who underwent colonoscopy for positive FIT. We estimated AAs per year if 'one-time' FIT was used for screening in 75% and 100% of the population and subtracted this from the estimated AAs per year under the Poisson model to determine missed AAs. We used previously described, age and gender specific estimates of the annual progression of AA to CRC. RESULTS: The estimated number of CRCs detected per year is 4.6/1785 males and 4.6/2086 females screened. With 75% FIT expansion, we estimate an additional 3.5 (95% CI 1.3, 9.5) and 2.2 (95% CI 0.64, 7.6) CRCs; with 100% FIT expansion, we estimate an additional 7.4 (95% CI 3.7, 14.9) and 4.2 (95% CI 1.7, 10.5) CRCs, in 5 years, in males and females, respectively. CONCLUSION: Expansion of FIT may substantially increase CRC incidence.

Organizational readiness to implement bundled interventions to increase HIV linkage and retention in care and treatment: results from the Black Women First (BWF) initiative.

BACKGROUND: Evidence-based and evidence-informed interventions designed to address gaps in the HIV care continuum have the potential to improve HIV care and treatment. However, inadequate organizational readiness can derail intervention uptake, prevent the integration of interventions, and contribute to suboptimal HIV treatment outcomes. This study sought to understand organizational readiness to implement bundled interventions for Black women with HIV and inform facilitators and barriers to implementation. METHODS: We conducted a mixed methods readiness assessment across 12 sites participating in the Black Women First (BWF) initiative to gauge preparedness to implement bundled interventions. Readiness was assessed using the organizational readiness for implementing change (ORIC) scale, and two open-ended questions examined facilitators and barriers. Associations between participant and organizational level factors were evaluated using linear models with clustering by site at baseline, 6- and 12-months. Pre-implementation interviews were conducted with staff virtually and transcripts were managed in NVivo. Directed content analysis was used to explore implementation barriers and facilitators. FINDINGS: Sites demonstrated high levels of organizational readiness at baseline; overall organizational readiness for implementing change (ORIC) (mean 56.4, median 59, interquartile range [IQR] 5) and subscales of the ORIC change efficacy (mean 32.4, median 35, IQR 4), change commitment (mean 24, median 25, IQR 1), which is consistent with willingness and capability to implement bundled interventions for Black women with HIV. Organizational readiness remained high at 6- and 12-month follow-up periods. Staff role was significantly associated with organizational readiness (p = 0.007), change efficacy (p = 0.006), and change commitment (p = 0.020) at 6 months. Qualitative analysis indicated strategic planning and assessment (e.g., team coordination and the development of workflows to support implementation); organizational change through network weaving across silos within the organization, and communications systems that engage external partners, as well as resources available for hiring and training, supported readiness. Collaborative leadership and organizational buy-in, staff motivation, and partnerships facilitated implementation processes. CONCLUSIONS: Organizations in the BWF initiative have high levels of organizational readiness reflecting willingness and capability to implement bundled interventions for Black women with HIV. Future research should examine the relationship between readiness and clinical outcomes.

Dairy Foods, Weight Change, and Risk of Obesity During the Menopausal Transition.

BACKGROUND: Weight gain during the menopausal transition is common. Dairy consumption may impact weight change during this critical period, and different dairy foods may have different effects. OBJECTIVES: This study aimed to investigate the associations of different types of dairy foods with weight gain and risk of obesity in perimenopausal women from the Nurses' Health Study II cohort. METHODS: The examination at menopause was selected as the exam closest to the reported age at menopause. Weight change during 12 y surrounding menopause was derived from self-reported weight data for 3 exams before and 3 after menopause. The mean age of the first weight measure was 45.8 y and the average BMI was 25.0 kg/m2. Dairy food intakes were estimated as mean intakes over the same 12 y. Generalized linear models were used to assess the association between dairy foods and annualized weight change. Cox proportional hazard models were used to estimate the adjusted relative risks for becoming obese over 12 y surrounding menopause. RESULTS: In longitudinal analyses, those with the highest yogurt intakes had the lowest weight gain at every exam. This was not the case for other forms of dairy. After adjusting for potential covariates, those consuming ≥2.0 servings/wk of yogurt (compared with <1.0 serving/month) had a 31% (RR: 0.69; 95% CI: 0.64, 0.74) lower risk of obesity. The highest total dairy intake (≥2.0 servings/d compared with <1.0) was associated with only a 12% (RR: 0.88; 95% CI: 0.82, 0.95) reduction in obesity risk. Higher activity levels and alternative healthy eating index scores were independently associated with statistically significant reductions in risk of obesity, but higher intakes of yogurt strengthened these beneficial associations. CONCLUSION: Yogurt intake was associated with less weight gain and lower obesity risk in women during the menopausal transition.

