Concordance and Discordance Between Patient-reported Remission, Patient-reported Outcomes, and Physician Global Assessment.

BACKGROUND: Although validated patient-reported outcome (PRO) measurements can categorize patients with inflammatory bowel disease (IBD) into clinical remission or active disease, patients may have different definitions of remission. The purpose of this study was to compare patient-defined remission to remission based on PRO measures and physician global assessment (PGA) and to understand the clinical and demographic factors associated with disagreements. METHODS: We retrospectively analyzed 3257 de-identified surveys from 2004 IBD patients who consented to participate in the Crohn's and Colitis Foundation's IBD Qorus Learning Health System between September 2019 and February 2021. We used logistic regression models with generalized estimating equations to analyze the clinical and demographic factors (eg, age, disease duration, health confidence) associated with discordance between patient-defined remission (yes/no) and PRO-defined remission for ulcerative colitis (UC; PRO2: stool frequency, rectal bleeding) and Crohn's disease (CD; PRO-3: average number of liquid stools, abdominal pain, well-being). RESULTS: Among patients with UC, overall concordance was 79% between patient self-report and PRO2-defined remission and 49% between patient self-report and PGA-defined remission. Among patients with CD, overall concordance was 69% between patient self-report and PRO3-defined remission and 54% between patient self-report and PGA-defined remission. Patients in PRO-defined remission were more likely to report active disease if they had IBD <5 years and low health confidence. Patients with PRO-defined active disease were more likely to report remission if they were not using prednisone and had high health confidence. CONCLUSION: Discordance exists between how remission is defined by patients, PRO measures, and PGA.

Discordance between patients' self-reported remission and remission defined based on patient-reported outcomes was observed in 31% of Crohn's disease visits and 21% of ulcerative colitis visits. Disease duration and health confidence were associated with discordance.

An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease.

BACKGROUND: Despite regular need for colonoscopy in patients with Crohn's disease (CD), the efficacy and tolerability of bowel preparation (BP) agents is rarely assessed in this population. Assessing BP quality with existing scales may be challenging in CD due to presence of inflammation, bowel resection, and strictures. AIMS: To provide recommendations for assessing BP quality in clinical trials for CD using a modified Research and Development/University of California, Los Angeles appropriateness process. METHODS: Based on systematic reviews and a literature search, 110 statements relating to BP quality assessment in CD were developed. A panel of 15 gastroenterologists rated the statements as appropriate, uncertain, or inappropriate using a 9-point Likert scale. RESULTS: Panelists considered it appropriate that central readers, either alone or with local assessment, score BP quality in clinical trials. Central readers should be trained on scoring BP quality and local endoscopists on performing high-quality video recording. Both endoscope insertion and withdrawal phases should be reviewed to score BP quality in each colonic segment and segments should align with endoscopic disease activity indices. The Harefield Cleansing Scale and the Boston Bowel Preparation Scale were considered appropriate. The final score should be calculated as the average of all visualized segments. Both total and worst segment scores should also be assessed. CONCLUSIONS: We developed a framework for assessing BP quality in patients with CD based on expert feedback. This framework could support the development or refinement of BP quality scales and the integration of BP quality assessment in future CD studies.

Risks of Development of COVID-19 Among Patients With Inflammatory Bowel Disease: A Comparative Assessment of Risk Factors for Incident Infection.

Background: Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. Methods: In a prospective cohort of adult IBD patients, we captured data on clinical risk factors and IBD medication utilization. The outcome of interest was development of patient-reported laboratory confirmed COVID-19. We calculated incidence rate and performed bivariate analyses to describe the effects of risk factors (age, immunosuppression use, obesity, and race) on development of COVID-19. We utilized logistic regression models to determine the independent risks associated with each factor. Results: A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). A total of 103 individuals developed COVID-19 during follow-up (2.6%, rate of 45 per 1000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18-9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72-1.75), nor was age (OR 1.00, 95% CI 0.99-1.02), nor obesity (OR 1.01, 95% CI 0.61-1.66). Conclusions: Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.

Health Economic Impact of a Multicenter Quality-of-Care Initiative for Reducing Unplanned Healthcare Utilization Among Patients With Inflammatory Bowel Disease.

INTRODUCTION: A multicenter adult inflammatory bowel disease learning health system (IBD Qorus) implemented clinical care process changes for reducing unplanned emergency department visits and hospitalizations using a Breakthrough Series Collaborative approach. METHODS: Using Markov decision models, we determined the health economic impact of participating in the Collaborative from the third-party payer perspective. RESULTS: Across all 23 sites, participation in the Collaborative was associated with lower annual costs by an average of $2,528 ± $233 per patient when compared with the baseline period. DISCUSSION: Implementing clinical care process changes using a Collaborative approach was associated with overall cost savings. Future work should examine which specific interventions are most effective and whether such cost savings are sustainable.

Evaluating the Impact of Cost on the Treatment Algorithm for Chronic Idiopathic Constipation: Cost-Effectiveness Analysis.

