Racialized environments and syringe services program implementation: County-level factors.

OBJECTIVE: Racialized health inequities in substance use-related harms might emerge from differential access to syringe service programs (SSPs). To explore this, we examined the association between county-level racialized environments, other factors, and (1) SSP presence, and (2) per capita syringe and (3) naloxone distribution. METHODS: 2021 US National Survey of SSP data (n=295/412;72 % response rate) was used to identify SSP presence and the sum of syringes and naloxone doses distributed in 2020 by county. Study measures included racial residential segregation (RRS; i.e., divergence and dissimilarity indexes for Black:Non-Hispanic White & Hispanic:Non-Hispanic White) and covariates (i.e., demographic proportions, urban/suburban/rural classifications, 2020 US presidential Republican vote share, and overdose mortality from 2019). We used logit Generalized Estimating Equations to determine factors associated with county-level SSP presence, and zero inflated negative binomial regression models to determine factors associated with per capita syringe and naloxone distribution. RESULTS: SSPs were reported in 9 % (283/3106) of US counties. SSP presence was associated with higher divergence and dissimilarity indexes, urban and suburban counties, higher opioid overdose mortality, and lower 2020 Republican presidential vote share. Per capita syringes distributed was associated with lower RRS (divergence and Hispanic:White dissimilarity), lower racially minoritized population proportions and rural counties, while per capita naloxone distribution was associated with lower Hispanic and "other" population proportions, and rural counties. CONCLUSIONS: Racialized environments are associated with SSP presence but not the scope of those programs. Preventing HIV and HCV outbreaks, and overdose deaths requires addressing community level factors that influence SSP implementation and accessibility.

User Experience of a Just-in-Time Smartphone Resonance Breathing Application for Substance Use Disorder: Acceptability, Appropriateness, and Feasibility.

BACKGROUND: Addressing the negative impact of substance use disorders (SUDs) on individuals, families, and communities is a public health priority. Most treatments and interventions require engagement with a healthcare provider or someone who can offer recovery support. The need for interventions that facilitate self-management of relapse triggers at the moment they occur is also critical. Our study aimed to explore the user experience of individuals using a just-in-time smartphone episodic resonance breathing (eRPB) intervention to address stress, anxiety, and drug cravings. METHODS: We conducted an 8-week pilot study of the eRPB with 30 individuals in recovery from SUD. Data on 3 indicators of user experience-acceptability, appropriateness, and feasibility-were collected using survey questions (n = 30) and semi-structured interviews (n = 11). We performed univariate analysis on the survey data and deductive thematic analysis on the qualitative data. RESULTS: A majority of the survey respondents agreed that the application (app) was acceptable (> 77%), appropriate (> 82%), and feasible (> 89%). Several interview participants stated that the app helped them relax and manage stress and cravings and expressed appreciation for the simplicity of its design. Participants also reported barriers to feasibility (such as forgetting to use the app) and recommendations for improvement (such as the addition of motivational messages). CONCLUSIONS: Our findings show that individuals in recovery from SUD had highly positive experiences with the eRPB app. A positive user experience may improve adherence to the intervention and, ultimately, the self-management of stress, anxiety, and craving relapse triggers.

Financial barriers, facilitators, and strategies among syringe services programs in the U.S., and their impact on implementation and health outcomes.

Syringe Services Programs (SSPs) provide evidence-based services like drug use equipment to prevent infectious disease, overdose prevention education, and naloxone distribution to people who use drugs (PWUD). However, inadequate funding threatens provision of these interventions. This study aimed to document how the current funding landscape impacted determinants of SSP implementation, particularly describing financial and staffing barriers, facilitators, and proposed strategies, using qualitative methods informed by three implementation research frameworks. We interviewed 20 leaders of SSPs in the United States using a semi-structured interview guide. Participants described how structural stigma against PWUD led to insufficient and restrictive funding, and burdensome reporting for SSPs. This resulted in harming program implementation outcomes like reach, fidelity, and sustainability. Inadequate funding also led to insufficient staffing and subsequent staff stress, burnout, and turnover. Taken together, these barriers threatened the implementation of evidence-based interventions that SSPs provided, ultimately harming their ability to effectively address health outcomes like infectious disease transmission and opioid overdose mortality within their communities. Interviewees described how upstream policy strategies like political advocacy might address structural stigma at the federal level. Participants also highlighted state-level efforts like harm reduction-centered funding, technical assistance and capacity-building, and clearinghouse programs that may facilitate better implementation and health outcomes. A more robust understanding of the relationship between financial barriers, facilitators, and strategies on implementation and health outcomes represents a novel and vital area of research within harm reduction literature.

