Cost of Constipation: A New Look With a Focus on New Medications.

GOAL: The study was designed to assess drug costs for constipation therapy and to relate costs to markers of functional status. BACKGROUND: Secretagogues have been introduced as new agents for the treatment of constipation. Previously published modeling studies suggested that improved productivity lowers the indirect disease burden and balances the higher drug costs. STUDY: Data were abstracted from the publicly available Medical Expenditure Panel Survey to identify adults with a functional gastrointestinal disorder who received a prescription for laxatives or secretagogues covering >2 days. Demographic data, recorded health care utilization and cost, and markers of functional status were extracted for the years from 2005 to 2017 to determine differences between participants treated with secretagogues or laxatives. RESULTS: The cohort of 2006 persons was female predominant [67.8%; age: 56.9 (55.8-57.9) years] and spent $92.89 (75.68-110.10) for medications treating constipation. The use of secretagogues (10.3% of the cohort) was the best independent predictor of constipation treatment costs. Using quality of life measures, perceived limitations in activities or work, and absenteeism, there was no difference between participants receiving laxatives and those taking secretagogues. CONCLUSION: Using survey data designed to be representative of the United States population, the study identified secretagogues as a key cost factor in drug treatment of constipation. The results do not support models suggesting improved role functioning offsets these higher direct expenditures. While prospective comparative studies are needed to more definitively correlate costs with direct or indirect benefits of different agents, limiting the use of more expensive medications to otherwise refractory cases may help to reign in the spiraling health care costs in this country.

Perceived Barriers to Treatment in Persons Treated for Functional Gastrointestinal Disease with Constipation.

INTRODUCTION: Despite expanding treatment options, patients with functional gastrointestinal disorders (FGID) frequently express concerns about problems with access to care. We hypothesized that health insurance coverage contributes to the perceived problems with care delivery. METHODS: Using the Medical Expenditure Panel Survey, we examined a cohort of participants defined by the diagnosis code for FGID plus the recorded prescription for laxative therapy. Demographic data, healthcare utilization and cost, insurance coverage, comorbid conditions, and information about provider characteristics were extracted for the years 2005-2015. Age- and sex-matched controls were identified for each year included. Barriers to care were based on responses to questions about inability to receive timely care or medication. Logistic regression was used to identify independent predictors of perceived barriers. RESULTS: The cohort was female predominant (67.8%; mean age: 58.8 ± 0.33 years) with 15.4% reporting problems with access to care. Limited insurance coverage was most commonly cited by respondents. Consistent with this result, uninsured persons were significantly more likely to report barriers to care, while the type of insurance for those covered did not independently predict access problems. In addition, comorbidity burden and provider-specific factors, such as available contact options or insufficient explanations, correlated with perceived barriers to care delivery. CONCLUSION: While the study design cannot establish causal links, persons with FGID commonly report access problems, which correlate with lack of health insurance and comorbidities. Providers can influence this perception by offering more flexible office hours and incorporating patient expectations related to treatment explanations and shared decision-making.

Impact of Health Insurance, Poverty, and Comorbidities on Colorectal Cancer Screening: Insights from the Medical Expenditure Panel Survey.

BACKGROUND: Despite national campaigns and other efforts to improve colorectal cancer (CRC) screening, participation rates remain below targets set by expert panels. We hypothesized that availability and practice patterns of healthcare providers may contribute to this gap. METHOD: Using data of the Medical Expenditure Panel Survey for the years between 2000 and 2016, we extracted demographic, socioeconomic, and health-related data as well as reported experiences about barriers to care, correlating results with answers about recent participation in colorectal cancer screening. As CRC screening guidelines recommend initiation of testing at age 50, we focused on adults 50 years or older. RESULTS: We included responses of 163,564 participants for the period studied. There was a significant increase in CRC screening rates over time. Comorbidity burden, poverty, race, and ethnicity independently predicted participation in screening. Lack of insurance coverage and cost of care played an important role as reported barrier. Convenient access to care, represented by availability of appointments beyond typical business hours, and frequency of provider interactions, correlated with higher rates of screening. CONCLUSION: Our data show a positive effect of educational efforts and healthcare reform with coverage of screening. Easy and more frequent access to individual providers predicted a higher likelihood of completed screening tests. This finding could translate into more widespread implementation of screening programs, as the increasingly common virtual care delivery offers a new and convenient option to patients.

