Optimizing the Management Algorithm for Adults With Functional Constipation Failing a Fiber/Laxative Trial in General Gastroenterology: Cost-Effectiveness and Cost-Minimization Analysis.

INTRODUCTION: Anorectal function testing is traditionally relegated to subspecialty centers. Yet, it is an office-based procedure that appears capable of triaging care for the many patients with Rome IV functional constipation that fail empiric over-the-counter therapy in general gastroenterology, as an alternative to empirical prescription drugs. We aimed to evaluate cost-effectiveness of routine anorectal function testing in this specific population. METHODS: We performed a cost-effectiveness analysis from the patient perspective and a cost-minimization analysis from the insurer perspective to compare 3 strategies: (i) empiric prescription drugs followed by pelvic floor physical therapy (PFPT) for drug failure, (ii) empiric PFPT followed by prescription drugs for PFPT failure, or (iii) care directed by up-front anorectal function testing. Model inputs were derived from systematic reviews of prospective clinical trials, national cost data sets, and observational cohort studies of the impact of chronic constipation on health outcomes, healthcare costs, and work productivity. RESULTS: The most cost-effective strategy was upfront anorectal function testing to triage patients to appropriate therapy, in which the subset of patients without anal hypocontractility on anorectal manometry and with a balloon expulsion time of at least 6.5 seconds would be referred to PFPT. In sensitivity analysis, empiric PFPT was more cost effective than empiric prescription drugs except for situations in which the primary goal of treatment was to increase bowel movement frequency. If adopted, gastroenterologists would refer ∼17 patients per year to PFPT, supporting feasibility. DISCUSSION: Anorectal function testing seems to be an emergent technology to optimize cost-effective outcomes, overcoming testing costs by phenotyping care.

Up-Front Endoscopy Maximizes Cost-Effectiveness and Cost-Satisfaction in Uninvestigated Dyspepsia.

BACKGROUND & AIMS: Practice guidelines promote a routine noninvasive, non-endoscopic initial approach to investigating dyspepsia without alarm features in young patients, yet many patients undergo prompt upper endoscopy. We aimed to assess tradeoffs among costs, patient satisfaction, and clinical outcomes to inform discrepancy between guidelines and practice. METHODS: We constructed a decision-analytic model and performed cost-effectiveness/cost-satisfaction analysis over a 1-year time horizon on patients with uninvestigated dyspepsia without alarm features referred to gastroenterology. A RAND/UCLA expert panel informed model design. Four competing diagnostic/management strategies were evaluated: prompt endoscopy, testing for Helicobacter pylori and eradicating if present (test-and-treat), testing for H pylori and performing endoscopy if present (test-and-scope), and empiric acid suppression. Outcomes were derived from systematic reviews of clinical trials. Costs were informed by prospective observational cohort studies and national commercial/federal cost databases. Health gains were represented using quality-adjusted life years. RESULTS: From the patient perspective, costs and outcomes were similar for all strategies (maximum out-of-pocket difference of $30 and <0.01 quality-adjusted life years gained/year regardless of strategy). Prompt endoscopy maximized cost-satisfaction and health system reimbursement. Test-and-scope maximized cost-effectiveness from insurer and patient perspectives. Results remained robust on multiple one-way sensitivity analyses on model inputs and across most willingness-to-pay thresholds. CONCLUSIONS: Noninvasive management strategies appear to result in inferior cost-effectiveness and patient satisfaction outcomes compared with strategies promoting up-front endoscopy. Therefore, additional studies are needed to evaluate the drivers of patient satisfaction to facilitate inclusion in value-based healthcare transformation efforts.

Optimizing the Utility of Anorectal Manometry for Diagnosis and Therapy: A Roundtable Review and Recommendations.

BACKGROUND & AIMS: Anorectal manometry (ARM) is a comprehensive diagnostic tool for evaluating patients with constipation, fecal incontinence, or anorectal pain; however, it is not widely utilized for reasons that remain unclear. The aim of this roundtable discussion was to critically examine the current clinical practices of ARM and biofeedback therapy by physicians and surgeons in both academic and community settings. METHODS: Leaders in medical and surgical gastroenterology and physical therapy with interest in anorectal disorders were surveyed regarding practice patterns and utilization of these technologies. Subsequently, a roundtable was held to discuss survey results, explore current diagnostic and therapeutic challenges with these technologies, review the literature, and generate consensus-based recommendations. RESULTS: ARM identifies key pathophysiological abnormalities such as dyssynergic defecation, anal sphincter weakness, or rectal sensory dysfunction, and is a critical component of biofeedback therapy, an evidence-based treatment for patients with dyssynergic defecation and fecal incontinence. Additionally, ARM has the potential to enhance health-related quality of life and reduce healthcare costs. However, it has significant barriers that include a lack of education and training of healthcare providers regarding the utility and availability of ARM and biofeedback procedures, as well as challenges with condition-specific testing protocols and interpretation. Additional barriers include understanding when to perform, where to refer, and how to use these technologies, and confusion over billing practices. CONCLUSIONS: Overcoming these challenges with appropriate education, training, collaborative research, and evidence-based guidelines for ARM testing and biofeedback therapy could significantly enhance patient care of anorectal disorders.

