Elizabeth Cohn

Calorie Postings in Chain Restaurants in a Low-Income Urban Neighborhood: Measuring Practical Utility and Policy Compliance

Current strategies for combating obesity include recent federal legislation mandating calorie count postings in chain restaurants. This study describes the current practice of menu board calorie postings in a low-income urban neighborhood, identifies the extent to which current practice complies with existing policy, and evaluates the practical utility of menu boards to consumers. We conclude that although most postings were legally compliant, they did not demonstrate utility. Menu postings for individual servings are easily understood, but complex math skills are needed to interpret meals designed to serve more than one person. In some items, calories doubled depending on flavor and the calorie posting did not give enough information to make healthier selections. We identified specific strategies to improve practical utility and provide recommendations for policy implementation.

Changes in the institutional review board submission process for multicenter research over 6 years.

Although collaborative research across sites is essential to increase the statistical power and generalizability of research findings, the need to undergo multiple institutional review board (IRB) reviews is a challenge. The purposes of this paper are to describe changes in the IRB submission process in 2 national multisite studies before and after the implementation of the Health Information Portability and Accountability Act (HIPAA) Privacy rule (2002 and 2008) and to discuss implications for policy and practice related to human subjects research. In the second study, there was a shorter mean approval time and reduced variability in the decision about the level of review, the mean number of pages per application doubled, and an increased proportion of IRBs required conflict of interest and data use agreements. Possible approaches to further enhance the efficiency and streamlining of the research review process are suggested.

Measuring the process and quality of informed consent for clinical research: development and testing.

PURPOSE/OBJECTIVES To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC). DESIGN A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality. SETTING A major urban teaching hospital in the northeastern region of the United States. SAMPLE 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters. METHODS For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. MAIN RESEARCH VARIABLES The essential elements of information and communication for informed consent. FINDINGS The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting. CONCLUSIONS The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. IMPLICATIONS FOR NURSING The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it.

Distributive justice, diversity, and inclusion in precision medicine: what will success look like?

Distributive justice, diversity, and inclusion in precision medicine: what will success look like?

Increasing Participation in Genomic Research and Biobanking Through Community-Based Capacity Building

Achieving equitable minority representation in genomic biobanking is one of the most difficult challenges faced by researchers today. Capacity building—a framework for research that includes collaborations and on-going engagement—can be used to help researchers, clinicians and communities better understand the process, utility, and clinical application of genomic science. The purpose of this exploratory descriptive study was to examine factors that influence the decision to participate in genomic research, and identify essential components of capacity building with a community at risk of being under-represented in biobanks. Results of focus groups conducted in Central Harlem with 46 participants were analyzed by a collaborative team of community and academic investigators using content analysis and AtlisTi. Key themes identified were: (1) the potential contribution of biobanking to individual and community health, for example the effect of the environment on health, (2) the societal context of the science, such as DNA criminal databases and paternity testing, that may affect the decision to participate, and (3) the researchers’ commitment to community health as an outcome of capacity building. These key factors can contribute to achieving equity in biobank participation, and guide genetic specialists in biobank planning and implementation.

Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial

BackgroundStroke is a leading cause of adult disability and mortality. Intravenous thrombolysis can minimize disability when patients present to the emergency department for treatment within the 3 − 4½ h of symptom onset. Blacks and Hispanics are more likely to die and suffer disability from stroke than whites, due in part to delayed hospital arrival and ineligibility for intravenous thrombolysis for acute stroke. Low stroke literacy (poor knowledge of stroke symptoms and when to call 911) among Blacks and Hispanics compared to whites may contribute to disparities in acute stroke treatment and outcomes. Improving stroke literacy may be a critical step along the pathway to reducing stroke disparities. The aim of the current study is to test a novel intervention to increase stroke literacy in minority populations in New York City.Design and MethodsIn a two-arm cluster randomized trial, we will evaluate the effectiveness of two culturally tailored stroke education films – one in English and one in Spanish – on changing behavioral intent to call 911 for suspected stroke, compared to usual care. These films will target knowledge of stroke symptoms, the range of severity of symptoms and the therapeutic benefit of calling 911, as well as address barriers to timely presentation to the hospital. Given the success of previous church-based programs targeting behavior change in minority populations, this trial will be conducted with 250 congregants across 14 churches (125 intervention; 125 control). Our proposed outcomes are (1) recognition of stroke symptoms and (2) behavioral intent to call 911 for suspected stroke, measured using the Stroke Action Test at the 6-month and 1-year follow-up.DiscussionThis is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one church in almost every neighborhood in the USA, churches have the ability and reach to play an important role in the dissemination and translation of stroke prevention programs in minority communities.Trial registrationNCT01909271; July 22, 2013

Overcoming Challenges to Meaningful Informed Consent for Whole Genome Sequencing in Pediatric Cancer Research

Introducing whole genome sequencing (WGS) into pediatric cancer research at diagnosis poses unique challenges related to informed consent. WGS requires tissue obtained prior to initiating treatment, when families may be overwhelmed with uncertainty and fear. Motivation to participate may be high without fully understanding the range of possible results, including secondary findings. Little is known about parental knowledge, attitudes, and beliefs about this type of research.

Evaluation of Statistical Approaches in Quantitative Nursing Research

The purposes of this study were to (a) develop a tool to assess statistical methods and (b) use the tool to evaluate recently published quantitative research. We rated the statistical approaches used in 152 studies published in the 5 top impact-factor nursing research journals from September 2005 to August 2007. Studies were generally of high quality; 45% scored between 80% and 100%, and 22% achieved a score of 100%. Predictors of high scores were interdisciplinary authorship, a statistician coauthor, and the number of aims. The authors conclude that studies published in high impact-factor nursing journals are statistically sound and provide a solid foundation for evidence-based practice.

Including Marginalized Populations in HIV Clinical Trials: A New Role for Nurse-Researchers

This article proposes a new paradigm for nurse-researchers to strengthen communication with participants, investigators, and the community in clinical trials. The author reviews the current state of HIV vaccine development in response to the human and fiscal cost of the HIV epidemic, both in the United States and globally. A translational model is proposed for restructuring the process by which participants in HIV trials are recruited and the results disseminated. Finally, it is proposed that nurses should play a unique and essential role in implementing this new model, advocating for individuals, strengthening societal trust, and fostering equity.

Understanding the Landscape of Psychosocial Intervention Practices for Social, Emotional, and Behavioral Challenges in Youth With ASD: A Study Protocol

ABSTRACT Introduction: There is a significant gap between research and practice for mental health services for youth with autism spectrum disorder (ASD). Despite increased numbers of individuals with ASD treated in community settings, little is known about the array of practices used with this population and the extent to which providers are aware of and use evidence-based strategies. The goal of this article is to describe a protocol for developing a more comprehensive understanding of the landscape of current intervention practices and attitudes regarding the treatment of psychosocial issues in youth with ASD in community settings within the United States. Methods: This article describes our research protocol for developing a comprehensive survey—the Usual Care for Autism Survey (UCAS)—to capture the depth and breadth of practices for youth with ASD and attitudes of community-based providers. Phase 1 will involve a comprehensive review of published literature to identify intervention practices for social difficulties, anxiety, and externalizing symptoms in youth with ASD (7–22 years). Phase 2 will involve developing and piloting the UCAS using the qualitative approaches and Delphi methodology. In Phase 3, we will distribute the UCAS to approximately 700 providers across the United States to ascertain the frequency of intervention practices being delivered to youth with ASD and provider attitudes toward practices in usual care practice settings. Conclusions: Results will assist the work of researchers, clinicians, and policymakers to support the implementation of effective practices and improve the quality of services for youth with ASD.