INTRODUCTION: Chronic idiopathic constipation (CIC) is a common and burdensome illness. We performed a cost-effectiveness analysis of the US Food and Drug Administration-approved CIC drugs to evaluate and quantify treatment preferences compared with usual care from insurer and patient perspectives. METHODS: We evaluated the subset of patients with CIC and documented failure of over-the-counter (OTC) osmotic or bulk-forming laxatives. A RAND/UCLA consensus panel of 8 neurogastroenterologists informed model design. Treatment outcomes and costs were defined using integrated analyses of registered clinical trials and the US Centers for Medicare and Medicaid Services-supported cost databases. Quality-adjusted life years (QALYs) were calculated using health utilities derived from clinical trials. A 12-week time horizon was used. RESULTS: With continued OTC laxatives, CIC-related costs were $569 from an insurer perspective compared with $3,154 from a patient perspective (considering lost wages and out-of-pocket expenses). CIC prescription drugs increased insurer costs by $618-$1,015 but decreased patient costs by $327-$1,117. Effectiveness of CIC drugs was similar (0.02 QALY gained/12 weeks or ∼7 healthy days gained/year). From an insurer perspective, prescription drugs (linaclotide, prucalopride, and plecanatide) seemed less cost-effective than continued OTC laxatives (incremental cost-effectiveness ratio >$150,000/QALY gained). From a patient perspective, the cost-effective algorithm started with plecanatide, followed by choosing between prucalopride and linaclotide starting at the 145-µg dose (favoring prucalopride among patients whose disease affects their work productivity). The patient perspective was driven by drug tolerability and treatment effects on quality of life. DISCUSSION: Addressing costs at a policy level has the potential to enable patients and clinicians to move from navigating barriers in treatment access toward truly optimizing treatment choice.

Transforming Gastroenterology Care With Telemedicine.

Health care is changing rapidly, so we must change with the times to develop more efficient, practical, cost-effective, and, importantly, high-quality methods to care for patients. We teach medical students that optimal patient care requires face-to-face interaction to collect information on the patient's history and perform the physical examination. However, management of many patients-especially those with chronic diseases-does not always require physical examination. Telemedicine offers an opportunity to take advantage of technology while leveraging the progressive push toward efficiency and value but also requires the belief that excellent patient care is not always provided in person. Telemedicine can include a variety of aspects of patient care adapted to be performed remotely, such as telemonitoring, tele-education, teleconsultation, and telecare. All of these have been evaluated in gastroenterology practice and have demonstrated feasibility and patient preference but have produced mixed results regarding patient outcomes. By combining telemedicine tools and new care models, we can redesign chronic disease management to include fewer in-person visits when patients are well yet increase access for patients who need to be seen. This change could lead to higher-value care by improving the experience of care, decreasing costs, and improving the health of the population. Barriers include reimbursement, licensing, and fear of litigation. However, if we hope to meet the needs of patients within our changing health care system, telemedicine should be incorporated into our strategy.

Assessment of Gaps in Care and the Development of a Care Pathway for Anemia in Patients with Inflammatory Bowel Diseases.

BACKGROUND: Anemia is a common complication among patients with inflammatory bowel diseases (IBD) and is associated with high rates of IBD-related complications, resource utilization, and impaired quality of life. Despite practice guidelines for anemia in patients with IBD, gaps remain in the perceptions of anemia among health care providers. The aims of this study were to identify gaps in care and to develop a care pathway for anemia in patients with IBD. METHODS: The Crohn's & Colitis Foundation of America anemia care pathway was developed by a committee using principles of cognitive task analysis. Focus groups of providers of patients with IBD were performed to identify domains of perceptions and management decisions for anemia and IBD. Knowledge elicitation from subject experts in anemia was conducted using case-based scenarios of patients with IBD and anemia to determine decision-making branch points. The care pathway was modified in an iterative fashion to encompass clinical presentations of anemia in IBD and potential barriers to the recognition, management, and follow-up of anemia. RESULTS: Variations were observed in how providers define iron deficiency, thresholds for treatment of anemia, and route of iron therapy. A care pathway for anemia incorporating the World Health Organization definition of anemia, universal hemoglobin and ferritin screening, evaluation of iron stores using ferritin and transferrin saturation, management of anemia based on adequacy of iron stores, and follow-up was developed. CONCLUSIONS: The authors identified domains of how providers perceive and manage patients with IBD and anemia, and developed a care pathway to align clinical practices with guideline recommendations.

Increasing Patient Activation Could Improve Outcomes for Patients with Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) is a complex disease process that often requires the integration of skills from various health care providers to adequately meet the needs of patients with IBD. The medical and surgical treatment options for IBD have become more complicated and are frequently a source of angst for both the patient and provider. However, it has become more important than ever to engage patients in navigating the treatment algorithm. Although novel in the IBD world, the concept of patients' becoming more active and effective managers of their care has been well studied in other disease processes such as diabetes mellitus and mental illness. This idea of patient activation refers to a patient understanding his or her role in the care process and having the skill sets and self-reliance necessary to manage his or her own health care. Over the past decade, evidence supporting the role of patient activation in chronic illness has grown, revealing improved health outcomes, enhanced patient experiences, and lower overall costs. Patient activation can be measured, and interventions have been shown to improve levels of activation over time and influence outcomes. A focus on patient activation is very appropriate for patients with IBD because this may potentially serve as a tool for IBD providers to not only improve patient outcomes and experience but also reduce health care costs.