Stressful life events and incident depression among U.S. military personnel.

PURPOSE: Although stressful life events (i.e., stressors) and depression are often assumed to be linked, the relation between stressors and incident depression is rarely studied, particularly in the military. The National Guard is a part-time subset of the U.S. military for whom civilian life stressors may be particularly salient, due to the soldiers' dual roles and frequent transitions between military and civilian life. METHODS: We used a dynamic cohort study of National Guard members from 2010 to 2016 to investigate the relationship between recent stressful experiences (e.g., divorce) and incident depression, with an exploratory analysis of effect modification by income. RESULTS: Respondents endorsing at least one of nine past-year stressful events (a time-varying exposure, lagged by 1 year) had almost twice the adjusted rate of incident depression compared to those with no stressful events (HR = 1.8; 95% CI 1.4, 2.4). This association may be modified by income: among individuals making under $80,000 per year, those with past-year stressors had twice the rate of depression compared to those with no stressors, but among those making over $80,000, past-year stressors were associated with only 1.2 times the rate of depression. CONCLUSION: Stressful life events outside of deployment are important determinants of incident depression among National Guard servicemembers, but the effect of these events may be buffered by higher income.

The Black women first initiative: using implementation science to examine bundled interventions to improve care and treatment coordination for Black women with HIV.

BACKGROUND: Black cisgender and transgender women are disproportionately affected by the HIV epidemic compared to women of other racial and ethnic identities. Twelve demonstration sites across the United States are adapting, implementing and evaluating a comprehensive bundle of two or more evidence informed interventions to improve health and outcomes and quality of life for Black women with HIV. METHODS: Guided by Greenhalgh's Conceptual Model of Diffusion of Innovations in Health Service Organizations and Proctor's model for use of implementation strategies and evaluating implementation, service and client outcomes, this mixed methods study documents outcomes at the client, organization, and system level. Participant eligibility for the bundled interventions includes: individuals who are 18 years or older, identify as Black or African-American, identify as cisgender or transgender female and have a diagnosis of HIV. Qualitative data are collected systematically through a series of annual site visits and a standardized monthly call form to assess the barriers and facilitators to the implementation process and the key determinants impacting the intervention uptake and implementation strategies. Quantitative data collection for the implementation, service and client outcomes is conducted through a pre-post prospective study to examine the impact on Black women's health and well-being. Implementation outcomes include: the reach to Black women with HIV, adoption of interventions across the sites and their community; the fidelity to the components of the bundled interventions; the costs of the intervention; and the sustainability of the intervention in the organization and community. Primary service and client outcomes are improved linkage to and retention in HIV care and treatment, increased and sustained viral suppression, improved quality of life and resilience, and stigma reduction. DISCUSSION: The study protocol presented is specifically designed to advance the evidence for adopting culturally responsive and relevant care into clinic and public health settings to improve the health and well-being for Black women with HIV. In addition the study may advance the implementation science field by furthering what is known about the ways in which bundled interventions can address barriers to care and facilitate the uptake of organizational practices to improve health.

Polycystic ovary syndrome and risk of adverse pregnancy outcomes: a registry linkage study from Massachusetts.

