Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial.

Importance: Rural Black participants need effective intervention to achieve better blood pressure (BP) control. Objective: Among Black rural adults with persistently uncontrolled hypertension attending primary care clinics, to determine whether peer coaching (PC), practice facilitation (PF), or both (PCPF) are superior to enhanced usual care (EUC) in improving BP control. Design, Setting, and Participants: A cluster randomized clinical trial was conducted in 69 rural primary care practices across Alabama and North Carolina between September 23, 2016, and September 26, 2019. The participating practices were randomized to 4 groups: PC plus EUC, PF plus EUC, PCPF plus EUC, and EUC alone. The baseline EUC approach included a laptop for each participating practice with hyperlinks to participant education on hypertension, a binder of practice tips, a poster showing an algorithm for stepped care to improve BP, and 25 home BP monitors. The trial was stopped on February 28, 2021, after final data collection. The study included Black participants with persistently uncontrolled hypertension. Data were analyzed from February 28, 2021, to December 13, 2022. Interventions: Practice facilitators helped practices implement at least 4 quality improvement projects designed to improve BP control throughout 1 year. Peer coaches delivered a structured program via telephone on hypertension self-management throughout 1 year. Main Outcomes and Measures: The primary outcome was the proportion of participants in each trial group with BP values of less than 140/90 mm Hg at 6 months and 12 months. The secondary outcome was a change in the systolic BP of participants at 6 months and 12 months. Results: A total of 69 practices were randomized, and 1209 participants' data were included in the analysis. The mean (SD) age of participants was 58 (12) years, and 748 (62%) were women. In the intention-to-treat analyses, neither intervention alone nor in combination improved BP control or BP levels more than EUC (at 12 months, PF vs EUC odds ratio [OR], 0.94 [95% CI, 0.58-1.52]; PC vs EUC OR, 1.30 [95% CI, 0.83-2.04]; PCPF vs EUC OR, 1.02 [95% CI, 0.64-1.64]). In preplanned subgroup analyses, participants younger than 60 years in the PC and PCPF groups experienced a significant 5 mm Hg greater reduction in systolic BP than participants younger than 60 years in the EUC group at 12 months. Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the trial's participants. Conclusions and Relevance: The results of this cluster randomized clinical trial demonstrated that neither PC nor PF demonstrated a superior improvement in overall BP control compared with EUC. However, PC led to a significant reduction in systolic BP among younger adults. Trial Registration: ClinicalTrials.gov Identifier: NCT02866669.

Chapter 2: What Is Life?

The question "What is life?" has existed since the beginning of recorded history. However, the scientific and philosophical contexts of this question have changed and been refined as advancements in technology have revealed both fine details and broad connections in the network of life on Earth. Understanding the framework of the question "What is life?" is central to formulating other questions such as "Where else could life be?" and "How do we search for life elsewhere?" While many of these questions are addressed throughout the Astrobiology Primer 3.0, this chapter gives historical context for defining life, highlights conceptual characteristics shared by all life on Earth as well as key features used to describe it, discusses why it matters for astrobiology, and explores both challenges and opportunities for finding an informative operational definition.

Chapter 1: The Astrobiology Primer 3.0.

The Astrobiology Primer 3.0 (ABP3.0) is a concise introduction to the field of astrobiology for students and others who are new to the field of astrobiology. It provides an entry into the broader materials in this supplementary issue of Astrobiology and an overview of the investigations and driving hypotheses that make up this interdisciplinary field. The content of this chapter was adapted from the other 10 articles in this supplementary issue and thus represents the contribution of all the authors who worked on these introductory articles. The content of this chapter is not exhaustive and represents the topics that the authors found to be the most important and compelling in a dynamic and changing field.

Comparative analysis of hospitalization risk for incident heart failure in non-Hispanic Black versus non-Hispanic White individuals with type 2 diabetes on empagliflozin (Empa-AA): Insights from real-world data.

