Mesoporous Gold: Substrate-Dependent Growth Dynamics, Strain Accumulation, and Electrocatalytic Activity for Biosensing.

Understanding the growth of mesoporous crystalline materials, such as mesoporous metals, on different substrates can provide valuable insights into the crystal growth dynamics and the redox reactions that influence their electrochemical sensing performance. Herein, it is demonstrated how the amorphous nature of the glass substrate can suppress the typical <111> oriented growth in mesoporous Au (mAu) films. The suppressed <111> growth is manifested as an accumulation of strain, leading to the generation of abundant surface defects, which are beneficial for enhancing the electrochemical activity. The fine structuring attained enables dramatically accelerated diffusion and enhances the electrochemical sensing performance for disease-specific biomolecules. As a proof-of-concept, the as-fabricated glass-grown mAu film demonstrates high sensitivity in electrochemical detection of SARS-CoV-2-specific RNA with a limit of detection (LoD) as low as 1 attomolar (aM).

A machine learning approach to improve implementation monitoring of family-based preventive interventions in primary care.

Background: Evidence-based parenting programs effectively prevent the onset and escalation of child and adolescent behavioral health problems. When programs have been taken to scale, declines in the quality of implementation diminish intervention effects. Gold-standard methods of implementation monitoring are cost-prohibitive and impractical in resource-scarce delivery systems. Technological developments using computational linguistics and machine learning offer an opportunity to assess fidelity in a low burden, timely, and comprehensive manner. Methods: In this study, we test two natural language processing (NLP) methods [i.e., Term Frequency-Inverse Document Frequency (TF-IDF) and Bidirectional Encoder Representations from Transformers (BERT)] to assess the delivery of the Family Check-Up 4 Health (FCU4Health) program in a type 2 hybrid effectiveness-implementation trial conducted in primary care settings that serve primarily Latino families. We trained and evaluated models using 116 English and 81 Spanish-language transcripts from the 113 families who initiated FCU4Health services. We evaluated the concurrent validity of the TF-IDF and BERT models using observer ratings of program sessions using the COACH measure of competent adherence. Following the Implementation Cascade model, we assessed predictive validity using multiple indicators of parent engagement, which have been demonstrated to predict improvements in parenting and child outcomes. Results: Both TF-IDF and BERT ratings were significantly associated with observer ratings and engagement outcomes. Using mean squared error, results demonstrated improvement over baseline for observer ratings from a range of 0.83-1.02 to 0.62-0.76, resulting in an average improvement of 24%. Similarly, results demonstrated improvement over baseline for parent engagement indicators from a range of 0.81-27.3 to 0.62-19.50, resulting in an approximate average improvement of 18%. Conclusions: These results demonstrate the potential for NLP methods to assess implementation in evidence-based parenting programs delivered at scale. Future directions are presented. Trial registration: NCT03013309 ClinicalTrials.gov.

Research has shown that evidence-based parenting programs effectively prevent the onset and escalation of child and adolescent behavioral health problems. However, if they are not implemented with fidelity, there is a potential that they will not produce the same effects. Gold-standard methods of implementation monitoring include observations of program sessions. This is expensive and difficult to implement in delivery settings with limited resources. Using data from a trial of the Family Check-Up 4 Health program in primary care settings that served Latino families, we investigated the potential to make use of a form of machine learning called natural language processing (NLP) to monitor program delivery. NLP-based ratings were significantly associated with independent observer ratings of fidelity and participant engagement outcomes. These results demonstrate the potential for NLP methods to monitor implementation in evidence-based parenting programs delivered at scale.

Drone-Robot to Clean Power Line Insulators.

The inspection and maintenance of transmission systems are necessary for their proper functioning. In this way, among the line's critical points are the insulator chains, which are responsible for providing insulation between conductors and structures. The accumulation of pollutants on the insulator surface can cause failures in the power system, leading to power supply interruptions. Currently, the cleaning of insulator chains is performed manually by operators who climb towers and use cloths, high-pressure washers, or even helicopters. The use of robots and drones is also under study, presenting challenges to be overcome. This paper presents the development of a drone-robot for cleaning insulator chains. The drone-robot was designed to identify insulators by camera and perform cleaning through a robotic module. This module is attached to the drone and carries a battery-powered portable washer, a reservoir for demineralized water, a depth camera, and an electronic control system. This paper includes a literature review on the state of the art related to strategies used for cleaning insulator chains. Based on this review, the justification for the construction of the proposed system is presented. The methodology used in the development of the drone-robot is then described. The system was validated in a controlled environment and in field experimental tests, with the ensuing discussions and conclusions formulated, along with suggestions for future work.

