Magnesium Oxide in Constipation.

Magnesium oxide has been widely used as a laxative for many years in East Asia, yet its prescription has largely been based on empirical knowledge. In recent years, several new laxatives have been developed, which has led to a resurgence in interest and increased scientific evidence surrounding the use of magnesium oxide, which is convenient to administer, of low cost, and safe. Despite these advantages, emerging clinical evidence indicates that the use of magnesium oxide should take account of the most appropriate dose, the serum concentration, drug-drug interactions, and the potential for side effects, especially in the elderly and in patients with renal impairment. The aim of this review is to evaluate the evidence base for the clinical use of magnesium oxide for treating constipation and provide a pragmatic guide to its advantages and disadvantages.

Continuous Assessment of Gastric Motility and Its Relation to Gastric Emptying in Adult Critically Ill Patients.

BACKGROUND: Critically ill patients frequently develop feeding intolerance, which is difficult to predict. In healthy subjects, gastric motility, assessed by nasogastric balloon tube, correlated with gastric emptying. We now investigated this correlation in critically ill patients, as well as the feasibility and safety of such application in a pilot study. METHODS: Endotracheally intubated adults scheduled to receive enteral nutrition (EN) were included. After insertion of a double-lumen nasogastric balloon tube and radiographic confirmation of position, balloon pressure was recorded for 10 hours after inflation (4 hours fasted, 2 hours during administration of 13 C-labeled EN, and 4 hours postprandially). Gastric motility was expressed as Gastric Balloon Motility Index (GBMI), reflecting the fraction of time in which phasic gastric contractions occurred. Gastric emptying was assessed by 13 C-octanoate breath test and expressed as gastric half-emptying time (GET½). Correlation between GBMI (assessed in different time intervals) and GET½ was investigated by Pearson/Spearman correlation. Feasibility was defined as the success of tube placement and pressure recording. Safety was assessed based on adverse device effects. RESULTS: Thirty patients were enrolled, of whom 19 had paired GBMI and GET½ data. There was no correlation between GBMI and GET½. The tube was successfully placed in 28/30 (93.3%) patients. In 3/28 (10.7%) patients, balloon leakage precluded analysis. Two safety events were directly linked to the device. CONCLUSION: This pilot study showed no significant correlation between balloon-assessed gastric motility and emptying in critically ill patients. The feasibility/safety profile of the balloon tube appears similar to that of standard nasogastric tubes.

Functional Constipation: Individualising Assessment and Treatment.

Chronic constipation is one of the five most common symptoms seen by gastroenterologist. In the absence of alarm symptoms, a confident symptom-based diagnosis can often be made using the Rome criteria. Three different subtypes have been identified to date: normal transit constipation, defaecatory disorders and slow transit constipation. Differentiation between these subtypes can be made through functional testing using tests such as anorectal manometry with balloon expulsion and a radio-opaque marker test. In general, patients are initially advised to increase their fluid and fibre intake. When these general lifestyle recommendations do not improve patients' symptoms, a step-wise and add-on treatment approach should be applied. This review summarises the diagnostic criteria to differentiate functional constipation from other causes of chronic constipation. In addition, current drug treatment options, including discussion of new therapeutic targets are discussed. Further, practical treatment approaches (choice and dosing), include discussion of combination/augmentation, treatment failure (adherence/expectations), and relapse prevention are mentioned. Finally, treatment and management of pain and bloating aspects are included.

Towards a catheter-based impedimetric sensor for the assessment of intestinal histamine levels in IBS patients.