Time Trends in Healthcare Utilization Due to Self-Reported Functional Diseases of the Stomach.

INTRODUCTION: Cohort studies from referral centers suggest an increasing burden of functional gastric disorders, with frequent emergency room (ER) visits, hospitalizations, or absenteeism. We hypothesized that recruitment from tertiary care sites skews results and thus investigated the burden of these illnesses, using the population-based data of the Medical Expenditure Panel Survey (MEPS). METHODS: Using MEPS data for the years 2000-2015, demographic, economic, healthcare-related, and quality-of-life indicators were extracted for adults reporting the diagnosis of functional gastric diseases to assess trends and to compare results with data from all adults surveyed. RESULTS: Between 2000 and 2015, 2.7 ± 0.2% of the adults surveyed reported a functional gastric illness. Within the period studied, 28.8 ± 2.8% and 17.9 ± 1.6% of this cohort reported ER visits or hospitalizations, respectively. Only a fraction of these persons attributed the ER visits (22.6 ± 0.9%) or admissions (10.9 ± 0.8%) to the functional gastric disorder. Rates remained stable rates during the period studied. Female sex, measures of physical function, comorbidities, and an income below the poverty line were predictors of healthcare utilization. While utilization was stable over time, annual costs increased by 113.9 ± 16.6% during the study period, outpacing the inflation rate of 37.6%. CONCLUSIONS: Persons with functional gastric disorders have significant healthcare needs and face increasing costs of care, largely due to coexisting illnesses. While it is important to recognize this impact, the need for emergency care or hospitalizations remained stable and lower than reported for patients seen in tertiary referral centers, providing reassuring information for patients and providers.

Pharmacological Treatment of Opioid-Induced Constipation Is Effective but Choice of Endpoints Affects the Therapeutic Gain.

BACKGROUND: Widespread opioid use has led to increase in opioid-related adverse effects like constipation. We examined the impact of study endpoints on reported treatment benefits. METHODS: Using MEDLINE, EMBASE, and ClinicalTrials.gov, we searched for randomized control trials targeting chronic opioid-induced constipation (OIC) and subjected them to meta-analysis. Data are given with 95% confidence intervals. RESULTS: Thirty trials met our inclusion criteria. Combining all dichotomous definitions of responders, active drugs were consistently more effective than placebo, with an odds ratio (OR): 2.30 [2.01-2.63; 15 studies], independent of the underlying drug mechanism. The choice of endpoints significantly affected the therapeutic gain. When time from drug administration to defecation was used, the OR decreased from 4.74 [2.71-4.74] at 6 h or less to 2.46 [1.80-3.30] at 24 h (P < 0.05). Using other response definitions, the relative benefit over placebo was 2.10 [1.77-2.50; 12 studies] for weekly bowel frequency, 2.03 [1.39-2.95; 9 studies] for symptom scores, 2.21 [1.25-3.90; 4 studies] for global assessment scales, and 1.27 [0.79-2.03; 7 studies] for rescue laxative use. CONCLUSION: While treatment of OIC with active drugs is more effective than placebo, the relative gain depends on the choice of endpoints. The commonly used time-dependent response definition is associated with the highest response rate but is of questionable relevance in a chronic disorder. The limited data do not clearly demonstrate a unique advantage of the peripherally restricted opioid antagonists, suggesting that treatment with often cheaper agents should be optimized before shifting to these novel expensive agents.

Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline.

BACKGROUND & AIMS: The Food and Drug Administration approved eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome despite cases of pancreatitis in early stage trials. We investigated the frequency of pancreatitis attributed to eluxadoline in postmarketing surveillance. METHODS: We extracted reports on eluxadoline submitted to the Federal Adverse Event Reporting System from January through September 2016. We collected data on patient age and sex, event date, reporting entity (consumer, physician, pharmacist, legal worker, or other), medications, dosages, presumed role in the event (coinciding, primary, or secondary suspect), treatment indication, and outcome (death, life threatening, hospitalization, disability, or other).We compared data for eluxadoline with data from antidiarrheals, oxycodone, and rifaximin using the κ2 test, Kruskal-Wallis rank test, and analysis of variance; findings with P < .05 were considered statistically significant. RESULTS: Pancreatitis accounted for 16.4% of the 597 reports of adverse events linked to eluxadoline; 53 cases required hospitalization. Pancreatitis was listed as treatment complication of other agents in significantly lower proportions of cases (loperamide, 0.3%; diphenoxylate, 0.4%; oxycodone, 0.2%; rifaximin, 0.5%), with 75% of these submissions not considering the agent as causal. CONCLUSIONS: In an analysis of reports on eluxadoline submitted to the Federal Adverse Event Reporting System, we confirmed a previously reported risk of pancreatitis associated with eluxadoline. The need for hospitalization in at least half of these instances and a recent report of 2 fatalities should prompt reassessments of the agent's risk-benefit ratio.