Categorising implementation determinants and strategies within the US HIV implementation literature: a systematic review protocol.

INTRODUCTION: Despite decreased rates of new infections, HIV/AIDS continues to impact certain US populations. In order to achieve the goals laid out in the Ending the HIV Epidemic (EHE) in the US initiative, implementation science is needed to expand the sustained use of effective prevention and treatment interventions, particularly among priority populations at risk for and living with HIV/AIDS. Over 200 HIV-related implementation studies have been funded by the US National Institutes of Health. Therefore, a comprehensive review of the literature identifying implementation determinants (barriers and facilitators) and categorising implementation strategies across the continuum of HIV prevention and care in the USA is appropriate and needed to enhance current knowledge and help achieve the goals laid out in the EHE national strategic plan. METHODS AND ANALYSIS: This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Between November 2020 and January 2022, a broad database search strategy of Ovid MEDLINE, PsycINFO and Web of Science was conducted to capture implementation-related studies along the HIV prevention and care continuum. Articles were eligible for inclusion if they were: conducted in the USA, published after the year 2000, written in English, related to HIV/AIDS, focused on outcomes related to dissemination and implementation (ie, did not test/evaluate/explore implementation determinants or strategies) and were behavioural studies (ie, not basic science). We plan to conduct three systematic reviews to identify and categorise determinants and strategies associated with three HIV focus areas: pre-exposure prophylaxis, testing/diagnosing and linkage to care, and treatment. Determinants will be coded according to an adapted Consolidated Framework for Implementation Research 2.0. Implementation strategies and outcomes will be categorised in accordance with existing taxonomies and frameworks. ETHICS AND DISSEMINATION: Ethics approval is not applicable. No original data will be collected. Results will be disseminated through peer-reviewed publications, conference presentations and via online tools. PROSPERO REGISTRATION NUMBER: CRD42021233089.

Accounting for Context in Randomized Trials after Assignment.

Many preventive trials randomize individuals to intervention condition which is then delivered in a group setting. Other trials randomize higher levels, say organizations, and then use learning collaboratives comprised of multiple organizations to support improved implementation or sustainment. Other trials randomize or expand existing social networks and use key opinion leaders to deliver interventions through these networks. We use the term contextually driven to refer generally to such trials (traditionally referred to as clustering, where groups are formed either pre-randomization or post-randomization - i.e., a cluster-randomized trial), as these groupings or networks provide fixed or time-varying contexts that matter both theoretically and practically in the delivery of interventions. While such contextually driven trials can provide efficient and effective ways to deliver and evaluate prevention programs, they all require analytical procedures that take appropriate account of non-independence, something not always appreciated. Published analyses of many prevention trials have failed to take this into account. We discuss different types of contextually driven designs and then show that even small amounts of non-independence can inflate actual Type I error rates. This inflation leads to rejecting the null hypotheses too often, and erroneously leading us to conclude that there are significant differences between interventions when they do not exist. We describe a procedure to account for non-independence in the important case of a two-arm trial that randomizes units of individuals or organizations in both arms and then provides the active treatment in one arm through groups formed after assignment. We provide sample code in multiple programming languages to guide the analyst, distinguish diverse contextually driven designs, and summarize implications for multiple audiences.

Determinants of Implementation for HIV Pre-exposure Prophylaxis Based on an Updated Consolidated Framework for Implementation Research: A Systematic Review.

BACKGROUND: Delivery and use of HIV pre-exposure prophylaxis (PrEP) are suboptimal in the United States. Previous reviews of barriers and facilitators have not used an implementation science lens, limiting comprehensiveness and the link to implementation strategies. To summarize the state of the science, we systematically reviewed determinants of PrEP implementation using the updated Consolidated Framework for Implementation Research (CFIR 2.0). SETTING: PrEP-eligible communities and delivery settings in the United States. METHODS: In January 2021, we searched Ovid MEDLINE, PsycINFO, and Web of Science for peer-reviewed articles related to HIV/AIDS, interventions, implementation, and determinants or strategies. We identified 286 primary research articles published after 1999 about US-based PrEP implementation. Team members extracted discrete "mentioned" and "measured" determinants, coding each by setting, population, valence, measurement, and CFIR 2.0 construct. RESULTS: We identified 1776 mentioned and 1952 measured determinants from 254 to 239 articles, respectively. Two-thirds of measured determinants were of PrEP use by patients as opposed to delivery by providers. Articles contained few determinants in the inner setting or process domains (ie, related to the delivery context), even among studies of specific settings. Determinants across priority populations also focused on individual patients and providers rather than structural or logistical factors. CONCLUSION: Our findings suggest substantial knowledge in the literature about general patient-level barriers to PrEP use and thus limited need for additional universal studies. Instead, future research should prioritize identifying determinants, especially facilitators, unique to understudied populations and focus on structural and logistical features within current and promising settings (eg, pharmacies) that support integration of PrEP into clinical practice.

