Translational Research Infrastructure Research Articles

Differences in the annotation between facial images and videos for training an artificial intelligence for skin type determination.

The Grand-AID research project, consisting of GRANDEL-The Beautyness Company, the dermatology department of Augsburg University Hospital and the Chair of IT Infrastructure for Translational Medical Research at Augsburg University, is currently researching the development of a digital skin consultation tool that uses artificial intelligence (AI) to analyze the user's skin and ultimately perform a personalized skin analysis and a customized skin care routine. Training the AI requires annotation of various skin features on facial images. The central question is whether videos are better suited than static images for assessing dynamic parameters such as wrinkles and elasticity. For this purpose, a pilot study was carried out in which the annotations on images and videos were compared. Standardized image sequences as well as a video with facial expressions were taken from 25 healthy volunteers. Four raters with dermatological expertise annotated eight features (wrinkles, redness, shine, pores, pigmentation spots, dark circles, skin sagging, and blemished skin) with a semi-quantitative and a linear scale in a cross-over design to evaluate differences between the image modalities and between the raters. In the videos, most parameters tended to be assessed with higher scores than in the images, and in some cases significantly. Furthermore, there were significant differences between the raters. The present study shows significant differences between the two evaluation methods using image or video analysis. In addition, the evaluation of the skin analysis depends on subjective criteria. Therefore, when training the AI, we recommend regular training of the annotating individuals and cross-validation of the annotation.

108 Pilot Project Awardees Productivity Award Metrics at The Alliance Idea-CTR

OBJECTIVES/GOALS: Scholarly achievement metrics are essential for academic researchers since they are used for promotion and funding opportunities. Our objective was to create awareness among pilot project PIs about how these scholarly activities are evaluated and about the need for continuous auto-evaluation. METHODS/STUDY POPULATION: NIH-sponsored Clinical & Translational Research (CTR) infrastructure grants are a critical mechanism to increase scholarly activity. The Pilot Project Program Core (PPP) of The Alliance IDeA-CTR created a weighted metrics system to evaluate activities including presentations, publications, promotion, honors, & community service. We used the revised evidence-based medicine pyramid to develop the metric instrument. Pilot project PIs received the metric table and met quarterly with a PPP member to discuss progress. The top PIs were acknowledged during the Alliance Research Day with a platform presentation and a monetary award for research expenses or travel to scientific meetings. RESULTS/ANTICIPATED RESULTS: During our first 2 pilot project calls (2020-2022) the PPP funded 7 one-year pilot projects for ($50,000 each). We had a total of 10 PIs, 2 of the projects were MPI. Seven PIs were early or new stage investigators (ESI/NSI). Using the productivity award metric we had a total of 33 presentations, 10 publications, 12 events of community service, and 2 external grant funding. These are significant outcomes considering the pandemics impact on clinical & translational research. A total of 3 awards were given, one award per year for funding and an overall award. The activity was well received by the PIs who actively participated in the tracking of their scholarly activities using the metric. DISCUSSION/SIGNIFICANCE: Productivity metrics are crucial for the career development of ESI and NSI by raising awareness regarding the importance of scholarly activities in their career. This activity will help them track their productivity in an ongoing manner while becoming independent researchers.

Florida-California Cancer Research, Education and Engagement (CaRE2) Health Equity Center: Structure, Innovations, and Initial Outcomes.

The Florida-California Cancer Research, Education, and Engagement (CaRE2) Health Equity Center is a triad partnership committed to increasing institutional capacity for cancer disparity research, the diversity of the cancer workforce, and community empowerment. This article provides an overview of the structure, process innovations, and initial outcomes from the first 4years of the CaRE2 triad partnership. CaRE2 serves diverse populations in Florida and California using a "molecule to the community and back" model. We prioritize research on the complex intersection of biological, environmental, and social determinants health, working together with scientific and health disparities communities, sharing expertise across institutions, bidirectional training, and community outreach. Partnership progress and outcomes were assessed using mixed methods and four Program Steering Committee meetings. Research capacity was increased through development of a Living Repository of 81 cancer model systems from minority patients for novel cancer drug development. CaRE2 funded 15 scientific projects resulting in 38 publications. Workforce diversity entailed supporting 94 cancer trainees (92 URM) and 34 ESIs (32 URM) who coauthored 313 CaRE2-related publications and received 48 grants. Community empowerment was promoted via outreaching to more than 3000 individuals, training 145 community cancer advocates (including 28 Community Scientist Advocates), and publishing 10 community reports. CaRE2 members and trainees together have published 639 articles, received 61 grants, and 57 awards. The CaRE2 partnership has achieved its initial aims. Infrastructure for translational cancer research was expanded at one partner institution, and cancer disparities research was expanded at the two cancer centers.

