Search

BackgroundAlthough the incidence of acute myocardial infarction (AMI) is rising in sub-Saharan Africa, the uptake of evidence-based care for the diagnosis and treatment of AMI is limited throughout the region. In Tanzania, studies have revealed common misdiagnosis of AMI, infrequent administration of aspirin, and high short-term mortality rates following AMI. ObjectiveThis study aims to evaluate the implementation and efficacy outcomes of an intervention, the Multicomponent Intervention to Improve Acute Myocardial Infarction Care (MIMIC), which was developed to improve the delivery of evidence-based AMI care in Tanzania. MethodsThis single-arm pilot trial will be conducted in the emergency department (ED) at a referral hospital in northern Tanzania. The MIMIC intervention will be implemented by the ED staff for 1 year. Approximately 400 adults presenting to the ED with possible AMI symptoms will be enrolled, and research assistants will observe their care. Thirty days later, a follow-up survey will be administered to assess mortality and medication use. The primary outcome will be the acceptability of the MIMIC intervention, which will be measured by the Acceptability of Intervention Measurement (AIM) instrument. Acceptability will further be assessed via in-depth interviews with key stakeholders. Secondary implementation outcomes will include feasibility and fidelity. Secondary efficacy outcomes will include the following: the proportion of participants who receive electrocardiogram and cardiac biomarker testing, the proportion of participants with AMI who receive aspirin, 30-day mortality among participants with AMI, and the proportion of participants with AMI taking aspirin 30 days following enrollment. ResultsImplementation of MIMIC began on September 1, 2023. Enrollment is expected to be completed by September 1, 2024, and the first results are expected to be published by December 31, 2024. ConclusionsThis study will be the first to evaluate an intervention for improving AMI care in sub-Saharan Africa. If MIMIC is found to be acceptable, the findings from this study will inform a future cluster-randomized trial to assess effectiveness and scalability. Trial RegistrationClinicalTrials.gov NCT04563546; https://clinicaltrials.gov/study/NCT04563546 International Registered Report Identifier (IRRID)DERR1-10.2196/59917

Abstract While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post‐trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings—or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post‐trial responsibilities, and then identify challenges for post‐trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision‐makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real‐world practice.

Abstract Background Evidence-based care for acute myocardial infarction (AMI) reduces morbidity and mortality. Prior studies in Tanzania identified substantial gaps in the uptake of evidence-based AMI care. Implementation science has been used to improve uptake of evidence-based AMI care in high-income settings, but interventions to improve quality of AMI care have not been studied in sub-Saharan Africa. Methods Purposive sampling was used to recruit participants from key stakeholder groups (patients, providers, and healthcare administrators) in northern Tanzania. Semi-structured in-depth interviews were conducted using a guide informed by the Consolidated Framework for Implementation Research (CFIR). Interview transcripts were coded to identify barriers to AMI care, using the 39 CFIR constructs. Barriers relevant to emergency department (ED) AMI care were retained, and the Expert Recommendations for Implementing Change (ERIC) tool was used to match barriers with Level 1 recommendations for targeted implementation strategies. Results Thirty key stakeholders, including 10 patients, 10 providers, and 10 healthcare administrators were enrolled. Thematic analysis identified 11 barriers to ED-based AMI care: complexity of AMI care, cost of high-quality AMI care, local hospital culture, insufficient diagnostic and therapeutic resources, inadequate provider training, limited patient knowledge of AMI, need for formal implementation leaders, need for dedicated champions, failure to provide high-quality care, poor provider-patient communication, and inefficient ED systems. Seven of these barriers had 5 strong ERIC recommendations: access new funding, identify and prepare champions, conduct educational meetings, develop educational materials, and distribute educational materials. Conclusions Multiple barriers across several domains limit the uptake of evidence-based AMI care in northern Tanzania. The CFIR-ERIC mapping approach identified several targeted implementation strategies for addressing these barriers. A multi-component intervention is planned to improve uptake of evidence-based AMI care in Tanzania.

Aim of the study: Survival to hospital discharge from out-of-hospital cardiac arrest (OHCA) after receiving treatment from emergency medical services (EMS) is less than 10% in the United States. Community-focused interventions improve survival rates, but there is limited information on how to gain support for new interventions or program activities within these populations. Using data from the RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial, we aimed to identify the factors influencing emergency response agencies’ support in implementing an OHCA intervention. Methods: North Carolina counties were stratified into high-performing or low-performing counties based on the county’s cardiac arrest volume, percent of bystander-cardiopulmonary resuscitation (CPR) performed, patient survival to hospital discharge, cerebral performance in patients after cardiac arrest, and perceived engagement in the RACE-CARS project. We randomly selected 4 high-performing and 3 low-performing counties and conducted semi-structured qualitative interviews with emergency response stakeholders in each county. Results: From 10/2021 to 02/2022, we completed 29 interviews across the 7 counties (EMS (n = 9), telecommunications (n = 7), fire/first responders (n = 7), and hospital representatives (n = 6)). We identified three themes salient to community support for OHCA intervention: (1) initiating support at emergency response agencies; (2) obtaining support from emergency response agency staff (senior leadership and emergency response teams); and (3) and maintaining support. For each theme, we described similarities and differences by high- and low-performing county. Conclusions: We identified techniques for supporting effective engagement of emergency response agencies in community-based interventions for OHCA improving survival rates. This work may inform future programs and initiatives around implementation of community-based interventions for OHCA.

