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.

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.

Impact of the 2008-2009 economic recession on screening colonoscopy utilization among the insured.

BACKGROUND & AIMS: Economic factors might affect the use of recommended preventative services. We sought to determine whether the recent severe economic recession was associated with diminished screening colonoscopy rates among an insured population and to assess the relationship between out-of-pocket (OOP) costs and screening colonoscopy use. METHODS: Administrative data from 106 health plans (IMS LifeLink Health Plan Claims Database) were analyzed to determine monthly rates of screening colonoscopies performed on beneficiaries ages 50 to 64 years between January 2005 and November 2007 (prerecession), as well as from December 2007 through June 2009 (recession). Segmented regression models were used to evaluate changes in screening colonoscopy rates, as well as the relationship between screening and OOP costs before and during the recession. RESULTS: Compared with prerecession trends, during the recession screening colonoscopy rates decreased by 68.9 colonoscopies/1 million individuals per month (95% confidence interval, -84.6 to -53.1; P < .001). Application of study estimates to the entire US population indicated that during the recession, commercially insured patients aged 50 to 64 years underwent approximately 500,000 fewer screening colonoscopies. Compared with those with low OOP costs, those with high OOP procedure costs had lower rates of screening before and during the recession, and had a greater reduction in screening rates during the recession (P = .035). CONCLUSIONS: During the recession of December 2007 to June 2009, insured individuals reduced their use of screening colonoscopy compared with the 2 years before the recession began. OOP costs were related inversely to screening use, especially during the recession. Policies to reduce cost sharing could increase adherence to recommended preventive services such as colonoscopy examinations.

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.

Increasing frequency of opioid prescriptions for chronic abdominal pain in US outpatient clinics.

BACKGROUND & AIMS: Opioids are sometimes used to treat chronic abdominal pain. However, opioid analgesics have not been proven to be an effective treatment for chronic abdominal pain and have been associated with drug misuse, constipation, and worsening abdominal pain. We sought to estimate the national prescribing trends and factors associated with opioid prescribing for chronic abdominal pain. METHODS: Chronic abdominal pain-related visits by adults to US outpatient clinics were identified using reason-for-visit codes from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey (1997-2008). Data were weighted to produce national estimates of opioid prescriptions over time. Logistic regression analyses, adjusted for complex survey design, were performed to identify factors associated with opioid use. RESULTS: The number of outpatient visits for chronic abdominal pain consistently decreased over time from 14.8 million visits (95% confidence interval [CI], 11.6-18.0 visits) in 1997 through 1999 to 12.2 million visits (95% CI, 9.0-15.6 visits) or 1863 visits per 100,000 population in 2006 through 2008 (P for trend = 0.04). Conversely, the adjusted prevalence of visits for which an opioid was prescribed increased from 5.9% (95% CI, 3.5%-8.3%) in 1997 through 1999 to 12.2% (95% CI, 7.5%-17.0%) in 2006 through 2008 (P = 0.03 for trend). Opioid prescriptions were most common among patients aged 25 to 40 years old (odds ratio [OR] 4.6; 95% CI, 1.2-18.4). Opioid prescriptions were less common among uninsured (OR 0.1; 95% CI, 0.04-0.40) and African American (OR 0.3; 95% CI, 0.1-0.9) patients. CONCLUSIONS: From 1997 to 2008 opioid prescriptions for chronic abdominal pain more than doubled. Further studies are needed to better understand the reasons for and consequences of this trend.

Development and validation of the irritable bowel syndrome satisfaction with care scale.

BACKGROUND & AIMS: Satisfaction with care is an important measure of quality, from the patients' perspective, and could also affect outcomes. However, there is no standard measure of patient satisfaction for irritable bowel syndrome (IBS) care; a multi-item, condition-specific instrument is needed. METHODS: Using standard qualitative methods, we conducted focus groups to identify items that patients associated with satisfaction in their care for IBS. These and additional items identified by experts were placed into a preliminary questionnaire, which was refined through pilot testing and cognitive debriefing by additional patients, as well as standard statistical methods. The resulting instrument and several external validation measures were administered to 300 adult US patients with IBS. Factor analysis was performed to identify clinically relevant subscales and then psychometric properties were assessed. RESULTS: We developed an IBS satisfaction with care scale (IBS-SAT) that has 38 items from 5 clinically relevant subscales (connection with provider, education, benefits of visit, office attributes, and access to care). This IBS-SAT had a high level of internal consistency (Crohnbach's α = .96). Convergent validity was established by correlations between the IBS-SAT and a single, global satisfaction with care question (r = 0.68; P < .001), and a generic, multi-item satisfaction scale (physician satisfaction questionnaire-18) (r = 0.75, P < .001). Discriminant validity (among known groups) was established across groups that were stratified based on IBS-quality of life (r = 0.34; P < .0001), IBS severity (functional bowel disorders severity index) (r = -0.21; P < .001), and number of unmet expectations (r = -0.38; P < .0001). CONCLUSIONS: The IBS-SAT is a validated measure of patient satisfaction with IBS care. As a new, condition-specific instrument, it is likely to be a useful tool for quality measurement, health services research, and clinical trials.

Quality of care for gastrointestinal conditions: a primer for gastroenterologists.

The Institute of Medicine's publications To Err Is Human and Crossing the Quality Chasm publicized the widespread deficits in health-care quality. The quality of care for digestive diseases has not been evaluated comprehensively, although emerging literature suggests that the gap between recommended care and actual practice may be quite substantial. This paper reviews the history of, the rationale behind, and current work related to quality of care and quality improvement in the area of digestive diseases, with particular attention to colonoscopy, inflammatory bowel diseases, gastroesophageal reflux disease, chronic hepatitis C virus infection, and liver transplantation.

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.

Direct-to-consumer and physician promotion of tegaserod correlated with physician visits, diagnoses, and prescriptions.

BACKGROUND & AIMS: Direct-to-consumer advertisement (DTCA) and physician promotion of drugs can influence patient and physician behaviors. We sought to determine the relationship between promotion of tegaserod and the number of office visits for abdominal pain, constipation, and bloating; diagnoses of irritable bowel syndrome (IBS); and tegaserod prescriptions. METHODS: We used an Integrated Promotional Services database to estimate tegaserod DTCA and promotion expenditures; the National Ambulatory/Hospital Medical Care Surveys (1997-2005) to estimate the number of ambulatory care visits for abdominal pain, constipation, and bloating and diagnoses of IBS; and IMS Health's National Prescription Audit Plus (Fairfield, CT) to estimate the number of prescriptions. We constructed segmented and multivariate regression models to analyze the data. RESULTS: In the 3 months immediately following the start of tegaserod DTCA, there was a significant increase in physician visits (by 1 million; 95% confidence interval [CI], 0.5-1.6 million) and IBS diagnoses (by 397,025; 95% CI, 3909-790,141). Subsequently, the trend of visits and IBS diagnoses was reduced. In multivariate analyses that examined the overall relationship of promotion with visits, diagnoses, and prescriptions, only the relationship between physician promotion and tegaserod prescribing was significant; every $1 million spent on physician promotion resulted in an additional 4108 prescriptions (95% CI, 2526-5691). CONCLUSIONS: The initial DTCA of tegaserod was associated with a significant, immediate increase in physician visits and IBS diagnoses. This trend reversed and, in multivariate models, neither DTCA nor physician promotion correlated with visits or diagnoses. Physician promotion (although not DTCA) correlated with tegaserod prescription volume.