Comparing the effect of two systems-level interventions on perinatal generalized anxiety disorder and post-traumatic stress disorder symptoms.

BACKGROUND: The Massachusetts Child Psychiatry Access Program (MCPAP for Moms) and PRogram In Support of Moms (PRISM) are designed to help obstetric practices address perinatal depression. PRISM includes the statewide MCPAP for Moms program plus proactive implementation support. OBJECTIVE: The goal of this study was to understand the impact of these programs on perinatal Generalized Anxiety Disorder (GAD) and Post-traumatic Stress Disorder (PTSD) symptoms among individuals screening positive for depression. STUDY DESIGN: We conducted a secondary analysis of 2017-2022 data from a cluster randomized controlled trial of MCPAP for Moms vs. PRISM. We included participants completing a GAD or PTSD screen at baseline (n=254) with antenatal Edinburgh Postnatal Depression Scale (EPDS) scores ≥ 10. We assessed change in GAD and PTSD symptoms at from pregnancy (4 to <25 weeks Gestational Age (GA) or 32-40 weeks GA), to 4-12 weeks postpartum and 11-13 months postpartum. We conducted a difference-in-difference analysis to compare symptom change from pregnancy to postpartum. We used adjusted linear mixed models with repeated measures to examine the impact of MCPAP for Moms and PRISM on changes in the Generalized Anxiety Disorder 7 (GAD-7) and the PTSD CheckList (PCL-C). RESULTS: Mean GAD-7 scores decreased by 3.6 (MCPAP for Moms) and 6.3 (PRISM) points at from pregnancy to 4-12 weeks postpartum. Mean PCL-C scores decreased by 6.2 and 10.0 points, respectively, at 4-12 weeks postpartum among individuals screening positive on the GAD-7 (n=83) or PCL-C (n=58) in pregnancy. GAD-7 and PCL-C scores decreased among both groups at 11-13 months postpartum. These changes were clinically meaningful. PRISM conferred a statistically significant greater decrease (2.7 points) on the GAD-7 than MCPAP for Moms at 4-12 weeks postpartum. No differences were found between MCPAP for Moms and PRISM in PCL-C or GAD-7 change at 11-13 months, although both were associated with a reduction in GAD and PTSD symptoms at 4-12 weeks and 11-13 months postpartum. CONCLUSION: Both MCPAP for Moms and PRISM could help to improve symptoms for individuals experiencing co-occurring symptoms of depression, GAD, or PTSD. PRISM may confer additional benefit in the early postpartum period, although this difference was not clinically significant.

Association of perinatal depression and postpartum contraception intent, choice, and actual use.

OBJECTIVES: Depression is common during pregnancy and the year following childbirth (the perinatal period). This study assessed the association of depressive symptoms and contraception decisions in perinatal individuals. STUDY DESIGN: We conducted a secondary analysis using data from the PRogram in Support of Moms (PRISM) study, a cluster randomized controlled trial of active interventions which aimed to address perinatal depression. This analysis included 191 individuals aged 18-45 who screened positive for depression on the Edinburgh Postnatal Depression Scale (EPDS, score ≥10) during pregnancy or up to 3 months postpartum. We assessed contraception intent and method choice at 1-3 months postpartum. At 5-7 months postpartum, we assessed contraceptive method used and EPDS depression scores. We used logistic regressions to examine the relationship between depression and contraceptive use/method. RESULTS: At 1-3 months postpartum, the majority of participants (76.4%) expressed an intention to use contraception. Of those, over half (53.4%) indicated a preference for higher effectiveness contraception methods. Participants with persistent depression symptoms (positive EPDS) at 5-7 months were significantly less likely to report using higher effectiveness contraceptive methods (aOR = 0.28, 95% CI = 0.11-0.70) compared to those without. Among participants with persistent depressive symptoms, 21.1% reported using a contraception method of lower effectiveness than had originally intended. CONCLUSION: Perinatal individuals with persistent depressive symptoms at 5-7 months postpartum reported greater use of less-effective contraception methods than originally planned. IMPLICATIONS: We found associations between perinatal depression and use of less effective contraception use. Provider discussions regarding contraception planning is important, particularly in those with perinatal depression symptoms.