Establishment of the Dutch Nationwide, Interdisciplinary Infrastructure and Biobank for Fundamental and Translational Ovarian Cancer Research: Archipelago of Ovarian Cancer Research

Objectives: Ovarian cancer has the worst overall survival rate of all gynecologic malignancies. For the majority of patients, the 5-year overall survival rate of less than 50% has hardly improved over the last decades. To improve the outcome of patients with all subtypes of ovarian cancer, large-scale fundamental and translational research is needed. To accommodate these types of ovarian cancer research, we have established a Dutch nationwide, interdisciplinary infrastructure and biobank: the Archipelago of Ovarian Cancer Research (AOCR). The AOCR will facilitate fundamental and translational ovarian cancer research and enhance interdisciplinary, national, and international collaboration. Design: The AOCR biobank is a prospective ovarian cancer biobank in which biomaterials are collected, processed, and stored in a uniform matter for future (genetic) scientific research. All 19 Dutch hospitals in which ovarian cancer surgery is performed participate and collaborate in the AOCR biobank. Participants/Materials, Setting, Methods: Patients of 16 years and older with suspected or diagnosed ovarian, fallopian tube, or primary peritoneal cancer are recruited for participation. Patients who agree to participate give written informed consent for collection, storage, and issue of their biomaterials for future studies. After inclusion, different blood samples are taken at various predefined time points both before and during treatment. In case of a diagnostic paracentesis or biopsy, the residual biomaterials of these procedures are stored in the biobank. During surgery, primary tumor tissue and, if applicable, tissue from metastatic sites are collected and stored. From each patient, a representative histological hematoxylin and eosin stained slide is digitalized for research purposes, including reassessment by a panel of gynecologic pathologists. Clinical and pathological data are obtained on a per-study basis from Dutch registries. Research proposals for the issue of biomaterials and data are evaluated by both the Archipelago Scientific Committee and the Steering Committee. Researchers using the biomaterials from the AOCR biobank are encouraged to enrich the biobank with data and materials resulting from their analyses and experiments. Limitations: The implementation and first 4 years of collection are financed by an infrastructural grant from the Dutch Cancer Society. Therefore, the main limitation is that the costs for sustaining the biobank after the funding period will have to be covered. This coverage will come from incorporation of budget for biobanking in future grant applications and from fees from external researchers and commercial parties using the biomaterials stored in the AOCR biobank. Moreover, we will apply for grants aimed at sustaining and improving research infrastructures and biobanks. Conclusions: With the establishment of the Dutch nationwide, interdisciplinary Archipelago of Ovarian Cancer Research infrastructure and biobank, fundamental and translational research on ovarian cancer can be greatly improved. The ultimate aim of this infrastructure is that it will lead to improved diagnostics, treatment, and survival of patients with ovarian cancer.

Evaluating systemic changes to support clinical and translational health research

In evaluation research, “programs” are often conceptualized as clearly bounded, narrow in scope, focused on specific outcomes, using a well-defined linear causal model, and hence, suitable for standard evaluation methods. The evaluation work reported here was carried out in a more challenging context, where large, complex, interwoven systems were targets for change as a means to influence a diffuse array of outcomes. Our evaluation of an NIH-funded program to improve statewide infrastructure for clinical and translational health research (“Advance-CTR”) used qualitative data provided by investigators who used the program’s services, were funded awardees, or were members of an internal advisory committee (leadership representatives from partnering institutions). We examined perceived barriers to systemic changes to enhance research, as well as how systems have changed due to the Rhode Island Advance-CTR program’s efforts, to what degree, and with what effects. Using the causal logic of our program to connect these more distal systemic outcomes to the services and components of Advance-CTR, we discuss the effects this program has had on researchers and their environments, contributing to the development of sustainable programs of research that ultimately improve the health and well-being of our state’s residents.

