Safety and Effectiveness of Nonsteroidal Anti-Inflammatory Drugs in Women with Crohn's Disease - The candidate, Erica Brenner MD, MSCR, is a pediatric gastroenterologist with training in epidemiology and qualitative methodology. Dr. Brenner’s long-term goal is to become an independently funded physician scientist focused on clinical trials and patient-centered research to improve women’s health for patients with inflammatory bowel disease (IBD). Dr. Brenner’s short-term goals are to: 1) train in psychometrics with a focus on developing and validating patient-reported outcome measures (PROMs), 2) acquire the necessary didactic and experiential training to design and conduct clinical trials, and 3) amass the professional training and conduct the preliminary studies required to successfully compete for R01 (or equivalent) funding. The proposed research activities, career development plan, mentorship team, and institutional environment are strategically designed to assist the applicant in achieving these aspirations. The overarching goal of the proposed work and subsequent research is to improve pain management in IBD by re-evaluating the use of non-steroidal anti-inflammatory drugs (NSAIDs) among women with Crohn’s disease (CD) and primary dysmenorrhea (painful menses without underlying pathology). Although patients with IBD commonly experience pain, they typically avoid NSAIDs due to concern for exacerbation of IBD, particularly CD, albeit based on weak data. Women with CD frequently experience dysmenorrhea, which may be debilitating, and thus represent an ideal sub-population to re-evaluate NSAID use in CD. The proposed aims for this K23 award will pave the way for a much-needed randomized control trial (RCT). In Aim 1, Dr. Brenner will develop PROMs for women with CD that capture primary dysmenorrhea severity while accounting for CD symptom overlap, using qualitative interviews followed by validation work in a two-center, prospective, longitudinal cohort. In Aim 2, Dr. Brenner will conduct a single-center pilot study to inform the design of a subsequent RCT to compare ibuprofen versus acetaminophen for primary dysmenorrhea treatment among women with CD. Dr. Brenner’s training goals include 1) PROM development and 2) the design and conduct of RCTs. Dr. Brenner will achieve these goals through the proposed advanced coursework and practical research experience, in addition to engaging in academic skill building activities. Dr. Brenner’s mentorship team, including a world- renowned health service researcher (Kappelman; primary mentor), an internationally recognized PROM development expert (Reeve; co-mentor), an epidemiologist and trialist (Baron; advisor), a gastroenterologist specializing in women’s health in IBD (Long; advisor), and a gynecologist with expertise in women’s health (Bryant; advisor), will guide Dr. Brenner through the proposed work. The environment at UNC, which includes the North Carolina Translational and Clinical Sciences Institute, the National Institutes of Health-funded Center for Gastrointestinal Biology and Disease, and the larger university community, will provide an ideal atmosphere for Dr. Brenner to pursue the above research and career development activities.