Comparing harm reduction and overdose response services between community-based and public health department syringe service programmes using a national cross-sectional survey.

Background: Syringe services programmes (SSPs) are an evidence-based strategy to reduce infectious diseases and deliver overdose prevention interventions for people who use drugs. They face regulatory, administrative, and funding barriers that limit their implementation in the US, though the federal government recently began providing funding to support these efforts. In this study we aim to understand whether the organisational characteristics of SSPs are associated with the provision of syringe and other overdose response strategies. Methods: We examine four outcomes using the National Survey of Syringe Services Programs (NSSSP) (N = 472): syringe distribution, naloxone distribution, fentanyl test strip (FTS) availability, and buprenorphine implementation. These outcomes are assessed across three organizational categories of SSPs-those operated by public health departments (DPH), community-based organizations (CBOs) with government funding, and CBOs without government funding-while adjusting for community-level confounders. Findings: The proportion of SSPs by organizational category was 36% DPH, 42% CBOs with government funding, and 22% CBOs without government funding. Adjusting for community-level differences, we found that CBO SSPs with government funding had significantly higher provision of all four syringe and overdose response services as compared to DPH SSPs and across three of the four services as compared to CBO SSPs without government funding. CBO SSPs without government funding still had significantly higher provision of three of the four services as compared to programmes maintained by the DPH. Interpretation: CBO SSPs have strong potential to expand overdose response services nationally, particularly if provided with sustained and adequate funding. Communities should aim to provide funding that does not hinder SSP innovation so they can remain flexible in responding to local needs. Funding: This study was supported by Arnold Ventures (20-05172).

Funding and Delivery of Syringe Services Programs in the United States, 2022.

Objectives. To describe the current financial health of syringe services programs (SSPs) in the United States and to assess the predictors of SSP budget levels and associations with delivery of public health interventions. Methods. We surveyed all known SSPs operating in the United States from February to June 2022 (n = 456), of which 68% responded (n = 311). We used general estimating equations to assess factors influencing SSP budget size and estimated the effects of budget size on multiple measures of SSP services. Results. The median SSP annual budget was $100 000 (interquartile range = $20 159‒$290 000). SSPs operating in urban counties and counties with higher levels of opioid overdose mortality had significantly higher budget levels, while SSPs located in counties with higher levels of Republican voting in 2020 had significantly lower budget levels. SSP budget levels were significantly and positively associated with syringe and naloxone distribution coverage. Conclusions. Current SSP funding levels do not meet minimum benchmarks. Increased funding would help SSPs meet community health needs. Public Health Implications. Federal, state, and local initiatives should prioritize sustained SSP funding to optimize their potential in addressing multiple public health crises. (Am J Public Health. 2024;114(4):435-443. https://doi.org/10.2105/AJPH.2024.307583).

Updates on syringe coverage and service uptake among needle and syringe programs in the United States, 2019-2020.