Tumour irradiation in mice with a laser-accelerated proton beam

Recent oncological studies identified beneficial properties of radiation applied at ultrahigh dose rates, several orders of magnitude higher than the clinical standard of the order of Gy min–1. Sources capable of providing these ultrahigh dose rates are under investigation. Here we show that a stable, compact laser-driven proton source with energies greater than 60 MeV enables radiobiological in vivo studies. We performed a pilot irradiation study on human tumours in a mouse model, showing the concerted preparation of mice and laser accelerator, dose-controlled, tumour-conform irradiation using a laser-driven as well as a clinical reference proton source, and the radiobiological evaluation of irradiated and unirradiated mice for radiation-induced tumour growth delay. The prescribed homogeneous dose of 4 Gy was precisely delivered at the laser-driven source. The results demonstrate a complete laser-driven proton research platform for diverse user-specific small animal models, able to deliver tunable single-shot doses up to around 20 Gy to millimetre-scale volumes on nanosecond timescales, equivalent to around 109 Gy s–1, spatially homogenized and tailored to the sample. The platform provides a unique infrastructure for translational research with protons at ultrahigh dose rates.

Medical Device Development for Children and Young People-Reviewing the Challenges and Opportunities.

Development of specific medical devices (MDs) is required to meet the healthcare needs of children and young people (CYP). In this context, MD development should address changes in growth and psychosocial maturation, physiology, and pathophysiology, and avoid inappropriate repurposing of adult technologies. Underpinning the development of MD for CYP is the need to ensure MD safety and effectiveness through pediatric MD-specific regulations. Contrary to current perceptions of limited market potential, the global pediatric healthcare market is expected to generate around USD 15,984 million by 2025. There are 1.8 billion young people in the world today; 40% of the global population is under 24, creating significant future healthcare market opportunities. This review highlights a number of technology areas that have led to successful pediatric MD, including 3D printing, advanced materials, drug delivery, and diagnostic imaging. To ensure the targeted development of MD for CYP, collaboration across multiple professional disciplines is required, facilitated by a platform to foster collaboration and drive innovation. The European Pediatric Translational Research Infrastructure (EPTRI) will be established as the European platform to support collaboration, including the life sciences industrial sector, to identify unmet needs in child health and support the development, adoption, and commercialization of pediatric MDs.

Role of Biobanks for Cancer Research and Precision Medicine in Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a highly complex and deadly cancer. There is an urgent need for new and effective treatment modalities. Since the primary goal in the management of cancer is to cure and improve survival, personalized therapy can increase survival, reduce mortality rates, and improve quality of life. Biobanks hold potential in leading to breakthroughs in biomedical research and precision medicine (PM). They serve as a biorepository, collecting, processing, storing, and supplying specimens and relevant data for basic, translational, and clinical research. We aimed to highlight the fundamental role of biobanks, harboring high quality, sustainable collections of patient samples in adequate size and variability, for developing diagnostic, prognostic, and predictive biomarkers to develop and PM approaches in the management of HCC. We obtained information from previously published articles and BBMRI directory. Biobanking of high-quality biospecimens along with patient clinical information provides a fundamental scientific infrastructure for basic, translational, and clinical research. Biobanks that control and eliminate pre-analytical variability of biospecimens, provide a platform to identify reliable biomarkers for the application of PM. We believe, establishing HCC biobanks will empower to underpin molecular mechanisms of HCC and generate strategies for PM. Thus, first, we will review current therapy approaches in HCC care. Then, we will summarize challenges in HCC management. Lastly, we will focus on the best practices for establishing HCC biobanking to support research, translational medicine in the light of new experimental research conducted with the aim of delivering PM for HCC patients.

