Best Practices for Conducting Clinical Trials With Indigenous Children in the United States.

We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices.

Hawai'i IDeA Center for Pediatric and Adolescent Clinical Trials.

As one of 17 clinical sites of the Environmental influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN), the Hawai'i IDeA Center for Pediatric and Adolescent Clinical Trials (HIPACT) was established in 2016 to participate in community-valued and scientifically-valid multi-center pediatric clinical trials to improve health and well-being of diverse multi-ethnic populations of Hawai'i. Hawai'i is home to large populations of diverse rural and underserved populations, including indigenous Hawaiian communities and immigrant populations of Pacific Islanders and Asians. Many of these communities experience significant health disparities, made worse by their geographic isolation and many socio-economic factors.

Addressing health disparities through multi-institutional, multidisciplinary collaboratories.

The national research leadership has recently become aware of the tremendous potential of translational research as an approach to address health disparities. The Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) is a research network that supports multi-institutional, multidisciplinary collaboration with a focus on key diseases and conditions for which disproportionately adverse racial and ethnic health disparities exist. The RTRN is designed to facilitate the movement of scientific advances across the translational research spectrum by providing researchers at different institutions with the infrastructure and tools necessary to collaborate on interdisciplinary and transdisciplinary research projects relating to specific health outcomes for which major racial/ethnic disparities exist.

The role of translational research in addressing health disparities: a conceptual framework.

Translational research has tremendous potential as a tool to reduce health disparities in the United States, but a lack of common understanding about the scope of this dynamic, multidisciplinary approach to research has limited its use. The term "translational research" is often associated with the phrase "bench to bedside," but the expedited movement of biomedical advances from the laboratory to clinical trials is only the first phase of the translational process. The second phase of translation, wherein innovations are moved from the bedside to real-world practice, is equally important, but it receives far less attention.

Traumatic brain injury: outcomes from rural and urban locations over a 5-year period (Part 1).

The national death rates from rural trauma are disproportionately higher compared to urban areas. Traumatic brain injury is a major cause of hospital admissions in Hawai'i. This is the first in a two part series to explore this significant public health concern.

Self identity through Ho'oponopono as adjunctive therapy for hypertension management.

Objective: Self Identity through Ho'oponopono is a step-by-step problem-solving approach to identify and relieve stress. The objective of this study was to determine if Self Identity through Ho'oponopono along with standard medical therapy might better control hypertension than standard therapy alone.

Design, Setting, Participants: Twenty-three Asian, Hawaiian, and other Pacific Islanders from a local community in Hawaii participated in a longitudinal design comparing pre- and post-intervention measures of blood pressure.

Hawaii cohort study of serum micronutrient concentrations and clearance of incident oncogenic human papillomavirus infection of the cervix.

The degree to which the resolution of human papillomavirus (HPV) infection parallels exposure to other factors, particularly those related to nutritional status, is a relatively unexplored area of research. We established a cohort of women for long-term follow-up to examine the association of serum retinol, carotenoid, and tocopherol concentrations with the clearance of incident cervical HPV infection. Interviews and biological specimens were obtained at baseline and at 4-month intervals.

Use of provider delivered complementary and alternative therapies in Hawai'i: results of the Hawai'i Health Survey.

Background: Provider delivered complementary and alternative medicine (CAM) is used increasingly as a treatment option. Nevertheless, data related to the prevalence of provider delivered CAM (or PDCAM) use in diverse racial and ethnic populations is limited. The purpose of this investigation was to describe the use of provider delivered CAM in Hawaiian, Asian, and other Pacific Island populations in Hawai'i.

The research subject advocate at the University of Hawai'i Clinical Research Center: an added resource for protection of human subjects.

In early 2001 the National Institutes of Health (NIH) created the Research Subject Advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human subjects participating in clinical research studies. The purpose of this article is to describe the RSA position in the context of clinical research, with a particular emphasis upon the role of the RSA in one of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants.

The research subject advocate at minority Clinical Research Centers: an added resource for protection of human subjects.

In early 2001, the National Institutes of Health (NIH) created the research subject advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human participants in clinical research studies. We describe the RSA position in the context of clinical research, with a particular emphasis on the role of the RSA in two of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants.

Oral health disparities and periodontal disease in Asian and Pacific Island populations.

Introduction: While oral health disparities exist in many ethnic groups in Hawaii, the challenge of developing research and intervention programs is hampered by the lack of a dental school and adequate state resources.

Objective: To use a collaboration model to establish a mentoring relationship with a research-intensive school of dentistry to reduce oral health disparities in Hawaii.

Methods: Collaborative interactions with the University of Hawaii School of Medicine (UH) and the University of North Carolina School of Dentistry at Chapel Hill (UNC) included bimonthly teleconferences, on-site planning and mentoring sessions, yearly conferences in Hawaii open to the community using UNC faculty, and on-site skills training sessions.