BACKGROUND: As injection drug use has increased in the US, so too has the prevalence of receptive syringe sharing. Since the 1980s, Needle and Syringe Programs (NSPs) have been an important source of clean injection equipment and disposal of used syringes. This study reports national syringe coverage and examines the impact of program attributes on organizational-level service uptake, defined as number of syringes distributed per participant contact per year. METHODS: In 2019 and 2020, we administered an annual cross-sectional survey to NSPs operating in the US (n = 260). A national estimate of coverage was calculated by dividing the total number of syringes distributed by the 2019 and 2020 population estimate of people who inject drugs (PWID). Frequency distributions and percentages were calculated for categorical variables (e.g., funding, census region, distribution policy/modality), and median and interquartile ranges (IQR) were calculated for continuous variables (e.g., participant contacts, syringes distributed). Bivariate and multivariable mixed effects logistic regression models were used to estimate the odds ratio associated with organizational characteristics on increasing service uptake at the NSP level. RESULTS: From 2019 to 2020, the total number of participant contacts by NSPs increased from 871,976 to 898,891, and the number of syringes distributed increased from 92,648,529 to 113,071,748. The national coverage estimate increased from 29.5 (95 % CI = 15.0, 58.2) to 35.8 (95 % CI = 18.2, 70.6) syringes per PWID. Fifty-eight percent of NSPs increased service uptake in 2020 as compared to the previous year. NSPs that received government funding and NSPs that changed to a less restrictive syringe distribution policy were more likely to increase service uptake (aOR 1.80, 95 % CI = 1.01, 3.22 and aOR 3.33, 95 % CI = 1.11, 9.94, respectively). Syringe distribution modalities also diversified, with more NSPs reaching participants via backpacking/outreach, fixed site pop-ups, mobile delivery, mail-based delivery, leaving supplies out, and secondary distribution. CONCLUSION: Both governmental investment in harm reduction programming and needs-based distribution of syringes increased service uptake and thus should be expanded and sustained to reduce harms associated with injection drug use.

Systems analysis and improvement approach to improve naloxone distribution within syringe service programs: study protocol of a randomized controlled trial.

BACKGROUND: More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone's ability to improve naloxone distribution in general and among BIPOC specifically. METHODS: We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone's ability to improve SSPs' naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness. DISCUSSION: This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.

Optimizing naloxone distribution to prevent opioid overdose fatalities: results from piloting the Systems Analysis and Improvement Approach within syringe service programs.

BACKGROUND: Opioid overdose fatalities are preventable with timely administration of naloxone, an opioid antagonist, during an opioid overdose event. Syringe service programs have pioneered naloxone distribution for potential bystanders of opioid overdose. The objective of this study was to pilot test a multi-component implementation strategy-the systems analysis and improvement approach for naloxone (SAIA-Naloxone)-with the goal of improving naloxone distribution by syringe service programs. METHODS: Two syringe service programs participated in a 6-month pilot of SAIA-Naloxone, which included (1) analyzing program data to identify gaps in the naloxone delivery cascade, (2) flow mapping to identify causes of attrition and brainstorm programmatic changes for improvement, and (3) conducting continuous quality improvement to test and assess whether modifications improve the cascade. We conducted an interrupted time series analysis using 52 weeks of data before and 26 weeks of data after initiating SAIA-Naloxone. Poisson regression was used to evaluate the association between SAIA-Naloxone and the weekly number of participants receiving naloxone and number of naloxone doses distributed. RESULTS: Over the course of the study, 11,107 doses of naloxone were distributed to 6,071 participants. Through SAIA-Naloxone, syringe service programs prioritized testing programmatic modifications to improve data collection procedures, proactively screen and identify naloxone-naïve participants, streamline naloxone refill systems, and allow for secondary naloxone distribution. SAIA-Naloxone was associated with statistically significant increases in the average number of people receiving naloxone per week (37% more SPP participants; 95% CI, 12% to 67%) and average number of naloxone doses distributed per week (105% more naloxone doses; 95% CI, 79% to 136%) beyond the underlying pre-SAIA-Naloxone levels. These initial increases were extended by ongoing positive changes over time (1.6% more SSP participants received naloxone and 0.3% more naloxone doses were distributed in each subsequent week compared to the weekly trend in the pre-SAIA Naloxone period). CONCLUSIONS: SAIA-Naloxone has strong potential for improving naloxone distribution from syringe service programs. These findings are encouraging in the face of the worsening opioid overdose crisis in the United States and support testing SAIA-Naloxone in a large-scale randomized trial within syringe service programs.

Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: It is uncertain whether hormone therapy should be used for the primary prevention of chronic conditions such as heart disease, osteoporosis, or some types of cancers. Objective: To update evidence for the US Preventive Services Task Force on the benefits and harms of hormone therapy in reducing risks for chronic conditions. Data Sources: PubMed/MEDLINE, Cochrane Library, EMBASE, and trial registries from January 1, 2016, through October 12, 2021; surveillance through July 2022. Study Selection: English-language randomized clinical trials and prospective cohort studies of fair or good quality. Data Extraction and Synthesis: Dual review of abstracts, full-text articles, and study quality; meta-analyses when at least 3 similar studies were available. Main Outcomes and Measures: Morbidity and mortality related to chronic conditions; health-related quality of life. Results: Twenty trials (N = 39 145) and 3 cohort studies (N = 1 155 410) were included. Participants using estrogen only compared with placebo had significantly lower risks for diabetes over 7.1 years (1050 vs 903 cases; 134 fewer [95% CI, 18-237]) and fractures over 7.2 years (1024 vs 1413 cases; 388 fewer [95% CI, 277-489]) per 10 000 persons. Risks per 10 000 persons were statistically significantly increased for gallbladder disease over 7.1 years (1113 vs 737 cases; 377 more [95% CI, 234-540]), stroke over 7.2 years (318 vs 239 cases; 79 more [95% CI, 15-159]), venous thromboembolism over 7.2 years (258 vs 181 cases; 77 more [95% CI, 19-153]), and urinary incontinence over 1 year (2331 vs 1446 cases; 885 more [95% CI, 659-1135]). Participants using estrogen plus progestin compared with placebo experienced significantly lower risks, per 10 000 persons, for colorectal cancer over 5.6 years (59 vs 93 cases; 34 fewer [95% CI, 9-51]), diabetes over 5.6 years (403 vs 482 cases; 78 fewer [95% CI, 15-133]), and fractures over 5 years (864 vs 1094 cases; 230 fewer [95% CI, 66-372]). Risks, per 10 000 persons, were significantly increased for invasive breast cancer (242 vs 191 cases; 51 more [95% CI, 6-106]), gallbladder disease (723 vs 463 cases; 260 more [95% CI, 169-364]), stroke (187 vs 135 cases; 52 more [95% CI, 12-104]), and venous thromboembolism (246 vs 126 cases; 120 more [95% CI, 68-185]) over 5.6 years; probable dementia (179 vs 91 cases; 88 more [95% CI, 15-212]) over 4.0 years; and urinary incontinence (1707 vs 1145 cases; 562 more [95% CI, 412-726]) over 1 year. Conclusions and Relevance: Use of hormone therapy in postmenopausal persons for the primary prevention of chronic conditions was associated with some benefits but also with an increased risk of harms.

Measurement Error-Corrected Estimation of Clinically Significant Change Trajectories for Interventions Targeting Comorbid PTSD and Substance Use Disorders in OEF/OIF Veterans.

In randomized control trials (RCTs), a focus on average differences between treatment arms often limits our understanding of whether individuals show clinically significant improvement or deterioration. The present study examined differences in individual-level clinical significance trajectories between Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) and Relapse Prevention (RP). Eighty-one treatment-seeking veterans with a comorbid PTSD/SUD diagnosis were randomized to COPE or RP; data from an additional n = 48 patients who did not meet criteria for both disorders was used to establish a normative threshold. A newly developed, modernized approach to the Jacobson and Truax (1991) clinically significant change framework, using (a) moderated nonlinear factor analysis (MNLFA) scale scoring and (b) measurement error-corrected multilevel modeling (MEC-MLM) was used; this approach was compared to other approaches using conventional total scores and/or assuming no measurement error. Using a conventional approach to estimating the Reliable Change Index (RCI) yielded no differences between COPE and RP in the percentage of patients achieving statistically significant improvement (SSI; 88.9% for both groups). However, under MNLFA/MEC-MLM, higher percentages of patients receiving COPE (75.0%) achieved SSI compared to RP (40.7%). Findings suggest that, even though COPE and RP appear to reduce the same number of PTSD symptoms, MNLFA scoring of outcome measures gives greater weight to interventions that target and reduce "hallmark" PTSD symptoms.