Anti-inflammatory Diet for Interstitial Cystitis (AID-IC): Study Protocol for a Randomized Controlled Cross-Over Trial

ObjectivesIC/BPS is characterized by pelvic pain, pressure, or discomfort in the bladder and pelvic area coupled with urinary frequency and urgency. The cause is unknown. Dietary intake appears to exacerbate IC/BPS symptoms for many patients; however, the association is not well understood. The potential role of saturated fat and other inflammatory dietary components in provoking IC/BPS symptoms will be explored. Animal studies associate high dietary intake of saturated fats with activation of toll-like receptor (TLR4) cell signaling and pro-inflammatory responses. Saturated free fatty acids were linked to changes in the bladder on a cellular level. The goal of the AID-IC study is to investigate the efficacy of an anti-inflammatory diet (limits lipid intake and increases antioxidant intake) on symptom severity. MethodsIn a 22-week, crossover study, women with IC/BPS will be randomized into two groups. Group one will receive 10 weeks of a therapeutic anti-inflammatory diet that eliminates foods commonly bothersome for those with this condition; 5 days/week prepared, home-delivered meals were provided. Group 2 will receive counseling from a dietitian on standard IC/BPS dietary recommendations (control diet). After a two-week washout period, dietary interventions for the two groups will be switched. Primary outcomes include changes in inflammatory biomarkers (TNF-alpha and IL-1) and scores on three validated symptom severity surveys. ResultsWe hypothesize that an anti-inflammatory diet that excludes foods commonly bothersome for individuals with IC/BPS will help manage symptomology for these patients. Furthermore, we hypothesize that the severity of symptoms will be mediated by the reduction of pro-inflammatory responses associated with the influence of a diet low in saturated fats and high in anti-inflammatory dietary components. ConclusionsThe feasibility of managing IC/BPS symptoms by influencing inflammatory activity via restricting lipid intake and increasing antioxidant-rich foods has not previously been investigated. The findings may offer preliminary data on a cost-effective, noninvasive therapy. Funding SourcesMountain West Clinical & Translational Research Infrastructure Network (National Institute of General Medical Sciences, NIH).

Children's Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure).

The paucity of evidence-based data on formulation characteristics preferred by the children is known to limit the design of tailored paediatric dosage forms. The European Paediatric Translational Research Infrastructure (EPTRI) commissioned a study to evaluate children’s dosage forms perceived preferences in some European countries and explore the feasibility of using the young persons advisory groups (YPAGs) to involve children in formulation research. An online, age-adapted survey was developed and translated into six languages. The survey link was disseminated across seven European countries: Albania, Italy, the Netherlands, and Dutch-speaking part of Belgium, Romania, Spain, and the United Kingdom. Respondents’ (n = 1172) perceived preferences for oral dosage forms primarily differed based on age, health status, and experience. Conventional dosage forms, i.e., liquid (35%), tablets (19%), and capsules (14%), were the most selected. Liquid was widely selected by children less than 12 years and by those healthy and taking medicines rarely. Monolithic solid forms were mostly chosen by adolescents and by children with a chronic disease taking medicines frequently. There was a clear lack of familiarity with more novel dosage forms (e.g., orodispersible films and granules). Noteworthy, granules were not appreciated, particularly by adolescents (52.8%). To rationalise the creation of paediatric formulations, it is important to involve children as active stakeholders and to apply tools assessing children’s perspectives on medicines to inform acceptable dosage form development from the start.

25475 Healthcare Delivery Science in LA: Addressing patient and health system priorities with cross-sector research infrastructure