Examining racial/ethnic inequities in treatment participation among perinatal individuals with depression.

OBJECTIVE: A cluster randomized controlled trial (RCT) of two interventions for addressing perinatal depression treatment in obstetric settings was conducted. This secondary analysis compared treatment referral and participation among Minoritized perinatal individuals compared to their non-Hispanic white counterparts. METHODS: Among perinatal individuals with depression symptoms, we examined rates of treatment 1) referral (i.e., offered medications or referred to mental health clinician), 2) initiation (i.e., attended ≥1 mental health visit or reported prescribed antidepressant medication), and 3) sustainment (i.e., attended >1 mental health visit per study month or prescribed antidepressant medication at time of study interviews). We compared non-Hispanic white (NHW) (n = 149) vs. Minoritized perinatal individuals (Black, Asian, Hispanic/Latina, Pacific Islander, Native American, Multiracial, and white Hispanic/Latina n = 157). We calculated adjusted odds ratios (aOR) for each outcome. RESULTS: Minoritized perinatal individuals across both interventions had significantly lower odds of treatment referral (aOR = 0.48;95% CI = 0.27-0.88) than their NHW counterparts. There were no statistically significant differences in the odds of treatment initiation (aOR = 0.64 95% CI:0.36-1.2) or sustainment (aOR = 0.54;95% CI = 0.28-1.1) by race/ethnicity. CONCLUSIONS: Perinatal mental healthcare inequities are associated with disparities in treatment referrals. Interventions focusing on referral disparities across race and ethnicity are needed.

Examining Race-Based and Gender-Based Discrimination, Trust in Providers, and Mental Well-Being Among Black Women.

OBJECTIVES: To examine experiences of discrimination among Black women, and to determine if experiencing race- and gender-based discrimination is associated with mental well-being and trust. METHODS: Data from the TRUST study were used to examine experiences of discrimination among 559 Black women with hypertension receiving healthcare at a safety-net hospital in Birmingham, Alabama. A three-level variable was constructed to combine the race-based and gender-based measures of the Experiences of Discrimination scale. Linear regression was used to examine the association between experiences of discrimination with mental well-being and trust. RESULTS: Women who reported no experiences of race- or gender-based discrimination were older and reported higher mental well-being scores and greater trust. Fifty-three percent of study participants reported experiencing discrimination. Compared to participants who did not experience race- or gender-based discrimination, participants reporting experiences of race- or gender-based discrimination and those reporting experiencing both race- and gender-based discrimination were more likely to report poorer mental health. CONCLUSION: Reported experiences of gender- and/or race-based discrimination in this study were associated with lower mental health scores and less trust in health care providers. Our findings highlight the importance of examining experiences of discrimination among Black women, and the role of discrimination as a stressor and in reducing trust for providers. Incorporating an understanding and acknowledgement of experiences of discrimination into interventions, programs, and during clinical encounters may foster more trusting relationships between providers and patients.

Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial.

