Browsing by Author "Bennett, Rachel"

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    509 Regulatory Lens of a QA/QC Project Manager
    (Cambridge University Press, 2024-04-03) Bennett, Rachel; Caldwell, Christine Sego; Medicine, School of Medicine
    OBJECTIVES/GOALS: The primary purpose of the QA/QC Project Manager (PM), appointed under the NCATS UL1 administrative supplement award, is to facilitate quality and timely NCATS prior approval submissions preventing study start delays. Other goals include supporting these projects’ IRB applications and monitoring to ensure data quality and compliance. METHODS/STUDY POPULATION: At the Indiana CTSI, the QA/QC PM is assigned to the Regulatory Knowledge and Support program (RKS) and functions as a unique regulatory service provider. Through monitoring, auditing, and personalized consultations, the IN CTSI QA/QC PM provides study teams with regulatory, GCP, and other compliant study conduct insights while managing NCATS prior approval and RPPR submission quality and timeliness. In contrast to many CTSAs, this role is uniquely situated within RKS and provides QA/QC support through a regulatory lens. The Indiana CTSI QA/QC PM serves on the CTSA QA/QC Lead Team collaborating with NCATS and other CTSA QA/QC personnel. The Lead Team engages with NCATS to host monthly/quarterly meetings and participate in a discussion forum of NCATS and other CTSA QA/QC personnel. RESULTS/ANTICIPATED RESULTS: Not all CTSAs employ the QA/QC PM as regulatory support and the role and skill sets at each CTSA vary, yet the collaborative nature of these individuals across the CTSAs facilitates sharing of resources and knowledge. While prior approval and RPPR submissions vary widely, the QA/QC PMs can rely on their counterparts for guidance complying with the same regulations and policies within unique research settings and institutional nuances. The IN CTSI QA/QC PM, in collaboration with the QA/QC Lead Team, provided quality assurance revisions to the NCATS prior approval instructions which were adopted and published by NCATS January 2022 for implementation at all CTSAs. Ongoing, quality control efforts are accomplished through education, monitoring, and regulatory consultations. DISCUSSION/SIGNIFICANCE: As the research environment evolves, the QA/QC PM responsibilities shift in response to needs within RKS and NCATS. The versatility of the position enables QA/QC to occur at all stages of a study. QA/QC strategies aim to facilitate communication, quality NCATS prior approval and RPPR submissions, and compliance with proposed study conduct.
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    Increasing serum pre-adipocyte factor-1 (Pref-1) correlates with decreased body fat, increased free fatty acids, and level of recent alcohol consumption in excessive alcohol drinkers
    (Elsevier, 2014-12) Liangpunsakul, Suthat; Bennett, Rachel; Westerhold, Chi; Ross, Ruth A.; Crabb, David W.; Lai, Xianyin; Witzmann, Frank A.; Department of Medicine, IU School of Medicine
    Patients with alcoholic liver disease have been reported to have a significantly lower percentage of body fat (%BF) than controls. The mechanism for the reduction in %BF in heavy alcohol users has not been elucidated. In adipose tissue, Pref-1 is specifically expressed in pre-adipocytes but not in adipocytes. Pref-1 inhibits adipogenesis and elevated levels are associated with reduced adipose tissue mass. We investigated the association between serum Pref-1 and %BF, alcohol consumption, and serum free fatty acids (FFA) in a well-characterized cohort of heavy alcohol users compared to controls. One hundred forty-eight subjects were prospectively recruited. The Time Line Follow-Back (TLFB) questionnaire was used to quantify the amount of alcohol consumed over the 30-day period before their enrollment. Anthropometric measurements were performed to calculate %BF. Serum Pref-1 and FFA were measured. Fifty-one subjects (mean age 32 ± 9 years, 88% men) were non-excessive drinkers whereas 97 were excessive drinkers (mean age 41 ± 18 years, 69% men). Compared to non-excessive drinkers, individuals with excessive drinking had significantly higher levels of Pref-1 (p<0.01), FFA (p < 0.001), and lower %BF (p = 0.03). Serum levels of Pref-1 were associated with the amount of alcohol consumed during the previous 30 days. Serum Pref-1 was negatively correlated with %BF, but positively associated with serum FFA. Our data suggest that elevated Pref-1 levels in excessive drinkers might inhibit the expansion of adipose tissue, decreasing %BF in alcoholics. Further work is needed to validate these findings and to better understand the role of Pref-1 and its clinical significance in subjects with heavy alcohol use.