Background: Veterans living with HIV have up to twice the risk of atherosclerotic cardiovascular disease (ASCVD) compared to those without HIV. Objective: Our study seeks to test a non-physician led virtual self-management implementation strategy to reduce ASCVD risk among people living with HIV (PWH). We aim to conduct a randomized control trial among PWH (n = 300) with a diagnosis of hypertension (HTN) who are enrolled in Veterans Health Administration (VHA) clinics, on suppressive antiretroviral therapy (ART), randomized 1:1 to intervention vs. education control for a 12-month duration. Methods: Using human centered design approach, we have adapted a previous 5-component telehealth focused, non-physician led intervention to a Veteran population. The education control arm receives enhanced education in addition to usual care. The primary outcome is 6 mmHg reduction in systolic BP over 12-month in the intervention arm compared to the control arm. The secondary outcome is a 12-month difference in non-HDL cholesterol. While each component of our intervention has an evidence base, they have not been tested together in an HIV context. Conclusion: The proposed multicomponent intervention has the potential to improve cardiovascular outcomes in PWH using novel virtual care methods in a patient centered care approach.

Background: The purpose of this study is to compare the 90-day complications and readmission rates between patients undergoing total shoulder arthroplasty (TSA) in an ambulatory surgery center (ASC) with glenoid bone loss requiring an augmented glenoid component compared to patients without bone loss. Methods: This is a retrospective cohort study of patients undergoing outpatient TSA at an ASC (2018-2021). Readmission, direct transfer, and complications were recorded. Major and minor complications were compared. Secondary outcomes included operative time, estimated blood loss, range of motion, and patient-reported outcome measures. Results: There were 44 patients (45 shoulders) included in the study, 20 with augmented implants for glenoid bone loss and 25 nonaugmented with a concentric glenoid. There were no statistical differences in demographics. Two complications were seen in both the augmented and nonaugmented groups (10% vs. 8%). There were no readmissions or direct transfers. The augmented group had significantly increased preoperative glenoid retroversion (23° vs. 9°, P

Background: Venous thromboembolic events (VTEs) following orthopedic surgery may lead to serious morbidity and mortality. Fortunately, VTEs following upper extremity procedures are uncommon. However, the true incidence is likely underreported. The aim of this study is to provide a systematic review, excluding large database studies, to report on the incidence of VTEs following shoulder arthroscopic procedures. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, a systematic review of multiple databases was performed. A comprehensive search of several databases from inception to September 1, 2021, limited to English language and excluding animal studies, was designed and conducted. Studies were screened by 2 independent reviewers. A decision to exclude studies from large surgical or insurance claim databases was made to minimize the risk of including overlapping data points in this systematic review. Results: Thirteen studies met inclusion and exclusion criteria and form part of this systematic review. A total of 32,407 patients were included in this study. Among these patients, the deep vein thrombosis, pulmonary embolism, and overall VTE rates were 0.15%, 0.08%, and 0.21%, respectively. Among the patients specified to have undergone arthroscopic rotator cuff repair, the rate of deep vein thrombosis, pulmonary embolism, and overall VTE was 0.71%, 0.37%, and 1.04%, respectively. Conclusion: While symptomatic VTEs are rare following shoulder arthroscopic procedures, surgeons must be aware that they still account for a certain number of postoperative complications. Factors such as operative time, open procedures, obesity, and altitude may increase the risk of postoperative VTE although conflicting data exist. Current literature supports the idea that chemical antithrombotic prophylaxis likely provides no significant advantage over early mobilization in reducing VTEs following shoulder arthroscopy in low-risk patients.

BackgroundAdvance care planning (ACP) improves patient-provider communication and aligns care to patient values, preferences, and goals. Within a multisite Meta-network Learning and Research Center ACP study, one health system deployed an electronic health record (EHR) notification and algorithm to alert providers about patients potentially appropriate for ACP and the clinical study. ObjectiveThe aim of the study is to describe the implementation and usage of an EHR notification for referring patients to an ACP study, evaluate the association of notifications with study referrals and engagement in ACP, and assess provider interactions with and perspectives on the notifications. MethodsA secondary analysis assessed provider usage and their response to the notification (eg, acknowledge, dismiss, or engage patient in ACP conversation and refer patient to the clinical study). We evaluated all patients identified by the EHR algorithm during the Meta-network Learning and Research Center ACP study. Descriptive statistics compared patients referred to the study to those who were not referred to the study. Health care utilization, hospice referrals, and mortality as well as documentation and billing for ACP and related legal documents are reported. We evaluated associations between notifications with provider actions (ie, referral to study, ACP not documentation, and ACP billing). Provider free-text comments in the notifications were summarized qualitatively. Providers were surveyed on their satisfaction with the notification. ResultsAmong the 2877 patients identified by the EHR algorithm over 20 months, 17,047 unique notifications were presented to 45 providers in 6 clinics, who then referred 290 (10%) patients. Providers had a median of 269 (IQR 65-552) total notifications, and patients had a median of 4 (IQR 2-8). Patients with more (over 5) notifications were less likely to be referred to the study than those with fewer notifications (57/1092, 5.2% vs 233/1785, 13.1%; P

BackgroundSuboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate. ObjectiveThe primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence. MethodsThis open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS. ResultsWe enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers. ConclusionsThere was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS. Trial RegistrationClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449

BackgroundHealth care providers are increasingly screening patients for unmet social needs (eg, food, housing, transportation, and social isolation) and referring patients to relevant community-based resources and social services. Patients’ connection to referred services is often low, however, suggesting the need for additional support to facilitate engagement with resources. SMS text messaging presents an opportunity to address barriers related to contacting resources in an accessible, scalable, and low-cost manner. ObjectiveIn this multi-methods pilot study, we aim to develop an automated SMS text message–based intervention to promote patient connection to referred social needs resources within 2 weeks of the initial referral and to evaluate its feasibility and patient acceptability. This protocol describes the intervention, conceptual underpinnings, study design, and evaluation plan to provide a detailed illustration of how SMS technology can complement current social needs screening and referral practice patterns without disrupting care. MethodsFor this pilot prospective cohort study, this SMS text message–based intervention augments an existing social needs screening, referral, and navigation program at a federally qualified health center. Patients who received at least one referral for any identified unmet social need are sent 2 rounds of SMS messages over 2 weeks. The first round consists of 5-10 messages that deliver descriptions of and contact information for the referred resources. The second round consists of 2 messages that offer a brief reminder to contact the resources. Participants will evaluate the intervention via a survey and a semistructured interview, informed by an adapted technology acceptance model. Rapid qualitative and thematic analysis will be used to extract themes from the responses. Primary outcomes are implementation feasibility and patient acceptability. Secondary outcomes relate to intervention effectiveness: self-reported attempt to connect and successful connection to referred resources 2 weeks after the initial referral encounter. ResultsThe study received regulatory approval in May 2021, and we anticipate enrolling 15-20 participants for this initial pilot. ConclusionsThis protocol presents detailed implementation methods about a novel automated SMS intervention for social care integration within primary care. By sharing the study protocol early, we intend to facilitate the development and adoption of similar tools across different clinical settings, as more health care providers seek to address the unmet social needs of patients. Study findings will provide practical insights into the design and implementation of SMS text message–based interventions to improve social and medical care coordination. International Registered Report Identifier (IRRID)DERR1-10.2196/37316

Background P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. Methods and Results This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients’ bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent‐to‐treat) potentially eligible patients, of whom 803 (per protocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent‐to‐treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (−3.4%; 98.3% CI, −1.2% to −5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%–7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%–4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (−1.7%; 98.3% CI, −2.3% to –1.1%). Conclusions A 4‐component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.

Abstract Background Transportation barriers limit access to cancer care services and contribute to suboptimal clinical outcomes. Our objectives were to describe the frequency of Veterans reporting and the factors associated with transportation barriers to or from colorectal cancer (CRC) care visits. Methods Between November 2015 and September 2016, Veterans with incident stage I, II, or III CRC completed a mailed survey to assess perceived barriers to recommended care. Participants who reported difficulty with transportation to or from CRC care appointments were categorized as experiencing transportation barriers. We assessed pairwise correlations between transportation barriers, transportation-related factors (e.g., mode of travel), and chaotic lifestyle (e.g., predictability of schedules), and used logistic regression to examine the association between the reporting of transportation difficulties, distance traveled to the nearest Veterans Affairs (VA) facility, and life chaos. Results Of the 115 Veterans included in this analysis, 18% reported experiencing transportation barriers. Distance to the VA was not strongly correlated with the reporting of transportation barriers (Spearman’s ρ = 0.12, p = 0.19), but chaotic lifestyle was both positively and significantly correlated with experiencing transportation barriers (Spearman’s ρ = 0.22, p = 0.02). Results from the logistic regression model modestly supported the findings from the pairwise correlations, but were not statistically significant. Conclusions Transportation is an important barrier to or from CRC care visits, especially among Veterans who experience greater life chaos. Identifying Veterans who experience chaotic lifestyles would allow for timely engagement in behavioral interventions (e.g., organizational skills training) and with support services (e.g., patient navigation).

Abstract Background People with HIV (PWH) experience increased cardiovascular disease (CVD) risk. Many PWH in the USA receive their primary medical care from infectious disease specialists in HIV clinics. HIV care teams may not be fully prepared to provide evidence-based CVD care. We sought to describe local context for HIV clinics participating in an NIH-funded implementation trial and to identify facilitators and barriers to integrated CVD preventive care for PWH. Methods Data were collected in semi-structured interviews and focus groups with PWH and multidisciplinary healthcare providers at three academic medical centers. We used template analysis to identify barriers and facilitators of CVD preventive care in three HIV specialty clinics using the Theoretical Domains Framework (TDF). Results Six focus groups were conducted with 37 PWH. Individual interviews were conducted with 34 healthcare providers and 14 PWH. Major themes were captured in seven TDF domains. Within those themes, we identified nine facilitators and 11 barriers to CVD preventive care. Knowledge gaps contributed to inaccurate CVD risk perceptions and ineffective self-management practices in PWH. Exclusive prioritization of HIV over CVD-related conditions was common in PWH and their providers. HIV care providers assumed inconsistent roles in CVD prevention, including for PWH with primary care providers. HIV providers were knowledgeable of HIV-related CVD risks and co-located health resources were consistently available to support PWH with limited resources in health behavior change. However, infrequent medical visits, perceptions of CVD prevention as a primary care service, and multiple co-location of support programs introduced local challenges to engaging in CVD preventive care. Conclusions Barriers to screening and treatment of cardiovascular conditions are common in HIV care settings and highlight a need for greater primary care integration. Improving long-term cardiovascular outcomes of PWH will likely require multi-level interventions supporting HIV providers to expand their scope of practice, addressing patient preferences for co-located CVD preventive care, changing clinic cultures that focus only on HIV to the exclusion of non-AIDS multimorbidity, and managing constraints associated with multiple services co-location. Trial registration ClinicalTrials.gov , NCT03643705

