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INTRODUCTION:Most quality improvement (QI) initiatives in inflammatory bowel disease (IBD) address clinical processes such as screening and vaccinations. Applying the principles and methods of QI, we conducted an initiative that encompassed insurance-related workflow processes required for prompt patient access to biologic IBD therapies.METHODS:The QI cohort comprised 22 gastroenterologists who were attending staff in an academic medical center (N = 14) or center-affiliated community clinics (N = 8). At baseline, the gastroenterologists completed a survey designed to assess their self-reported knowledge and practices involving insurance-related processes. We retrospectively audited the charts for 200 of the gastroenterologists' patients with confirmed active ulcerative colitis or Crohn's disease who had been prescribed a biologic medication. Assessments included the number of days between prescription request and various milestones involving prior authorization (PA) and prescriptions being filled and dispensed. In the intervention phase, the gastroenterologists and their clinical teams participated in a series of accredited grand rounds activities. Participants received audit feedback and developed action plans to reduce identified delays in patient access to biologic medications. Six months after the interventions, we audited the charts of 100 additional patients, assessing the same temporal measures as in the baseline review.RESULTS:The baseline survey findings indicated that 41% (21% academic vs 75% community) of gastroenterologists reported having limited or no confidence in understanding pre-authorization requirements; 18% (29% vs 0%) had standardized letters of necessity for patients needing biologics; and 9% (7% vs 13%) received approval for treatment coverage within 3-4 days. Patient characteristics were similar across the 2 sampling periods; median age was 37 (19-82) years, 54% were female, 62% had Crohn's disease, and 88% were covered by commercial insurance (Table 1). Across the baseline to follow-up audits, the mean number of days was reduced for key milestones, including prescription request to PA approval (11 vs 7 days), prescription written (18 vs 10 days), and prescription dispensed (43 vs 21 days; Figure 1).CONCLUSION:These findings reflect the potential for extending QI principles and methods to workflow processes in order to reduce insurance-related delays and facilitate prompt patient access to needed biologic therapies.Table 1.Patient and Disease Characteristics

Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high-diversity FMT donors is a promising treatment to induce remission in ulcerative colitis.MethodsWe designed a prospective, open-label pilot study to assess the safety, clinical efficacy, and microbial engraftment of single FMT delivery by colonoscopy for active ulcerative colitis using a 2-donor fecal microbiota preparation (FMP). Safety and clinical endpoints of response, remission, and mucosal healing at week 4 were assessed. Fecal DNA and rectal biopsies were used to characterize the microbiome and mucosal CD4+ T cells, respectively, before and after FMT.ResultsOf the 20 patients enrolled in this study, 7 patients (35%) achieved a clinical response by week 4. Three patients (15%) were in remission at week 4 and 2 of these patients (10%) achieved mucosal healing. Three patients (15%) required escalation of care. No serious adverse events were observed. Microbiome analysis revealed that restricted diversity of recipients pre-FMT was significantly increased by high-diversity 2-donor FMP. The microbiome of recipients post-transplant was more similar to the donor FMP than the pretransplant recipient sample in both responders and nonresponders. Notably, donor composition correlated with clinical response. Mucosal CD4+ T-cell analysis revealed a reduction in both Th1 and regulatory T-cells post-FMT.ConclusionsHigh-diversity, 2-donor FMP delivery by colonoscopy seems safe and effective in increasing fecal microbial diversity in patients with active ulcerative colitis. Donor composition correlated with clinical response and further characterization of immunological parameters may provide insight into factors influencing clinical outcome.

This study evaluated the effects of the Breath–Body–Mind Workshop (BBMW) (breathing, movement, and meditation) on psychological and physical symptoms and inflammatory biomarkers in inflammatory bowel disease (IBD).MethodsTwenty-nine IBD patients from the Jill Roberts IBD Center were randomized to BBMW or an educational seminar. Beck Anxiety Inventory, Beck Depression Inventory, Brief Symptom Inventory 18, IBD Questionnaire, Perceived Disability Scale, Perceived Stress Questionnaire, Digestive Disease Acceptance Questionnaire, Brief Illness Perception Questionnaire, fecal calprotectin, C-reactive protein, and physiological measures were obtained at baseline and weeks 6 and 26.ResultsThe BBMW group significantly improved between baseline and week 6 on Brief Symptom Inventory 18 (P = 0.02), Beck Anxiety Inventory (P = 0.02), and IBD Questionnaire (P = 0.01) and between baseline and week 26 on Brief Symptom Inventory 18 (P = 0.04), Beck Anxiety Inventory (P = 0.03), Beck Depression Inventory (P = 0.01), IBD Questionnaire (P = 0.01), Perceived Disability Scale (P = 0.001), and Perceived Stress Questionnaire (P = 0.01) by paired t tests. No significant changes occurred in the educational seminar group at week 6 or 26. By week 26, median C-reactive protein values decreased significantly in the BBMW group (P = 0.01 by Wilcoxon signed-rank test) versus no significant change in the educational seminar group.ConclusionsIn patients with IBD, participation in the BBMW was associated with significant improvements in psychological and physical symptoms, quality of life, and C-reactive protein. Mind–body interventions, such as BBMW, which emphasize Voluntarily Regulated Breathing Practices, may have significant long-lasting benefits for IBD symptoms, anxiety, depression, quality of life, and inflammation. BBMW, a promising adjunctive treatment for IBD, warrants further study.

Ulcerative colitis (UC) is frequently refractory to conventional medical therapy and new strategies are needed to induce remission. Fecal microbiota transplantation (FMT) is an alternate therapeutic strategy, which has been reported to improve remission rates when delivered via enema without significant adverse effects. To evaluate the safety and therapeutic efficacy of colonoscopic FMT for active UC, we performed an open-label, pilot study of 20 patients with non-infectious, active UC using a 2-donor fecal microbiota preparation (FMP) to enhance the biodiversity of the transplanted material.MethodsPatients with active UC (Mayo Score ≥3 and endoscopic subscore ≥1) were recruited from the Jill Roberts IBD Center. Twenty patients with stool samples negative for C. difficile and conventional gastrointestinal pathogens were enrolled. FMT was performed by colonoscopic delivery of a single 120 mL infusion of a 2-donor FMP concentrate (provided by OpenBiome) into the ileum and right colon. The primary outcome was clinical response (defined by a change in Mayo score ≥ 3 and a bleeding subscore ≤1) at week 4. Secondary endpoints included remission of UC (defined by a Mayo score ≤2 and no subscore >1) and mucosal healing (defined by an endoscopy subscore of 0) at week 4. Patients provided stool samples for microbiome analysis before and at week 2 and 4 following FMT.ResultsAll 20 patients completed clinical and endoscopic evaluation at week 4. No serious adverse events were noted. Seven patients (35%) achieved the primary outcome of clinical response by week 4. Three patients (15%) were in remission at week 4 and 2 of these patients (10%) achieved mucosal healing. Three patients (15%) required escalation of care (anti-TNFa therapy, N = 2; colectomy, N = 1). 16S rRNA analysis revealed that FMT significantly increased the recipient's microbial diversity (P = 0.001, Mann-Whitney) and that community composition at week 2 and week 4 was more similar to the donor FMP than recipient at baseline (PERMANOVA, P = 0.001).ConclusionsColonoscopic FMT using a 2-donor FMP is safe and effective in achieving clinical response by week 4 in patients with active UC. Longer-term follow up and correlation with microbial parameters will provide insight into factors influencing clinical outcome.