Gastroenterologists' Views of Shared Decision Making for Patients with Inflammatory Bowel Disease.

BACKGROUND: There is limited information on gastroenterologists' perspectives of shared decision making (SDM) in discussions of therapeutic agents with inflammatory bowel disease (IBD) patients. AIMS: To examine gastroenterologists' perspectives about SDM with IBD patients, using a novel statistical hybrid approach to analyze qualitative data. METHODS: Physician interviews and online surveys were conducted from a panel of gastroenterologists in April 2012. Gastroenterologists were asked about their barriers to SDM, SDM practices, relationship to their patients, knowledge of SDM, and insights into SDM implementation. Key audio excerpts adapted from the interviews were used for moment-to-moment affect trace analysis in an online survey. Cluster analysis was used to segment gastroenterologists into mutually exclusive provider groups. RESULTS: One hundred and six gastroenterologists completed the survey (88 % male; 55 % ≤ 50 years of age). Over three-fourths of gastroenterologists were familiar with SDM (77 %). The vast majority of gastroenterologists (80 %) tried to use a form of SDM with their patients; only 12 % stated that they have a systematic, consistent, and formally documented approach to SDM. Three unique physician clusters were identified: SDM Believers (20 %, n = 20); SDM Skeptics (47 %, n = 47); and SDM Enthusiasts (34 %, n = 34). The three key barriers to practicing SDM were lack of the following: time (74 %), reimbursement (70 %), and tools (51 %). Twenty-two percent of gastroenterologists do not currently use SDM tools. CONCLUSIONS: Gastroenterologists lack the systematic approaches and tools for implementing SDM within their IBD practices. These data offer a foundation for future research in developing and testing SDM programs for gastroenterologists and their IBD patients.

Adverse events do not outweigh benefits of combination therapy for Crohn's disease in a decision analytic model.

BACKGROUND & AIMS: The Study of Biologic and Immunomodulator-Naïve Patients With Crohn's Disease (SONIC) showed that combination therapy with infliximab and azathioprine (IFX/AZA) is more effective than treatment with IFX alone. Numbers and types of adverse events were roughly equivalent among groups, although enrollment was limited, so it was not clear how rare adverse events might affect overall outcomes in practice. We sought to define the frequency at which a rare adverse event would have to occur for the risks of combination therapy to outweigh the benefits of treatment. METHODS: We constructed a decision model to compare the risks and benefits of IFX/AZA with IFX monotherapy. Model parameters were taken from SONIC and other published literature. The base-case analysis was patients with active Crohn's disease who are naïve to both medications (similar to those in SONIC) who were treated for 1 year. We used sensitivity analyses to determine the thresholds at which the risks of side effects from IFX/AZA outweigh its benefits. RESULTS: During 1 year, the benefits of IFX/AZA would outweigh the risks, unless serious infections occurred in 20% or more of the population or lymphoma in 3.9% or more. These thresholds are 5-fold and 65-fold higher than base-case estimates, respectively. CONCLUSIONS: On the basis of data from 1 year of SONIC, the combination of IFX/AZA was more effective than IFX alone in patients with Crohn's disease who are naïve to either drug. For the risks of combination therapy to outweigh the benefits in this time frame, the incidence of serious adverse events would have to be higher than seems clinically realistic.

Impact of ulcerative colitis from patients' and physicians' perspectives: Results from the UC: NORMAL survey.

BACKGROUND: Two national internet surveys were conducted to understand how patients perceive the impact of ulcerative colitis (UC) relative to gastroenterologists. METHODS: In total, 451 patients with UC (20% mild, 63% moderate, 13% severe, 4% unsure [patient self-assessment]) were recruited for one survey and 300 gastroenterologists (not associated with the patients) were recruited for the other survey. RESULTS: Patients reported, on average, 8 (self-defined) flares per year; this was more than the number anticipated by gastroenterologists. Sixty-two percent of patients with UC reported that their disease made it difficult to lead a normal life, compared with gastroenterologists' estimations of 36%. Only 42% of patients believed that being in remission could mean living without symptoms. Both patients and gastroenterologists reported that it is difficult for patients to take medication as prescribed every day (42% and 90%) and that managing UC medication is a struggle for patients (49% and 41%). Forty-six percent of patients admitted nonadherence to their therapy over the previous week, while gastroenterologists believed that 41% of their patients were not adherent. CONCLUSIONS: These surveys identified disparities between patients' and gastroenterologists' perceptions of the impact of UC on patients' lives. The results suggest that more patients than gastroenterologists estimated chose to adapt their lives to accommodate UC rather than act to optimize therapy and adherence. Improved communication between patients and gastroenterologists, as well as better management strategies and education are necessary.