STUDY QUESTION: Do women with polycystic ovary syndrome (PCOS) have a greater risk of adverse pregnancy complications (gestational diabetes, preeclampsia, cesarean section, placental abnormalities) and neonatal outcomes (preterm birth, small for gestational age, prolonged delivery hospitalization) compared to women without a PCOS diagnosis and does this risk vary by BMI, subfertility and fertility treatment utilization? SUMMARY ANSWER: Deliveries to women with a history of PCOS were at greater risk of complications associated with cardiometabolic function, including gestational diabetes and preeclampsia, as well as preterm birth and prolonged length of delivery hospitalization. WHAT IS KNOWN ALREADY: Prior research has suggested that women with PCOS may be at increased risk of adverse pregnancy outcomes. However, findings have been inconsistent possibly due to lack of consistent adjustment for confounding factors, small samples size and other sources of bias. STUDY DESIGN, SIZE, DURATION: Massachusetts deliveries among women ≥18 years old during 2013-2017 from state vital records linked to hospital discharges, observational stays and emergency department visits were linked to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) and the Massachusetts All-Payers Claims Database (APCD). PARTICIPANTS/MATERIALS, SETTING, METHODS: PCOS was identified by ICD9 and ICD10 codes in APCD prior to index delivery. Relative risks (RRs) and 95% CI for pregnancy and delivery complications were modeled using generalized estimating equations with a log link and a Poisson distribution to take multiple cycles into account and were adjusted a priori for maternal age, BMI, race/ethnicity, education, plurality, birth year, chronic hypertension and chronic diabetes. Tests for homogeneity investigated differences between maternal pre-pregnancy BMI categories (<30, ≥30, <25 and ≥25 kg/m2) and between non-infertile deliveries and deliveries that used ART or had a history of subfertility (defined by birth certificates, SART CORS records, APCD or hospital records). MAIN RESULTS AND THE ROLE OF CHANCE: Among 91 825 deliveries, 3.9% had a history of PCOS. Women with a history of PCOS had a 51% greater risk of gestational diabetes (CI: 1.38-1.65) and a 25% greater risk of preeclampsia (CI: 1.15-1.35) compared to women without a diagnosis of PCOS. Neonates born to women with a history of PCOS were more likely to be born preterm (RR: 1.17, CI: 1.06-1.29) and more likely to have a prolonged delivery hospitalization after additionally adjusting for gestational age (RR: 1.23, CI: 1.09-1.40) compared to those of women without a diagnosis of PCOS. The risk for gestational diabetes for women with PCOS was greater among women with a pre-pregnancy BMI <30 kg/m2. LIMITATIONS, REASONS FOR CAUTION: PCOS was defined by ICD documentation prior to delivery so there may be women with undiagnosed PCOS or PCOS diagnosed after delivery included in the unexposed group. The study population is limited to deliveries within Massachusetts among most private insurance payers and inpatient or observational hospitalization in Massachusetts during the follow-up window, therefore there may be diagnoses and or deliveries outside of the state or outside of our sample that were not captured. WIDER IMPLICATIONS OF THE FINDINGS: In this population-based study, women with a history of PCOS were at greater risk of pregnancy complications associated with cardiometabolic function and preterm birth. Obstetricians should be aware of patients' PCOS status and closely monitor for potential pregnancy complications to improve maternal and infant perinatal health outcomes. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by the NIH (R01HD067270). S.A.M. receives grant funding from NIH, AbbVie and the Marriot Family Foundation; payment/honoraria from the University of British Columbia, World Endometriosis Research Foundation and Huilun Shanghai; travel support for attending meetings for ESHRE 2019, IASP 2019, National Endometriosis Network UK meeting 2019; SRI 2022, ESHRE 2022; participates on the data safety monitoring board/advisory board for AbbVie, Roche, Frontiers in Reproductive Health; and has a leadership role in the Society for Women's Health Research, World Endometriosis Research Foundation, World Endometriosis Society, American Society for Reproductive Medicine and ESHRE. The other authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.

Medicaid Expansion and Change in Federally Qualified Health Center Accessibility From 2008 to 2016.