BACKGROUND: Perinatal depression is a common and undertreated condition, with potential deleterious effects on maternal, obstetric, infant, and child outcomes. We aimed to compare the effectiveness of two systems-level interventions in the obstetric setting-the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the PRogram In Support of Moms (PRISM)-in improving depression symptoms and participation in mental health treatment among women with perinatal depression. METHODS: In this cluster-randomised, active-controlled trial, obstetric practices across Massachusetts (USA) were allocated (1:1) via covariate adaptive randomisation to either continue participating in the MCPAP for Moms intervention, a state-wide, population-based programme, or to participate in the PRISM intervention, which involved MCPAP for Moms plus a proactive, multifaceted, obstetric practice-level intervention with intensive implementation support. English-speaking women (aged ≥18 years) who screened positive for depression (Edinburgh Postnatal Depression Scale [EPDS] score ≥10) were recruited from the practices. Patients were followed up at 4-25 weeks of gestation, 32-40 weeks of gestation, 0-3 months postpartum, 5-7 months postpartum, and 11-13 months postpartum via telephone interview. Participants were masked to the intervention; investigators were not masked. The primary outcome was change in depression symptoms (EPDS score) between baseline assessment and 11-13 months postpartum. Analysis was done by intention to treat, fitting generalised linear mixed models adjusting for age, insurance status, education, and race, and accounting for clustering of patients within practices. This trial is registered with ClinicalTrials.gov, NCT02760004. FINDINGS: Between July 29, 2015, and Sept 20, 2021, ten obstetric practices were recruited and retained; five (50%) practices were randomly allocated to MCPAP for Moms and five (50%) to PRISM. 1265 participants were assessed for eligibility and 312 (24·7%) were recruited, of whom 162 (51·9%) were enrolled in MCPAP for Moms practices and 150 (48·1%) in PRISM practices. Comparing baseline to 11-13 months postpartum, EPDS scores decreased by 4·2 (SD 5·2; p<0·0001) among participants in MCPAP for Moms practices and by 4·3 (SD 4.5; p<0·0001) among those in PRISM practices (estimated difference between groups 0·1 [95% CI -1·2 to 1·4]; p=0·87). INTERPRETATION: Both the MCPAP for Moms and PRISM interventions were equally effective in improving depression symptoms. This finding is important because the 4-point decrease in EPDS score is clinically significant, and MCPAP for Moms has a lower intensity and greater population-based reach than does PRISM. FUNDING: US Centers for Disease Control and Prevention.

Pediatric High Blood Pressure Follow-Up Guideline Adherence in a Massachusetts Health Care System.

OBJECTIVES: To describe adherence to the American Academy of Pediatrics' (AAP) 2017 clinical practice guidelines for follow-up after high blood pressure (BP) screening by pediatric and family medicine providers in a Massachusetts health care system and to assess differences in receipt of follow-up according to child- and clinic-level factors. METHODS: Electronic health record data were analyzed for children aged 3 to 17years who had an outpatient primary care visit during 2018 with a high BP screening (according to AAP guidelines). We classified AAP guideline adherent follow-up as BP follow-up within 6months after an elevated finding (+2-week buffer) and within 2weeks after a hypertensive finding (+2-week buffer). Differences in receipt of guideline adherent follow-up by child- and clinic-level factors were assessed via multilevel mixed effects logistic regression models. RESULTS: The median age of the 4563 included children was 12years and 43% were female. Overall, guideline adherent follow-up was received by 17.7% of children within the recommended time interval; 27.4% for those whose index BP was elevated and 5.4% for those whose index BP was hypertensive. Modeling revealed older children and those belonging to clinics with more providers, smaller patient panels, and smaller proportion of Medicaid patients were more likely to receive adherent follow-up. CONCLUSIONS: Few children received guideline adherent BP follow-up and most differences in adherence were related to clinic resources. System-level interventions are needed to improve BP follow-up.

Disparities in Receipt of Guideline-adherent Blood Pressure Screening: An Observational Examination of Electronic Health Record Data from a Massachusetts Healthcare System.

OBJECTIVE: To describe the prevalence of blood pressure (BP) screening according to the 2017 American Academy of Pediatrics (AAP) guidelines and differences according to social vulnerability indicators. STUDY DESIGN: We extracted electronic health record data from January 1, 2018, through December 31, 2018, from the largest healthcare system in Central Massachusetts. Outpatient visits for children aged 3-17 years without a prior hypertension diagnosis were included. Adherence was defined by the American Academy of Pediatrics guideline (≥1 BP screening for children with a body mass index [BMI] of <95th percentile) and at every encounter for children with a BMI of ≥95th percentile). Independent variables included social vulnerability indicators at the patient level (insurance type, language, Child Opportunity Index, race/ethnicity) and clinic level (location, Medicaid population). Covariates included child's age, sex, and BMI status, and clinic specialty, patient panel size, and number of healthcare providers. We used direct estimation to calculate prevalence estimates and multivariable mixed effects logistic regression to determine the odds of receiving guideline-adherent BP screening. RESULTS: Our sample comprised 19 695 children (median age, 11 years; 48% female) from 7 pediatric and 20 family medicine clinics. The prevalence of guideline-adherent BP screening was 89%. In our adjusted model, children with a BMI of ≥95th percentile, with public insurance, and who were patients at clinics with larger Medicaid populations and larger patient panels had a lower odds of receiving guideline-adherent BP screening. CONCLUSIONS: Despite overall high adherence to BP screening guidelines, patient- and clinic-level disparities were identified.