Priority domains, aims, and testable hypotheses for implementation research: Protocol for a scoping review and evidence map.

BACKGROUND: The challenge of implementing evidence-based innovations within practice settings is a significant public health issue that the field of implementation research (IR) is focused on addressing. Significant amounts of funding, time, and effort have been invested in IR to date, yet there remains significant room for advancement, especially regarding IR's development of scientific theories as defined by the National Academy of Sciences (i.e., a comprehensive explanation of the relationship between variables that is supported by a vast body of evidence). Research priority setting (i.e., promoting consensus about areas where research effort will have wide benefits to society) is a key approach to helping accelerate research advancements. Thus, building upon existing IR, general principles of data reduction, and a general framework for moderated mediation, this article identifies four priority domains, three priority aims, and four testable hypotheses for IR, which we organize in the priority aims and testable hypotheses (PATH) diagram. METHODS: The objective of this scoping review is to map the extent to which IR has examined the identified PATH priorities to date. Our sample will include IR published in leading implementation-focused journals (i.e., Implementation Science, Implementation Science Communications, and Implementation Research and Practice) between their inception and December 2020. The protocol for the current scoping review and evidence map has been developed in accordance with the approach developed by Arksey and O'Malley and advanced by Levac, Colquhoun, and O'Brien. Because scoping reviews seek to provide an overview of the identified evidence base rather than synthesize findings from across studies, we plan to use our data-charting form to provide a descriptive overview of implementation research to date and summarize the research via one or more summary tables. We will use the PATH diagram to organize a map of the evidence to date. DISCUSSION: This scoping review and evidence map is intended to help accelerate IR focused on suggested priority aims and testable hypotheses, which in turn will accelerate IR's development of National Academy of Sciences-defined scientific theories and, subsequently, improvements in public health. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework https://osf.io/3vhuj/.

Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS).

BACKGROUND: Implementing and sustaining evidence-based programs with fidelity may require multiple implementation strategies tailored to address multi-level, context-specific barriers and facilitators. Ideally, selecting and tailoring implementation strategies should be guided by theory, evidence, and input from relevant stakeholders; however, methods to guide the selection and tailoring of strategies are not well-developed. There is a need for more rigorous methods for assessing and prioritizing implementation determinants (barriers and facilitators) and linking implementation strategies to determinants. The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment. COAST-IS will enable organizational leaders and clinicians to use Intervention Mapping to select and tailor implementation strategies to address their site-specific needs. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change. METHODS: COAST-IS will be piloted with community mental health organizations that are working to address the needs of children and youth who experience trauma-related emotional or behavioral difficulties by engaging in a learning collaborative to implement an evidence-based psychosocial intervention (trauma-focused cognitive behavioral therapy). Organizations will be matched and then randomized to participate in the learning collaborative only (control) or to receive additional support through COAST-IS. The primary aims of this study are to (1) assess the acceptability, appropriateness, feasibility, and perceived utility of COAST-IS; (2) evaluate the organizational stakeholders' fidelity to the core elements of COAST-IS; and (3) demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. DISCUSSION: COAST-IS is a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. If effective, COAST-IS has the potential to improve the implementation and sustainment of a wide range of evidence-based practices in mental health and other sectors. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov (NCT03799432) on January 10, 2019 (last updated August 5, 2019).

Correction to: Comparative Effectiveness of Combining MTX with Biologic Drug Therapy Versus Either MTX or Biologics Alone for Early Rheumatoid Arthritis in Adults: a Systematic Review and Network Meta-analysis.

This article has been amended to include open access.

Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Preterm delivery results in adverse outcomes; identifying and treating bacterial vaginosis may reduce its occurrence. Objective: To update the evidence on screening and treatment of asymptomatic bacterial vaginosis in pregnancy for the US Preventive Services Task Force. Data Sources: MEDLINE, Cochrane Library, and trial registries through May 29, 2019; bibliographies from retrieved articles, experts, and surveillance of the literature through December 31, 2019. Study Selection: Fair- or good-quality English-language studies evaluating diagnostic accuracy of tests feasible within primary care; randomized clinical trials (RCTs); nonrandomized controlled intervention studies (for harms only); or meta-analyses of metronidazole or clindamycin. Data Extraction and Synthesis: Two reviewers independently assessed titles/abstracts and full-text articles, extracted data, and assessed study quality; when at least 3 similar studies were available, meta-analyses were conducted. Main Outcomes and Measures: Sensitivity, specificity, preterm delivery, maternal adverse effects, congenital birth defects, childhood cancer. Results: Forty-four studies (48 publications) were included. No studies evaluated the benefits or harms of screening. Twenty-five studies (n = 15 785) evaluated the accuracy of screening tests; across individual studies and tests, sensitivity ranged from 0.36 to 1.0 and specificity ranged from 0.49 to 1.0. Among trials reporting findings from general obstetric populations (n = 7953), no significant association was observed between treatment and spontaneous delivery before 37 weeks (pooled absolute risk difference [ARD], -1.44% [95% CI, -3.31% to 0.43%]; 8 RCTs, n = 7571) or any delivery before 37 weeks (pooled ARD, 0.20% [95% CI, -1.13% to 1.53%]; 6 RCTs, n = 6307). Among 5 trials reporting findings among women with a prior preterm delivery, findings were inconsistent; 3 showed a significant beneficial effect, while 2 did not. Maternal adverse events from treatment were infrequent and minor (eg, candidiasis) but were slightly more common with active treatment compared with placebo across 8 RCTs. Two meta-analyses of observational studies reported no significant association between metronidazole exposure and congenital malformations (odds ratio, 0.96 [95% CI, 0.75 to 1.22]; odds ratio, 1.08 [95% CI, 0.90 to 1.29]). One cohort study reported no significantly increased incidence of childhood cancer among metronidazole-exposed children (adjusted relative risk, 0.81 [95% CI, 0.41 to 1.59]). However, studies of in utero exposure had important limitations. Conclusions and Relevance: Accuracy of screening tests for bacterial vaginosis varies. The evidence suggests no difference in the incidence of preterm delivery and related outcomes from treatment for asymptomatic bacterial vaginosis in a general obstetric population but was inconclusive for women with a prior preterm delivery. Maternal adverse events from treatment appear to be infrequent and minor, but the evidence about harms from in utero exposure was inconclusive.

Determinants of Implementing Evidence-Based Trauma-Focused Interventions for Children and Youth: A Systematic Review.

A systematic review was conducted to identify determinants (barriers and facilitators) of implementing evidence-based psychosocial interventions for children and youth who experience emotional or behavioral difficulties due to trauma exposure. Determinants were coded, abstracted, and synthesized using the Exploration, Preparation, Implementation, and Sustainment framework. Twenty-three articles were included, all of which examined implementation of Trauma-Focused Cognitive Behavioral Therapy or Cognitive-Behavioral Intervention for Trauma in Schools. This review identified multilevel and multiphase determinants that can be addressed by implementation strategies to improve implementation and clinical outcomes, and suggests how future studies might address gaps in the evidence base.

Comparative Effectiveness of Combining MTX with Biologic Drug Therapy Versus Either MTX or Biologics Alone for Early Rheumatoid Arthritis in Adults: a Systematic Review and Network Meta-analysis.

