The concept of quality in clinical research

Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000. An earlier version of the paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

Emotional expression and heart rate in high-risk infants during the face-to-face/still-face

In infants, eye constriction—the Duchenne marker—and mouth opening appear to index the intensity of both positive and negative facial expressions. We combined eye constriction and mouth opening that co-occurred with smiles and cry-faces (respectively, the prototypic expressions of infant joy and distress) to measure emotional expression intensity. Expression intensity and heart rate were measured throughout the face-to-face/still-face (FFSF) in a sample of infants with prenatal cocaine exposure who were at risk for developmental difficulties. Smiles declined and cry-faces increased in the still-face episode, but the distribution of eye constriction and mouth opening in smiles and cry-faces did not differ across episodes of the FFSF. As time elapsed in the still face episode potential indices of intensity increased, cry-faces were more likely to be accompanied by eye constriction and mouth opening. During cry-faces there were also moderately stable individual differences in the quantity of eye constriction and mouth opening. Infant heart rate was higher during cry-faces and lower during smiles, but did not vary with intensity of expression or by episode. In sum, infants express more intense negative affect as the still-face progresses, but do not show clear differences in expressive intensity between episodes of the FFSF.     

Perseverative Thinking and Health: Neurovisceral Concomitants

In the present paper we present the outlines of a model that may help to guide us in our understanding of the relationship between perseverative thinking and health. We will emphasize the relationship between perseverative thinking and vagal cardiac control and propose a group of underlying neural structures that serve to integrate these functions in the service of self-regulation and adaptability of the organism. We will attempt to place this network in the context of systems models which involve feedback and feedforward circuits with special attention to negative feedback mechanisms and inhibitory processes. From a systems perspective, inhibitory processes can be viewed as negative feedback circuits that allow for the interruption of ongoing behavior and the re-deployment of resources to other tasks. When these negative feedback mechanisms are compromised, positive feedback loops may develop as a result of dis-inhibition. From this perspective, the relative sympathetic activation seen in perseverative thinking may represent dis-inhibition due to faulty inhibitory mechanisms.     

A Social Ecological Model of Syndemic Risk affecting Women with and At-Risk for HIV in Impoverished Urban Communities

Syndemic risk is an ecological construct, defined by co‐occurring interdependent socio‐environmental, interpersonal and intrapersonal determinants. We posited syndemic risk to be a function of violence, substance use, perceived financial hardship, emotional distress and self‐worth among women with and at‐risk for HIV in an impoverished urban community. In order to better understand these interrelationships, we developed and validated a system dynamics (SD) model based upon peer‐reviewed literature; secondary data analyses of a cohort dataset including women living with and at‐risk of HIV in Bronx, NY (N = 620); and input from a Bronx‐based community advisory board. Simulated model output revealed divergent levels and patterns of syndemic risk over time across different sample profiles. Outputs generated new insights about how to effectively explore multicomponent multi‐level programs in order to strategically develop more effective services for this population. Specifically, the model indicated that effective multi‐level interventions might bolster women’s resilience by increasing self‐worth, which may result in decreased perceived financial hardship and risk of violence. Overall, our stakeholder‐informed model depicts how self‐worth may be a major driver of vulnerability and a meaningful addition to syndemic theory affecting this population.     

How does commuting behavior change due to incentives? An empirical study of the Beijing Subway System

This study examines the impact of incentives on commuters’ travel behavior based upon a questionnaire survey conducted with respect to the Beijing Subway System. Overall, we find that offering incentives to commuters, particularly fast food restaurant-related services and reduced ticket fares, has a positive influence on avoiding the morning rush hour. Furthermore, by using an interaction analysis, we discover that a flexible work schedule has an impact on commuters’ behavior and the efficiency of the subway system. Finally, we recommend two possible policies to maximize the utility of the subway system and to reduce congestion at the peak of morning service: (1) a set of incentives that includes free wireless internet service with a coupon for breakfast and a discount on ticket fares before the morning peak and (2) the introduction of a flexible work schedule.     