Prevalence of Nausea and Vomiting in Adults Using Ropinirole: A Systematic Review and Meta-Analysis.

BACKGROUND: Nausea and vomiting are commonly associated with medication use. Dopaminergic agonists have been associated with these symptoms, but their impact in patients without Parkinson's disease, such as those with restless legs syndrome (RLS), is not well characterized. AIMS: We sought to determine whether the non-ergoline dopamine agonist ropinirole is associated with nausea and vomiting in adults with RLS. METHODS: We conducted a systematic review using PUBMED, EMBASE, and clinical trial databases to identify placebo-controlled clinical trials of ropinirole for RLS treatment. We extracted data including dosing schedule and the proportion of patients reporting nausea and/or vomiting. We also determined hazard ratios (HR) using a random effects proportional hazard model. RESULTS: We extracted data from a pool of 13 studies. The prevalence of nausea in the ropinirole-treated RLS group (RLS-R; N = 1528) was 37.2% compared to 9.4% in the placebo-treated RLS group (RLS-P; N = 1395) (p < 0.0001). The prevalence of vomiting in the RLS-R group was 10.9% compared to 2.6% in the RLS-P group (p < 0.0001). Ropinirole use was associated with a higher risk of reporting nausea (HR 5.924 [4.410-7.959], p < 0.001) and experiencing vomiting (HR 4.628 [3.035-7.057], p < 0.0001). Nausea and vomiting represented nearly 50% of all adverse events reported. CONCLUSIONS: Nausea and vomiting are quite common side effects in those using ropinirole for RLS. As RLS is more widely recognized and treated; the prevalence of ropinirole-induced nausea and vomiting could grow substantially. Ropinirole use should be considered as a cause of chronic nausea and vomiting.

From Harmful Treatment to Secondary Gain: Adverse Event Reporting in Dyspepsia and Gastroparesis.

INTRODUCTION: Medical management of gastroparesis and functional dyspepsia remains difficult with several recent trials showing limited or no benefit. If treatment comes with only marginal improvements, concerns about adverse events become more relevant. We therefore examined the type and outcomes of side effects submitted to a public repository. METHODS: We searched the Federal Adverse Event Reporting System for reports associated with the treatment of dyspepsia or gastroparesis. Demographic data, medications used and implicated, side effects, and outcomes were abstracted for the years 2004-2015. RESULTS: Acid-suppressive agents and prokinetics were the most commonly listed medications with a stronger emphasis on prokinetics in gastroparesis. Submissions related to metoclopramide by far exceeded reports about other agents and mostly described tardive dyskinesia or other neurological concerns. They peaked around 2012, driven by submissions through legal workers. Most reports about metoclopramide described short-term use to prevent or treat nausea and vomiting. Concerns about acid-suppressive medications increased over time and spanned a wide spectrum of potential problems, including osteoporosis, worsening renal function, or cardiac events. CONCLUSION: Despite biasing factors, such as pending legal action, the voluntary repository of adverse events provides insight into current medical practice and its associated risk. Knowing about common and uncommon, but potentially serious risks may enable patients and providers to decide on effective and safe management strategies.

Association between opioid use and readmission following liver transplantation.

The aim of this study was to assess the independent association between pre-transplant prescription opioid use and readmission following liver transplantation. We reviewed the medical records of all patients at a single medical center undergoing primary, single-organ, liver transplantation from 2004 to 2014. We assessed factors associated with hospital readmission 30 days and 1 year after hospital discharge using multivariable competing risk regression models. Among 1056 transplant recipients, 49 (4.6%) were prescribed pre-transplant prescription opioids. Readmission occurred in 421 (40%) patients within 30 days and 689 (65%) within 1 year. Patients with pre-transplant opioid use had a significantly higher risk of readmission at 30 days (HR 1.7; 95% CI 1.1-2.5) and a non-significantly elevated risk at 1 year (HR 1.4; 95% CI 1.0-1.9) when controlling for other potential confounders. Although pain was the major reason for readmission in only 12 (3%) patients at 30 days and 33 (6%) patients at 1 year, pre-transplant opioid use was significantly associated with pain-related readmission at both time points. In conclusion, prescription opioid use pre-transplantation was significantly associated with all-cause 30-day readmissions and pain-related readmissions at 30 days and 1 year.

Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System.

BACKGROUND: More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies associated with development of IC. METHODS: The Federal Adverse Event Reporting System was queried for the time between January 2004 and September 2015. We identified reports listing IC as treatment complication and extracted suspected causative and concomitantly administered drugs, indications for their use and outcomes. RESULTS: After eliminating duplicates, we found 2811 cases of IC (68.4 % women; 59.4 ± 0.4 years). Patients with IBS accounted for 3.9 % of the cases, mostly attributed to tegaserod or alosetron. Chemotherapeutic and immunosuppressive drugs, sex hormones, and anticoagulants were the most commonly suspected causes. Bisphosphonates, nonsteroidal anti-inflammatory drugs, antipsychotics, triptans, interferon therapy, and laxative use prior to colonoscopy were among the more commonly listed treatments. In 8 %, the adverse event contributed to the patient's death with male sex and older age predicting fatal outcomes. CONCLUSION: Beyond confirming known risks of IC, the results identified several potential culprits of ischemic colitis. This information may not only explain the development of this serious adverse event, but could also guide treatment decisions, cautioning healthcare providers when considering these agents in persons with known risk factors or other drugs that may increase their risk of IC.

Inflammation, psychiatric symptoms, and opioid use are associated with pain and disability in patients with cirrhosis.

BACKGROUND & AIMS: Cirrhosis is associated with significant pain and disability, the etiologies of which are poorly understood. We investigated whether the pain and disability in patients with cirrhosis are associated with systemic inflammation and psychiatric symptoms. METHODS: In a prospective study, we recruited 193 patients with cirrhosis caused by hepatitis C virus infection, nonalcoholic steatohepatitis, or alcohol from the hepatology clinic at the University of Pittsburgh. Patients were assessed using the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale, the Pittsburgh Sleep Quality Index, and the Pain Disability Index. Serum samples were collected and markers of inflammation were measured using standardized Luminex assays (Milipore, St. Charles, MO). We evaluated factors associated with pain, pain-related disability, and chronic opioid use by using multivariable regression models. RESULTS: Pain was reported by 79% of patients, pain-related disability was reported by 75%, and depression and/or anxiety was reported by 47%; the average Model for End-Stage Liver Disease score was 12 ± 5. Serum samples from 58% percent of patients had increased levels of C-reactive protein. Opioids were prescribed for 30% of patients with pain. In multivariate analysis, factors significantly associated with pain included younger age (odds ratio [OR]/y, 0.93; 95% confidence interval [CI], 0.90-0.99), serum level of interleukin 6 (OR per pg/L, 1.63; 95% CI, 1.09-2.58), Hospital Anxiety and Depression Scale score (OR/point, 1.14; 95% CI, 1.07-1.24), and etiology (hepatitis C virus infection vs alcohol: OR, 3.70; 95% CI, 1.27-11.11). Disability scores were related significantly to psychiatric symptoms (incidence rate ratio [IRR]/point, 1.04; 95% CI, 1.02-1.05), prescription opioid use (IRR, 1.49; 95% CI, 1.14-1.94), Model for End-Stage Liver Disease score (IRR/point, 1.02; 95% CI, 1.0001-1.05), level of C-reactive protein (IRR per mg/dL, 1.13; 95% CI, 1.02-1.24), and pain severity (IRR/point, 1.19; 95% CI, 1.08-1.32). CONCLUSIONS: Pain and disability are common among patients with cirrhosis, and are associated with inflammation, psychiatric symptoms, and opioid use, which potentially are modifiable. Although opioids are used commonly to treat pain, psychiatric symptoms and inflammation also might be treatment targets in this population.

Low-FODMAP Diet for Irritable Bowel Syndrome: Is It Ready for Prime Time?