Social Determinants, Blood Pressure Control, and Racial Inequities in Childbearing Age Women With Hypertension, 2001 to 2018.

Background Hypertension is an important modifiable risk factor of serious maternal morbidity and mortality. Social determinants of health (SDoH) influence hypertension outcomes and may contribute to racial and ethnic differences in hypertension control. Our objective was to assess SDoH and blood pressure (BP) control by race and ethnicity in US women of childbearing age with hypertension. Methods and Results We studied women (aged 20-50 years) with hypertension (systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg or use of antihypertensive medication) in the National Health and Nutrition Examination Surveys 2001 to 2018. SDoH and BP control (systolic BP <140 mm Hg and diastolic BP <90 mm Hg) were examined by race and ethnicity (White race, Black race, Hispanic ethnicity, and Asian race). Using multivariable logistic regression, odds of uncontrolled BP by race and ethnicity were modeled, adjusting for SDoH, health factors, and modifiable health behaviors. Responses on hunger and affording food determined food insecurity status. Across women of childbearing age with hypertension (N=1293), 59.2% were White race, 23.4% were Black race, 15.8% were Hispanic ethnicity, and 1.7% were Asian race. More Hispanic and Black women experienced food insecurity than White women (32% and 25% versus 13%; both P<0.001). After SDoH, health factor, and modifiable health behavior adjustment, Black women maintained higher odds of uncontrolled BP than White women (odds ratio, 2.31 [95% CI, 1.08-4.92]), whereas Asian and Hispanic women showed no difference. Conclusions We identified racial inequities in uncontrolled BP and food insecurity among women of childbearing age with hypertension. Further exploration beyond the SDoH measured is needed to understand the inequity in hypertension control in Black women.

Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial.

Importance: Novel data science and marketing methods of smoking-cessation intervention have not been adequately evaluated. Objective: To compare machine learning recommender (ML recommender) computer tailoring of motivational text messages vs a standard motivational text-based intervention (standard messaging) and a viral peer-recruitment tool kit (viral tool kit) for recruiting friends and family vs no tool kit in a smoking-cessation intervention. Design, Setting, and Participants: This 2 ×2 factorial randomized clinical trial with partial allocation, conducted between July 2017 and September 2019 within an online tobacco intervention, recruited current smokers aged 18 years and older who spoke English from the US via the internet and peer referral. Data were analyzed from March through May 2022. Interventions: Participants registering for the online intervention were randomly assigned to the ML recommender or standard messaging groups followed by partially random allocation to access to viral tool kit or no viral tool kit groups. The ML recommender provided ongoing refinement of message selection based on user feedback and comparison with a growing database of other users, while the standard system selected messages based on participant baseline readiness to quit. Main Outcomes and Measures: Our primary outcome was self-reported 7-day point prevalence smoking cessation at 6 months. Results: Of 1487 participants who smoked (444 aged 19-34 years [29.9%], 508 aged 35-54 years [34.1%], 535 aged ≥55 years [36.0%]; 1101 [74.0%] females; 189 Black [12.7%] and 1101 White [78.5%]; 106 Hispanic [7.1%]), 741 individuals were randomly assigned to the ML recommender group and 746 individuals to the standard messaging group; viral tool kit access was provided to 745 participants, and 742 participants received no such access. There was no significant difference in 6-month smoking cessation between ML recommender (146 of 412 participants [35.4%] with outcome data) and standard messaging (156 of 389 participants [40.1%] with outcome data) groups (adjusted odds ratio, 0.81; 95% CI, 0.61-1.08). Smoking cessation was significantly higher in viral tool kit (177 of 395 participants [44.8%] with outcome data) vs no viral tool kit (125 of 406 participants [30.8%] with outcome data) groups (adjusted odds ratio, 1.48; 95% CI, 1.11-1.98). Conclusions and Relevance: In this study, machine learning-based selection did not improve performance compared with standard message selection, while viral marketing did improve cessation outcomes. These results suggest that in addition to increasing dissemination, viral recruitment may have important implications for improving effectiveness of smoking-cessation interventions. Trial Registration: ClinicalTrials.gov Identifier: NCT03224520.