Gastrointestinal Features of 22q11.2 Deletion Syndrome Include Chronic Motility Problems From Childhood to Adulthood.

OBJECTIVES: 22q11.2 deletion syndrome (22q11.2DS) is the most common chromosomal microdeletion syndrome and has a multisystemic presentation including gastrointestinal features that have not yet been fully described. Our aim was to examine lifetime gastrointestinal problems in a large cohort of patients with 22q11.2DS. METHODS: All patients followed in the 22q and You Center at the Children's Hospital of Philadelphia (n = 1421) were retrospectively screened for: 1) age ≥ 17 years, 2) documented chromosomal microdeletion within the 22q11.2 LCR22A-LCR22D region, and 3) sufficient clinical data to characterize the adult gastrointestinal phenotype. Gastrointestinal problems in childhood, adolescence, and adulthood were summarized. Statistical association testing of symptoms against other patient characteristics was performed. RESULTS: Included patients (n = 206; 46% female; mean age, 27 years; median follow-up, 21 years) had similar clinical characteristics to the overall cohort. Genetic distribution was also similar, with 96% having deletions including the critical LCR22A-LCR22B segment (95% in the overall cohort). Most patients experienced chronic gastrointestinal symptoms in their lifetime (91%), but congenital gastrointestinal malformations (3.5%) and gastrointestinal autoimmune diseases (1.5%) were uncommon. Chronic symptoms without anatomic or pathologic abnormalities represented the vast burden of illness. Chronic symptoms in adulthood are associated with other chronic gastrointestinal symptoms and psychiatric comorbidities ( P < 0.01) but not with deletion size or physiologic comorbidities ( P > 0.05). One exception was increased nausea/vomiting in hypothyroidism ( P = 0.002). CONCLUSIONS: Functional gastrointestinal disorders (FGIDs) are a common cause of ill health in children and adults with 22q11.2DS. Providers should consider screening for the deletion in patients presenting with FGIDs and associated comorbidities such as neuropsychiatric illness, congenital heart disease, and palatal abnormalities.

Can FLIP guide therapy in idiopathic esophagogastric junction outflow obstruction?

BACKGROUND: Esophagogastric junction outflow obstruction (EGJOO) has a variable disease course. Currently, barium swallow (BaS) and manometric parameters are used to characterize clinically significant EGJOO. The esophagogastric junction distensibility index (EGJ-DI) measured via functional lumen imaging probe (FLIP) can provide complementary information. Our aim was to assess symptom response in patients with EGJOO and an abnormal EGJ-DI after botulinum toxin (BT) treatment. METHODS: A prospective cohort study of adults with idiopathic EGJOO was performed from September 2019 to March 2021. Patients with dysphagia underwent upper endoscopy with FLIP. If the EGJ-DI was abnormally low, BT was injected. Data examined included demographics, medical history, endoscopic and FLIP findings, BaS, manometry, and Eckardt score (ES). ES improvement was assessed via paired samples t-test. Pearson's chi-square tests were used to assess for associations. RESULTS: Of the 20 patients, 75% had an abnormal EGJ-DI and underwent BT injections. Mean ES for patients with abnormal EGJ-DIs significantly improved from baseline to 1, 3, and 6 month follow-up (P-values: 0.01, 0.05, and 0.02, respectively). There was a significant association between an abnormal EGJ-DI with delayed bolus transit and presence of rapid drink challenge panesophageal pressurization on manometry: P = 0.03 and P = 0.03. CONCLUSION: This prospective study revealed that an abnormal EGJ-DI can guide BT as assessed via symptomatic response. Additionally, abnormal EGJ-DI measurements were significantly associated with other parameters used previously to determine clinically relevant EGJOO. Larger follow-up studies are warranted to further elucidate guidance for therapy in EGJOO.

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.

Low Yield of Cross-Sectional Imaging in Patients With Esophagogastric Junction Outflow Obstruction.