AIM: There are limited data to evaluate hospitalization for heart failure (hHF) in non-Hispanic Black (hereafter Black) or non-Hispanic White (hereafter White) individuals without previous hHF. Our goal was to evaluate the risk of hHF among Black versus White patients with type 2 diabetes (T2DM) who were initially prescribed empagliflozin using real-world data. METHODS: This multicentre retrospective cohort study included participants aged ≥18 years who had T2DM, were either Black or White, had no previous hHF, and were prescribed empagliflozin between August 2014 and December 2019. Our primary outcome was time to first hHF after the initial prescription of empagliflozin. A propensity-score (PS)-weighted analysis was performed to balance characteristics by race. The inverse probability treatment weighting method based on PS was used to make treatment comparisons. To compare Black with White, a PS-weighted Cox's cause-specific hazards model was used. RESULTS: In total, 8789 participants were eligible for inclusion (Black = 3216 vs. White = 5573). The Black cohort was significantly younger, had a higher proportion of females, and had a higher prevalence of chronic kidney disease, hypertension and diabetic retinopathy, while the White cohort had a higher prevalence of coronary artery disease. After adjustment for confounding factors such as age, gender, coronary artery disease, hypertension and diabetic retinopathy, the hazard ratio for first-time hHF was not significantly different between the two racial groups [hazard ratio (95% confidence interval) = 1.09 (0.84-1.42), p = .52]. CONCLUSION: This study showed no significant difference in incident hHF among Black versus White individuals with T2DM following a prescription for empagliflozin.

Sulfur cycling connects microbiomes and biogeochemistry in deep-sea hydrothermal plumes.

In globally distributed deep-sea hydrothermal vent plumes, microbiomes are shaped by the redox energy landscapes created by reduced hydrothermal vent fluids mixing with oxidized seawater. Plumes can disperse over thousands of kilometers and their characteristics are determined by geochemical sources from vents, e.g., hydrothermal inputs, nutrients, and trace metals. However, the impacts of plume biogeochemistry on the oceans are poorly constrained due to a lack of integrated understanding of microbiomes, population genetics, and geochemistry. Here, we use microbial genomes to understand links between biogeography, evolution, and metabolic connectivity, and elucidate their impacts on biogeochemical cycling in the deep sea. Using data from 36 diverse plume samples from seven ocean basins, we show that sulfur metabolism defines the core microbiome of plumes and drives metabolic connectivity in the microbial community. Sulfur-dominated geochemistry influences energy landscapes and promotes microbial growth, while other energy sources influence local energy landscapes. We further demonstrated the consistency of links among geochemistry, function, and taxonomy. Amongst all microbial metabolisms, sulfur transformations had the highest MW-score, a measure of metabolic connectivity in microbial communities. Additionally, plume microbial populations have low diversity, short migration history, and gene-specific sweep patterns after migrating from background seawater. Selected functions include nutrient uptake, aerobic oxidation, sulfur oxidation for higher energy yields, and stress responses for adaptation. Our findings provide the ecological and evolutionary bases of change in sulfur-driven microbial communities and their population genetics in adaptation to changing geochemical gradients in the oceans.

The design and rationale of a multicenter real-world trial: The Southeastern Collaboration to Improve Blood Pressure Control in the US Black Belt - Addressing the Triple Threat.