Association of neighborhood-level social determinants of health with psychosocial distress in patients newly diagnosed with lung cancer.

BACKGROUND AND AIM: Patients with lung cancer experience high rates of psychosocial distress. They are also more likely to have unresolved, unmet social needs which may contribute to psychosocial distress. Despite this, neighborhood-level social determinants of health (SDOH) in relation to psychosocial distress have not been adequately investigated in patients with lung cancer. The goal of this study is to examine the association between neighborhood-level SDOH and psychosocial distress among a sample of newly diagnosed patients with lung cancer. METHODS: This cross-sectional study included newly diagnosed, adult lung cancer patients from an accredited cancer center. Psychosocial distress was measured with the Distress Thermometer. Neighborhood-level SDOH indicators for income and education were used to create a composite SDOH variable categorized into low, medium, and high deprivation levels. Covariates were age, gender, race/ethnicity, comorbidity index, cancer stage, and insurance status. Using multivariate logistic regression modeling, the association of psychosocial distress with the neighborhood-level SDOH was examined. RESULTS: The prevalence of psychosocial distress in the sample was 58.4%. Neighborhood-level SDOH indicators were not significantly associated with psychosocial distress. Higher odds of psychosocial distress were significantly associated with being female and having distant or regional cancer versus localized cancer. The age group 66-75 years was significantly associated with lower distress compared with those aged <65 years. CONCLUSIONS: Psychosocial distress was consistently high across all the SDOH deprivation categories; but these neighborhood-level SDOH indicators do not appear to be predictive of psychosocial distress at the time of diagnosis of lung cancer.

Differences in Hospital, Emergency Room and Outpatient Visits Among Adults With and Without Monoclonal Gammopathy of Undetermined Significance.

INTRODUCTION: This study evaluated the impact of receiving a monoclonal gammopathy of undetermined significance (MGUS) diagnosis on healthcare utilization from patients at a community-based multispecialty provider organization. METHODS: A cohort of patients with MGUS (n = 429) were matched on sex, age, and length of enrollment to a cohort of patients without MGUS (n = 1286). Healthcare utilization was assessed: 1-12 months before, 1 month before and after, and 1-12 months after diagnosis/index date. Multivariable conditional Poisson models compared change in utilization of each service in patients with and without MGUS. RESULTS: During the 2 months around diagnosis/index date, the rates of emergency room, hospital and outpatient visits were higher for patients with MGUS than patients without MGUS. In the year before MGUS diagnosis, the association was still elevated, although attenuated. CONCLUSION: Understanding the care of MGUS patients is important given that multiple myeloma patients with a pre-existing MGUS diagnosis may have a better prognosis.

Home Blood Pressure Monitoring in Women of Child-Bearing Age With Hypertension From 2009 to 2014.

BACKGROUND: Hypertension (HTN) is a leading cause of maternal mortality, and HTN guidelines recommend home blood pressure monitoring (HBPM) to help achieve blood pressure (BP) control. Evidence suggests that HBPM be coupled with a care team to maximize its effectiveness. HBPM use and the prevalence of provider counseling in child-bearing age women with HTN are unknown. METHODS: We used data from 3,614 women in the cross-sectional National Health and Nutrition Examination Surveys 2009-2014 to determine HBPM use and provider counseling for women of child-bearing age (20-50 years) with and without HTN. HBPM use and provider counseling were self-reported. We examined rates of HBPM use by race/ethnicity, poverty-income ratio (PIR), education, and insurance. RESULTS: Among women of child-bearing age with HTN, the mean (SE) age was 37.0 (0.3) years, the mean (SE) BMI was 35.5 (0.6) kg/m2, and 73% were on BP medication. Of these women with HTN, 49.6% reported HBPM use in the past year and 40.4% received provider counseling. There was no significant difference in HBPM use by race/ethnicity, PIR, or insurance, though higher education was associated with HBPM use. Women with HTN who received provider counseling were more likely to use HBPM (odds ratio = 15.7, 95% confidence interval 9.1-26.9). CONCLUSIONS: Nearly half of child-bearing age women with HTN have adopted HBPM, and provider counseling was strongly associated with HBPM use. This highlights a need and opportunity for providers to improve BP management by supporting a popular and valuable monitoring approach among women of child-bearing age with HTN.