Crisis text-line interventions: Evaluation of texters' perceptions of effectiveness.

OBJECTIVE: Crisis Text Line (CTL), the largest provider of text-based crisis intervention services in the U.S., has answered nearly 7 million conversations since its inception in 2013. The study's objective was to assess texter's perceptions of the effectiveness of CTL crisis interventions. METHOD: Survey data completed by 85,877 texters linked to volunteer crisis counselor (CC) reports from October 12, 2017, to October 11, 2018 were analyzed. The relationship of several effectiveness measures with texters' demographic and psychosocial characteristics, frequency of CTL usage, and texters' perceptions of engagement with their CCs was examined using a series of logistic regression analyses. RESULTS: By the end of the text-based conversation, nearly 90% of suicidal texters reported that the conversation was helpful, and nearly half reported being less suicidal. CONCLUSIONS: Our study offers evidence for CTL's perceived effectiveness. These findings are of critical importance in light of the launch of a nationwide three-digit number (988) for suicide prevention and mental health crisis supports in the U.S., which will include texting.

Individuals who text crisis text line: Key characteristics and opportunities for suicide prevention.

OBJECTIVE: Text-based crisis services are increasingly prominent, with inclusion in the national 988 crisis number launching in 2022. Yet little is known about who uses them. This study seeks to understand the population served by Crisis Text Line (CTL), the largest crisis text service in the United States. METHODS: Secondary data analysis was conducted on de-identified Crisis Counselor reports, texter post-conversation survey responses, and anonymized text conversation data from 85,877 texters who contacted CTL during a 12-month period. We examined Crisis Counselor's ratings of suicide ideation severity, texters' reports of race, gender, sexual orientation, recent mental health symptoms, and additional sources of help, and logs of frequency of contact. RESULTS: 76% of texters were under 25. 79% were female. 48% identified as other than heterosexual/straight. 64% had only one conversation. 79% were above the clinical cutoff for depression and 80% for anxiety, while 23% had thoughts of suicide. 23% received help from a doctor or therapist, and 28% received help only from CTL. CONCLUSIONS: CTL reaches a highly distressed, young, mostly female population, including typically underserved minorities and a substantial percentage of individuals who do not receive help elsewhere. These findings support the decision to include texting in the forthcoming national 988 implementation.

Eritema pigmentado fijo ampolloso medicamentoso relacionado con el uso de ivermectina en paciente con Neumonía por SARS-Cov-2: Reporte de caso / Drug-related bullous fixed pigmented erythema related to the use of ivermectin in a patient with SARS-Cov2 pneumonia: Case Report

RESUMEN Introducción: El eritema pigmentado fijo ampolloso, es una forma de toxicodermia potencialmente grave. Se caracteriza por la aparición de lesiones cutáneas y/o mucosas, únicas o múltiples, pueden aparecer en cualquier zona, tras la administración de un fármaco u otra sustancia. Se presenta un varón de 73 años con diagnóstico de eritema pigmentado fijo ampolloso secundario a la ingesta de ivermectina. Es necesario que el medico sepa reconocer los efectos adversos de la automedicación con ivermectina contra el SARS CoV-2, a fin de realizar un diagnóstico temprano e iniciar un tratamiento oportuno.

ABSTRACT Background: Bullous fixed pigmented erythema is a potentially serious form of toxicoderma. It is characterized by the appearance of cutaneous and / or mucosal lesions, single or multiple, which can appear in any area, after the administration of a drug or other substance. A 73-year-old man is presented with a diagnosis of bullous fixed pigmented erythema secondary to the ingestion of ivermectin. It is necessary for the physician to recognize the adverse effects of self-medication with ivermectin against SARS CoV-2, to make an early diagnosis and initiate timely treatment.