BACKGROUND: Impoverished African Americans (AA) with hypertension face poor health outcomes. PURPOSE: To conduct a cluster-randomized trial testing two interventions, alone and in combination, to improve blood pressure (BP) control in AA with persistently uncontrolled hypertension. METHODS: We engaged primary care practices serving rural Alabama and North Carolina residents, and in each practice we recruited approximately 25 AA adults with persistently uncontrolled hypertension (mean systolic BP >140 mmHg over the year prior to enrollment plus enrollment day BP assessed by research assistants ≥140/90 mmHg). Practices were randomized to peer coaching (PC), practice facilitation (PF), both PC and PF (PC + PF), or enhanced usual care (EUC). Coaches met with participants from PC and PC + PF practices weekly for 8 weeks then monthly over one year, discussing lifestyle changes, medication adherence, home monitoring, and communication with the healthcare team. Facilitators met with PF and PC + PF practices monthly to implement ≥1 quality improvement intervention in each of four domains. Data were collected at 0, 6, and 12 months. RESULTS: We recruited 69 practices and 1596 participants; 18 practices (408 participants) were randomized to EUC, 16 (384 participants) to PF, 19 (424 participants) to PC, and 16 (380 participants) to PC + PF. Participants had mean age 57 years, 61% were women, and 56% reported annual income <$20,000. LIMITATIONS: The PF intervention acts at the practice level, possibly missing intervention effects in trial participants. Neither PC nor PF currently has established clinical reimbursement mechanisms. CONCLUSIONS: This trial will fill evidence gaps regarding practice-level vs. patient-level interventions for rural impoverished AA with uncontrolled hypertension.

Hard to Swallow: A Review of Interventions to Improve Swallowing Solid Medication.

Solid oral medications are preferred over intravenous or liquid formulations; however, difficulty swallowing solid medication remains a common barrier to adherence. Previous reviews have demonstrated limited evidence on interventions to improve solid medication swallowing abilities. PubMed, Medline (OVID), CINAHL, Scopus, and Web of Science databases were searched for interventions to improve the pediatric population's ability to swallow solid medications. We included studies in English published after the latest review, from January 2014 through April 2022, with pediatric patients not having comorbid conditions affecting swallowing ability. The authors independently reviewed each study's sampling strategy, study design, and the strength of outcome measures and assigned a numerical rating representing "poor," "fair," or "good" for each category. Individual ratings were averaged per category and a final quality rating score given based on the average of all 3 categories. Our search identified 581 unique records; 10 were included in the final review. Interventions varied and included behavioral therapies and novel products or medication formulations. Three received a "good" quality rating, 5 were "fair," and 2 were "poor." All studies showed their intervention(s) to be successful in improving a child's ability to swallow solid oral medications. Despite the availability of several different effective interventions, pediatric providers do not routinely address patients' difficulty with swallowing solid oral medications. Patients would benefit from implementation of a universal screening process followed by a guideline for appropriate patient-centered interventions; the opportunity exists to use this process as a national quality benchmark reflecting institutional commitment to high-value care.

Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control.

Background: Racial disparities related to hypertension prevalence and control persist, with Black persons continuing to have both high prevalence and suboptimal control. The Black Belt region of the US Southeast is characterized by multiple critical priority populations: rural, low-income, and minority (Black). Methods: In a cluster-randomized, controlled, pragmatic implementation trial, the Southeastern Collaboration to Improve Blood Pressure Control evaluated two multi-component, multi-level functional interventions - peer coaching (PC) and practice facilitation (PF) (separately and combined) - as adjuncts to usual care to improve blood pressure control in the Black Belt. The overall goal was to randomize 80 primary care practices (later reduced to 69 practices) in Alabama and North Carolina to one of four interventions: 1) enhanced usual care (EUC); 2) EUC plus PC; 3) EUC plus PF; or 4) EUC plus both PC and PF. Several measures to facilitate recruitment and retention of practices were employed, including practice readiness assessment. Results: Contact was initiated with 248 practices during the study enrollment period. Of these, 99 declined participation, 39 were ineligible, and 41 were being evaluated for inclusion when the target number of practices was reached. The remaining 69 practices eventually were enrolled, with 18 practices randomized to EUC, 19 to PC, 16 to PF, and 16 to PC plus PF. Only two practices (2.9%) were withdrawn during the study. Several facilitators of and barriers to practice recruitment and retention were identified. Conclusion: Our findings underscore the importance of a structured approach to recruiting primary care practices in a pragmatic implementation trial.ClinicalTrials.gov registration number NCT02866669.

Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension.