ABSTRACT IMPACT: Effective healthcare interventions improve access, quality of care, and health outcomes for underserved, high-disparity populations of Los Angeles county and beyond. OBJECTIVES/GOALS: We will expand our successful, Los Angeles-based public-academic partnership to develop and evaluate health system interventions aimed at improving healthcare for underserved communities, as well as develop workforce skilled in healthcare delivery science. METHODS/STUDY POPULATION: Together with the LA County Department of Health Services, the two LA-based CTSA hubs at USC and UCLA have established critical infrastructure for effective cross-sector translational research: (1) New funding mechanisms to evaluate health system interventions in county hospitals and clinics in areas of mutual interest; (2) Specialized research service cores (Safety-net Health Innovation core, Clinical Research Informatics core, and Healthcare Delivery Science core), and (3) Training and mentorship programs tailored for healthcare delivery scientists. RESULTS/ANTICIPATED RESULTS: Outcomes from the first four years of the partnership include: (1) Significant impact on health outcomes from eight funded projects, e.g., lowered A1c levels by 0.9%; (2) Successful, coordinated service to dozens of research projects, e.g., a teleretinal screening program decreased ophthalmology visit wait times from 158 to 17 days; (3) New virtual coursework in seven domains (healthcare delivery science, dissemination and implementation science, systems engineering, behavioral economics, informatics, team science, and community engagement); (4) A published ‘synergy paper’ w/ CTSA hubs in three other urban cities examining common themes of academic-public partnerships; and (5) Rapid and streamlined COVID-19 research policy setting with county leadership. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our sustainable infrastructure is effectively bridging research-policy-practice gaps in Los Angeles and addressing patients’ and the health system’s priorities.

Northern Colorado SARS-CoV-2 Biorepository (NoCo-COBIO): A Multi-Matrix, Longitudinal Biobank of COVID-19 Patient Specimens

Background: SARS-CoV-2 has swept across the globe and caused over 1.5 million deaths worldwide. Successful prevention and treatment of COVID-19 is dependent on in-depth knowledge of viral behavior across the spectrum of patient phenotypes and physiologic responses. Biobanking provides a valuable resource of easily-accessed, quality-controlled samples for researchers to study current and future pandemics.Methods: Patients with a history of a positive SARS-CoV-2 nasopharyngeal PCR are recruited to enroll in the Northern Colorado SARS-CoV-2 Biorepository (NoCo-COBIO). Participants are enrolled in the acute phase of their disease or from the community during convalescence. Blood, saliva, nasopharyngeal, and stool specimens, as well as extensive clinical and demographic data, are collected at the time of enrollment. This biobanking effort has a longitudinal patient follow-up of four time points, with standardized multi-matrix sample and data collections over a 6-month period. One-year follow up will be performed to assess mortality data and sequelae.Findings: To date, we have enrolled and collected samples from 60 acute and 40 convalescent participants. Twenty (33%) of the acute participants have had one or more follow-up visits, and 90% of participants enrolled during convalescence have completed 2 or more visits.Interpretation: We have successfully created a multi-faceted biobank of specimens from individuals with COVID-19 to advance human SARS-CoV-2 research.Trial Registration: ClinicalTrials.gov (NCT05603677).Funding Statement: The biorepository was initiated by and supported with funding and translational research infrastructure in the CSU ERHS department (Elizabeth P. Ryan) and with the University of Colorado Health Northern Colorado Trauma Research Department (Julie Dunn).Declaration of Interests: The authors disclose no conflict of interest related to the manuscript.Ethics Approval Statement: This biorepository was approved by CSU’s Research Integrity and Compliance Review Office Institutional Review Board (protocol ID 20-10063H), as well as UCH Institutional Review Board (Colorado Multiple Institutional Review Board 20-6043).

Infrastructuring an organizational node for a federated research and data network: A case study from a sociotechnical perspective.

Local nodes on federated research and data networks (FR&DNs) provide enabling infrastructure for collaborative clinical and translational research. Studies in other fields note that infrastructuring, that is, work to identify and negotiate relationships among people, technologies, and organizations, is invisible, unplanned, and undervalued. This may explain the limited literature on nodes in FR&DNs in health care. A retrospective case study of one PCORnet® node explored 3 questions: (1) how were components of infrastructure assembled; (2) what specific work was required; and (3) what theoretically grounded, pragmatic questions should be considered when infrastructuring a node for sustainability. Artifacts, work efforts, and interviews generated during node development and implementation were reviewed. A sociotechnical lens was applied to the analysis. Validity was established with internal and external partners. Resources, services, and expertise needed to establish the node existed within the organization, but were scattered across work units. Aligning, mediating, and institutionalizing for sustainability among network and organizational teams, governance, and priorities consumed more work efforts than deploying technical aspects of the node. A theoretically based set of questions relevant to infrastructuring a node was developed and organized within a framework of infrastructuring emphasizing enacting technology, organizing work, and institutionalizing; validity was established with internal and external partners. FR&DNs are expanding; we provide a sociotechnical perspective on infrastructuring a node. Future research should evaluate the applicability of the framework and questions to other node and network configurations, and more broadly the infrastructuring required to enable and support federated clinical and translational science.