BACKGROUND: The Affordable Care Act expanded health coverage for low-income residents through Medicaid expansion and increased funding for Health Center Program New Access Points from 2009 to 2015, improving federally qualified health center (FQHC) accessibility. The extent to which these provisions progressed synergistically as intended when states could opt out of Medicaid expansion is unknown. OBJECTIVE: To compare change in FQHC accessibility among census tracts in Medicaid expansion and nonexpansion states. RESEARCH DESIGN: Tract-level FQHC accessibility scores for 2008 and 2016 were estimated applying the 2-step floating catchment area method to American Community Survey and Health Resources and Services Administration data. Multivariable linear regression compared changes in FQHC accessibility between tracts in Medicaid expansion and nonexpansion states, adjusting for sociodemographic and health system factors and accounting for state-level clustering. SUBJECTS: In total, 7058 census tracts across 10 states. RESULTS: FQHC accessibility increased comparably among tracts in Medicaid expansion and nonexpansion states (coef: 0.3; 95% CI: -0.3, 0.8; P -value: 0.36). FQHC accessibility increased more in tracts with higher poverty and uninsured rates, and those with lower proportions of non-English speakers and Black or African American residents. CONCLUSION: Similar gains in FQHC accessibility across Medicaid expansion and nonexpansion states indicate improvements progressed independently from Medicaid expansion, rather than synergistically as expected. Accessibility increases appeared consistent with HRSA's goal to improve access for individuals experiencing economic barriers to health care but not for those experiencing cultural or language barriers to health care.

Pregnancy outcomes among women with endometriosis and fibroids: registry linkage study in Massachusetts.

BACKGROUND: Endometriosis and uterine fibroids are common gynecologic conditions associated with a greater risk for infertility. Previous research has suggested that these conditions are associated with adverse pregnancy outcomes, potentially because of increased utilization of fertility treatments. OBJECTIVE: Our objective was to investigate whether women with a history of endometriosis or fibroids had a greater risk for adverse pregnancy outcomes and whether this risk varied by infertility history and fertility treatment utilization. STUDY DESIGN: Deliveries (2013-2017) recorded in Massachusetts' vital records were linked to assisted reproductive technology data, hospital stays, and all-payer claims database. We identified endometriosis and fibroids diagnoses via the all-payer claims database before index delivery. Adjusted relative risks for pregnancy complications were modeled using generalized estimating equations with a log link and Poisson distribution. The influence of subfertility or infertility and assisted reproductive technology was also investigated. RESULTS: Among 91,825 deliveries, 1560 women had endometriosis and 4212 had fibroids. Approximately 30% of women with endometriosis and 26% of women with fibroids experienced subfertility or infertility without utilizing assisted reproductive technology, and 34% of women with endometriosis and 21% of women with fibroids utilized assisted reproductive technology for the index delivery. Women with a history of endometriosis or fibroids were at a greater risk for pregnancy-induced hypertension, preeclampsia, or eclampsia (endometriosis relative risk, 1.17; fibroids relative risk, 1.08), placental abnormalities (endometriosis relative risk, 1.65; fibroids relative risk, 1.38), and cesarean delivery (endometriosis relative risk, 1.22; fibroids relative risk, 1.17) than women with no history of those conditions. Neonates born to women with a history of endometriosis or fibroids were also at a greater risk for preterm birth (endometriosis relative risk, 1.24; fibroids relative risk, 1.17). Associations between fibroids and low birthweight varied by fertility status or assisted reproductive technology (P homogeneity=.01) and were stronger among noninfertile women. CONCLUSION: Endometriosis or fibroids increased the risk for adverse pregnancy outcomes, possibly warranting differential screening or treatment.

Calculating power for the Finkelstein and Schoenfeld test statistic for a composite endpoint with two components.

The Finkelstein and Schoenfeld (FS) test is a popular generalized pairwise comparison approach to analyze prioritized composite endpoints (eg, components are assessed in order of clinical importance). Power and sample size estimation for the FS test, however, are generally done via simulation studies. This simulation approach can be extremely computationally burdensome, compounded by increasing number of composite endpoints and with increasing sample size. Here we propose an analytical solution to calculate power and sample size for commonly encountered two-component hierarchical composite endpoints. The power formulas are derived assuming underlying distributions in each of the component outcomes on the population level, which provide a computationally efficient and practical alternative to the standard simulation approach. Monte Carlo simulation results demonstrate that performance of the proposed power formulas are consistent with that of the simulation approach, and have generally desirable objective properties including robustness to mis-specified distributional assumptions. We demonstrate the application of the proposed formulas by calculating power and sample size for the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial.