Abstract Background Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs. Methods Based on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals. Results Site recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6–8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled). Conclusions Future studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a “ramp-up” period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out. Trial registration ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.

Objective Medication nonadherence is more common in African Americans compared with Caucasians. We examined the racial adherence gaps among patients with systemic lupus erythematosus (SLE) and explored factors associated with nonadherence. Methods Cross‐sectional data were obtained from consecutive patients prescribed SLE medications seen at an academic lupus clinic between August 2018 and February 2019. Adherence was measured using both self‐report and pharmacy refill data. High composite adherence was defined as having both high self‐reported adherence and high refill rates. Covariates were patient‐provider interaction, patient‐reported health status, and clinical factors. We compared adherence rates by race and used race‐stratified analyses to identify factors associated with low composite adherence. Results Among 121 patients (37% Caucasian, 63% African American), the median age was 44 years (range 22‐72), 95% were female, 51% had a college education or more, 46% had private insurance, and 38% had high composite adherence. Those with low composite adherence had higher damage scores, patient‐reported disease activity scores, and more acute care visits. High composite adherence rate was lower among African Americans compared with Caucasians (30% vs 51%, P = 0.02), and the gap was largest for those taking mycophenolate (26% vs 75%, P = 0.01). Among African Americans, low composite adherence was associated with perceiving fewer “Compassionate respectful” interactions with providers and worse anxiety and negative affect. In contrast, among Caucasians, low composite adherence was only associated with higher SLE medication regimen burden and fibromyalgia pain score. Conclusion Significant racial disparities exist in SLE medication adherence, which likely contributes to racial disparities in SLE outcomes. Interventions may be more effective if tailored by race, such as improving patient‐provider interaction and mental health among African Americans.

Abstract Background Epilepsy affects nearly 50 million people worldwide. Self-management is critical for individuals with epilepsy in order to maintain optimal physical, cognitive, and emotional health. Implementing and adopting a self-management program requires considering many factors at the person, program, and systems levels. We conducted a systematic review of qualitative and mixed-methods studies to identify facilitators and barriers that impact implementation and adoption of self-management programs for adults with epilepsy. Methods We used established systematic review methodologies for qualitative and mixed-methods studies. We included studies addressing facilitators (i.e., factors that aided) or barriers (i.e., factors that impeded) to implementation and adoption of self-management interventions for adults with epilepsy. We conducted a narrative thematic synthesis to identify facilitators and barriers. Results The literature search identified 2700 citations; 13 studies met eligibility criteria. Our synthesis identified five themes that categorize facilitators and barriers to successful implementation epilepsy self-management: (1) relevance, intervention content that facilitates acquisition of self-management skills; (2) personalization, intervention components that account for the individual’s social, physical, and environmental characteristics; (3) intervention components, components and dosing of the intervention; (4) technology considerations, considerations that account for individual’s use, familiarity with, and ownership of technology; and (5) clinician interventionist, role and preparation of the individual who leads intervention. We identified facilitators in 11 of the 13 studies and barriers in 11 of the 13 studies and classified these by social-ecological level (i.e., patient/caregiver, program, site/system). Conclusion Identification of facilitators and barriers at multiple levels provides insight into disease-specific factors that influence implementation and adoption of self-management programs for individuals with epilepsy. Our findings indicate that involving individuals with epilepsy and their caregivers in intervention development, and then tailoring intervention content during the intervention, can help ensure the content is relevant to intervention participants. Our findings also indicate the role of the clinician (i.e., the individual who provides self-management education) is important to intervention implementation, and key issues with clinicians were identified as barriers and opportunities for improvement. Overall, our findings have practical value for those seeking to implement and adopt self-management interventions for epilepsy and other chronic illnesses. Systematic review registration PROSPERO registration number is CRD42018098604 .