Efficacy of a Gender-Relevant Smoking Cessation Intervention Among Women in Brazil: Findings from a Group Randomized Controlled Trial.

Background: There is scarcity of smoking cessation programs that take gender into account during its development, implementation, and evaluation. We evaluated the efficacy of a theory-based, culturally, and gender-relevant smoking cessation intervention delivered by Community Health Workers (CHWs) among Brazilian women that augments the smoking cessation program offered through the public health system (PHS). Materials and Methods: A total of 328 women current smokers (100% cigarette smokers) were recruited across 8 towns in a tobacco producing state in Brazil between 2014 and 2017. Four towns were randomly assigned to the intervention (12 home visits by a CHW and a scheduled appointment to attend the smoking cessation program at the PHS) and four towns to the control condition (scheduled appointment to attend the cessation program at the PHS). The primary outcome was self-reported 7-day smoked tobacco abstinence at 7-month follow-up with biochemical verification. Results: Retention at 7-month follow-up was 80.7% (intervention) and 85.1% (control). Using intention-to-treat analysis, abstinence at 7-month-follow-up was 20% in the intervention arm versus 11% in the control arm. Multivariable modeling showed that participants in the intervention arm had 1.88 times the odds of self-reported smoking cessation than control participants after adjustment for depressive symptomatology, self-efficacy, and having someone in the house who smokes. Besides the intervention, only self-efficacy remained significant in the full model as a predictor of cessation. Replication of these analyses using the objective measure of carbon monoxide at a cutoff score of 8 ppm yielded similar results. Conclusions: A theory-based, culturally, and gender-relevant intervention, delivered by CHWs, can successfully promote smoking cessation among women. Clinical Trial Registration No. NCT03845413.

Uptake of hepatitis C virus treatment in a multi-state Medicaid population, 2013-2017.

OBJECTIVE: To examine trends in the direct acting antiviral (DAA) uptake in a multi-state Medicaid population with hepatitis C virus (HCV) prior to and after ledipasvir/sofosbuvir (LDV/SOF) approval and changes in prior authorization (PA) requirements. DATA SOURCES: Analyses utilized enrollment, medical, and pharmacy claims in four states, December 2013-December 2017. STUDY DESIGN: An interrupted time series examined trends in uptake (1+ claim for a DAA) before and after two events: LDV/SOV approval (October 2014) and lifting of PA requirements for 40% of members (July 2016). Analyses were also performed in subgroups defined by the number and dates of change in PA requirements in members' Medicaid plans. DATA COLLECTION/EXTRACTION METHODS: Members aged 18-64 years with an ICD code for HCV were included in the sample from diagnosis date until treatment initiation or Medicaid disenrollment. PRINCIPAL FINDINGS: The annual sample size ranged from 38,302 to 45,005 with approximately 30% ages 18-34 years and 40% female. In December 2013, 0.08% was treated, rising to 0.74% in December 2017 (p < 0.001). Uptake increased from 0.34%/month in October 2014 to 0.70%/month after LDV/SOF approval, (p < 0.001), and increased relative to the pre-LDV/SOV trend through June 2016 (p = 0.04). Uptake increased to 1.18%/month after PA change, (p < 0.001) and remained flat through 2017 (p = 0.64). Cumulatively, 20.1% were treated by December 2017. In plans with few/no requirements through 2017, uptake increased to 1.19%/month after LDV/SOF approval (p < 0.001) and remained flat through 2017 (p = 0.11), with 22.2% cumulatively treated. Among plans that lifted PA requirements from three to zero in mid-2016, uptake did not increase after LDV/SOF approval (p = 0.36) but did increase to 1.41%/month (p < 0.001) after PA change, with 18.1% cumulatively treated. CONCLUSIONS: HCV Treatment increased through 2017. LDV/SOF approval and lifting PA requirements led to an increase in uptake followed by flat monthly utilization. Cumulative uptake was higher in plans with few/no PA requirements relative to those with three requirements through mid-2016.