Reducing Readmission of Hospitalized Patients With Depressive Symptoms: A Randomized Trial.

PURPOSE: To determine if hospitalized patients with depressive symptoms will benefit from post-discharge depression treatment with care transition support. METHODS: This is a randomized controlled trial of hospitalized patients with patient health questionnaire-9 score of 10 or more. We delivered the Re-Engineered Discharge (RED) and randomized participants to groups receiving RED-only or RED for Depression (RED-D), a 12-week post-discharge telehealth intervention including cognitive behavioral therapy, self-management support, and patient navigation. Primary outcomes were hospital readmission and reutilization rates at 30 and 90 days post discharge. RESULTS: We randomized 709 participants (353 RED-D, 356 RED-only). At 90 days, 265 (75%) intervention participants had received at least 1 RED-D session (median 4). At 30 days, the intention-to-treat analysis showed no differences between RED-D vs RED-only in hospital readmission (9% vs 10%, incidence rate ratio [IRR] 0.92 [95% CI, 0.56-1.52]) or reutilization (27% vs 24%, IRR 1.14 [95% CI, 0.85-1.54]). The intention-to-treat analysis also showed no differences at 90 days in readmission (28% vs 21%, IRR 1.30 [95% CI, 0.95-1.78]) or reutilization (70% vs 57%, IRR 1.22 [95% CI, 1.01-1.49]). In the as-treated analysis, each additional RED-D session was associated with a decrease in 30- and 90-day readmissions. At 30 days, among 104 participants receiving 3 or more sessions, there were fewer readmissions (3% vs 10%, IRR 0.30 [95% CI, 0.07-0.84]) compared with the control group. At 90 days, among 109 participants receiving 6 or more sessions, there were fewer readmissions (11% vs 21%, IRR 0.52 [95% CI, 0.27-0.92]). Intention-to-treat analysis showed no differences between study groups on secondary outcomes. CONCLUSIONS: Care transition support and post-discharge depression treatment can reduce unplanned hospital use with sufficient uptake of the RED-D intervention.

Does HIV Stigma Predict Social Networks Over Time: A Latent Growth Curve Analysis.

Persons living with HIV (PLWH) with socio-economic vulnerabilities are especially vulnerable to HIV stigma and adverse HIV outcomes. Stigma related to HIV may intersect with marginalized socio-economic conditions to negatively affect social networks. HIV stigma may limit the ability of individuals to sustain social relationships. This study examined the potential cross-sectional and longitudinal associations between HIV stigma and the quality and quantity of social networks for PLWH. PLWH (n = 1,082) who were experiencing housing, employment, and medical care-related difficulties were recruited to participate in a one-year navigation and system coordination intervention to improve housing stability and employment. Neither stigma reduction nor social networks were the main components of the intervention. A series of latent growth curves were estimated to assess the cross-sectional and longitudinal relationships among internalized and anticipated HIV stigma and social networks. Anticipated HIV stigma predicted social networks both cross-sectionally and longitudinally. Internalized HIV stigma predicted social networks cross-sectionally but not longitudinally in this population. These data support the HIV Stigma Framework and suggest that anticipated stigma seems to have a strong association with social networks. As anticipated stigma decreases over time, social network scores increase. Interventions to decrease anticipated HIV stigma as a mechanism of improving social networks warrants further investigation.

Outcomes from the Adaptation of an Evidence-Based Peer Linkage & Re-Engagement Intervention for Women of Color with HIV in Three Urban Clinics.