Background: Obesity prevalence is higher in women veterans overall than their civilian counterparts considering 44% of women veterans are obese. Thus, there is a critical need to understand the facilitators and barriers to women veterans' participation in weight management programs. The objective of this study is to explore facilitators and barriers to weight loss for women veterans enrolled in the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (VA MOVE!) weight management program and gather feedback on the design and delivery of the MOVE! program. Materials and Methods: Primary qualitative data were collected from women veterans who completed at least one MOVE! visit via semistructured telephone interviews. Two authors independently reviewed transcripts for data-derived codes. A content analysis approach was used within the software to code the transcripts. Results: The mean age of participants was 52 years. Sixty-eight percent (N?=?17/25) were black, and 52% (N?=?13/25) lived >64 kilometers from the location of the MOVE! program. Facilitators to participation included both intrinsic (e.g., drive to become healthy) and extrinsic (e.g., drive to improve laboratories) motivating factors. Women expressed difficulty with learning in a group setting and applying lessons to their everyday lives. Others reported the setup of group classes triggered their post-traumatic stress disorder and prevented them from fully participating in the program. Additional barriers included distance traveled to group sessions and lack of access to exercise space. Conclusions: Our results illuminate barriers and facilitators to engagement in the MOVE! program. Many of the barriers highlighted by these women veterans mirror barriers civilian women face, highlighting the possibility that our results could be applied to other programs designed to target weight loss in women.

Rationale & Objective: Little is known about how socioeconomic status (SES) relates to the prioritization of medical care spending over personal expenditures in individuals with multiple comorbid conditions, and whether this relationship differs between Blacks and non-Blacks. We aimed to explore the relationship between SES, race, and medical spending among individuals with multiple comorbid conditions. Study Design: Cross-sectional evaluation of baseline data from a randomized controlled trial. Setting & Participants: The STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study is a completed randomized controlled trial of Duke University primary care patients with diabetes, hypertension, and chronic kidney disease. Participants underwent survey assessments inclusive of measures of socio-demographics and medication adherence. Predictors: Race (Black or non-Black) and socioeconomic status (income, education, and employment). Outcomes: The primary outcomes were based on 4 questions related to spending, asking about reduced spending on basic/leisure needs or using savings to pay for medical care. Participants were also asked if they skipped medications to make them last longer. Analytical Approach: Multivariable logistic regression stratified by race and adjusted for age, sex, and household chaos was used to determine the independent effects of SES components on spending. Results: Of 263 STOP-DKD participants, 144 (55%) were Black. Compared with non-Blacks, Black participants had lower incomes with similar levels of education and employment but were more likely to reduce spending on basic needs (29.2% vs 13.5%), leisure activities (35.4% vs 20.2%), and to skip medications (31.3% vs 15.1%), all P < 0.05. After multivariable adjustment, Black race was associated with increased odds of reduced basic spending (OR, 2.29; 95% CI, 1.14-4.60), reduced leisure spending (OR, 1.94; 95% CI, 1.05-3.58), and skipping medications (OR, 2.12; 95% CI, 1.12-4.04). Limitations: This study was conducted at a single site in Durham, North Carolina, and nearly exclusively included insured patients. Further, the impact of the number of comorbid conditions, medication costs, or copayments was not assessed. Conclusions: In primary care patients with multiple chronic diseases, Black patients are more likely to reduce spending on basic needs and leisure activities to afford their medical care than non-Black patients of equivalent SES. ClinicalTrials.gov Identifier: NCT01829256

Abstract Background Approximately 3.5 million Americans are infected with the hepatitis C virus (HCV). Although many patients with HCV are asymptomatic, HCV is the leading cause of infection-related death in the U.S. With advances in curative medication therapy for HCV, many of these deaths are preventable. Access to innovative therapies may be unevenly distributed. Our objective was to describe medication prescribers’ adoption of innovative HCV pharmacotherapy across prescriber, geographical location, and time. Methods This is a retrospective, secondary data analysis among a national cohort of patients prescribed direct-acting antiviral HCV medications with curative intent. We assessed prescriptions by time, geographic location, and provider type. Results The peak of the adoption rate occurred within 45 days; nearly one-sixth of all prescribers had already prescribed one of the new drugs. Geographical regions (Midwest, South, and West all p ≥ 0.05) nor gender (p = 0.455) of a prescriber impacted adoption. Similarly, patient income did not influence the likelihood of a prescriber to adopt the new drugs earlier (p = 0.175). Gastroenterologists or hepatologists were more likely earlier adopters compared to primary care physicians (p = 0.01). Conclusions Because of the relative advantage of newer therapies, we anticipated that there would be an initial surge as early adopters prescribed the new medications and use would dwindle over time as the initial HCV cohort was cured. The data demonstrate that our hypothesis is essentially supported. There is a reduction in prescriptions at approximately 5 months post-approval and treatment is typically required for 3 months. There has been a surge in clinicians’ adoption of innovative HCV treatments. As patients are cured of their infection, we anticipate a decreased need for chronic management of HCV. Trial registration Not applicable. Keywords Dissemination researchHealth services researchInfectious diseaseHepatitis C

