The Natural History of Overall Mortality with Diagnosed Symptomatic Gallstone Disease in the United States: A Sequential Mixed-methods Study Evaluating Emergency, Non-emergency, and No Cholecystectomy

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Project Abstract Surgery is often indicated when asymptomatic gallstone disease, with a prevalence as high as 20% in the US population, becomes symptomatic; this occurs when gallstones block the digestive drainage of the gallbladder, pancreas, liver, or intestine. Cholecystectomy, occurring in a million people in the US annually, is the surgical removal of the gallbladder to treat this diagnosed symptomatic gallstone disease (dSGD). Whether patients have a more morbid and costly emergency rather than a non-emergency cholecystectomy, may depend on many factors which are largely unknown. However, since emergency cholecystectomy has been suggested to possibly have 5 to 10x the mortality elective cholecystectomy has, if gallstone disease could be avoided completely via high-quality prevention and non-surgical therapy, or when surgery is indicated it could be elective rather than an emergency, overall mortality from this extremely common condition might be reduced. The objective of this K23 is to start population-based research on disease requiring emergency surgery, currently representing over two- thirds of healthcare delivery in US hospitals and alarmingly over half of total mortality and cost. This will begin with a study of the frequency of, and mortality from, emergency cholecystectomy, informed by the overall population experience with dSGD. The main hypothesis of this study is emergency has higher mortality than non-emergency cholecystectomy; if the natural history of dSGD were shifted from emergency to non-emergency cholecystectomy this leads to a decrease in the overall mortality rate with dSGD. The goal this program of research begins will be to provide population-based data to decrease less safe emergency surgery, moving toward safer non-emergency surgery or non-surgical care, decreasing the overall US mortality of dSGD in the process. The proposed study fits well with the candidate’s career development goals and 4-year training and mentoring program to evolve into an independent clinical epidemiologist studying digestive diseases requiring emergency surgery. The candidate is pivoting from a primarily clinical career to a research career. He has strong experience in emergency surgery and public health, and seeks training in rigorous clinical epidemiology methods, claims data research, deeper biostatistical expertise, new skills to collaborate on mixed-methods patient-oriented research, and a mentored transition to designing new etiologic studies of his own. The mentorship team consists of recognized experts in clinical epidemiology research and training, gallstone epidemiology, inferential biostatistics, prevention and qualitative methods, and emergency surgery, who will oversee the execution of the training and career development plan. Research and training will occur at Rutgers, which is a ripe environment for fostering this junior investigator through a transition to research independence. At the conclusion of this project, the candidate will have documented the natural epidemiology and the overall mortality of dSGD in the US, and how this may or may not have changed in response to increasing health insurance. This will inform the candidate’s design of future etiologic (R01) studies to understand and eventually to reduce mortality from dSGD.