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Pragmatic clinical research is part of five focus areas of the Challenges in IBD research document, which also includes preclinical human IBD mechanisms, environmental triggers, novel technologies, and precision medicine. The Challenges in IBD research document provides a comprehensive overview of current gaps in inflammatory bowel diseases (IBD) research and delivers actionable approaches to address them. It is the result of multidisciplinary input from scientists, clinicians, patients, and funders, and represents a valuable resource for patient centric research prioritization. In particular, the pragmatic clinical research section is focused on highlighting gaps that need to be addressed in order to optimize and standardize IBD care. Identified gaps include: 1) understanding the incidence and prevalence of IBD; 2) evaluating medication positioning to increase therapeutic effectiveness; 3) understanding the utility of therapeutic drug monitoring (TDM); 4) studying pain management; and 5) understanding healthcare economics and resources utilization. To address these gaps, there is a need to emphasize the use of emerging data sources and real-world evidence to better understand epidemiologic and therapeutic trends in IBD, expanding on existing data to better understand how and where we should improve care. Proposed approaches include epidemiological studies in ethnically and geographically diverse cohorts to estimate incidence and prevalence of IBD and impact of diversity on treatment patterns and outcomes. The implementation of new clinical trial design and methodologies will be essential to evaluate optimal medication positioning, appropriate use of TDM in adults and children, and multidisciplinary approaches to IBD pain management and its impact on healthcare resources., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: To estimate the prevalence of gastrointestinal (GI) and non-GI comorbidities and the risk of incident comorbidities among patients with and without chronic constipation (CC)., Research Design and Methods: Adults with CC were identified from a large retrospective US claims database. Each CC patient was matched 1:3 to CC-free patients by birth year, sex, and region of residence., Main Outcome Measures: Prevalence of GI and non-GI comorbidities was measured over a 1-year period. Relative risk of new comorbidities was also estimated among patients who were free of the studied comorbidity prior to the index date., Results: Mean age was 61.9 years; 33.3% of patients were male. The 1-year prevalence of GI comorbidities was significantly higher in CC (N = 28,854) vs. CC-free (N = 86,562) patients (all p < 0.05). The risk of developing new GI conditions was also significantly higher in CC patients for all studied conditions except ulcerative colitis: megacolon (hazard ratio [95% confidence interval] HR [CI] = 11.96 [8.16-17.53]), intestinal impaction (10.56 [9.22-12.10]), volvulus (7.12 [5.42-9.35]), other specified functional intestinal disorders (6.67 [5.57-8.00]), and other unspecified functional disorders of intestine (4.60 [3.61-5.87]). Similarly, 1-year prevalence of non-GI comorbidities was higher in CC patients, as was the risk of developing new conditions: depression and mood disorder (HR [CI] = 1.84 [1.77-1.90]), neurological disorders (1.68 [1.62-1.74]), iron deficiency anemia (1.52 [1.47-1.57]), hypothyroidism (1.40 [1.34-1.46]), and peripheral vascular disorders (1.40 [1.34-1.46])., Limitations: An algorithm was used to define CC as there is no specific diagnosis code to identify CC., Conclusions: CC patients had significantly higher prevalence and were at increased risk of developing new GI and non-GI comorbidities than age-, gender- and region-matched CC-free patients. Future research is warranted to better understand these associations.

Background: Chronic constipation (CC) is a highly prevalent health problem, potentially associated with increased risk of colorectal cancer (CRCancer)., Aim: To investigate the association between CC, its severity, and CRCancer by estimating the relative risk of developing CRCancer and benign colorectal neoplasm (BCN) among severity-stratified patients with and without CC., Methods: Chronic constipation patients from a large retrospective US claims database were matched 1:3 with CC-free controls by demographic characteristics. CRCancer and BCN prevalence were measured over 1 year. In pre-index CRCancer- and BCN-free patients, incidence rate ratios (IRRs) of new CRCancer and BCN were calculated. Multivariate regression models adjusted for comorbidities and family history. CC patients' disease severity was rated based on CC-related resource use. IRRs for new CRCancer and BCN were estimated for CC severity groups and controls., Results: Chronic constipation (N = 28,854) and CC-free (N = 86,562) patients had mean age 61.9 years; 66.7% were female. One-year CRCancer prevalence was 2.7% and 1.7%, and BCN prevalence was 24.8% and 11.9% for CC and CC-free patients, respectively. Adjusted IRRs between CC and CC-free patients were 1.59 [95% confidence interval (CI): 1.43-1.78] and 2.60 [95% CI: 1.51-2.70] for CRCancer and BCN, respectively. Patients with severe and very severe CC had significantly greater incidence of CRCancer and BCN. At ≥ 2 and ≥ 5 years of observation, CRCancer and BCN incidence remained consistently and significantly higher for CC patients., Conclusions: Patients with chronic constipation are associated with significantly higher prevalence and incidence of colorectal cancer and benign colorectal neoplasm than matched chronic constipation-free patients. These risks increase with the severity of chronic constipation., (© 2014 John Wiley & Sons Ltd.)

Constipation is one of the most common digestive disorders in the United States; however, the association of this condition with related comorbidities, both gastrointestinal and extraintestinal, is poorly documented. Here, we have reviewed the association of constipation with specific comorbidities. The data suggest that there are considerable clinical consequences associated with constipation. Ultimately, realization of the disease risks associated with chronic constipation may provide the impetus needed to direct new research, and shift attention on the part of patients and practitioners to methods for preventing significant and potentially costly comorbid medical problems.