In this work, we report on the development of a catheter-based sensor designed for measuring the concentration of histamine in the human duodenum. Certain gut disorders, such as the irritable bowel syndrome (IBS), are associated with elevated levels of intestinal histamine due to chronic immune activation. As it is still impossible to determine histamine concentrations in vivo, a nasointestinal catheter with histamine-sensing capabilities has the potential to become a valuable diagnostic instrument. Regarding the sensing principle, we selected impedance spectroscopy using voltages that are compatible with intra-body applications with molecularly imprinted polymers (MIPs) as recognition elements. MIPs are synthetic receptors that offer the advantages of robustness, high specificity and selectivity for histamine as a target. In this specific case, the MIPs were synthesized from acryclic acid monomers, which guarantees a uniform binding capacity within the pH range of intestinal fluid. We have validated the catheter sensor on human intestinal liquids spiked with histamine in a testing setup that mimics the environment inside the duodenum. The dose-response curves show an analytical range between 5 and 200 nM of histamine, corresponding to physiologically normal conditions while higher concentrations correlate with disease. The key output signal of the sensor is the resistive component of the MIP-functionalized titanium electrodes as derived from the equivalent-circuit modelling of full-range impedance spectra. Future applications could be catheters tailored to cardiovascular, urological, gastrointestinal, and neurovascular applications. This, in combination with the versatility of the MIPs, will make this sensor platform a versatile diagnostic tool.

Subliminal fatty acid-induced gut-brain signals attenuate sensitivity to exteroceptive rewards in food but not in sex or financial domains, in healthy men.

Background Reward sensitivity can generalize across domains, but evidence for generalization of suppressive reward-related stimulation is sparse, especially in the context of interoceptive nutrient-related stimuli. We hypothesized that subliminal fatty acid-induced gut-brain signals could attenuate sensitivity to exteroceptive rewards, not only within the food domain but also across domains. Method Intragastric infusion of 2.5 g lauric acid (fat condition) or saline (saline condition) was administered to 59 healthy heterosexual male volunteers in a blinded fashion. To assess whether the resulting interoceptive signals attenuate reward sensitivity within the food domain, participants rated the palatability of food images and performed a progressive ratio task. To assess whether such attenuation effect generalizes to the sexual and financial reward domains, participants rated attractiveness of female face images and performed an intertemporal monetary choice task. Results Participants' ratings of food images were lower (F1,172 = 4.51, p = 0.035, Cohen's d: -0.20) in the fat condition. The progressive ratio task terminated earlier in the fat condition compared to saline (F1,52 = 4.17, p = 0.046, odds ratio = 0.31, 95%CI [0.11, 0.98]). Participants' ratings of female face images did not differ between conditions (F1,172 = 1.85, p = 0.19, Cohen's d: -0.15). Moreover, the monetary discounting rate did not differ significantly between conditions. Conclusion Overall, these findings suggest a domain-specific effect of subliminal fatty acid infusion on decreasing reward sensitivity.

How to select patients for antireflux surgery? The ICARUS guidelines (international consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for antireflux surgery).

OBJECTIVE: Antireflux surgery can be proposed in patients with GORD, especially when proton pump inhibitor (PPI) use leads to incomplete symptom improvement. However, to date, international consensus guidelines on the clinical criteria and additional technical examinations used in patient selection for antireflux surgery are lacking. We aimed at generating key recommendations in the selection of patients for antireflux surgery. DESIGN: We included 35 international experts (gastroenterologists, surgeons and physiologists) in a Delphi process and developed 37 statements that were revised by the Consensus Group, to start the Delphi process. Three voting rounds followed where each statement was presented with the evidence summary. The panel indicated the degree of agreement for the statement. When 80% of the Consensus Group agreed (A+/A) with a statement, this was defined as consensus. All votes were mutually anonymous. RESULTS: Patients with heartburn with a satisfactory response to PPIs, patients with a hiatal hernia (HH), patients with oesophagitis Los Angeles (LA) grade B or higher and patients with Barrett's oesophagus are good candidates for antireflux surgery. An endoscopy prior to antireflux surgery is mandatory and a barium swallow should be performed in patients with suspicion of a HH or short oesophagus. Oesophageal manometry is mandatory to rule out major motility disorders. Finally, oesophageal pH (±impedance) monitoring of PPI is mandatory to select patients for antireflux surgery, if endoscopy is negative for unequivocal reflux oesophagitis. CONCLUSION: With the ICARUS guidelines, we generated key recommendations for selection of patients for antireflux surgery.