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disease, which adversely affects the quality of life. Its prevalence has been reported to be around 10-15 % in North America and constitutes the most common cause for gastroenterology referral. Unfortunately, the pathophysiology of IBS is not completely understood. Not surprisingly, the management strategies can leave the patients with inadequate symptom control, making IBS a debilitating gastrointestinal syndrome. Dietary interventions as a treatment strategy for IBS have been recently evaluated. One such intervention includes dietary restriction of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs). FODMAPs define a group of short-chain carbohydrates that are incompletely absorbed in small intestine and later fermented in the colon. Evidence in the form of randomized controlled trials and observational studies have evaluated the mechanism of action and efficacy of low-FODMAP diet. This dietary intervention has showed promising results in symptom reduction in IBS patients. However, latest trials have also shown that the low-FODMAP diet is associated with marked changes in gut microbiota specifically reduction in microbiota with prebiotic properties. Implications of such changes on gastrointestinal health need to be further evaluated in future trials.

Fibromyalgia symptoms and cirrhosis.

BACKGROUND: An association between fibromyalgia and hepatitis C virus (HCV) has been previously described. However, the relationship between nonalcoholic steatohepatitis (NASH) and fibromyalgia symptoms has not been assessed, though they share several risk factors. AIM: We aimed to assess the factors associated with fibromyalgia symptoms across etiologies of liver disease. METHODS: Patients with cirrhosis due to HCV, NASH, or alcohol were recruited from an outpatient hepatology clinic and administered the Hospital Anxiety and Depression Score, Pittsburgh Sleep Quality Index, and the modified 2010 American College of Rheumatology Diagnostic Criteria for Fibromyalgia. Serum inflammatory markers were measured with standard luminex assays. RESULTS: Of 193 participants, 53 (27 %) met criteria for fibromyalgia. Fibromyalgia symptoms were significantly associated with etiology of liver disease (HCV: 35 %, NASH: 30 %, alcohol-related liver disease: 12 %, p < 0.01). Using logistic regression, mood symptoms (OR 1.14, 95 % CI 1.06, 1.22), sleep disturbance (OR 1.32, 95 % CI 1.16, 1.52), and etiology of liver disease (NASH vs. HCV not different, alcohol vs. HCV OR 0.19, 95 % CI 0.05, 0.63) were associated with fibromyalgia symptoms. If abdominal pain was included in the model, etiology became nonsignificant, indicating that it may be central sensitization due to abdominal pain in patients with chronic liver disease that explains fibromyalgia symptoms rather than the etiology of liver disease or inflammation. CONCLUSIONS: Fibromyalgia symptoms were significantly associated with HCV and NASH cirrhosis and with psychiatric symptoms. Future work should focus on the underlying pathophysiology and management of widespread pain in patients with cirrhosis.

The impact of chronic opioid use on colonoscopy outcomes.

BACKGROUND: Endoscopic procedures are frequently performed on patients chronically on opioids, raising concerns about the safety and efficacy of conventional sedation. AIMS: We hypothesized that chronic opioid use is associated with longer procedure times, higher dosages of sedation medications, and an increase in adverse effects. METHODS: This is a retrospective review from June 2012 to June 2013. Patients on chronic opioids (opioids use ≥ 12 weeks) were compared to randomly selected patients matched for age, race, and sex. Multivariate regression analysis was performed to identify factors that were independently predictive of longer procedure times. RESULTS: Patients on chronic opioids required higher doses of fentanyl (122.0 ± 45.3 vs. 105.8 ± 47.2 µg; P < 0.0001) and midazolam (5.3 ± 5.3 vs. 4.4 ± 2 mg; P = 0.0037) and were more likely to receive diphenhydramine (42.8 vs. 22.6 %; P < 0.001). The induction period (11.3 ± 8.8 vs. 7.5 ± 4.0 min), duration of procedure (39.1 ± 17.5 vs. 33.4 ± 14.1 min), and recovery times (38.7 ± 15.3 vs. 33.8 ± 12.1 min) were significantly longer for patients on chronic opioids. In the multivariate regression analysis, opioid use was an independent predictor of longer procedure duration (P < 0.05). Hypotensive episodes did not differ between groups (2.8 vs. 2.7 %; P = 0.8). However, patients on chronic opioids experienced more pain (13.4 vs. 5.9 %; P 0.001) and hypertensive episodes (8.1 vs. 2.8 %; P 0.002). CONCLUSION: Patients on chronic opioids represent a high-risk population with longer procedural times and more discomfort, despite higher dosages of sedative agents. Prospective studies are required to define the risks and benefits of more costly alternative sedation strategies for patients on chronic opioids.