Moving with the Times: The Health Science Alliance (HSA) Biobank, Pathway to Sustainability.

Human biobanks are recognised as vital components of translational research infrastructure. With the growth in personalised and precision medicine, and the associated expansion of biomarkers and novel therapeutics under development, it is critical that researchers can access a strong collection of patient biospecimens, annotated with clinical data. Biobanks globally are undertaking transformation of their operating models in response to changing research needs; transition from a ‘classic’ model representing a largely retrospective collection of pre-defined specimens to a more targeted, prospective collection model, although there remains a research need for both models to co-exist. Here we introduce the Health Science Alliance (HSA) Biobank, established in 2012 as a classic biobank, now transitioning to a hybrid operational model. Some of the past and current challenges encountered are discussed including clinical annotation, specimen utilisation and biobank sustainability, along with the measures the HSA Biobank is taking to address these challenges. We describe new directions being explored, going beyond traditional specimen collection into areas involving bioimages, microbiota and live cell culture. The HSA Biobank is working in collaboration with clinicians, pathologists and researchers, piloting a sustainable, robust platform with the potential to integrate future needs.

European research networks to facilitate drug research in children.

Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summarises recent efforts to overcome these barriers in Europe. Two exemplar initiatives are described. The European Paediatric Translational Research Infrastructure facilitates preclinical research and other work that underpins clinical trials. conect4children facilitates the design and implementation of clinical trials. Both these initiatives listen to the voices of children and their advocates. Coordination of research needs specific effort that supplements work on science, resources and the policy context.

The Impact of the Clinical and Translational Research Infrastructure Network (CTR-IN) Program on Oncology Research in the Mountain West (MW) Region

The MW CTR-IN grant is a U-54 Institutional Development Award (IDeA) funded by the NIH / NIGMS to increase and enhance research capacity. The CTR-IN Program (ctrin.unlv.edu) is only one of 11 clinical and translational research centers funded by NIGMS in the US. The CTR-IN involves a partnership with the 13 major public universities in the MW region (i.e., Nevada, New Mexico, Wyoming, Montana, Idaho, Alaska and Hawaii) that covers 1/3rd of the US land mass and almost 1/3rd of all IDeA states. Of the 13 CTR-IN partner public universities, only 4 have schools of medicine (SOM). In order to increase and enhance research capacity, the CTR-IN Program initiated a pilot grant (PG) program for eligible research faculty of the 13 MW University partners in 2013 that is now in its 7th year with a very successful track record of producing independent extramural grant funding. We conducted a retrospective review of our CTR-IN PGs to determine their impact on oncology research in the Mountain West region. All of our PGs undergo a rigorous "NIH-like” review process and our funding percentile is typically in the 25th - 30% range. The typical funding range for our PGs is usually $60 - $66k each with a duration of one year. During the initial grant cycle (2013 - 2017), a total of 83 PGs were funded for approximately $60 - $66k each in many different areas including cancer. Eight (9.6%) of the 83 PGs had a cancer focus. We analyzed and compared various major outcome metrics such as the Journal Impact Factor (JIF) of the published manuscripts, the Extramural Grant Funding (EMGF) and Return on Investment (ROI = total EMGF amount / total awarded PG amount x 100%) for the cancer focused PGs (n=8) vs. the non-cancer PG awards (n=75). Exact comparisons of the means of the major outcomes (i.e., JIF, EMGF, ROI) between the cancer focused PGs vs. the non-cancer PGs were conducted. Of the 8 pilot grants funded in cancer research, only 2 were funded for faculty at a SOM while the others were funded at other schools (i.e., Biological Sciences, Allied Health, Social Work, Nursing and Computer / Mathematical Sciences) at our 13 partner universities. The major outcomes for the cancer focused PGs vs. the non-cancer focused PGs were as follows, respectively: (1) Mean JIF = 3.94 (SD = 4.83) for 24 publications for the cancer focused PGs vs. Mean JIF = 3.05 (SD = 1.69) for 126 publications for the non-cancer focused PGs, p = 0.102; (2) Mean Amount of EMGF = $1,255,913 (SD = $294,931) for a total EMGF amount of $2,511,826 involving 4 grants (all from faculty at non-SOM Universities) vs. Mean Amount of EMGF = $2,317,870 (SD = $3,669,986) for a total EMGF amount of $46,358,174 involving 43 grants, p = 0.765; (3) ROI was 2,002% (SD = 792%) vs. 3,644 % (SD = 6,643%), p = 0.789. Hence, there were no statistically significant differences between the cancer focused PGs awardees as compared to the non-cancer focused PG awardees as measured by the major scholarship outcomes (i.e., JIF, EMGF and ROI). Despite not having medical schools at majority of our 13 partner institutions, our comparative analysis reveals that our cancer focused PG awardees were just as competitive and successful as our non-cancer focused PG awardees as measured by the major scholarship outcomes (i.e., JIF, EMGF and ROI). The MW CTR-IN Program has been instrumental in seeding a culture of investigator initiated clinical and translational research through its pilot grant program including oncology research despite the sparsity of medical schools in the MW region.

