Plecanatide Improves Symptoms of Irritable Bowel Syndrome with Constipation: Results of an Integrated Efficacy and Safety Analysis of Two Phase 3 Trials.

Purpose: Patients with irritable bowel syndrome with constipation (IBS-C) experience abdominal pain with altered bowel movements. Plecanatide is indicated as IBS-C treatment in adults. This integrated analysis further characterizes plecanatide efficacy and safety in IBS-C. Patients and Methods: Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks. A daily diary recorded stool frequency/symptoms, with abdominal pain, bloating, cramping, discomfort, fullness, and straining intensity individually rated. Overall response (primary endpoint) was defined as ≥30% improvement from baseline in average worst abdominal pain severity and increase of ≥1 complete spontaneous bowel movement, during same week (composite), for ≥6 of 12 weeks. Secondary endpoints included sustained response (overall response, plus meeting weekly composite criteria during ≥2 of last 4 treatment weeks) and changes from baseline in individual symptoms. Safety assessments included adverse event monitoring. Results: Overall, 2176 patients (74.0% female; mean [SD] age, 43.5 [14.1] years) were included in efficacy analyses (plecanatide 3 mg [n = 724], 6 mg [n = 723], placebo [n = 729]). A significantly greater percentage of patients achieved overall response with plecanatide 3 mg (25.6%) and 6 mg (26.7%) versus placebo (16.0%; both P < 0.001 vs placebo). A significantly greater percentage of patients were sustained responders with plecanatide 3 mg (24.3%) and 6 mg (25.6%) versus placebo (15.6%; both P < 0.001 vs placebo). Significant improvements from baseline in abdominal discomfort, abdominal fullness, abdominal pain, bloating, and cramping occurred as early as Week 1 (Week 2 for abdominal pain) with plecanatide and were maintained through Week 12 versus placebo. Diarrhea, the most common adverse event, occurred in 4.3% (3 mg), 4.0% (6 mg) and 1.0% (placebo) of patients, leading to study discontinuation in 1.2%, 1.4%, and 0 patients, respectively. Conclusion: Plecanatide is safe and effective for treating global and individual IBS-C symptoms.

Assessment of Stakeholder Perceptions and Cost of Implementing a Telemedicine Specialty Program at Correctional Facilities in North Carolina.

Background Delivering in-person health care to the more than 1.2 million incarcerated adults can be expensive, logistically challenging, fragmented, and pose security risks. The purpose of this study was to evaluate the implementation of a specialty care telemedicine program in statewide prisons in North Carolina during the COVID-19 pandemic. Methods We evaluated the first 6 months of implementation of a new telemedicine program to deliver specialty care to adults incarcerated in 55 North Carolina prison facilities. We measured patient and practitioner perceptions and the impact on the cost of care. Results A total of 3232 telemedicine visits were completed across 55 prisons within the first 6 months of the program. Most patients reported that the ability to use telemedicine contributed to their overall personal well-being and safety. Many practitioners found that working with the on-site nursing staff to conduct physical exams and to make collective decisions were key drivers to the success of telemedicine. A direct relationship was found between the telemedicine experience and patients' preference for future visits such that as satisfaction increased, the desire to use telemedicine increased. Telemedicine reduced total costs of care by $416,020 (net: -$95,480) within the first 6 months, and $1,195,377 estimated in the first 12 months postimplementation (95% confidence interval: $1,100,166-$1,290,587). Conclusions Implementing specialty care telemedicine in prison facilities enhanced patient and practitioner experiences and reduced costs within the prison system. The implementation of telemedicine in prison systems can increase access to care and reduce public safety risks by eliminating unnecessary off-site medical center visits.

Implementing Collaborative Care Management of Behavioral Health for Patients with Inflammatory Bowel Disease.

Background: Individuals with inflammatory bowel disease (IBD) are up to twice as likely to suffer from anxiety and/or depression. Collaborative care management (CoCM) is an evidence-based approach to treating behavioral health disorders that have proven effective for a range of conditions in primary care and some specialty settings. This model involves a team-based approach, with care delivered by a care manager (case reviews and behavioral therapy), psychiatrist (case reviews and psychopharmacological recommendations), and medical provider (ongoing care including psychopharmacological prescriptions). We assessed the feasibility and effectiveness of CoCM in reducing anxiety and depressive symptoms in patients with IBD. Methods: Patients with psychological distress identified by clinical impression and/or the results of the Patient Health Questionaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) were referred to the CoCM program. Data from our 9-month CoCM pilot were collected to assess depression and anxiety response and remission rates. We obtained provider surveys to assess provider acceptability with delivering care in this model. Results: Though the SARS-CoV2 COVID-19 pandemic interrupted screening, 39 patients enrolled and 19 active participants completed the program. Overall, 47.4% had either a response or remission in depression, while 36.8% had response or remission in anxiety. The gastroenterologists highly agreed that the program was a beneficial resource for their patients and felt comfortable implementing the recommendations. Discussion: CoCM is a potentially feasible and well accepted care delivery model for treatment of depression and anxiety in patients with IBD in a specialty gastroenterology clinic setting.

Backslide or forward progress? Virtual care at U.S. healthcare systems beyond the COVID-19 pandemic.