Improving Hawaiian and Filipino involvement in clinical research opportunities: qualitative findings from Hawai'i.

Objective: Investigate the barriers to participation in medical research that involves Asian and Pacific Islander (API) populations in Hawai'i.

Participants: Fifty people (27 Filipinos, 23 Hawaiian/Pacific Islanders) in five different communities on Oahu.

Design: Nine focus groups with an ethnically matched moderator were held to explore people's feelings, problems, and recommendations regarding medical research.

Anal human papillomavirus infection in women and its relationship with cervical infection.

Human papillomavirus (HPV), the primary cause of cervical cancer, is also associated with the development of anal cancer. Relatively little is known about the epidemiology of anal HPV infection among healthy females and its relationship to cervical infection. We sought to characterize anal HPV infection in a cohort of adult women in Hawaii.

Growth in clinical research productivity and funding at the University of Hawaii's John A. Burns School of Medicine: the past 10 years.

Over the last ten years, faculty at the John A. Burns School of Medicine (JABSOM) and the University of Hawaii (UH) have been actively engaged in ongoing efforts to increase the quantity and improve the quality of biomedical research in the State of Hawaii. JABSOM's Clinical Research Center (CRC), funded in 1995 by the National Center for Research Resources (NCRR) and the Research Centers in Minority Institutions (RCMI) of the National Institutes of Health, has provided research infrastructure that has been essential to these efforts.

The Clinical Research Center of Hawaii: a nine year progress report.

The UH-CRC is an NIH minority funded infrastructure program at the University of Hawaii in partnership with Hawaii Pacific Health, now in its ninth year. The main purpose of the UH-CRC is to foster clinical research at UH in order to improve the health of the citizens of Hawaii, particularly those who suffer disproportionately from disorders affecting these communities. This status report documents the continued success and progress of the Center Manuscripts published or in press have increased from an average of 43 in years 1-3 to 54 in years 4-6 to 84 for years 7-9.

Addressing oral health disparities in settings without a research-intensive dental school: collaborative strategies.

Research suggests that oral health is linked to systemic health, and those with poor oral health are potentially at greater risk for important diseases, including cardiovascular disease, stroke, diabetes mellitus, and adverse pregnancy outcomes. Asians and Pacific Islanders (APIs) in Hawaii have high rates of many such diseases. Studies in children in Hawaii have revealed disparities in dental health; for example, API children have significantly higher rates of cavities than other groups.

Lavage administration of dilute surfactant in a piglet model of meconium aspiration.

Maldistribution of exogenous surfactant may preclude any clinical response in acute lung injury associated with surfactant dysfunction. Our previous studies have shown the effectiveness of surfactant lavage after homogenous lung injury. The present study utilizes a histologically confirmed non-homogeneous lung injury model induced by saline lung-lavage followed by meconium injected into a mainstem bronchus.

The relationship between ethnicity and obesity in Asian and Pacific Islander populations: a literature review.

The purpose of this literature review is to explore the potential relationship between ethnicity and obesity, and obesity-related risks, with a particular emphasis on disparities between Asian and Pacific Islander populations. We conducted a comprehensive search of available medical literature related to the rise of obesity in the United States, factors contributing to obesity, evidence-based clinical guidelines, and obesity and related risks as they occur in Hawaii. In conducting this search, we sought to illuminate obesity rates in Asians and Pacific Islanders in connection with various factors, such as diet and lifestyle, acculturation, and body image, as they occur in diverse cultural contexts.

Agreement between maternal self-reported ethanol intake and tobacco use during pregnancy and meconium assays for fatty acid ethyl esters and cotinine.

Reliance on self-reported use of tobacco and intake of ethanol during pregnancy is associated with a high probability of error. Use of biological markers, or biomarkers, potentially offers a more valid method to assess exposure. Although cotinine is an established biomarker for tobacco use, there is no established biomarker for in utero ethanol exposure.

Healthy people in Hawaii?: an overview of ethnic health disparities in Hawaii for the Healthy People 2010 initiative targeted health concerns.

Significant health disparities exist between ethnic groups in the United States. The authors reviewed literature examining the epidemiology of health disparities in Hawaii's multiethnic population. One of the primary goals of the Healthy People 2010 initiative is to eliminate health disparities, specifically cancer, cardiovascular disease, diabetes, infant mortality, child and adult immunizations and HIV/AIDS.

Six years and counting: the NIH-funded Clinical Research Center of Hawaii.

The CRC was developed in 1995 to make Hawaii a site of innovative, progressive research. Since then, the numbers of researchers and publications supported by the CRC have increased. In the next several years, the CRC will expand further into Hawaii's research community and apply for GCRC status, a strategy that will attract even more resources and investigators to JABSOM.