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Using Real-Wolrd Healthcare Data to Define and Prevent Complications in Inflammatory Bowel Disease

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Using Real-Wolrd Healthcare Data to Define and Prevent Complications in Inflammatory Bowel Disease USING REAL-WOLRD HEALTHCARE DATA TO DEFINE AND PREVENT COMPLICATIONS IN INFLAMMATORY BOWEL DISEASE by Alyce Jane Marsh Anderson Biochemistry & Nutritional Science, University of Wisconsin – Madison, 2010 Submitted to the Graduate Faculty of the School of Medicine in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Clinical and Translational Sciences University of Pittsburgh 2017 UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE This dissertation was presented by Alyce JM Anderson It was defended on July 24, 2017 and approved by Galen Switzer, PhD, Professor, Medicine, Kaleab Abebe, PhD, Associate Professor, Medicine Ken Smith, MD, MS, Professor, Medicine Laura Ferris, MD, PhD, Associate Professor, Dermatology Dissertation Advisor: David Binion, MD, Professor, Medicine ii Copyright © by Alyce Anderson 2017 iii USING REAL-WOLRD HEALTHCARE DATA TO DEFINE AND PREVENT COMPLICATIONS IN INFLAMMATORY BOWEL DISEASE Alyce Anderson University of Pittsburgh, 2017 Inflammatory bowel disease (IBD) is a collection of chronic, immune mediated disorders of the gastrointestinal track, characterized by relapsing and remitting disease activity. Despite our growing understanding of risk factors associated with developing disease, we still lack understanding of the impact of disease complications and how to best avoid complications with preventive care. Two known complications of IBD include the increased predisposition to Clostridium difficile infection and the increased risk of non-melanoma and melanoma skin cancers. This thesis aims to (1) define the long-term impact of Clostridium difficile infection on IBD patients after accounting for patients’ inherent risk of infection, (2) evaluate the rate at which IBD patients access dermatologic preventive care for skin cancer screening, and (3) model the cost-effectiveness of melanoma screening strategies in the IBD patient population. We found that Clostridium difficile infection was significantly associated with more steroid and antibiotic exposure, elevated inflammatory markers, increased disease activity, worse quality of life, and increased healthcare utilization in the year of infection. During the year after infection, patients in the Clostridium difficile group continued to have increased exposure to Clostridium difficile targeted antibiotics and other systemic antibiotics, while having more clinic visits, telephone encounters, and a five-fold increase in healthcare charges. We determined that 21% of IBD patients utilized dermatology from 2010-2016, and 2.6% of patients had at least one total body exam for skin cancer screening. Between 8% and 11% of patients recommended by gastroenterology preventive care guidelines visited dermatology each iv year, suggesting only a small proportion of IBD patients recommended for screening obtain dermatologic care. Finally, we used a Markov model to estimate intervention costs and effectiveness of melanoma screening in the IBD population. We found screening for melanoma in IBD patients was more effective, but expensive. Among model variations, screening every other year was the most cost-effective strategy. In conclusion, the dissertation reveals the long-term impact of infection among IBD patients, the underutilization of dermatologic preventive care, and provides a cost effectiveness model to inform the development of skin cancer screening programs in IBD. v TABLE OF CONTENTS PREFACE ................................................................................................................................. XIII 1.0 INTRODUCTION................................................................................................................ 1 1.1 INFLAMMATORY BOWEL DISEASE (IBD) ........................................................ 1 1.1.1 Epidemiology of IBD ........................................................................................ 1 1.1.2 Complications of IBD ....................................................................................... 1 1.1.2.1 Clostridium difficile infection .............................................................. 2 1.1.2.2 Extraintestinal manifestations ............................................................. 3 1.1.2.3 Skin Cancer ........................................................................................... 3 1.2 STATEMENT OF PROBLEM AND MAJOR QUESTIONS................................. 4 2.0 IBD RESEARCH REGISTRY METHODOLOGY ......................................................... 6 2.1 INTRODUCTION ....................................................................................................... 7 2.2 METHODS ................................................................................................................... 8 2.2.1 Registry Setting ................................................................................................ 8 2.2.2 Registry Enrollment ......................................................................................... 9 2.2.3 Registry Design and Measures ...................................................................... 10 2.2.4 Quality Assurance .......................................................................................... 16 2.2.5 Registry Team................................................................................................. 16 2.2.6 Ethical Considerations ................................................................................... 17 vi 2.3 RESULTS ................................................................................................................... 17 2.4 DISCUSSION ............................................................................................................. 24 3.0 THE LASTING IMPACT OF CLOSTRIDIUM DIFFICILE INFECTION IN INFLAMMATORY BOWEL DISEASE: A PROPENSITY-SCORE MATCHED ANALYSIS .................................................................................................................................. 29 3.1 INTRODUCTION ..................................................................................................... 30 3.2 MATERIALS, METHODS AND DESIGN ............................................................ 31 3.2.1 Study design and participants ....................................................................... 31 3.2.2 Data collection and organization .................................................................. 32 3.2.3 Propensity score matching ............................................................................ 34 3.2.4 Statistical analysis .......................................................................................... 36 3.2.5 Ethical Considerations ................................................................................... 37 3.3 RESULTS ................................................................................................................... 37 3.3.1 Year of infection ............................................................................................. 40 3.3.2 Year after infection ........................................................................................ 42 3.3.3 Year after infection, excluding patients with multiple infections .............. 45 3.4 DISCUSSION ............................................................................................................. 46 4.0 LOW RATES OF DERMATOLOGIC CARE AND SKIN CANCER SCREENING AMONG INFLAMMATORY BOWEL DISEASE PATIENTS ............................................ 50 4.1 INTRODUCTION ..................................................................................................... 51 4.2 METHODS ................................................................................................................. 52 4.2.1 Study population ............................................................................................ 52 4.2.2 Clinical data collection ................................................................................... 53 vii 4.2.2.1 IBD related clinical information ........................................................ 53 4.2.2.2 Dermatology utilization data ............................................................. 54 4.2.3 Definition of high-risk subgroups for skin cancer screening ..................... 55 4.2.4 Capturing skin cancer diagnoses .................................................................. 56 4.2.5 Statistical analysis .......................................................................................... 56 4.2.6 Ethical considerations .................................................................................... 57 4.3 RESULTS ................................................................................................................... 57 4.3.1 Study cohort .................................................................................................... 57 4.3.2 Dermatology healthcare utilization .............................................................. 59 4.3.3 Indications for dermatologic care ................................................................. 59 4.3.4 Annual rate of dermatology use in IBD patients ......................................... 60 4.3.5 IBD characteristics associated with dermatology utilization ..................... 62 4.3.6 Skin cancer screening .................................................................................... 63 4.3.7 Skin cancer diagnoses .................................................................................... 66 4.4 DISCUSSION ............................................................................................................
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