**Background:** Sickle cell disease (SCD) is a genetic condition affecting primarily individuals of African descent, who happen to be disproportionately impacted by poverty and who lack access to health care. Individuals with SCD are at high likelihood of high acute care utilization and chronic pain episodes. The multiple complications seen in SCD contribute to significant morbidity and premature mortality, as well as substantial costs to the healthcare system. **Objectives:** SCD is a complex chronic disease resulting in the need for primary, specialty and emergency care. Many providers do not feel prepared to care for individuals with SCD, despite the existence of evidence-based guidelines. We report the development of a SCD toolbox and the dissemination process to primary care and emergency department (ED) providers in North Carolina (NC). We report the effect of this dissemination on health-care utilization, cost of care, and overall cost-benefit. **Methods:** The SCD toolbox was adapted from the National Heart, Lung, and Blood Institute recommendations. Toolbox training was provided to quality improvement specialists who then disseminated the toolbox to primary care providers (PCPs) affiliated with the only NC managed care coordination system and ED providers. Tools were made available in paper, online, and in app formats to participating managed care network practices (n=1 800). Medicaid claims data were analyzed for total costs and benefits of the toolbox dissemination for a 24-month pre- and 18-month post-intervention period. **Results:** There was no statistically significant shift in the number of outpatient specialty visits, ED visits or hospitalizations. There was a small decrease in the number of PCP visits in the post-implementation period. The dissemination resulted in a net cost-savings of \$361 414 (\$14.03 per-enrollee per-month on average). However, the estimated financial benefit associated with the dissemination of the SCD toolbox was not statistically significant. **Conclusions:** Although we did not find the expected shift to increased PCP visits and decreased ED visits and hospitalizations, there were many lessons learned.

In implementation science (IS), conducting well-targeted and reproducible literature searches is challenging due to non-specific and varying terminology that is fragmented over multiple disciplines. A list of journals that publish IS-relevant content for use in search strings can support this process. We conducted a cross-sectional online survey of 56 Australian, European, and North American IS experts to identify and prioritize relevant journals that publish IS articles. Journals' relevance was assessed by providing each with a list of 12 journals, to which they were encouraged to add additional journal names and comments as free text. We also assessed which journals had published special IS-focused issues—identified via PubMed and Google searches—over the last 20 years. Data were analyzed descriptively. Between February 28 and March 15, 2020, a purposive sample of 34/56 experts participated in the survey (response rate: 60.7%). Implementation Science and BMC Health Services Research were perceived as relevant by 97.1% of participants; other journals' relevance varied internationally. Experts proposed 50 additional journals from various clinical fields and health science disciplines. We identified 12 calls and 53 special issues on IS published within various journals and research fields. Experts' comments confirmed the described challenges in identifying IS literature. This report presents experts' ratings of IS journals, which can be included in strategies supporting searches of IS evidence. However, challenges in identifying IS evidence remain geographically and interdisciplinary. Further investment is needed to develop reproducible search strings to capture IS evidence as an important step in improving IS research quality.

Background: Uncontrolled blood pressure (BP) is common among Veterans. Rural Veterans are at risk for suboptimal care coordination as successful programs may be implemented at lower rates due to individual- and system-level factors. There is strong evidence to support the use of remotely delivered support and patient-generated data from home BP monitors and virtual BP visits to manage BP. Objective: The purpose of this project is to augment the current approach to addressing uncontrolled BP so that existing clinical staff can reach a larger patient population. Methods: Our project will address uncontrolled BP by leveraging team-based care, the Veteran's Health Administration Electronic Health Record, and patient-centered medical home data to address patient, provider, and system barriers to cardiovascular disease (CVD) preventive care. We will implement this project in cardiovascular disease practices in three rural Veterans Health Administration clinics. We will evaluate implementation processes as well as patient-level (e.g., clinical outcomes, referrals to specialty services) outcomes in a one-arm, pre-post design. Discussion: This manuscript describes our process in expanding the implementation of a successful project to improve BP control in high-risk, rural Veterans. Findings from our study will inform an understanding of both implementation and clinical effectiveness outcomes of a potentially scalable BP intervention in rural, community-based clinics. Appropriate management of Veterans with uncontrolled BP can reduce morbidity and mortality related to CVD. In turn, improvements in BP, can lead to improved quality metrics and potentially decrease costs for a healthcare system.

Purpose: The purpose of this systematic review was to examine the effect that sex has on recurrence of anterior shoulder instability following primary arthroscopic anterior shoulder stabilization. Methods: A systematic review using PRISMA guidelines was performed by searching PubMed, Embase and Cochrane Library databases to identify studies reporting recurrence rates following arthroscopic anterior shoulder stabilization with a minimum follow-up period of 2 years. Patient demographics as well as preoperative, intraoperative and postoperative findings, including patient-reported outcomes and recurrence rates, were analyzed by 2 independent reviewers. Recurrence was defined as an episode of dislocation, subluxation or instability following primary arthroscopic anterior shoulder stabilization. Study methodological quality was evaluated with the Modified Coleman Methodology Score (MCMS). Risk bias was evaluated using the Methodological Index for Non-randomized Studies (MINORS score). Descriptive statistics are presented. Results: Ten studies (1 Level I, 1 Level II, 5 Level III, and 3 Level IV), including a total of 7,102 patients with primary traumatic and/or recurrent traumatic shoulder instability without previous procedures who underwent primary arthroscopic anterior shoulder stabilization, were included (mean follow-up, 34.6 months; mean age, 25.4 years). There was a total of 5,097 males (71.8%) and 2,005 females (28.2%). There was a higher recurrence rate in males (6%-37%) compared to females (0-32%). Clinical outcomes were inconsistently reported, so no quantitative analysis of clinical outcomes or return-to-sport between sexes was possible. The average MCMS of all 10 studies was 76.8 ± 8.0, indicating good methodology. Conclusions: Males may have higher recurrence rates than females following primary arthroscopic anterior shoulder stabilization; however, the heterogeneity of the included studies precludes any definitive conclusions. Level of evidence: IV, Systematic Review of Level I-IV.