Effect of Educational Short Message Service (SMS) on Excessive Gestational Weight Gain (GWG)

Abstract Objectives The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population. It was expected that the intervention group, which received text messages on nutrition and physical activity during pregnancy, would experience less GWG when compared to the control group. Methods Participants (n = 83) were recruited at WIC clinics on the island of O‘ahu, Hawai‘i at 15–20 weeks gestational age. Eligibility criteria were: body mass index (BMI) of 25–45 kg/m2 in the first trimester, 18 years of age or older at the time of recruitment, and possession of a cellular phone with the ability to receive text messages. After recruitment, participants were randomized into intervention (n = 42) and control (n = 41) groups. The intervention group received SMS on nutrition and physical activity during pregnancy per the Institute of Medicine and American College of Obstetricians and Gynecologists guidelines, respectively. The control group received SMS about general health topics during pregnancy. Both groups received one text message per week for eighteen weeks. GWG was defined as the difference between the last weight taken before delivery and participants’ self-reported weight before pregnancy. GWG in intervention and control groups was compared using a linear regression model. Results Women were age 27.7 ± 5.3y on average, 65.5% were Native Hawaiian, Pacific Islander or American Indian, 54.8% had some college or more and 37.8% were employed. The average weight before pregnancy was higher in the intervention group (80.6 + 17.7 kg) than that in the control group (76.2 + 15.9 kg), but this difference was not significant (P = 0.24). GWG was lower in the control group (14.1 + 11.4 kg) compared to the intervention group (15.5 + 11.6 kg), but this result was not significant (P = 0.58). Conclusions There was no significant difference in gestational weight gain between the intervention and control groups. Trials that begin earlier in pregnancy or before pregnancy with longer interventions and more frequent messages are needed. Funding Sources Mountain West Clinical Translational Research Infrastructure Network under a grant from the National Institute of General Medicine Sciences of the National Institutes of Health.