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    Long-acting reversible contraception knowledge & intent to use among US university students.
    (European Society of Contraception and Reproductive Health, 2020-03) Asdell, Stephanie; Bennett, Rachel; Cordon, Sabrina; Zhao, Qiuhong; Peipert, Jeffrey
    OBJECTIVES: More than 50% of births to women in the United States in their early 20s are unintended, and unintended pregnancies have adverse consequences on students’ education.Long-acting reversible contraceptives (LARC) offer highly-effective, long-term prevention of pregnancy, yet are utilized at low rates. Thus, we sought to assess the level of students’ LARC knowledge and any association with intent to use LARC at a large, urban university in the Midwest United States. We hypothesized that students with higher levels of LARC knowledge would be more likely to intend to use LARC in the future. We also hypothesized that fewer students would use LARC compared to the US rate of 15.8% of all contraceptive users in 2017. Data on student knowledge and attitudes regarding LARC will be used to inform a campus LARC initiative. METHODS: We designed and administered a cross-sectional survey to 300 undergraduates, graduate students, and resident physicians that assessed sexual experiences, contraceptive use, LARC knowledge, and intent to use LARC. The survey was administered at the university’s student center and student health facility in Indianapolis, Indiana. Participants’ demographic characteristics and LARC knowledge were summarized using descriptive statistics. Awareness of different LARC methods was assessed using McNemar’s test. The association between students’ reported LARC knowledge and future intent to use a LARC method was calculated with Fisher’s exact test. RESULTS: Our preliminary analysis includes 126 students. The mean age was 20.2 years. Mean score on the 10-question LARC assessment was 5.2/10. Higher levels of LARC knowledge were positively associated with future intent to use LARC (P < 0.05). Only 7.9% of contraceptive users surveyed used LARC, compared to 15.8% of US contraceptive users in 2017. Differences in awareness of the copper IUD (61.1%), hormonal IUD (74.6%) and implant (88.9%) were statistically significant (P < 0.05). The most common reason cited for not considering LARC use was “need for more information.” Conclusions: University students surveyed displayed low LARC knowledge, low LARC use, and a need for more information on LARC. A positive association between LARC knowledge and future intent to use LARC amongst students at this university further supports need for a campus-wide contraceptive initiative that will empower students to make informed reproductive decisions. Understanding student use and knowledge of LARC could also provide a model for starting other university LARC initiatives across the United States, at which uptake of LARC has been historically low.
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    The Association between Sleep and Depression during Late Pregnancy and the Early Postpartum Period
    (Thieme, 2024-01-23) Jones, Angela G.; Hadaie, Bachar S.; Bennett, Rachel; Kumar, Nimisha; Saha, Chandan K.; Haas, David M.; Obstetrics and Gynecology, School of Medicine
    Objective: To assess and correlate sleep quality and depressed mood symptoms in the late pregnancy and early postpartum periods. Study Design: In a prospective pilot observational study, participants completed the Pittsburgh Sleep Quality Index (PSQI) and the Edinburgh Postnatal Depression Scale (EPDS) questionnaires at delivery, 1, and 2 months postpartum. Pearson's correlation coefficients and PROC MIXED function estimated overall correlation for repeated measures. Results: Twenty-six women were enrolled with a mean gestational age at delivery of 38.4 (± 2.4) weeks. Sleep quality and mood data were available at the three time points for 24, 16, and 11 participants, respectively. Poor sleep scores were noted by 75.0, 87.5, and 72.7% of women at the three time points. An elevated EPDS score of 10 or higher was claimed by 20.8, 12.5, and 18.2% of women, respectively. Higher PSQI scores were positively associated with higher EPDS scores overall ( r  = 0.71, p  < 0.001) and at each of the individual time points ( r  = 0.79, p  < 0.0001; r  = 0.52, p  = 0.04; and r  = 0.70, p  = 0.016, respectively). None of the women reporting good sleep quality had elevated EPDS scores. Conclusion: Poor sleep is commonly reported around delivery, and at 1 and 2 months postpartum, and there is an association between poor sleep and depression symptoms.