Implementation methodology from a social systems informatics and engineering perspective applied to a parenting training program.

OBJECTIVE: For implementation of an evidence-based program to be effective, efficient, and equitable across diverse populations, we propose that researchers adopt a systems approach that is often absent in efficacy studies. To this end, we describe how a computer-based monitoring system can support the delivery of the New Beginnings Program (NBP), a parent-focused evidence-based prevention program for divorcing parents. METHOD: We present NBP from a novel systems approach that incorporates social system informatics and engineering, both necessary when utilizing feedback loops, ubiquitous in implementation research and practice. Examples of two methodological challenges are presented: how to monitor implementation, and how to provide feedback by evaluating system-level changes due to implementation. RESULTS: We introduce and relate systems concepts to these two methodologic issues that are at the center of implementation methods. We explore how these system-level feedback loops address effectiveness, efficiency, and equity principles. These key principles are provided for designing an automated, low-burden, low-intrusive measurement system to aid fidelity monitoring and feedback that can be used in practice. DISCUSSION: As the COVID-19 pandemic now demands fewer face-to-face delivery systems, their replacement with more virtual systems for parent training interventions requires constructing new implementation measurement systems based on social system informatics approaches. These approaches include the automatic monitoring of quality and fidelity in parent training interventions. Finally, we present parallels of producing generalizable and local knowledge bridging systems science and engineering method. This comparison improves our understanding of system-level changes, facilitates a program's implementation, and produces knowledge for the field. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

BACKGROUND: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. OBJECTIVES: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. METHODS: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. RESULTS: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. CONCLUSION: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

Sustainability planning in the US response to the opioid crisis: An examination using expert and text mining approaches.

Between January 2016 and June 2020, the Substance Abuse and Mental Health Services Administration rapidly distributed $7.5 billion in response to the U.S. opioid crisis. These funds are designed to increase access to medications for addiction treatment, reduce unmet treatment need, reduce overdose death rates, and provide and sustain effective prevention, treatment and recovery activities. It is unclear whether or not the services developed using these funds will be sustained beyond the start-up period. Based on 34 (64%) State Opioid Response (SOR) applications, we assessed the states' sustainability plans focusing on potential funding sources, policies, and quality monitoring. We found variable commitment to sustainability across response plans with less than half the states adequately describing sustainability plans. States with higher proportions of opioid prescribing, opioid misuse, and poverty had somewhat higher scores on sustainment. A text mining/machine learning approach automatically rated sustainability in SOR applications with an 82% accuracy compared to human ratings. Because life saving evidence-based programs and services may be lost, intentional commitment to sustainment beyond the bolus of start-up funding is essential.

The prospects for sustaining evidence-based responses to the US opioid epidemic: state leadership perspectives.

BACKGROUND: The US 21st Century Cures Act provided $7.5 billion in grant funding to states and territories for evidence-based responses to the opioid epidemic. Currently, little is known about optimal strategies for sustaining these programs beyond this start-up funding. METHODS: Using an inductive, conventional content analysis, we conducted key informant interviews with former and current state leaders (n = 16) about barriers/facilitators to sustainment and strategies for sustaining time-limited grants. RESULTS: Financing and reimbursement, service integration, and workforce capacity were the most cited barriers to sustainment. Status in state government structure, public support, and spending flexibility were noted as key facilitators. Effective levers to increase chances for sustainment included strong partnerships with other state agencies, workforce and credentialing changes, and marshalling advocacy through public awareness campaigns. CONCLUSIONS: Understanding the strategies that leaders have successfully used to sustain programs in the past can inform how to continue future time-limited, grant-funded initiatives.

Landscape of HIV Implementation Research Funded by the National Institutes of Health: A Mapping Review of Project Abstracts.

In 2019, the requisite biomedical and behavioral interventions to eliminate new HIV infections exist. "Ending the HIV Epidemic" now becomes primarily a challenge of will and implementation. This review maps the extent to which implementation research (IR) has been integrated into HIV research by reviewing the recent funding portfolio of the NIH. We searched NIH RePORTER for HIV and IR-related research projects funded from January 2013 to March 2018. The 4629 unique studies identified were screened using machine learning and manual methods. 216 abstracts met the eligibility criteria of HIV and IR. Key study characteristics were then abstracted. NIH currently funds HIV studies that are either formally IR (n = 109) or preparatory for IR (n = 107). Few (13%) projects mentioned a guiding implementation model, theory, or framework, and only 56% of all studies explicitly mentioned measuring an implementation outcome. Considering the study aims along an IR continuum, 18 (8%) studies examined barriers and facilitators, 43 (20%) developed implementation strategies, 46 (21%) piloted strategies, 73 (34%) tested a single strategy, and 35 (16%) compared strategies. A higher proportion of formal IR projects involved established interventions (e.g., integrated services) compared to newer interventions (e.g., pre-exposure prophylaxis). Prioritizing HIV-related IR in NIH and other federal funding opportunity announcements and expanded training in implementation science could have a substantial impact on ending the HIV pandemic. This review serves as a baseline by which to compare funding patterns and the sophistication of IR in HIV research over time.