Multi-trajectory models of serum biomarkers among patients with monoclonal gammopathy of undetermined significance.

Understanding the progression of monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma (MM) is needed to identify patients who would benefit from closer clinical surveillance. Given that two of the defining criteria of MM are renal failure and anemia, we described the trajectories of creatinine (Cr) and hemoglobin (Hgb) over time in patients with a diagnosis of MGUS. Patients diagnosed with MGUS (n = 424) were identified by a previously validated case-finding algorithm using health claims and electronic health record data (2007-2015) and followed through 2018. Group-based trajectory modeling identified patients with distinct laboratory value trajectories of Cr (mg/dl) and Hgb (g/dl). Most patients were non-Hispanic White (97.6%) with a mean age of 75 years at MGUS diagnosis. Three multi-trajectory groups were identified: (1) Normal Cr/Hgb (n = 225; 53.1%)-stable serum Cr levels and decreasing, normal Hgb levels; (2) Normal Cr/lower-normal Hgb group (n = 188; 44.3%)-stable, slightly elevated levels of Cr and decreasing levels of Hgb; and (3) High Cr/borderline Hgb group (n = 11; 2.6%)-increased Cr levels and stable low levels of Hgb. Patients with MGUS in Group 2 were older than patients in other groups, and patients in group 3 had more comorbidities than participants in all other groups. Few patients developed MM during the study period. We were able to identify distinct biomarker trajectories in patients with MGUS over time. Future research should investigate how these trajectories may be related to the risk of progression to MM, including M-protein levels.

Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit: A Randomized Clinical Trial.

IMPORTANCE: Most trials of behavioral or pharmaceutical interventions for people who smoke are limited to individuals reporting they are ready to quit smoking. Engaging individuals who initially report they are not yet ready to quit in brief, precessation, skills-building interventions (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) is challenging. OBJECTIVE: To test an integrated behavioral plus NRT-sampling intervention using a gamification approach supported by mobile health. DESIGN, SETTING, AND PARTICIPANTS: A multisite randomized clinical trial with site-level 1-to-1 allocation into 2 conditions was conducted in 4 US health care systems. A total of 433 individuals who were currently smoking and reported at enrollment that they were not ready to quit smoking were enrolled. The study was conducted from November 7, 2016, to July 31, 2020. INTERVENTIONS: Take a Break (TAB) was a 3-week game experience and included 5 behavioral components (motivational messaging, challenge quizzes, brief abstinence goal setting, mobile health apps for cravings management, and reward points for participation) integrated with NRT sampling. TAB draws on social cognitive theory and game mechanics concepts to engage participants in health behavior change. The comparison included NRT sampling only. MAIN OUTCOMES AND MEASURES: Time to first quit attempt (duration from TAB experience to primary outcome) and carbon monoxide level-verified smoking cessation at 6-month follow-up. All analyses used an intention-to-treat approach. RESULTS: Of the 433 individuals included in the trial, 223 were women (52%); mean (SD) age was 54 (13) years. More than half (53% [112 of 213]) of the TAB participants completed 100% of the daily challenge quizzes in the first week, 73% (145 of 199) of participants who completed the goal-setting call set a brief abstinence goal (most frequently 1-2 days of abstinence from cigarettes), and 75% (159 of 213) of participants used the mobile health apps to manage nicotine cravings. Time to the first quit attempt was lower for the TAB vs comparison group (hazard ratio, 1.68; 95% CI, 1.09-2.60; P = .02). At the 6-month follow-up, 18% (28 of 160) of TAB participants and 10% (17 of 171) of the comparison (χ2 test, P = .045) participants obtained carbon monoxide level-verified smoking cessation (accounting for clustering of outcomes by site; odds ratio, 1.92; 95% CI, 1.01-3.68; P = .048). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial demonstrate that individuals not yet ready to quit smoking could be engaged in a brief abstinence game. Six months later, the TAB group had nearly double the rate of smoking cessation vs the NRT sampling comparison group. Integrating a skills-building game experience with brief NRT sampling can enhance long-term cessation among those not yet ready to quit smoking. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02973425.