Economic burden of moderate to severe irritable bowel syndrome with constipation in six European countries.

BACKGROUND: Irritable bowel syndrome with predominant constipation (IBS-C) is a complex disorder with gastrointestinal and nervous system components. The study aim was to assess the economic burden of moderate to severe IBS-C in six European countries (France, Germany, Italy, Spain, Sweden and the UK). METHODS: An observational, one year retrospective-prospective (6 months each) study of patients diagnosed in the last five years with IBS-C (Rome III criteria) and moderate to severe disease at inclusion (IBS Symptom Severity Scale score ≥ 175). The primary objective was to assess the direct cost to European healthcare systems. RESULTS: Five hundred twenty-five patients were included, 60% (range: 43.1-78.8%) suffered from severe IBS-C. During follow-up 11.1-24.0% of patients had a hospitalisation/emergency room (ER) visit, median stay range: 1.5-12.0 days and 41.1-90.4% took prescription drugs for IBS-C. 21.4-50.8% of employed patients took sick leave (mean: 11.6-64.1 days). The mean annual direct cost to the healthcare systems was €937.1- €2108.0. The total direct cost (combined costs to healthcare systems and patient) for IBS-C was €1421.7-€2487.1. CONCLUSIONS: IBS-C is not a life-threatening condition; however, it has large impact on healthcare systems and society. Direct and indirect costs for moderate to severe IBS-C were high with the largest direct cost driver being hospitalisations/ER visits.

A retrospective and prospective 12-month observational study of the socioeconomic burden of moderate to severe irritable bowel syndrome with constipation in Spain.

INTRODUCTION: The socioeconomic burden of irritable bowel syndrome with constipation (IBS-C) has never been formally assessed in Spain. PATIENTS AND METHODS: This 12-month (6-month retrospective and prospective periods) observational, multicentre study assessed the burden of moderate-to-severe IBS-C in Spain. Patients were included if they had been diagnosed with IBS-C (Rome III criteria) within the last 5 years and had moderate-to-severe IBS-C (IBS Symptom Severity Scale score [IBS-SSS] ≥175) at inclusion. The primary objective was to assess the direct cost to the Spanish healthcare system (HS). RESULTS: A total of 112 patients were included, 64 (57%) of which had severe IBS-C at inclusion. At baseline, 89 (80%) patients reported abdominal pain and distention. Patient quality of life (QoL), measured by the IBS-C QoL and EQ-5D instruments, was found to be impaired with a mean score of 59 and 57 (0-100, worst-best), respectively. Over the 6-month prospective period the mean IBS-C severity, measured using the IBS-SSS showed some improvement (315-234 [0-500, best-worst]). During the year, 89 (80%) patients used prescription drugs for IBS-C, with laxatives being the most frequently prescribed (n=70; 63%). The direct cost to the HS was €1067, and to the patient was €568 per year. The total direct cost for moderate-to-severe IBS-C was €1635. DISCUSSION: The majority of patients reported continuous IBS-C symptoms despite that 80% were taking medication to treat their IBS-C. Overall healthcare resource use and direct costs were asymmetric, with a small group of patients consuming the majority of resources.

Development of a real-time patient-reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method.

BACKGROUND: Patient-reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end-of-day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology. METHODS: An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients' understanding of the selected items and to create the definitive PROM. KEY RESULTS: A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients' understanding. CONCLUSIONS AND INFERENCES: A novel digital ESM-based PROM for real-time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.

A comparison of various intragastric balloons for the assessment of gastric motility.