Peer interventions have demonstrated efficacy with improving HIV health outcomes. Yet, little is known about factors associated with their uptake into the clinic setting. Three urban sites in the US were funded to adapt, implement and evaluate a peer intervention to improve HIV health outcomes for 173 out of care and newly diagnosed women of color. Peers worked with cis and transgender women of color for four months to achieve the goals of linkage and retention in HIV case management and medical care. Results were 96% of women were linked to medical care, 73% were retained in care and 81% were virally suppressed post 12 months. The average duration of the peer intervention was seven months. Women who received four peer encounters had a 10% increase in retention in care and viral suppression. The findings highlight key elements such as dose and duration of client interaction for peer staff as part of the health care team.

Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care.

BACKGROUND: Patient navigation is an evidence-based intervention for reducing delays in oncology care among underserved populations. In order to address the financial sustainability of this intervention, information is needed on the cost of implementing patient navigation in diverse healthcare settings. Because patient navigation programs and care settings are highly variable, this paucity of cost data creates difficulties in identifying best practices and decisions about the feasibility of implementing navigation programs within a health care system. One barrier to collecting these cost data is the lack of assessment tools available to support patient navigation programs. These tools must be relevant to the wide variety of navigation activities that exist in health care settings, and be flexible enough to collect cost data important to stakeholders in fee-for-service and value-based care environments. METHODS AND RESULTS: We present a novel approach and methods for assessing the cost of a patient navigation program implemented across six hospital systems to enhance timely entry and uptake of breast cancer care and treatment. These methods and tools were developed in partnership with breast oncology patient navigators and supervisors using principles of stakeholder engagement, with the goal of increasing usability and feasibility in the field. CONCLUSIONS: This methodology can be used to strengthen cost analysis and assessment tools for other navigation programs for improving care and treatment for patients with chronic conditions. TRIAL REGISTRATION: NCT03514433.

Embryo biopsy and maternal and neonatal outcomes following cryopreserved-thawed single embryo transfer.

BACKGROUND: Contemporary embryo biopsy in the United States involves the removal of several cells from a blastocyst that would become the placenta for preimplantation genetic testing. Embryos are then cryopreserved while patients await biopsy results, with transfers occurring in a subsequent cycle as a single frozen-thawed embryo transfer, if euploid. OBJECTIVE: We sought to determine if removal of these cells for preimplantation genetic testing was associated with adverse obstetrical or neonatal outcomes after frozen-thawed single embryo transfer. STUDY DESIGN: We linked assisted reproductive technology surveillance data from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System to birth certificates and maternal and neonatal hospitalization discharge diagnoses in Massachusetts from 2014 to 2017, considering only singleton births after frozen-thawed single embryo transfers. We compared outcomes of cycles having embryo biopsy (n=585) to those having no biopsy (n=2191) using chi-square for categorical and binary variables and logistic regression for adjusted odds ratios and 95% confidence intervals, adjusting for mother's age, race, education, parity, body mass index, birth year, insurance, and all infertility diagnoses. RESULTS: Considering no biopsy as the reference, there was no difference between groups with respect to preeclampsia (adjusted odds ratio, 0.82; 95% confidence interval, 0.42-1.61; P=.5685); pregnancy-induced hypertension (adjusted odds ratio, 0.85; 95% confidence interval, 0.46-1.59; P=.6146); placental disorders, including placental abruption, placenta previa, placenta accreta, placenta increta, and placenta percreta (adjusted odds ratio, 1.16; 95% confidence interval, 0.60-2.24; P=.6675); preterm birth (adjusted odds ratio, 1.22; 95% confidence interval 0.73-2.03; P=.4418); low birthweight (adjusted odds ratio, 1.12; 95% confidence interval, 0.58-2.15; P=.7355); cesarean delivery (adjusted odds ratio, 1.04; 95% confidence interval, 0.79-1.38; P=.7762); or gestational diabetes mellitus (adjusted odds ratio, 0.83; 95% confidence interval, 0.50-1.38; P=.4734). In addition, there was no difference between the groups for prolonged hospital stay for mothers (adjusted odds ratio, 1.23; 95% confidence interval, 0.83-1.80; P=.3014) or for infants (95% confidence interval, 1.29; 95% confidence interval, 0.72-2.29; P=.3923). CONCLUSION: Embryo biopsy for preimplantation genetic testing does not increase the odds for diagnoses related to placentation (preeclampsia, pregnancy-related hypertension, placental disorders, preterm delivery, or low birthweight), maternal conditions (gestational diabetes mellitus), or maternal or infant length of stay after delivery.