BACKGROUND: Comparative effectiveness of early rheumatoid arthritis (RA) treatments remains uncertain. PURPOSE: Compare benefits and harms of biologic drug therapies for adults with early RA within 1 year of diagnosis. DATA SOURCES: English language articles from the 2012 review to October 2017 identified through MEDLINE, Cochrane Library and International Pharmaceutical Abstracts, gray literature, expert recommendations, reference lists of published literature, and supplemental evidence data requests. STUDY SELECTION: Two persons independently selected studies based on predefined inclusion criteria. DATA EXTRACTION: One reviewer extracted data; a second reviewer checked accuracy. Two independent reviewers assigned risk of bias ratings. DATA SYNTHESIS: We identified 22 eligible studies with 9934 participants. Combination therapy with tumor necrosis factor (TNF) or non-TNF biologics plus methotrexate (MTX) improved disease control, remission, and functional capacity compared with monotherapy of either MTX or a biologic. Network meta-analyses found higher ACR50 response (50% improvement) for combination therapy of biologic plus MTX than for MTX monotherapy (relative risk range 1.20 [95% confidence interval (CI), 1.04 to 1.38] to 1.57 [95% CI, 1.30 to 1.88]). No significant differences emerged between treatment discontinuation rates because of adverse events or serious adverse events. Subgroup data (disease activity, prior therapy, demographics, serious conditions) were limited. LIMITATIONS: Trials enrolled almost exclusively selected populations with high disease activity. Network meta-analyses were derived from indirect comparisons relative to MTX due to the dearth of head-to-head studies comparing interventions. No eligible data on biosimilars were found. CONCLUSIONS: Qualitative and network meta-analyses suggest that the combination of MTX with TNF or non-TNF biologics reduces disease activity and improves remission when compared with MTX monotherapy. Overall adverse event and discontinuation rates were similar between treatment groups. REGISTRATION: PROSPERO (available at http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017079260 ).

Behavioral Health Integration With Primary Care: Implementation Experience and Impacts From the State Innovation Model Round 1 States.

Policy Points Individuals with behavioral health (BH) conditions comprise a medically complex population with high costs and high health care needs. Considering national shortages of BH providers, primary care providers serve a critical role in identifying and treating BH conditions and making referrals to BH providers. States are increasingly seeking ways to address BH conditions among their residents. States funded by the Centers for Medicare and Medicaid Services under the first round of the State Innovation Models (SIM) Initiative all invested in BH integration. States found sharing data among providers, bridging professional divides, and overcoming BH provider shortages were key barriers. Nonetheless, states made significant strides in integrating BH care. Beyond payment models, a key catalyst for change was facilitating informal relationships between BH providers and primary care physicians. Infrastructure investments such as promoting data sharing by connecting BH providers to a health information exchange and providing tailored technical assistance for both BH and primary care providers were also important in improving integration of BH care. CONTEXT: Increasing numbers of states are looking for ways to address behavioral health (BH) conditions among their residents. The first round of the State Innovation Models (SIM) Initiative provided financial and technical support to six states since 2013 to test the ability of state governments to lead health care system transformation. All six SIM states invested in integration of BH and primary care services. This study summarizes states' progress, challenges, and lessons learned on BH integration. Additionally, the study reports impacts on expenditure, utilization, and quality-of-care outcomes for persons with BH conditions across four SIM states. METHODS: We use a mixed-methods design, drawing on focus groups and key informant interviews to reach conclusions on implementation and quantitative analysis using Medicaid claims data to assess impact. For three Medicaid accountable care organization (ACO) models funded under SIM, we used a difference-in-differences regression model to compare outcomes for model participants with BH conditions and an in-state comparison group before-and-after model implementation. For the behavioral health home (BHH) model in Maine, we used a pre-post design to assess how outcomes for model participants changed over time. FINDINGS: Informal relationship building, tailored technical assistance, and the promotion of data sharing were key factors in making progress. After three years of implementation, the growth in total expenditures was less than the comparison group by $128 (-$253, -$3; p < 0.10) and $62 (-$87, -$36; p < 0.001) per beneficiary per month for beneficiaries with BH conditions attributed to an ACO in Minnesota and Vermont, respectively. Likewise, there were reductions in emergency department use for ACO participants in all three states after two to four years of implementation. However, there was no improvement in BH-related quality metrics for ACO beneficiaries in all three states. Although participants in the BHH model had increased expenditures after two years of implementation, use of primary care and specialty care services increased by 3% and 8%, respectively, and antidepressant medication adherence also improved. CONCLUSIONS: The SIM Round 1 states made considerable progress in integrating BH and primary care services, and there were promising findings for all models. Taken together, there is some evidence that Medicaid payment models can improve patterns of care for beneficiaries with BH conditions.

Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Women: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Postmenopausal status coincides with increased risks for chronic conditions such as heart disease, osteoporosis, cognitive impairment, or some types of cancers. Previously, hormone therapy was used for the primary prevention of these chronic conditions. Objective: To update evidence for the US Preventive Services Task Force on the benefits and harms of hormone therapy in reducing risks for chronic conditions. Data Sources: MEDLINE, Cochrane Library, EMBASE, and trial registries from June 1, 2011, through August 1, 2016. Surveillance for new evidence in targeted publications was conducted through July 1, 2017. Study Selection: English-language randomized clinical trials reporting health outcomes. Data Extraction and Synthesis: Dual review of abstracts, full-text articles, and study quality; meta-analyses when at least 3 similar studies were available. Main Outcomes and Measures: Beneficial or harmful changes in risks for various chronic conditions. Results: Eighteen trials (n = 40 058; range, 142-16 608; mean age, 53-79 years) were included. Women using estrogen-only therapy compared with placebo had significantly lower risks, per 10 000 person-years, for diabetes (-19 cases [95% CI, -34 to -3]) and fractures (-53 cases [95% CI, -69 to -39]). Risks were statistically significantly increased, per 10 000 person-years, for gallbladder disease (30 more cases [95% CI, 16 to 48]), stroke (11 more cases [95% CI, 2 to 23]), venous thromboembolism (11 more cases [95% CI, 3 to 22]), and urinary incontinence (1261 more cases [95% CI, 880 to 1689]). Women using estrogen plus progestin compared with placebo experienced significantly lower risks, per 10 000 person-years, for colorectal cancer (-6 cases [95% CI, -9 to -1]), diabetes (-14 cases [95% CI, -24 to -3), and fractures (-44 cases [95% CI, -71 to -13). Risks, per 10 000 person-years, were significantly increased for invasive breast cancer (9 more cases [95% CI, 1 to 19]), probable dementia (22 more cases [95% CI, 4 to 53]), gallbladder disease (21 more cases [95% CI, 10 to 34]), stroke (9 more cases [95% CI, 2 to 19]), urinary incontinence (876 more cases [95% CI, 606 to 1168]), and venous thromboembolism (21 more cases [95% CI, 12 to 33]). Conclusions and Relevance: Hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms. The available evidence regarding benefits and harms of early initiation of hormone therapy is inconclusive.

The Epidemiology of Sleep Quality, Sleep Patterns, Consumption of Caffeinated Beverages, and Khat Use among Ethiopian College Students.

Objective. To evaluate sleep habits, sleep patterns, and sleep quality among Ethiopian college students; and to examine associations of poor sleep quality with consumption of caffeinated beverages and other stimulants. Methods. A total of 2,230 undergraduate students completed a self-administered comprehensive questionnaire which gathered information about sleep complaints, sociodemographic and lifestyle characteristics,and theuse of caffeinated beverages and khat. We used multivariable logistic regression procedures to estimate odds ratios for the associations of poor sleep quality with sociodemographic and behavioral factors. Results. Overall 52.7% of students were classified as having poor sleep quality (51.8% among males and 56.9% among females). In adjusted multivariate analyses, caffeine consumption (OR = 1.55; 95% CI: 1.25-1.92), cigarette smoking (OR = 1.68; 95% CI: 1.06-2.63), and khat use (OR = 1.72, 95% CI: 1.09-2.71) were all associated with increased odds of long-sleep latency (>30 minutes). Cigarette smoking (OR = 1.74; 95% CI: 1.11-2.73) and khat consumption (OR = 1.91; 95% CI: 1.22-3.00) were also significantly associated with poor sleep efficiency (<85%), as well as with increased use of sleep medicine. Conclusion. Findings from the present study demonstrate the high prevalence of poor sleep quality and its association with stimulant use among college students. Preventive and educational programs for students should include modules that emphasize the importance of sleep and associated risk factors.