The COVID-19 pandemic forced most U.S. healthcare systems to quickly pivot to virtual care. However, since peaking in late April, care has largely shifted back to in-person. Health systems are now challenged to further develop and integrate useful, usable, and sustainable virtual care tools into their broader care model in ways that benefit their organizations and the communities they serve.

An integrated electronic health record-based workflow to improve management of colonoscopy-generated pathology results.

PURPOSE: Managing and communicating colonoscopy-generated pathology results and appropriate follow-up recommendations can be challenging. To improve this process, we developed and implemented a standardized electronic health record-based intervention with built-in decision support. METHODS: Fourteen attending endoscopists performed enough colonoscopies to qualify for the study. For each, we randomly sampled and abstracted data from 35 colonoscopies that met prespecified inclusion criteria during both the pre-intervention and also post-intervention periods. Follow-up recommendations were compared to guidelines. We used the Wilcoxon Signed Rank Test to assess the change in the proportion of cases with guideline-concordant results, the proportion with a documented follow-up result letter, and the median time to letter completion. A brief survey assessed endoscopists' satisfaction with the intervention. RESULTS: In total, 1,947 colonoscopies were extracted, of which 968 met inclusion criteria. The proportion of follow-up recommendations that were guideline concordant increased from a median of 82.9% pre-intervention to 85.7% post-intervention (P=0.72). The proportion of observations with a documented follow-up result letter increased from a median of 88.9% pre-intervention to 97.1% post-intervention (P=0.07). The number of calendar days between the date of the colonoscopy and the date the letter was sent decreased from a median of 7.7 days pre-intervention to 6.8 days post-intervention (P=0.79). Eighty-six percentage of endoscopists were either "very satisfied" or "satisfied" with the overall process. CONCLUSION: The intervention was not associated with a statistically significant increase in guideline-concordant recommendations or efficiency measures, perhaps due to high baseline performance. The intervention was well received by endoscopists and captured data necessary for important downstream processes.

Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials.

OBJECTIVES: Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C). METHODS: Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks. The primary efficacy end point was the percentage of overall responders (patients reporting ≥30% reduction from baseline in worst abdominal pain plus an increase of ≥1 complete spontaneous bowel movement (CSBM)/week from baseline in the same week for ≥6 of 12 treatment weeks). Safety was assessed by adverse events (AEs). RESULTS: Overall, 2189 individuals were randomized across the two studies and 1879 completed the studies. Demographic and baseline characteristics were similar across treatment groups and between studies. The percentage of overall responders in Study 1 was 30.2% and 29.5% for plecanatide 3 and 6 mg, respectively, vs. 17.8% placebo (P < 0.001 for each dose vs. placebo), and in Study 2 was 21.5% (P = 0.009) and 24.0% (P < 0.001) for plecanatide 3 and 6 mg, respectively, compared to 14.2% for placebo. The percentage of sustained efficacy responders (overall responders plus weekly responders for ≥2 of last 4 weeks of the 12-week treatment period) was significantly greater for both doses of plecanatide vs. placebo across both studies. All secondary end points (stool frequency/consistency, straining, abdominal symptoms) showed statistically significant improvements compared with placebo. The most common AE was diarrhea (3 mg, 4.3%; 6 mg, 4.0%; placebo, 1.0%). Discontinuation due to diarrhea was infrequent (3 mg, 1.2%; 6 mg, 1.4%; placebo, 0). CONCLUSIONS: Plecanatide significantly improved both abdominal pain and constipation symptoms of IBS-C with minimal associated side effects and high levels of tolerability.

Quality Measurement in Gastroenterology: Confessions of a Realist.

Clinicians are required to report their performance on an ever-increasing number of quality measures. However, it is difficult to measure health care quality and it is unclear whether broadly applying accountability measures effectively improves care. This article considers these challenges and includes recommendations that may help gastroenterologists respond to demands for increased quality measurement.

WITHDRAWN: Quality Measurement in Gastroenterology: Confessions of a Realist.

The Publisher regrets that this article is an accidental duplication of an article that has already been published, http://dx.doi.org/10.1016/j.cgh.2015.07.033. The duplicate article has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.

The Italian translation of the celiac disease-specific quality of life scale in celiac patients on gluten free diet.

BACKGROUND: A recently devised tool, the celiac disease-specific quality of life scale has been proposed to assess specifically quality of life in celiac patients. AIM: To assess the validity and reliability of the Italian translation of the celiac disease-specific quality of life scale. METHODS: The celiac disease-specific quality of life scale underwent forward/backward translation. Adults patients on gluten free diet by at least one year, consecutively recruited, completed SF36 questionnaire, the Italian version of celiac disease-specific quality of life scale, the health related quality of life question and an abdominal pain scale. The study fulfilled criteria for acceptable psychometric assessment according to the International Quality of Life Assessment project. RESULTS: Two-hundred-thirty celiac patients were recruited after about nine years from diagnosis. Factor analysis indicates that there are some similarities and discrepancies between the English and the Italian questionnaires. Despite this, the Italian celiac disease-specific quality of life scale was able to identify the same four factors characterizing the patients' answers (dysphoria, limitations, health concerns, inadequate treatment). CONCLUSION: The celiac disease-specific quality of life scale is useful for assessing celiac disease-related quality of life. A wide use of the Italian celiac disease-specific quality of life scale may be of help in obtaining comparable data on QOL in different setting and countries.