Comparative Effectiveness Research and Patient Reported Outcomes in Diverticulitis

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PROJECT SUMMARY This is an application for a three-year mentored patient-oriented research career development award (K23). The overall goals are to 1) contribute to our understanding about the effectiveness, benefits and harms of antibiotics for acute diverticulitis and to develop a novel acute diverticulitis specific patient reported outcome measure through patient-oriented research; 2) educate and mentor the candidate clinician investigator while she transitions to independence. The candidate is a motivated clinical researcher at the University of North Carolina Chapel Hill with a background in digestive disease epidemiology and a solid publication record. The mentoring team includes an expert in gastrointestinal epidemiology (Sandler), pharmacoepidemiology and comparative effectiveness research (Sturmer) and patient reported outcome measures (Basch). Each member of the mentoring team has an established record of mentoring junior faculty, high research productivity, and substantial peer-reviewed support. The research and training environment at the University of North Carolina Chapel Hill is strong and well established. For fiscal year 2015, the University of North Carolina at Chapel Hill ranked ninth among both private and public universities nationwide for National Institutes of Health (NIH) research funding to domestic institutions of higher education. The candidate’s career development objectives are as follows: 1) to develop the knowledge and experience needed to perform analytic studies using large datasets with an emphasis on pharmacoepidemiology and comparative effectiveness research; 2) to develop knowledge and experience in patient-reported outcomes measures; 3) to transition to independence. To achieve these goals, the candidate will: 1) participate in advanced, graduate level coursework and conferences in pharmacoepidemiology, comparative effectiveness research and patient reported outcome measures; 2) attend The North Carolina Translational & Clinical Sciences Principal Investigator Development Series and join the R-Writing Group; 3) conduct mentor guided research. The specific aims of the research project are: 1) To evaluate the comparative effectiveness of antibiotic therapy with a combination a fluoroquinolone and metronidazole compared to amoxicillin-clavulanate alone for a first occurrence of medically managed outpatient acute diverticulitis on recurrence and complications using administrative claims data; 2) To develop an acute diverticulitis specific patient reported outcome measure: a) To identify the symptom domains relevant to patients with acute diverticulitis using qualitative research methods; b) To select items for an acute diverticulitis specific patient reported outcome measure using existing PRO instruments; c) To perform cognitive interviews with patients with acute diverticulitis to ensure content validity. The support and mentorship provided by a K23 is critical to achieve the candidate’s goal of transitioning to an independent physician-scientist in the field of digestive diseases.