Esophagogastric junction outflow obstruction (EGJOO) is an abnormal finding on high-resolution manometry (HRM) characterized by an elevated median integrated relaxation pressure with some intact peristalsis.1 EGJOO is associated with heterogeneous symptoms, disease course, and response to treatment.1-4 It can be idiopathic or secondary with causes including malignancy, infiltrative disease, or structural etiology.1,3 Therefore, Chicago Classification of Esophageal Motility Disorders version 3.0 (CC v3.0) states a finding of EGJOO should prompt further investigation with cross-sectional imaging (CSI): endoscopic ultrasound (EUS) or computed tomography (CT) scan. However, there are limited data on the added yield of CSI to conventional modalities, namely esophagogastroduodenoscopy (EGD) and barium esophagram (BE). In previous studies, yield was small or unspecified.2,5-8 The aim of this study was to examine the yield of CSI for diagnosing secondary causes of EGJOO.

Poor Health Literacy and Medication Burden Are Significant Predictors for Inadequate Bowel Preparation in an Urban Tertiary Care Setting.

GOALS: The goal of this study was to identify factors impacting the quality of bowel preparation in an urban tertiary care setting. BACKGROUND: Inadequate bowel preparation is encountered in 17% to 32% of colonoscopies performed in the United States. Suboptimal colonic visualization reduces the yield of screening colonoscopies and increases healthcare costs because of longer procedure times and aborted procedures. STUDY: We performed a cross-sectional survey in patients undergoing outpatient colonoscopy within the Johns Hopkins Health System. A Boston Bowel Preparation Score (BBPS) score of <5 was considered inadequate. Fisher's exact, χ tests and univariate and multivariate binary logistic regression were performed to assess the strength of the association for selected factors with a BBPS<5. RESULTS: In total, 467 patients (76.3% response rate) completed the survey between August 2017 and October 2017. The median BBPS score was 7, and 81.4% of patients had an adequate bowel preparation (BBPS≥5). There was significant association between bowel preparation adequacy and level of education, health literacy, functional status, income, and medication burden. When adjusted for other factors, poor confidence in filling forms (OR, 24.1; P<0.001), multiple daily prescription medications (OR, 12.49; P=0.02) and poor functional status (OR, 2.82; P=0.03) had the highest odds of predicting inadequate bowel preparation. CONCLUSIONS: Inadequate bowel preparation is a significant problem accounting for reduced yield of screening and increased health care costs. Poor health literacy, functional status, and number of daily medications are significant factors predicting inadequate bowel preparation in the tertiary care setting.

Popular Remedies for Esophageal Symptoms: a Critical Appraisal.

PURPOSE OF REVIEW: Popular remedies are of ongoing interest to patients experiencing common esophageal symptoms, particularly as typical pharmacologic interventions have been subject to increased scrutiny. Herein we summarize the available data regarding potential risks and benefits of several such remedies. RECENT FINDINGS: With emphasis on reflux and non-cardiac chest pain, research is ongoing into the clinical utility and diverse physiologic mechanisms underlying a variety of complementary and alternative modalities, including dietary manipulation, apple cider vinegar, melatonin, acupuncture, and various herbal products (rikkunshito, STW 5, slippery elm, licorice, and peppermint oil, among others). A substantial gap persists between anecdotal and empirical understandings of the majority of non-pharmacologic remedies for esophageal symptoms. This landscape of popular treatments nevertheless raises several interesting mechanistic hypotheses and compelling opportunities for future research.

An international, multicenter, comparative trial of EUS-guided gastrogastrostomy-assisted ERCP versus enteroscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy.

BACKGROUND AND AIMS: ERCP is challenging in patients with Roux-en-Y gastric bypass (RYGB) anatomy. EUS-guided gastrogastrostomy (GG) creation is a promising novel technique to access the excluded stomach to facilitate conventional ERCP. We aimed to compare procedural outcomes and adverse events (AEs) between EUS-guided GG-assisted ERCP (EUS-GG-ERCP) and enteroscopy-assisted ERCP (e-ERCP) in patients with RYGB. METHODS: Patients with RYGB anatomy who underwent EUS-GG-ERCP or e-ERCP between 2014 and 2016 at 5 tertiary centers were included. The primary outcome was technical success of ERCP, defined as successful cannulation of the selected duct with successful intervention as intended. Secondary outcomes included total procedural time (in the EUS-GG group, total procedural time included EUS-GG creation plus ERCP procedure time), length of hospital stay, and rate/severity of AEs graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: A total of 60 patients (mean age, 57.2 ± 13.2; 75% women) were included, of whom 30 (50%) underwent EUS-GG-ERCP and 30 (50%) underwent e-ERCP (double-balloon enteroscope ERCP, 19; single-balloon enteroscope ERCP, 11). The technical success rate was significantly higher in the EUS-GG-ERCP versus the e-ERCP group (100% vs 60.0%, P < .001). Total procedure time was significantly shorter in patients who underwent EUS-GG-ERCP (49.8 minutes vs 90.7 minutes, P < .001). Postprocedure median length of hospitalization was shorter in the EUS-GG group (1 vs 10.5 days, P = .02). Rate of AEs was similar in both groups (10% vs 6.7%, P = 1). CONCLUSIONS: EUS-GG-ERCP may be superior to e-ERCP in patients with RYGB anatomy in terms of a higher technical success and shorter procedural times and offers a similar safety profile.