Use of Level 1 and 2 driving automation on horizontal curves on interstates and freeways

Little is known about how the actual use of Level 1 and 2 driving automation systems may be affected by geometric road characteristics in naturalistic driving environments. This study examined the use of these systems on horizontal curves on interstates and freeways. It used travel data collected in a field operational test conducted with two 2016 Land Rover Range Rover Evoque vehicles equipped with adaptive cruise control (ACC) and two 2017 Volvo S90 vehicles equipped with ACC and Pilot Assist (PA). Logistic regression models estimated changes in the likelihood of ACC use associated with horizontal curvature in the Evoque vehicles, and of PA and ACC use in the S90 vehicles, while accounting for traffic conditions. Drivers were less likely to drive with ACC or PA on as horizontal curves became sharper. In the Evoque vehicles, the likelihood of using ACC was 71.6% lower on the sharpest category of horizontal curves (those with a degree of curvature>2.5 degrees per 100 feet of arc or a radius smaller than 2,292 feet), compared with straight road segments or the flattest horizontal curve category (those with a degree of curvature <= 1.5 degrees per 100 feet of arc or a radius no <3,820 feet). In the S90 vehicles, the likelihood of using PA and ACC declined 74.6 and 66.3%, respectively, on the sharpest curves. Many driving automation systems face challenges on horizontal curves, even within their operational design domain. Future implementations that improve functionality may enhance driver experience and boost drivers’ confidence in these systems, which should increase their use and maximize the safety benefits these systems might offer.     

Systems of Care: New Partnerships for Community Psychology

For almost two decades, the federal government has supported the development of integrated models of mental health service delivery for children and families, known as systems of care (SOCs), that strive to be child-centered, family-focused, community-based, and culturally competent. These efforts align well with the values and principles (e.g., empowerment, collaboration, strengths emphasis, focus on macro-level social/system change) central to community psychology (CP; Kloos et al. in Community psychology, Cengage Learning, Belmont, 2012). Despite the convergence of many core values, CPs have historically been underrepresented in key roles in SOC initiatives. However, this has changed in recent years, with increasing examples of community psychology skills and principles applied to the development, implementation, and evaluation of SOCs. Because successful and sustainable implementation of SOCs requires community and system-level change, and SOCs are increasingly being urged to adopt a stronger "public health" orientation (Miles et al. in A public health approach to children's mental health: a conceptual framework, Georgetown University Center for Child and Human Development, National Technical Assistance Center for Children's Mental Health, Washington, DC, 2010), there is great potential for CPs to play important roles in SOCs. This paper discusses opportunities and roles for CPs in SOCs in applied research and evaluation, community practice, and training.     

System-Level Change in Cultural and Linguistic Competence (CLC): How Changes in CLC are Related to Service Experience Outcomes in Systems of Care

As US demographic trends shift toward more diversity, it becomes increasingly necessary to address differential needs of diverse groups of youth in mental health service systems. Cultural and linguistic competence (CLC) is essential to providing the most appropriate mental health services to youth and their families. The successful implementation of CLC often begins at the system level. Though various factors may affect change and system-level factors set the tone for broad acceptance of CLC within systems, there is limited empirical evidence linking culturally competent practices to outcomes. The purpose of the present study was to examine system-level CLC changes over time within systems of care and their associations with service experiences among youth and their families. Participants were 4,512 youth and their families enrolled in the national evaluation of the Children’s Mental Health Initiative (CMHI). Results suggest that implementation of CLC at the system level improves over time in funded systems of care. Further, variation exists in specific system-level components of CLC. In addition, the changes in CLC at the system level are related to family/caregiver participation in treatment. Implications for supporting positive changes in CLC among systems of care communities, and specific strategies for community psychologists, are discussed.     

Implementation and Development of Federally-Funded Systems of Care Over Time

This study describes development in federally funded systems of care. Data for this study were collected using the System of Care Assessment that rated grantees' enactment of system of care principles in the infrastructure and service delivery domains. Data were collected by trained raters who conducted several site visits over the funding period. This study described system development over time across 61 sites and tested whether gains were statistically significant. Latent profile analysis was used to explore whether sites could be meaningfully grouped based on their baseline service delivery domain scores. Differences across groups were tested in terms of community, system, and client characteristics. Differential growth across groups was also examined. Overall, systems of care developed over time in both the infrastructure and service delivery domains. Although infrastructure scores were generally lower than service delivery scores, greater gains were seen for the infrastructure domain. Three groups of sites were identified that could be distinguished in terms of degree of development overall, and for specific system of care principles. The groups of sites differed in terms of community factors, system features, and client characteristics. In addition, repeated measures analyses found differential growth in system development over time across groups.