Effect of a Text Intervention During Pregnancy on Birth Weight in Participants of the WIC Program in Hawaii

Abstract Objectives There are limited studies testing the effect of a pregnancy educational intervention on infants’ birth weight. This study investigated the effect of a short message service (SMS), or text message, intervention for promoting adequate gestational weight gain on infants’ birth weight in a sample of pregnant women in Hawai‘i. Methods A randomized clinical trial was conducted among women participating in the Special Supplemental Nutrition Program for Women, Infant, and Children (WIC) program in Hawai‘i (n = 83). The intervention group (n = 42) received weekly SMS about appropriate energy intake and physical activity and the control group (n = 41) received weekly SMS about general health issues for 4 months during pregnancy. Weight and length at birth were obtained from the participant's chart in WIC and compared between groups. Birthweight was categorized as small (SGA), appropriate (AGA) or large (LGA) for gestational age. Results Women were age 27.7 ± 5.3y on average, 65.5% were Native Hawaiian, Pacific Islander or American Indian, 54.8% had some college or more and 37.8% were employed. Infant birth weight was similar in the intervention (3431 ± 682 g) and control groups (3232 ± 599 g; P > 0.05). Mothers in the control group had higher odds of having a SGA baby (OR: 2.21; 95% CI 0.40, 12.2) but similar risk of having a LGA baby (0.27; 95% CI 0.07, 1.05) compared to the intervention group. After adjusting for mothers’ age, education level and employment status, results were similar for SGA (OR: 2.34; 95% CI 0.43, 14.7) and LGA (OR: 0.35; 95% CI 0.08, 1.49). Conclusions There was no significant difference in birth weight between groups in mothers from the WIC program in Hawai‘i. More intensive educational interventions may be needed to observe an impact on birth weight. Funding Sources Mountain West Clinical Translational Research Infrastructure Network under a grant from the National Institute of General Medicine Sciences of the National Institutes of Health.

Socio-Demographic Correlates of Pre-Pregnancy Body Mass Index and Gestational Weight Gain Among Low-Income Women in Hawai’i WIC

Abstract Objectives The purpose of this study was to identify the socio-demographic correlates of pre-pregnancy body mass index (BMI) and gestational weight gain (GWG) among low-income women in the Women, Infants, and Children (WIC) program in Hawai‘i. Methods Participants were low-income pregnant women (n = 83) in Hawaii enrolled in a four-month text message-based nutrition intervention program. Participants reported pre-pregnancy weight and height and completed a demographics questionnaire. GWG was calculated by subtracting the last weight taken before delivery from pre-pregnancy weight. Univariate and multivariate analyses were conducted to examine the relationship between demographic variables and pre-pregnancy BMI and GWG. Results BMI before pregnancy, age and number of children were associated with GWG. Women who were obese before pregnancy gained 33 pounds less compared to those who had normal BMI (95% CI: 17 to 50, P < 0.0001). Women in the age group 30–35 gained 25 pounds (95% CI: 4 to 45, P = 0.012) and 27 pounds (95% CI: 9 to 45, P = 0.004) more compared to age groups 18–24 and 24–34, respectively. Those with three to five children gained 13.6 pounds less weight (95% CI: 0 to 28, P = 0.05): than those with fewer children. Additionally, age and race/ethnicity were marginally associated with BMI before pregnancy. The age group 30–35 had the highest BMI before pregnancy (P = 0.08) and Asian had lower BMI before pregnancy than the other races/ethnicities (P = 0.04). Conclusions Being 30–35 years old and having 3–5 children were associated with gaining more weight during pregnancy. These socio-demographic factors should be taken into account when designing interventions for promoting an adequate GWG. Funding Sources Mountain West Clinical Translational Research Infrastructure Network under a grant from National Institute of General Medicine Sciences of the National Institute of Health.

Promoting community health collaboration between CTSA programs and Cooperative Extension to advance rural health equity: Insights from a national Un-Meeting.

Addressing rural health disparities has unique challenges that require cross-sector collaborations to address social determinants of health and help those in need to get connected to care continuum. We brought the Clinical and Translational Science Award, Institutional Development Award Program Infrastructure for Clinical and Translational Research, and Cooperative Extension System Programs together for a one-day semi-structured meeting to discuss collaborative opportunities to address rural health disparities. Session notes and event materials were analyzed for themes to facilitate collaboration such as defining rural, critical issues, and organizational strengths in support of collaboration. Across 16 sessions, there were 26 broad topics of discussion. The most frequent topics included "barriers and challenges," "strategies and opportunities," and "defining rural." There is a growing understanding of the opportunity that collaboration between these large programs provides in addressing rural health disparities.