BACKGROUND/OBJECTIVE: Because racial disparities in hypertension treatment persist, the objective of the present study was to examine patient vs. practice characteristics that influence antihypertensive selection and treatment intensity for non-Hispanic Black (hereafter "Black") patients with uncontrolled hypertension in the rural southeastern USA. METHODS: We enrolled 25 Black patients from each of 69 rural practices in Alabama and North Carolina with uncontrolled hypertension (systolic blood pressure (BP) ≥ 140 mm Hg) in a 4-arm cluster randomized trial of BP control interventions. Patients' antihypertensive medications were abstracted from medical records and reconciled at the baseline visit. Treatment intensity was computed using the defined daily dose (DDD) method of the World Health Organization. Correlates of greater antihypertensive medication intensity were assessed by linear regression modeling, and antihypertensive medication classes were compared by baseline systolic BP (SBP) level. RESULTS: A total of 1431 patients were enrolled and had complete baseline data. Antihypertensive treatment intensity averaged 3.7 ± 2.6 equivalent medications at usual dosages and was significantly related to higher baseline systolic BP, older age, male sex, insurance availability, higher BMI, and concurrent diabetes, but not to practice type or medication barriers in regression models. Renin-angiotensin system inhibitors were the most commonly used medications, followed by diuretics and calcium channel blockers. CONCLUSION/RELEVANCE: Antihypertensive treatment intensity for Black patients in the rural southeastern USA with a history of uncontrolled hypertension averaged the equivalent of almost four medications at usual dosages and was significantly associated with baseline SBP levels and other patient characteristics, but not clinic type. TRIAL REGISTRATION: ClinicalTrials.gov NCT02866669.

Musculoskeletal Injections Performed by Family Medicine Residents Participating in a Clinical Sports Medicine Track.

BACKGROUND AND OBJECTIVES: Primary care physicians (PCPs) are front line providers of musculoskeletal (MSK) care and MSK injections. Little is known about the volume of common MSK injections performed by FM residents (FMRs) and those residents participating in a longitudinal clinical sports medicine (SM) track. This study outlines an SM track and demonstrates the MSK procedural experience of SM track residents (SMRs) and traditional FMRs (non-SMRs). METHODS: We utilized a retrospective study design. We compared billing codes and provider information for common MSK injections for the second (PGY-2) and third (PGY-3) postgraduate years for non-SMRs (n=39) and SMRs (n=7) graduating between 2018-2021. We used the average number of patient encounters for each comparison group (non-SMRs vs SMRs) to determine the percentage of patients receiving an MSK injection in each cohort by PGY status. RESULTS: Of patients receiving MSK injections across both groups, the most common was the landmark-guided large joint injection (64.23%), and the most frequent site was the knee (47.00%). SMRs performed significantly more MSK injections per patient evaluated compared to non-SMRs while in the SM clinic (PGY-2: 2.706% vs 0.913%, P<.001; PGY-3: 4.276% vs 0.862%, P<.001). No significant differences existed between PGY-2 groups when the influence of the SM clinic was removed, but PGY-3 SMRs performed significantly more injections than PGY-3 non-SMRs (1.225% vs 0.862%, P<.011). CONCLUSIONS: An SM track in the FM residency is associated with an increased volume of MSK injections among SMRs compared to their graduate year-matched non-SMRs.

vRhyme enables binning of viral genomes from metagenomes.

Genome binning has been essential for characterization of bacteria, archaea, and even eukaryotes from metagenomes. Yet, few approaches exist for viruses. We developed vRhyme, a fast and precise software for construction of viral metagenome-assembled genomes (vMAGs). vRhyme utilizes single- or multi-sample coverage effect size comparisons between scaffolds and employs supervised machine learning to identify nucleotide feature similarities, which are compiled into iterations of weighted networks and refined bins. To refine bins, vRhyme utilizes unique features of viral genomes, namely a protein redundancy scoring mechanism based on the observation that viruses seldom encode redundant genes. Using simulated viromes, we displayed superior performance of vRhyme compared to available binning tools in constructing more complete and uncontaminated vMAGs. When applied to 10,601 viral scaffolds from human skin, vRhyme advanced our understanding of resident viruses, highlighted by identification of a Herelleviridae vMAG comprised of 22 scaffolds, and another vMAG encoding a nitrate reductase metabolic gene, representing near-complete genomes post-binning. vRhyme will enable a convention of binning uncultivated viral genomes and has the potential to transform metagenome-based viral ecology.