Design Considerations for Implementing eHealth Behavioral Interventions for HIV Prevention in Evolving Sociotechnical Landscapes.

PURPOSE OF REVIEW: Despite tremendous potential for public health impact and continued investments in development and evaluation, it is rare for eHealth behavioral interventions to be implemented broadly in practice. Intervention developers may not be planning for implementation when designing technology-enabled interventions, thus creating greater challenges for real-world deployment following a research trial. To facilitate faster translation to practice, we aimed to provide researchers and developers with an implementation-focused approach and set of design considerations as they develop new eHealth programs. RECENT FINDINGS: Using the Accelerated Creation-to-Sustainment model as a lens, we examined challenges and successes experienced during the development and evaluation of four diverse eHealth HIV prevention programs for young men who have sex with men: Keep It Up!, Harnessing Online Peer Education, Guy2Guy, and HealthMindr. HIV is useful for studying eHealth implementation because of the substantial proliferation of diverse eHealth interventions with strong evidence of reach and efficacy and the responsiveness to rapid and radical disruptions in the field. Rather than locked-down products to be disseminated, eHealth interventions are complex sociotechnical systems that require continual optimization, vigilance to monitor and troubleshoot technological issues, and decision rules to refresh content and functionality while maintaining fidelity to core intervention principles. Platform choice and sociotechnical relationships (among end users, implementers, and the technology) heavily influence implementation needs and challenges. We present a checklist of critical implementation questions to address during intervention development. In the absence of a clear path forward for eHealth implementation, deliberate design of an eHealth intervention's service and technological components in tandem with their implementation plans is critical to mitigating barriers to widespread use. The design considerations presented can be used by developers, evaluators, reviewers, and funders to prioritize the pragmatic scalability of eHealth interventions in research.

Implementation Research Methodologies for Achieving Scientific Equity and Health Equity.

Implementation science has great potential to improve the health of communities and individuals who are not achieving health equity. However, implementation science can exacerbate health disparities if its use is biased toward entities that already have the highest capacities for delivering evidence-based interventions. In this article, we examine several methodologic approaches for conducting implementation research to advance equity both in our understanding of what historically disadvantaged populations would need-what we call scientific equity-and how this knowledge can be applied to produce health equity. We focus on rapid ways to gain knowledge on how to engage, design research, act, share, and sustain successes in partnership with communities. We begin by describing a principle-driven partnership process between community members and implementation researchers to overcome disparities. We then review three innovative implementation method paradigms to improve scientific and health equity and provide examples of each. The first paradigm involves making efficient use of existing data by applying epidemiologic and simulation modeling to understand what drives disparities and how they can be overcome. The second paradigm involves designing new research studies that include, but do not focus exclusively on, populations experiencing disparities in health domains such as cardiovascular disease and co-occurring mental health conditions. The third paradigm involves implementation research that focuses exclusively on populations who have experienced high levels of disparities. To date, our scientific enterprise has invested disproportionately in research that fails to eliminate health disparities. The implementation research methods discussed here hold promise for overcoming barriers and achieving health equity.

Redesigning Implementation Measurement for Monitoring and Quality Improvement in Community Delivery Settings.

The field of prevention has established the potential to promote child adjustment across a wide array of outcomes. However, when evidence-based prevention programs have been delivered at scale in community settings, declines in implementation and outcomes have resulted. Maintaining high quality implementation is a critical challenge for the field. We describe steps towards the development of a practical system to monitor and support the high-quality implementation of evidence-based prevention programs in community settings. Research on the implementation of an evidence-based parenting program for divorcing families called the "New Beginnings Program" serves as an illustration of the promise of such a system. As a first step, we describe a multidimensional theoretical model of implementation that links aspects of program delivery with improvements in participant outcomes. We then describe research on the measurement of each of these implementation dimensions and test their relations to intended program outcomes. As a third step, we develop approaches to the assessment of these implementation constructs that are feasible to use in community settings and to establish their reliability and validity. We focus on the application of machine learning algorithms and web-based data collection systems to assess implementation and provide support for high quality delivery and positive outcomes. Examples are presented to demonstrate that valid and reliable measures can be collected using these methods. Finally, we envision how these measures can be used to develop an unobtrusive system to monitor implementation and provide feedback and support in real time to maintain high quality implementation and program outcomes.