Background: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. Objectives: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. Methods: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. Conclusions: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens. Trial registration: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.

Summary: Background: Bystander cardiopulmonary resuscitation (CPR) increases an individual's chance of survival from out-of-hospital cardiac arrest (OHCA), but the frequency of bystander CPR is low in many communities. We aimed to assess the cumulative effect of CPR-targeted public health interventions in Singapore, which were incrementally introduced between 2012 and 2016. Methods: We did a secondary analysis of a prospective cohort study of adult, non-traumatic OHCAs, through the Singapore registry. National interventions introduced during this time included emergency services interventions, as well as dispatch-assisted CPR (introduced on July 1, 2012), a training programme for CPR and automated external defibrillators (April 1, 2014), and a first responder mobile application (myResponder; April 17, 2015). Using multilevel mixed-effects logistic regression, we modelled the likelihood of receiving bystander CPR with the increasing number of interventions, accounting for year as a random effect. Findings: The Singapore registry contained 11 465 OHCA events between Jan 1, 2011, and Dec 31, 2016. Paediatric arrests, arrests witnessed by emergency medical services, and healthcare-facility arrests were excluded, and 6788 events were analysed. Bystander CPR was administered in 3248 (48%) of 6788 events. Compared with no intervention, likelihood of bystander CPR was not significantly altered by the addition of emergency medical services interventions (odds ratio [OR] 1·33 [95% CI 0·98–1·79]; p=0·065), but increased with implementation of dispatch-assisted CPR (3·72 [2·84–4·88]; p

Abstract Background Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults. Methods We conducted a feasibility study in an academic health center and local community in Durham, North Carolina. We enrolled self-identified Spanish speaking overweight/obese adults (≥ 18) with OA of the knee and/or hip under the care of a primary health care provider. The 12-month patient intervention focused on physical activity, weight management, and cognitive behavioral pain management skills. The patient intervention was delivered via telephone with calls scheduled twice per month for the first 6 months, then monthly for the last 6 months (18 sessions). The one-time provider intervention included delivery of patient-specific OA treatment recommendations, based on patients’ baseline data and published guidelines. The primary measures were metrics of feasibility, including recruitment and intervention delivery. We also assessed pain, stiffness, and function using the Spanish-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results A total of 1879 participants were identified for potential enrollment. Of those, 1864 did not meet inclusion criteria, were not able to be reached or refused. Fifteen participants enrolled in the intervention. The mean number of phone calls completed was 14.7. Eighty percent completed more than 16 calls. The mean WOMAC baseline score (SD) was 39 (20); mean improvement in WOMAC scores between baseline and 12 months, among 11 participants who completed the study, was − 13.27 [95% CI, − 25.09 to − 1.46] points. Conclusion Recruitment of Hispanics/Latinos, continues to be a major challenge. A Spanish-based telephone delivering lifestyle intervention for OA management in Hispanic/Latino adults is feasible to deliver and may lead to improved OA symptoms. Future research is needed to further test the feasibility and effectiveness of this type of intervention in this segment of the population. Trial registration NCT01782417

Abstract Background Colorectal cancer (CRC) is the third most commonly diagnosed cancer in the US. CRC survivors may have complex healthcare needs requiring care from both specialists and primary care. Our objective was to understand how CRC survivors perceive their survivorship care, especially management of their cardiovascular-related chronic diseases. Methods We identified patients diagnosed with non-metastatic CRC between 10/1/2007 and 12/31/2015 at Veterans Affairs Medical Centers in North Carolina or Virginia. In 2016, we conducted telephone-based, semi-structured interviews to assess survivors’ experiences with cancer survivorship and changes in health priorities. Interviews were conducted until thematic saturation was reached. Interviews were audio-recorded, transcribed, and coded. Results The 25 participants were, on average, 64 years old and approximately 4 years post-CRC diagnosis at the time of interview; most were white (60%), male (92%), and diagnosed with colon cancer (64%) as opposed to rectal cancer. CRC survivors reported: (1) a shift in focus from surviving cancer to reducing cardiovascular disease risk (e.g., by managing weight); (2) challenges with taking medications for CVD-related conditions; (3) new recognition of the importance of engaging with primary care providers. Conclusions Experiences with cancer shapes how survivors view their health. Management of cardiovascular-related chronic disease is important to veteran CRC survivors. There is a need to deliver cardiovascular disease risk reduction programs tailored for CRC survivors.

Abstract Background Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans’ characteristics associated with insomnia and OSA symptoms. Methods Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use. Results Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (β (SE) = − 0.09 (0.04), 95% confidence interval [CI] = − 0.16, − 0.02), having a PTSD diagnosis (β (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (β (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (β (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99). Conclusions Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies. Trial registration NCT01130740.