Health Literacy, Self-management Activities, and Glycemic Control Among Adults With Type 2 Diabetes: A Path Analysis.

PURPOSE: This study evaluated a novel composite measure of health literacy and numeracy by assessing its predictive validity for diabetes self-care activities and glycemic control. METHODS: Patients (N = 102) with type 2 diabetes were recruited from a family medicine clinic at an academic medical center. Combined health literacy was assessed by combining the results of the Health Literacy Scale and the Subjective Numeracy Scale. Self-management activities were assessed by the Summary of Diabetes Self-Care Activities scale. Hemoglobin A1c (A1c) values were extracted from patients' medical records to assess glycemic control. Path models were used to test the predicted pathways linking health literacy and numeracy, independently and together, to self-management activities and glycemic control. RESULTS: The mean combined literacy score was 72.0 (range, 33-104); the mean health literacy score alone was 43.9 (range, 14-56); and the mean numeracy score alone was 28.1 (range, 8-48). The direct effects results showed that the combined health literacy score (B = 0.107, P < .05) and the health literacy score alone (B = 0.234, P < .05) were significantly associated with self-care activities. The health literacy score alone also had a significant direct effect on A1c (B = -0.081, P < .05). The indirect effects of the combined health literacy on glycemic control through self-care activities were not statistically significant. CONCLUSIONS: Findings from this study suggest that the combined health literacy has predictive validity for self-care activities whereas the health literacy alone has predictive validity for glycemic control. More research is needed to validate these findings. Higher patient health literacy skills were not consistently associated with higher perceived numeracy skills. Additional attention and efforts should be made to make sure patients understand medical instructions involving numerical calculations.

Social rehabilitation for military veterans with traumatic brain injury, psychological trauma, and chronic neuropsychiatric symptoms: Intervention development and initial outcomes.

OBJECTIVE: A subset of military veterans who have experienced both traumatic brain injury and psychological trauma present with chronic neuropsychiatric symptoms and experience persistent obstacles to social reintegration. This project aimed to develop a novel treatment targeting the unmet social rehabilitation needs of these veterans. Initial intervention development, feasibility, and outcome data are explored. METHOD: Four treatment groups were conducted (n = 20). A treatment workbook was developed during Groups 1 and 2 (n = 10) and research data were collected from Groups 3 and 4 (n = 10). RESULTS: There was a 0% attrition rate across all groups with unanimous requests for additional sessions. T test effect sizes were analyzed with bias-corrected Hedges' g. Improvements were observed on measures of depression (p = .026, g = 0.73), empathic perspective taking (p = .007, g = 0.94), social cognition (p = .002-.678, g = 0.27-1.30 across multiple measures), social relationships (p = .007, g = 1.50), traumatic brain injury-related quality of life (social: p = .014, g = 0.68, emotional: p = .009, g = 1.28) and nonsocial executive functioning (p = .006, g = 0.54). CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Preliminary evidence from this exploratory study suggests that targeting multiple layers of social competence using a combined psychotherapy and cognitive rehabilitation approach holds promise. Larger, controlled studies are needed to further evaluate the feasibility and efficacy of this intervention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or Regimen-Related Distress Symptoms: 12-Month Outcomes From COMRADE.