Protecting User Privacy and Rights in Academic Data-Sharing Partnerships: Principles From a Pilot Program at Crisis Text Line.

Data sharing between technology companies and academic health researchers has multiple health care, scientific, social, and business benefits. Many companies remain wary about such sharing because of unaddressed concerns about ethics, data security, logistics, and public relations. Without guidance on these issues, few companies are willing to take on the potential work and risks involved in noncommercial data sharing, and the scientific and societal potential of their data goes unrealized. In this paper, we describe the 18-month long pilot of a data-sharing program led by Crisis Text Line (CTL), a not-for-profit technology company that provides a free 24/7 text line for people in crisis. The primary goal of the data-sharing pilot was to design, develop, and implement a rigorous framework of principles and protocols for the safe and ethical sharing of user data. CTL used a stakeholder-based policy process to develop a feasible and ethical data-sharing program. The process comprised forming a data ethics committee; identifying policy challenges and solutions; announcing the program and generating interest; and revising the policy and launching the program. Once the pilot was complete, CTL examined how well the program ran and compared it with other potential program models before putting in place the program that was most suitable for its organizational needs. By drawing on CTL's experiences, we have created a 3-step set of guidelines for other organizations that wish to develop their own data-sharing program with academic researchers. The guidelines explain how to (1) determine the value and suitability of the data and organization for creating a data-sharing program; (2) decide on an appropriate data sharing and collaboration model; and (3) develop protocols and technical solutions for safe and ethical data sharing and the best organizational structure for implementing the program. An internal evaluation determined that the pilot satisfied CTL's goals of sharing scientific data and protecting client confidentiality. The policy development process also yielded key principles and protocols regarding the ethical challenges involved in data sharing that can be applied by other organizations. Finally, CTL's internal review of the pilot program developed a number of alternative models for sharing data that will suit a range of organizations with different priorities and capabilities. In implementing and studying this pilot program, CTL aimed both to optimize its own future data-sharing programs and to inform similar decisions made by others. Open data programs are both important and feasible to establish. With careful planning and appropriate resources, data sharing between big data companies and academic researchers can advance their shared mission to benefit society and improve lives.

An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).

BACKGROUND: Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations. METHODS: This (type II) hybrid effectiveness-implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children's hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods. DISCUSSION: This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care. TRIAL REGISTRATION: NCT03013309 ClinicalTrials.gov.

"Home Practice Is the Program": Parents' Practice of Program Skills as Predictors of Outcomes in the New Beginnings Program Effectiveness Trial.

An examination of the content and processes of evidence-based programs is critical for empirically evaluating theories about how programs work, the "action theory" of the program (West et al. in American Journal of Community Psychology, 21, 571-605, 1993). The New Beginnings Program (NBP; Wolchik et al., 2007), a parenting-after-divorce preventive intervention, theorizes that program-induced improvements in parenting across three domains: positive relationship quality, effective discipline, and protecting children from interparental conflict, will reduce the negative outcomes that are common among children from divorced families. The process theory is that home practice of program skills related to these parenting domains is the primary mechanism leading to positive change in parenting. This theory was tested using multi-rater data from 477 parents in the intervention condition of an effectiveness trial of the NBP (Sandler et al. 2016a, 2016b). Four research questions were addressed: Does home practice of skills predict change in the associated parenting outcomes targeted by the program? Is the effect above and beyond the influence of attendance at program sessions? What indicators of home practice (i.e., attempts, fidelity, efficacy, and competence) are most predictive of improvements in parenting? Do these indicators predict parenting improvements in underserved subpopulations (i.e., fathers and Latinos)? Structural Equation Modeling analyses indicated that parent-reported efficacy and provider-rated parent competence of home practice predicted improvements in the targeted parenting domains according to both parent and child reports. Moreover, indicators of home practice predicted improvements in parenting for fathers and Latinos, although patterns of effects varied by parenting outcome.