BACKGROUND: There is a clear need for a novel method to readily assess gastric motility in daily clinical practice. METHODS: In a crossover design, 10 noncompliant balloons of different shape and volume (25-350 mL), attached to a classic feeding tube, were introduced in the stomach of eight healthy volunteers. In the same experiment, a High-Resolution Manometry (HRM) catheter was positioned throughout the stomach. Gastric motility was recorded during fasting (2 hours) and liquid nutrient administration (30 minutes). Motility was quantified using a peak detection algorithm. Symptoms were recorded throughout the experiment using visual analog scales (100 mm). Results are presented as mean ± SD. KEY RESULTS: The % time during which motility-induced pressure increments could be detected with HRM but not by the balloon varied from 42 ± 24% in the smallest (25 mL) balloon to 1 ± 1% in the 330 mL balloon. On the other hand, bloating, discomfort and nausea scores were 0 ± 0, 0 ± 0 and 2 ± 5 mm, respectively, for the smallest balloon (25 mL) while these scores were 28 ± 38, 13 ± 30, and 38 ± 30 mm, respectively, for the largest balloon (350 mL). A phase III contraction pattern was consistently evoked in balloons with a volume >200 mL. CONCLUSION: Gastric motility could be assessed more accurately with larger volume balloons, while epigastric symptoms were evoked with increasing balloon volume. The optimal balloon to measure gastric motility has a 5 cm diameter and is 11 cm long (210 mL). A nasogastric balloon catheter can now be developed that enables relatively easy monitoring of gastric motility in patients with epigastric symptoms.

Pressure flow analysis in the assessment of preswallow pharyngeal bolus presence in Dysphagia.

Objectives. Preswallow pharyngeal bolus presence is evident in patients with oropharyngeal dysphagia. Pressure flow analysis (PFA) using high resolution manometry with impedance (HRMI) with AIMplot software is a method for objective interpretation of pharyngeal and upper esophageal sphincter (UES) pressures and bolus flow patterns during swallowing. This study aimed to observe alterations in PFA metrics in the event of preswallow pharyngeal bolus presence as seen on videofluoroscopy (VFSS). Methods. Swallows from 40 broad dysphagia patients and 8 controls were recorded with a HRMI catheter during simultaneous VFSS. Evidence of bolus presence and level reached prior to pharyngeal swallow onset was recorded. AIMPlot software derived automated PFA functional metrics. Results. Patients with bolus movement to the pyriform sinuses had a higher SRI, indicating greater swallow dysfunction. Amongst individual metrics, TNadImp to PeakP was shorter and flow interval longer in patient groups compared to controls. A higher pharyngeal mean impedance and UES mean impedance differentiated the two patient groups. Conclusions. This pilot study identifies specific altered PFA metrics in patients demonstrating preswallow pharyngeal bolus presence to the pyriform sinuses. PFA metrics may be used to guide diagnosis and treatment of patients with oropharyngeal dysphagia and track changes in swallow function over time.

Objective assessment of swallow function in children with suspected aspiration using pharyngeal automated impedance manometry.

OBJECTIVES: The purpose of the present study was to apply a new method, pharyngeal automated impedance manometry (AIM), as an objective assessment tool of swallow function relevant to aspiration, in a cohort of paediatric patients with dysphagia. METHODS: We studied 20 children (mean age 6 years [5 months to 13.4 years]) referred for videofluoroscopy to assess aspiration risk with simultaneous manometry-impedance. Fluoroscopic evidence of aspiration was scored using a validated aspiration-penetration score. Pressure-flow profiles were analysed using AIM analysis measuring peak pressure, pressure at nadir impedance, time from nadir impedance to peak pressure, and flow interval. These variables were combined into a swallow risk index (SRI). RESULTS: Six of 20 children presented with deglutitive aspiration during videofluoroscopic assessment of swallowing. Of 58 liquid swallows analysed, in 9 aspiration was observed. Multiple logistic regression identified longer flow interval (P < 0.05), higher SRI (P < 0.05) and increased pressure in the upper oesophageal sphincter during maximal bolus flow (P < 0.05) to be the dominant risk variables predictive of aspiration in children. Each of these nonradiologically derived pressure-flow variables correlated with higher aspiration scores on videofluoroscopy (P < 0.01). CONCLUSIONS: We present novel, preliminary findings in children with deglutitive aspiration, suggesting that pharyngeal AIM can detect alterations in pressure-flow characteristics of swallowing that predispose to aspiration risk.

IBS and the role of otilonium bromide.