OBJECTIVE:Patients with persistent poorly-controlled diabetes mellitus (PPDM) despite engagement in clinic-based care are at particularly high risk for diabetes complications and costs. Understanding this population's demographics, comorbidities and care utilization could guide strategies to address PPDM. We characterized factors associated with PPDM in a large sample of Veterans with type 2 diabetes. METHODS:We identified a cohort of Veterans with medically treated type 2 diabetes, who received Veterans Health Administration primary care during fiscal years 2012 and 2013. PPDM was defined by hemoglobin A1c levels uniformly >8.5% during fiscal year (FY) 2012, despite engagement with care during this period. We used FY 2012 demographic, comorbidity and medication data to describe PPDM in relation to better-controlled diabetes patients and created multivariable models to examine associations between clinical factors and PPDM. We also constructed multivariable models to explore the association between PPDM and FY 2013 care utilization. RESULTS:In our cohort of diabetes patients (n = 435,820), 12% met criteria for PPDM. Patients with PPDM were younger than better-controlled patients, less often married, and more often Black/African-American and Hispanic or Latino/Latina. Of included comorbidities, only retinopathy (OR 1.68, 95% confidence interval (CI): 1.63,1.73) and nephropathy (OR 1.26, 95% CI: 1.19,1.34) demonstrated clinically significant associations with PPDM. Complex insulin regimens such as premixed (OR 10.80, 95% CI: 10.11,11.54) and prandial-containing regimens (OR 18.74, 95% CI: 17.73,19.81) were strongly associated with PPDM. Patients with PPDM had higher care utilization, particularly endocrinology care (RR 3.56, 95% CI: 3.47,3.66); although only 26.4% of patients saw endocrinology overall. CONCLUSION:PPDM is strongly associated with complex diabetes regimens, although heterogeneity in care utilization exists. While there is evidence of underutilization, inadequacy of available care may also contribute to PPDM. Our findings should inform tailored approaches to meet the needs of PPDM, who are among the highest-risk, highest-cost patients with diabetes.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P < 0.001) and sustained (39.7% to 51.4%, P < 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P < 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU Toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167.

BackgroundSelf-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension.Methods and findingsMedline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes-change in mean clinic or ambulatory BP and proportion controlled below target at 12 months-were available from 15/19 possible studies (7,138/8,292 [86%] of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (sBP) compared to usual care at 12 months (-3.2 mmHg, [95% CI -4.9, -1.6 mmHg]). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (-1.0 mmHg [-3.3, 1.2]), to a 6.1 mmHg (-9.0, -3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (1,478 patients), which assessed self-monitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (clinic -0.2 mmHg [-2.2, 1.8]; ambulatory 1.1 mmHg [-0.3, 2.5]). Results for diastolic blood pressure (dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies.ConclusionsSelf-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.

We apply the color-magnitude intercept calibration method (CMAGIC) to the Nearby Supernova Factory SNe Ia spectrophotometric data set. The currently existing CMAGIC parameters are the slope and intercept of a straight line fit to the linear region in the color-magnitude diagram, which occurs over a span of approximately 30 days after maximum brightness. We define a new parameter, ω XY , the size of the “bump” feature near maximum brightness for arbitrary filters X and Y. We find a significant correlation between the slope of the linear region, β XY, in the CMAGIC diagram and ω XY. These results may be used to our advantage, as they are less affected by extinction than parameters defined as a function of time. Additionally, ω XY is computed independently of templates. We find that current empirical templates are successful at reproducing the features described in this work, particularly SALT3, which correctly exhibits the negative correlation between slope and “bump” size seen in our data. In 1D simulations, we show that the correlation between the size of the “bump” feature and β XY can be understood as a result of chemical mixing due to large-scale Rayleigh-Taylor instabilities.

Objective: This study examined the prevalence of food insecurity (FI) among students attending Historically Black Colleges and Universities (HBCUs) in the Southeastern United States. Participants: Students attending four HBCUs (N = 351) completed an anonymous Web-based survey. Methods: Food insecurity was assessed using the 2-item Hunger Vital Sign Tool. Summary statistics were used to quantify FI experiences. Logistic regression was conducted to determine if student demographic characteristics were significantly associated with FI outcomes. Results: Nearly 3 in 4 students (72.9%) reported some level of FI in the past year. Students representing all levels of postsecondary education reported FI. Meal plan participation did not prevent FI. Conclusions: Students attending HBCUs experience FI at levels that exceed estimates reported among students attending predominantly White institutions. More work is needed to understand the lived experience of food-insecure HBCU students as a means to ensure institution-level food policies support student academic success and wellbeing.

This study assessed the sustained effect of a physical activity (PA) counseling intervention on PA one year after intervention, predictors of sustained PA participation, and three classes of post-intervention PA trajectories (improvers, maintainers, and decliners) in 238 older Veterans. Declines in minutes of PA from 12 to 24 months were observed for both the treatment and control arms of the study. PA at 12 months was the strongest predictor of post-intervention changes in PA. To our surprise, those who took up the intervention and increased PA levels the most, had significant declines in post-intervention PA. Analysis of the three post-intervention PA trajectories demonstrated that the maintenance group actually reflected a group of nonresponders to the intervention who had more comorbidities, lower self-efficacy, and worse physical function than the improvers or decliners. Results suggest that behavioral counseling/support must be ongoing to promote maintenance. Strategies to promote PA appropriately to subgroups of individuals are needed.