The Relevance of Spastic Esophageal Disorders as a Diagnostic Category.

PURPOSE OF REVIEW: This review addresses the similarities and differences between the spastic esophageal disorders, including jackhammer esophagus, distal esophageal spasm (DES), and type III (spastic) achalasia. The pathophysiology, diagnosis, and treatment of each separate disorder are discussed herein, with an emphasis on overlapping and discordant features. RECENT FINDINGS: The Chicago Classification is a hierarchical organizational scheme for esophageal motility disorders, currently in its third iteration, with direct impact on the definitions of these three disorders. Complementary diagnostic tools such as impedance planimetry and novel manometric parameters continue to evolve. The suite of potential treatments for these disorders is also expanding, with progressive interest in the role of peroral endoscopic myotomy alongside established pharmacologic and mechanical interventions. Although jackhammer esophagus, distal esophageal spasm, and type III achalasia frequently overlap in terms of their clinical presentation and available management approaches, the divergences in their respective diagnostic criteria suggest that additional study may reveal additional mechanistic distinctions that lead in turn to further refinements in therapeutic decision-making.

The Role of Impedance Planimetry in the Evaluation of Esophageal Disorders.

PURPOSE OF REVIEW: Impedance planimetry measures tissue wall distensibility as a function of pressure and cross-sectional area. Recent interest in this technique's relevance to the gastrointestinal tract has been accelerated by the availability of the functional lumen imaging probe, a catheter-based system that dynamically quantitates these biomechanical properties. Herein, we review the device's particular utility in the setting of esophageal pathology, including processes affecting the esophageal body as well as the upper and lower esophageal sphincters. RECENT FINDINGS: An expanding suite of disease-specific indications for impedance planimetry includes achalasia, gastroesophageal reflux disease, and eosinophilic esophagitis. The technique has also demonstrated a role in the intraoperative guidance of therapy and in the definition of hitherto unrecognized patterns of esophageal dysmotility. Device-specific technology remains in active evolution, which, in conjunction with progressively larger datasets, sets the stage for broader clinical applicability in the near future.

Assessing Upper Esophageal Sphincter Function in Clinical Practice: a Primer.

The upper esophageal sphincter constitutes an important anatomic and functional landmark in the physiology of pharyngeal swallowing. A variety of clinical circumstances may call for a dedicated evaluation of this mechanism, from the etiologic evaluation of indeterminate symptoms to the generation of complex locoregional therapeutic strategies. Multiple diagnostic tools exist for the assessment of pharyngeal swallowing generally and of upper esophageal sphincter function specifically, some well established and others not yet settled into routine practice. This report reviews five specific modalities for use in making this assessment, outlining the strengths, weaknesses, and logistical considerations of each with respect to its potential use in clinical settings. In many cases, these studies will provide complementary information regarding pharyngeal function, suggesting the relative advantage of a multimodal evaluation.

Gastroenvironmental distress: metaphorical antecedents of the gut microbiome.

The human gut has been viewed for centuries as a potential mediator of systemic disease. The theory of autointoxication, which found its clearest articulation in the late nineteenth and early twentieth centuries, focused on altered bowel habits as the cause of widespread physical decay and advocated for the pursuit of health through regular defecation. More recently, under the banner of the microbiome, research on commensal bacteria makes a similar case for associations between alimentary dynamics and illness manifestations far outside the gastrointestinal tract. Surface distinctions between these two conceptual frameworks are apparently antipodal, the former championing emptiness and sterility, the latter abundance and restoration. Within both models, however, persists a common anxiety about the detrimental effects of civilisation on the body in relation to the natural world. As scientific understanding of the microbiome continues to mature, acknowledging the historical and moral parameters of its borrowed ecological idiom may facilitate critical distinctions between what is true and what feels like it should be.