INTRODUCTION: Awareness of the seriousness of irritable bowel disorder (IBS) remains low among clinicians. In this review, we summarize the current knowledge of IBS and highlight the major personal, economic, and social burden of the disease, and the importance of adequate treatment of what is still often viewed as a trivial disorder. In fact, IBS is a major reason for referral. PATHOPHYSIOLOGY: It is crucial that the varied pathophysiologies of this complex heterogeneous disease are understood in order to be able to treat both the presenting symptoms (pain, bloating, flatulence, abnormal defecation, diarrhea, constipation) and the underlying disorder effectively. Low-grade inflammatory and immune activation has been observed, but the precise triggers and mechanisms, and the relevance to symptom generation, remain to be established. TREATMENT: IBS patients require different treatment strategies according to the pattern, severity, frequency, and symptoms. While initial therapy traditionally targets the most bothersome symptom, long-term therapy aims at maintaining symptom control and preventing recurrence. In addition to dietary/lifestyle interventions and psychosocial strategies, a wide range of pharmacologic therapies are approved for use in IBS depending on the symptoms reported. Musculotropic spasmolytics, which act directly on intestinal smooth muscle contractility, such as otilonium bromide, are effective, particularly in the relief of abdominal pain and bloating, and are well tolerated in IBS. THE OBIS TRIAL: The recent large placebo-controlled Otilonium Bromide in Irritable Bowel Syndrome study demonstrated the superiority of otilonium bromide versus placebo not only in the reduction of pain and bloating, but also in protection from relapse due to the long-lasting effect.

A novel method for the nonradiological assessment of ineffective swallowing.

OBJECTIVES: This validation study evaluates a new manometry impedance-based approach for the objective assessment of pharyngeal function relevant to postswallow bolus residue. METHODS: We studied 23 adult and pediatric dysphagic patients who were all referred for a videofluoroscopy, and compared these patients with 10 adult controls. The pharyngeal phase of swallowing of semisolid boluses was recorded with manometry and impedance. Fluoroscopic evidence of postswallow bolus residue was scored. Pharyngeal pressure impedance profiles were analyzed. Computational algorithms measured peak pressure (Peak P), pressure at nadir impedance (PNadImp), time from nadir impedance to PeakP (PNadImp-PeakP), the duration of impedance drop in the distal pharynx (flow interval), upper esophaghageal sphincter (UES) relaxation interval (UES-RI), nadir UES pressure (NadUESP), UES intrabolus pressure (UES-IBP), and UES resistance. A swallow risk index (SRI) was derived by the formula: SRI=(FI × PNadImp)/(PeakP × (TNadImp-PeakP+1)) × 100. RESULTS: In all, 76 patient swallows (35 with residue) and 39 control swallows (12 with residue) were analyzed. Different functional variables were found to be altered in relation to residue. In both controls and patients, flow interval was longer in relation to residue. In controls, but not patients, residue was associated with an increased PNadImp (suggestive of increased pharyngeal IBP). Controls with residue had increased UES-IBP, NadUESP, and UES resistance compared with patients with residue. Residue in patients was related to a prolonged UES-RI. The SRI was elevated in relation to residue in both controls and patients and an average SRI of 9 was optimally predictive of residue (sensitivity 75% and specificity 80%). CONCLUSIONS: We present novel findings in control subjects and dysphagic patients showing that combined manometry and impedance recordings can be objectively analyzed to derive pressure-flow variables that are altered in relation to the bolus residual and can be combined to predict ineffective pharyngeal swallowing.

Emerging drugs for functional dyspepsia.