OBJECTIVE: This study evaluated the effect of cognitive behavioral therapy (CBT) plus lifestyle counseling in primary care on hemoglobin A1c (HbA1c) in rural adult patients with type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. RESEARCH DESIGN AND METHODS: This study was a randomized controlled trial of a 16-session severity-tailored CBT plus lifestyle counseling intervention compared with usual care. Outcomes included changes in HbA1c, RRD, depressive symptoms, self-care behaviors, and medication adherence across 12 months. RESULTS: Patients included 139 diverse, rural adults (mean age 52.6 ± 9.5 years; 72% black; BMI 37.0 ± 9.0 kg/m2) with T2D (mean HbA1c 9.6% [81 mmol/mol] ± 2.0%) and comorbid depressive or distress symptoms. Using intent-to-treat analyses, patients in the intervention experienced marginally significant improvements in HbA1c (-0.92 ± 1.81 vs. -0.31 ± 2.04; P = 0.06) compared with usual care. However, intervention patients experienced significantly greater improvements in RRD (-1.12 ± 1.05 vs. -0.31 ± 1.22; P = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; P = 0.01), self-care behaviors (1.10 ± 1.30 vs. 0.58 ± 1.45; P = 0.03), and medication adherence (1.00 ± 2.0 vs. 0.17 ± 1.0; P = 0.02) versus usual care. Improvement in HbA1c correlated with improvement in RRD (r = 0.3; P = 0.0001) and adherence (r = -0.23; P = 0.007). CONCLUSIONS: Tailored CBT with lifestyle counseling improves behavioral outcomes and may improve HbA1c in rural patients with T2D and comorbid depressive and/or RRD symptoms.

Veteran participation in the integrative health and wellness program: Impact on self-reported mental and physical health outcomes.

Complementary and integrative health (CIH) services are being used more widely across the nation, including in both military and veteran hospital settings. Literature suggests that a variety of CIH services show promise in treating a wide range of physical and mental health disorders. Notably, the Department of Veterans Affairs is implementing CIH services within the context of a health care transformation, changing from disease based health care to a personalized, proactive, patient-centered approach where the veteran, not the disease, is at the center of care. This study examines self-reported physical and mental health outcomes associated with participation in the Integrative Health and Wellness Program, a comprehensive CIH program at the Washington DC VA Medical Center and one of the first wellbeing programs of its kind within the VA system. Using a prospective cohort design, veterans enrolled in the Integrative Health and Wellness Program filled out self-report measures of physical and mental health throughout program participation, including at enrollment, 12 weeks, and 6 months. Analyses revealed that veterans reported significant improvements in their most salient symptoms of concern (primarily pain or mental health symptoms), physical quality of life, wellbeing, and ability to participate in valued activities at follow-up assessments. These results illustrate the potential of CIH services, provided within a comprehensive clinic focused on wellbeing not disease, to improve self-reported health, wellbeing, and quality of life in a veteran population. Additionally, data support recent VA initiatives to increase the range of CIH services available and the continued growth of wellbeing programs within VA settings. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Race-Specific Patterns of Treatment Intensification Among Hypertensive Patients Using Home Blood Pressure Monitoring: Analysis Using Defined Daily Doses in the Heart Healthy Lenoir Study.

BACKGROUND: Racial disparities in blood pressure (BP) control persist, but whether differences by race in antihypertensive medication intensification (AMI) contribute is unknown. OBJECTIVE: To compare AMI by race for patients with elevated home BP readings. METHODS: This prospective cohort study followed adult patients from 6 rural primary care practices who used home BP monitoring (HBPM) and recorded/reported values. For providers, AMI was encouraged when mean HBPM systolic blood pressure (SBP) values were ⩾135 mm Hg; patients received phone-based coaching on HBPM technique and sharing HBPM findings. AMI was assessed between baseline and 12 months using defined daily dose (DDD) and summed to create a total antihypertensive DDD value. RESULTS: A total of 217 patients (mean age = 61.4 ± 10.2 years; 66% female; 57% black) provided usable HBPM data. Among 90 (41%) intensification-eligible hypertensive patients (ie, mean HBPM SBP values for 6-months ⩾135 mm Hg), mean total antihypertensive DDD was increased in 61% at 12 months. Blacks had significantly higher mean DDD at baseline and 12 months, but intensification (+0.72 vs +0.65; P = 0.83) was similar by race. However, intensification was greater in males than females (+1.1 vs +0.39; P = 0.031). Reduction in mean SBP following intensification was greater in white versus black patients (-8.2 vs -3.9 mm Hg; P = 0.14). Conclusion/Relevance: Treatment intensification in HBPM users was similar by race, differed significantly by gender, and may produce a greater response in white patients. Differential AMI in HBPM users does not appear to contribute to persistent racial disparities in BP control.