Hypertension and contraceptive use among women of child-bearing age in the United States from 2001 to 2018.

BACKGROUND: Hypertension (HTN) in pregnancy is a leading cause of maternal mortality in the United States. Contraception is widely used, and estrogen-based combined hormonal forms are known to increase blood pressure (BP). With nearly half of pregnancies unplanned and many antihypertensive medications teratogenic, appropriate contraception is critical in child-bearing age women with HTN. METHODS: Using the National Health and Nutrition Examination Surveys (NHANES) from 2001 to 2018, we evaluated contraception and antihypertensive medication use in women of child-bearing age (20-50 years). Women who had undergone sterilization or menopause were excluded. HTN was defined based on a self-reported provider diagnosis and BP ≥130/80 mm Hg or antihypertensive medication use. Contraception included non-barrier methods (pills/patch/ring, injections, long-acting reversible contraceptives) or consistent condom use. Multivariable logistic regression was used to model the odds of contraception use. Temporal trends in contraception use were reported. RESULTS: Of the 8726 women, 12.4% had HTN with mean age (standard error) 36.0 (0.3) years. In women with HTN, 9.2% used non-barrier contraception and 10.4% used condoms only. Over half (52.7%) of women with HTN on antihypertensive medications were taking medications contraindicated in pregnancy, with no difference seen by contraceptive status. In logistic regression models, contraceptive use was lower in the older-aged women. In women with HTN on non-barrier contraception, combined hormonal contraceptive use declined, from 100% (2001-2006) to 81.4% (2013-2018, P < 0.001). CONCLUSIONS: Many women with self-reported HTN are not using adequate contraception. Of the small proportion on non-barrier contraceptives, the majority are using estrogen-based, BP-raising methods.

mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam.

BACKGROUND: Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. OBJECTIVE: The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. METHODS: We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. RESULTS: Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. CONCLUSIONS: This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30947.

Evaluating the use of a recommender system for selecting optimal messages for smoking cessation: patterns and effects of user-system engagement.

BACKGROUND: Motivational messaging is a frequently used digital intervention to promote positive health behavior changes, including smoking cessation. Typically, motivational messaging systems have not actively sought feedback on each message, preventing a closer examination of the user-system engagement. This study assessed the granular user-system engagement around a recommender system (a new system that actively sought user feedback on each message to improve message selection) for promoting smoking cessation and the impact of engagement on cessation outcome. METHODS: We prospectively followed a cohort of current smokers enrolled to use the recommender system for 6 months. The system sent participants motivational messages to support smoking cessation every 3 days and used machine learning to incorporate user feedback (i.e., user's rating on the perceived influence of each message, collected on a 5-point Likert scale with 1 indicating strong disagreement and 5 indicating strong agreement on perceiving the influence on quitting smoking) to improve the selection of the following message. We assessed user-system engagement by various metrics, including user response rate (i.e., the percent of times a user rated the messages) and the perceived influence of messages. We compared retention rates across different levels of user-system engagement and assessed the association between engagement and the 7-day point prevalence abstinence (missing outcome = smoking) by using multiple logistic regression. RESULTS: We analyzed data from 731 participants (13% Black; 73% women). The user response rate was 0.24 (SD = 0.34) and user-perceived influence was 3.76 (SD = 0.84). The retention rate positively increased with the user response rate (trend test P < 0.001). Compared with non-response, six-month cessation increased with the levels of response rates: low response rate (odds ratio [OR] = 1.86, 95% confidence interval [CI]: 1.07-3.23), moderate response rate (OR = 2.30, 95% CI: 1.36-3.88), high response rate (OR = 2.69, 95% CI: 1.58-4.58). The association between perceived message influence and the outcome showed a similar pattern. CONCLUSIONS: High user-system engagement was positively associated with both high retention rate and smoking cessation, suggesting that investigation of methods to increase engagement may be crucial to increase the impact of the recommender system for smoking cessation. TRIAL REGISTRATION: Registration Identifier: NCT03224520 . Registration date: July 21, 2017.