Revisiting methods for modeling longitudinal and survival data: Framingham Heart Study.

BACKGROUND: Statistical methods for modeling longitudinal and time-to-event data has received much attention in medical research and is becoming increasingly useful. In clinical studies, such as cancer and AIDS, longitudinal biomarkers are used to monitor disease progression and to predict survival. These longitudinal measures are often missing at failure times and may be prone to measurement errors. More importantly, time-dependent survival models that include the raw longitudinal measurements may lead to biased results. In previous studies these two types of data are frequently analyzed separately where a mixed effects model is used for the longitudinal data and a survival model is applied to the event outcome. METHODS: In this paper we compare joint maximum likelihood methods, a two-step approach and a time dependent covariate method that link longitudinal data to survival data with emphasis on using longitudinal measures to predict survival. We apply a Bayesian semi-parametric joint method and maximum likelihood joint method that maximizes the joint likelihood of the time-to-event and longitudinal measures. We also implement the Two-Step approach, which estimates random effects separately, and a classic Time Dependent Covariate Model. We use simulation studies to assess bias, accuracy, and coverage probabilities for the estimates of the link parameter that connects the longitudinal measures to survival times. RESULTS: Simulation results demonstrate that the Two-Step approach performed best at estimating the link parameter when variability in the longitudinal measure is low but is somewhat biased downwards when the variability is high. Bayesian semi-parametric and maximum likelihood joint methods yield higher link parameter estimates with low and high variability in the longitudinal measure. The Time Dependent Covariate method resulted in consistent underestimation of the link parameter. We illustrate these methods using data from the Framingham Heart Study in which lipid measurements and Myocardial Infarction data were collected over a period of 26 years. CONCLUSIONS: Traditional methods for modeling longitudinal and survival data, such as the time dependent covariate method, that use the observed longitudinal data, tend to provide downwardly biased estimates. The two-step approach and joint models provide better estimates, although a comparison of these methods may depend on the underlying residual variance.

Reliability and Validity of a Brief Self-Report Adherence Measure among People with HIV Experiencing Homelessness and Mental Health or Substance Use Disorders.

The study examines the reliability and validity of a 3-item self-report adherence measure among people with HIV (PWH) experiencing homelessness, substance use, and mental health disorders. 336 participants were included from nine sites across the US between September 2013 and February 2017. We assessed the validity of a self-report scale for adherence to antiretroviral therapy by comparing it with viral load (VL) abstracted from medical records at baseline, 6, 12, and 18 months. The items had high internal consistency (Cronbach's alpha coefficients at each time point were > 0.8). The adherence scale scores were higher in the group that achieved VL suppression compared to the group that did not. The c-statistic for the receiver-operating characteristic curves pooled across time points was 0.77 for each adherence sub-item and 0.78 for the overall score. The self-report adherence measure shows good internal consistency and validity that correlated with VL suppression in homeless populations.

Adverse psychosocial factors in pregnancy and preterm delivery.

BACKGROUND: Mental health symptoms, stress, and low psychosocial resources are associated with preterm delivery. It is unknown if there are groups of women who experience similar patterns of these adverse psychosocial factors during pregnancy and if the risk of preterm delivery differs among these groups. OBJECTIVE: To identify groups of women with similar patterns of adverse psychosocial factors during pregnancy and determine whether the risk of preterm delivery differs among these groups. METHODS: Spontaneous Prematurity and Epigenetics of the Cervix (SPEC) is a prospective cohort study of pregnant women, aged 18 and older. In this analysis, we included women who enrolled after 24 August 2014 and delivered by 20 January 2019. As women could enrol more than once, our cohort included 774 women with 787 pregnancies. We conducted a latent class analysis to identify groups of women with similar patterns of adverse psychosocial factors during pregnancy based on their responses to measures assessing depression, perceived stress, anxiety (pregnancy-related and generalised), stressful life events, resilience, and social support (partner and friend/family). After identifying the latent classes, we used log-binomial regression to compare the incidence of preterm delivery among the classes. RESULTS: The median age among participants was 33.2 years (interquartile range 30.3-36.3), and the majority were non-Hispanic white (56.9%). We identified three classes of adverse psychosocial factors (few, some, and many factors). In total, 63 (8.0%) pregnancies resulted in a preterm delivery. Compared to participants with few factors, the risk of preterm delivery was no different among participants with some (RR 1.23, 95% CI 0.68, 2.25) and many adverse factors (RR 1.62, 95% CI 0.73, 3.62). CONCLUSIONS: We identified three groups of pregnant women with similar patterns of adverse psychosocial factors. We did not observe a difference in the risk of preterm delivery among the classes.