Black bile of melancholy or gallstones of biliary colics: historical perspectives on cholelithiasis.

Barely 130 years after its first description, cholecystectomies are among the most commonly performed surgeries in the USA. The success of this operation with subsequent technical improvements, such as laparoscopic approaches, caused a paradigm shift in the management of gallstone disease. However, symptoms persist in 10-40 % of successfully operated patients. Reviewing monographs, textbooks, and articles published during the last 300 years, several important factors emerge as likely contributors to limited or poor treatment responses. Early on, clinicians recognized that cholelithiasis is quite common and thus often an incidental finding, especially if patients present with vague or atypical symptoms. Consistent with these observations, patients with such atypical symptoms are less likely to benefit from cholecystectomy. Similarly, lasting improvements are more reliably seen in patients with symptoms of presumed biliary origin and documented gallstones compared to individuals without stones, an important point in view of increasing rates of surgery for biliary dyskinesia. While cholelithiasis can cause serious complications, the overall incidence of clinically relevant problems is so low that prophylactic cholecystectomy cannot be justified. This conclusion corresponds to epidemiologic data showing that the rise in elective cholecystectomies decreased hospitalizations due to gallstone disease, but was associated with a higher volume of postoperative complications, ultimately resulting in stable combined mortality due to gallstone disease and its treatment. These trends highlight the tremendous gains in managing gallstone disease, while at the same time reminding us that the tightening rather than expanding indications for cholecystectomy may improve outcomes.

From ischochymia to gastroparesis: proposed mechanisms and preferred management of dyspepsia over the centuries.

Dyspeptic symptoms are common with most patients suffering functional disorders that remain a therapeutic challenge for medical practitioners. Within the last three decades, gastric infection, altered motility, and hypersensitivity have gained and lost traction in explaining the development of functional dyspepsia. Considering these shifts, the aim of this review was to analyze changing understanding of and approaches to dyspepsia over a longer time period. Monographs, textbooks, and articles published during the last three centuries show that our understanding of normal gastric function has improved dramatically. With increased insight came new ideas about disease mechanisms, diagnostic options, and treatments. Despite shifts over time, the importance of functional abnormalities was recognized early on and explained in the context of societal influences and stressors, anxieties, and biological influences, thus resembling the contemporary biopsychosocial model of illness. Symptoms were often attributed to changes in secretion, motility, and sensation or perception with technological innovation often influencing proposed mechanisms and treatments. Many of the principles or even agents applied more than a century ago are still part of today's approach. This includes acid suppression, antiemetics, analgesics, and even non-pharmacologic therapies, such as gastric decompression or electrical stimulation of the stomach. This historical information does not only help us understand how we arrived at our current state of knowledge and standards of care, it also demonstrates that enthusiastic adoption of various competing explanatory models and the resulting treatments often did not survive the test of time. In view of the benign prognosis of dyspepsia, the data may function as a call for caution to avoid the potential harm of overly aggressive approaches or treatments with a high likelihood of adverse effects.

Time trends in gastroparesis treatment.

INTRODUCTION: While delayed emptying is the defining criterion for gastroparesis, prokinetics often only have a limited impact on symptoms and have been associated with potentially serious adverse effects. The goal of this study was to determine how this information and regulatory changes affected gastroparesis management. METHODS: The electronic medical records of patients seen between 2003 and 2012 in the outpatient clinic of a large tertiary center were retrieved based on the billing diagnosis of gastroparesis. Demographic, clinical, and survival data were abstracted. RESULTS: A total of 709 patients were identified, with diabetes (21.2 %) and prior surgery (9.8 %) being the most common identifiable causes. The majority of patients (56 %) had idiopathic gastroparesis. The cohort was female predominant (79.5 %) with an average age of 45.4 ± 0.6 years. At the index encounter, 61.8 % received prokinetics. About one-third (37.7 %) used antiemetics at least intermittently. Between 2003 and 2012, prokinetic use dropped from 81 to 43 %, while the use of antiemetics increased from 14 to 41 %. Similarly, there was a significant increase in prescribed opioids and antidepressants. During the period of the study, 44 patients (6.2 %) died. Increasing age, a higher comorbidity burden, anxiety, and medication use were associated with higher mortality risks. CONCLUSION: This large outpatient cohort suggests that treatment trends move away from prokinetics and focus on symptom-oriented therapy and/or confounding mood disorders.