Validation of a combined health literacy and numeracy instrument for patients with type 2 diabetes.

OBJECTIVES: This study aimed to validate a new consolidated measure of health literacy and numeracy (health literacy scale [HLS] plus the subjective numeracy scale [SNS]) in patients with type 2 diabetes (T2DM). METHODS: A convenience sample (N = 102) of patients with T2DM was recruited from an academic family medicine center in the southeastern US between September-December 2017. Participants completed a questionnaire that included the composite HLS/SNS (22 questions) and a commonly used objective measure of health literacy-S-TOFHLA (40 questions). Internal reliability of the HLS/SNS was assessed using Cronbach's alpha. Criterion and construct validity was assessed against the S-TOFHLA. RESULTS: The composite HLS/SNS had good internal reliability (Cronbach's alpha = 0.83). A confirmatory factor analysis revealed there were four factors in the new instrument. Model fit indices showed good model-data fit (RMSEA = 0.08). The Spearman's rank order correlation coefficient between the HLS/SNS and the S-TOFHLA was 0.45 (p < 0.01). CONCLUSIONS: Our study suggests that the composite HLS/SNS is a reliable, valid instrument.

COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US.

BACKGROUND: Emerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes. DESIGN: This prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care. Outcomes included change from baseline to 12-months in HbA1c, diabetes related distress, depressive symptoms, and diabetes self-care activities. BASELINE RESULTS: 139 patients (Mean age = 52.6 ±â€¯9.6 years) with T2D from impoverished rural communities were enrolled (almost half reporting annual income of <$10,000 per year). Baseline data indicated that patients were experiencing profoundly uncontrolled T2D of a long duration (Mean HbA1c = 9.61 ±â€¯2.0; Mean BMI = 37.0 ±â€¯9.1; Mean duration = 11.2 ±â€¯8.9 years) along with high levels of distress (Mean DDS-17 Scale Score = 2.5 ±â€¯1.0) and/or depressive symptoms (Mean PHQ-9 Scale Score = 9.3 ±â€¯6.1). CONCLUSION: Patients with uncontrolled T2D of long duration manifest complex co-morbidities including associated obesity, depressive symptoms and/or diabetes related distress. A behavioral intervention for T2D that concurrently targets symptoms of depression and distress may lead to more effective outcomes in this high-risk population. CLINICAL TRIAL REGISTRATION: NCT02863523.

Formal Definitions of Unbounded Evolution and Innovation Reveal Universal Mechanisms for Open-Ended Evolution in Dynamical Systems.

Open-ended evolution (OEE) is relevant to a variety of biological, artificial and technological systems, but has been challenging to reproduce in silico. Most theoretical efforts focus on key aspects of open-ended evolution as it appears in biology. We recast the problem as a more general one in dynamical systems theory, providing simple criteria for open-ended evolution based on two hallmark features: unbounded evolution and innovation. We define unbounded evolution as patterns that are non-repeating within the expected Poincare recurrence time of an isolated system, and innovation as trajectories not observed in isolated systems. As a case study, we implement novel variants of cellular automata (CA) where the update rules are allowed to vary with time in three alternative ways. Each is capable of generating conditions for open-ended evolution, but vary in their ability to do so. We find that state-dependent dynamics, regarded as a hallmark of life, statistically out-performs other candidate mechanisms, and is the only mechanism to produce open-ended evolution in a scalable manner, essential to the notion of ongoing evolution. This analysis suggests a new framework for unifying mechanisms for generating OEE with features distinctive to life and its artifacts, with broad applicability to biological and artificial systems.