Optimizing the control group for evaluating ART outcomes: can outpatient claims data yield a better control group?

PURPOSE: We previously developed a subfertile comparison group with which to compare outcomes of assisted reproductive technology (ART) treatment. In this study, we evaluated whether insurance claims data in the Massachusetts All Payers Claims Database (APCD) defined a more appropriate comparison group. METHODS: We used Massachusetts vital records of women who delivered between 2013 and 2017 on whom APCD data were available. ART deliveries were those linked to a national ART database. Deliveries were subfertile if fertility treatment was marked on the birth certificate, had prior hospitalization with ICD code for infertility, or prior fertility treatment. An infertile group included women with an APCD outpatient or inpatient ICD 9/10 infertility code prior to delivery. Fertile deliveries were none of the above. Demographics, health risks, and obstetric outcomes were compared among groups. Multivariable generalized estimating equations were used to calculate adjusted relative risk (aRR) and 95% confidence intervals (CI). RESULTS: There were 70,726 fertile, 4,763 subfertile, 11,970 infertile, and 7,689 ART-treated deliveries. Only 3,297 deliveries were identified as both subfertile and infertile. Both subfertile and infertile were older, and had more education, chronic hypertension, and diabetes than the fertile group and less than the ART-treated group. Prematurity (aRR = 1.15-1.17) and birthweight (aRR = 1.10-1.21) were increased in all groups compared with the fertile group. CONCLUSION: Although the APCD allowed identification of more women than the previously defined subfertile categorization and allowed us to remove previously unidentified infertile women from the fertile group, it is not clear that it offered a clinically significantly improved comparison group.

Egg Intake Has No Adverse Association With Blood Lipids Or Glucose In Adolescent Girls.

OBJECTIVE: Longitudinal data on cardiometabolic effects of egg intake during adolescence are lacking. The current analyses aim to evaluate the impact of usual adolescent egg consumption on lipid levels, fasting glucose, and insulin resistance during late adolescence (age 17-20 years). METHODS: Data from 1392 girls, aged 9 to 10 at baseline and followed for 10 years, in the National Heart, Lung, and Blood Institute's National Growth and Health Study were used to examine the association between usual egg intake alone and in combination with other healthy lifestyle factors and late adolescent lipid levels, fasting glucose, and insulin resistance, measured as homeostasis model assessment of insulin resistance (HOMA-IR). Diet was assessed using 3-day food records during eight examination cycles. Girls were classified according to usual weekly egg intake, ages 9-17 years: <1 egg/wk (n = 361), 1 to <3 eggs/wk (n = 703), and ≥3 eggs/wk (n = 328). Analysis of covariance modeling was used to control for confounding by other behavioral and biological risk factors. RESULTS: Girls with low, moderate, and high egg intakes had adjusted low-density lipoprotein cholesterol levels of 99.7, 98.8, and 95.5 mg/dL, respectively (p = 0.0778). In combination with higher intakes of fiber, dairy, or fruits and vegetables, these beneficial effects were stronger and statistically significant. There was no evidence that ≥3 eggs/wk had an adverse effect on lipids, glucose, or HOMA-IR. More active girls who consumed ≥3 eggs/wk had the lowest levels of insulin resistance. CONCLUSION: These results suggest that eggs may be included as part of a healthy adolescent diet without adverse effects on glucose, lipid levels, or insulin resistance.