Biliary dyskinesia and symptomatic gallstone disease in children: two sides of the same coin?

BACKGROUND: Despite lack of consensus criteria, biliary dyskinesia (BD) is an increasingly accepted pediatric diagnosis. AIMS: We compared patient characteristics, outcomes, and resource utilization (before and after surgery) between children with BD and symptomatic cholecystolithiasis (LITH). METHODS: Data from the electronic medical record were abstracted for children diagnosed with BD or LITH between December 1, 2002, and November 30, 2012, at Children's Hospital of Pittsburgh. RESULTS: Four hundred and ten patients were identified (BD: 213 patients, LITH: 197 patients). Patients with BD had significantly lower BMI, longer symptom duration, more dyspeptic symptoms, and were more likely to present with other symptoms. Forty-one patients (13.8%) with BD underwent cholecystectomy despite a normal gallbladder ejection fraction (GB-EF). In 32 of these, sincalide triggered pain compared to 75 of the 155 patients with low GB-EF. After surgery, patients with BD more commonly visited gastroenterology clinics and had more GI-related hospitalizations, while emergency room visits decreased in both groups. Only the nature of biliary disease independently predicted continuing pain after surgery, which in turn was the best predictor for higher resource utilization after cholecystectomy. CONCLUSIONS: A large percentage of children with BD did not meet the adult diagnostic standards. Compared to those with LITH, children with BD have more widespread symptoms and continue to use more clinical resources after surgery. These findings suggest that despite its benign prognosis, BD is increasingly treated like other potentially acute gallbladder diseases, although it has the typical phenotype of FGIDs and should be treated using approaches used in such disorders.

Cholecystectomy for biliary dyskinesia: how did we get there?

BACKGROUND: The focus of biliary dyskinesia (BD) shifted within the last 30 years, moving from symptoms after cholecystectomy (CCY) to symptoms with morphological normal gallbladder, but low gallbladder ejection fraction. METHODS: We searched the pubmed database to systematically review studies focusing on the diagnosis and treatment of gallbladder dysfunction. RESULTS: Impaired gallbladder contraction can be found in about 20% of healthy controls and an even higher number of patients with various other disorders. Surgery for BD increased after introduction of laparoscopic CCY, with BD now accounting for >20% of CCY in adults and up to 60% in pediatric patients. The majority of cases reported were operated in the USA, which differs from surgical series for cholelithiasis. Postoperative outcomes do not differ between groups with abnormal or normal gallbladder function. CONCLUSION: Functional gallbladder testing should not be seen as an indicator of relevant biliary tract disease or prognostic marker to identify patients who may benefit from operative intervention. Instead biliary dyskinesia should be considered as a part of a spectrum of functional disorders, which are generally managed conservatively. Small proof of concept studies have demonstrated effects of medical therapy on biliary dysfunction and should thus be never tested in appropriately designed trials.

Fundoplication for gastroesophageal reflux disease: regional variability and factors predicting operative approach.

We have recently shown that the majority of patients undergoing fundoplication in the United States are women. Based on these findings, we hypothesized that nonbiological factors contribute to the decisions on surgical reflux therapy. Using State Inpatient Databases of the Agency for Healthcare Research and Quality, we extracted annual fundoplication rates, sex distribution, age cohorts, racial background, and insurance coverage. To account for potential differences in state populations, the results were normalized and correlated with Census data, adult obesity rates, median income, poverty rates, and physician workforce within the state. Fundoplication rates varied fivefold between states, ranging from 4.1±0.1 per 100,000 in New Jersey to 21.8±0.4 per 100,000 in Oregon. Higher poverty rates and a higher fraction of Caucasians within a state independently predicted higher fundoplication rates. While the majority of operations were performed laparoscopically, surgical approaches also differed between states with rates of laparoscopic ranging from 52.3±1.8% in Oklahoma to 87.4±1.7% in Hawaii. A lower number of pediatric and Medicaid-insured patient and a higher fraction of privately insured patients best predicted higher rates of laparoscopic surgery. Our study shows significant regional variation in surgical reflux management, which cannot be explained by differences in disease mechanisms. Insurance coverage and racial background influenced the likelihood of surgery, suggesting a role of financial incentives.