INTRODUCTION: Functional dyspepsia (FD) is a highly prevalent condition with a major impact on quality of life and high socio-economic and healthcare costs. To date, no treatment of established efficacy in FD is available. AREAS COVERED: This review of the literature summarizes recent progress in drug development for FD. Gastroprokinetics are considered therapeutically relevant in FD, although it has been difficult to prove symptomatic benefit. Recently studied drugs include 5-HT(4) receptor agonists (tegaserod), motilin receptor agonists (GSK962040 and others) and ghrelin receptor agonists (TZP-101, TZP-102). Fundic relaxant drugs are a novel approach to FD therapy. Recently studied drugs include 5-HT(1A) receptor agonists (buspirone, tandospirone, R137696) and acotiamide (or Z-338 or YM443), a first-in-class muscarinic M(1)/M(2) receptor antagonist and cholinesterase inhibitor. Extensive Phase II studies support the potential efficacy of acotiamide, especially for postprandial distress syndrome. In refractory cases, psychotropics are considered and recently studied agents include venlafaxine, which in a large multi-center study did not confirm efficacy, and a combination preparation of flupenthixol/melitracen, which showed potential efficacy in a small study. EXPERT OPINION: While many new prokinetic drugs are in the early stages of evaluation, acotiamide emerges as the drug with a promising efficacy profile. Convincing evidence for the efficacy of psychotropics is lacking.

Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders.

BACKGROUND AND AIMS: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia. METHODS: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened). RESULTS: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief ( P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21-1.28, and standard errors of measurement ranged from 0.29-0.63, depending on subscale and disease sample. CONCLUSIONS: The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.

Gastroparesis Cardinal Symptom Index (GCSI): development and validation of a patient reported assessment of severity of gastroparesis symptoms.

BACKGROUND: Patient-rated symptom assessments are needed for evaluating the effectiveness of medical treatments and for monitoring outcomes in gastroparesis. OBJECTIVE: This paper summarizes the development and psychometric evaluation of a new instrument, the Gastroparesis Cardinal Symptom Index (GCSI), for assessing severity of symptoms associated with gastroparesis. METHODS: The GCSI was based on reviews of the medical literature, patient focus groups, and interviews with clinicians. A sample of 169 patients with a documented diagnosis of gastroparesis participated in the psychometric evaluation study. Patients completed the GCSI, the SF-36 Health Survey, and disability days questions at baseline and after 8 weeks. A randomly selected sub-sample of 30 subjects returned at 2 weeks to assess test retest reliability. Clinicians rated severity of symptoms, and both clinicians and patients rated change in gastroparesis-related symptoms over the 8 week study. RESULTS: The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores. Construct validity was supported, given that we observed significant relationships between clinician assessed symptom severity and GCSI total score, significant differences between gastroparesis and dyspepsia patients (n = 760) on GCSI total (p < 0.0001) and subscale scores (p < 0.03 to p < 0.0001), moderate and significant relationships between GCSI total and SF-36 scores, and significant associations between GCSI total score and reports of restricted activity and bed disability days. Patients with greater symptom severity, as rated by clinicians, reported more symptom severity on GCSI total score. GSCI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians (p < 0.0001) and patients (p = 0.0004). CONCLUSION: The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring symptom severity in patients with gastroparesis.

Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: the PAGI-QOL.

OBJECTIVE: Summarize the Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QOL) development and provide results on its reliability and validity from the international psychometric validation in dyspepsia, GastroEsophageal Reflux Disease (GERD), and gastroparesis. METHODS: Subjects completed the pilot PAGI-QOL at baseline and 8 weeks; and a subsample also at 2 weeks. Other assessments were: Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, SF-36, number of disability days. RESULTS: 1736 patients completed the PAGI-QOL at baseline. The questionnaire was reduced, producing a 30-item final version covering five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship (REL), and Psychological Well-Being and Distress. Internal consistency was excellent (Cronbach's alpha range: 0.83-0.96). Test-retest reproducibility was good: intraclass correlations coefficients were over 0.70 except for the REL scale (0.61). Concurrent validity between the PAGI-QOL total score and all SF-36 subscale scores was good with moderate (0.52) to strong (0.72) correlations. PAGI-QOL scores showed excellent discriminant properties: patients who had spent some days in bed, had missed some days at work, and were kept from usual activities had much lower PAGI-QOL scores than those who did not (p < 0.0001). CONCLUSION: The PAGI-QOL is a valid and reliable instrument assessing quality of life in patients with dyspepsia, GERD, or gastroparesis.