Citations

AbstractBackgroundIn an open‐label study of 26 patients with IBS‐C and chronic constipation, treatment with a vibrating (VIBRANT) capsule twice a week for 7.5 weeks resulted in 88.5% responders. Effects on colonic transit are unclear. We aimed to compare effects of VIBRANT and sham capsule treatment on colonic transit in patients with functional constipation.MethodsPatients with functional constipation (Rome III criteria) were randomized to VIBRANT or sham capsule treatment for 8 weeks and underwent scintigraphic colonic transit measurements during week 8. We estimated the overall rate of colonic transit from the slope of progression of colonic geometric center over 48 hours. The capsule was activated 8 hours after ingestion, and the vibration sequence included 240 cycles.Key ResultsThere were no significant group differences in overall colonic transit [GC48, 2.76 (IQR 2.42‐4.03) for sham group and 3.46 (2.55‐4.61) for active treatment group (P=.13)]. Additionally, the progression of the isotope through the colon was numerically faster, though not significantly different (slope, P=.14) in the VIBRANT capsule group compared to the sham group. Three participants in the VIBRANT capsule group had accelerated colonic transit at 32 hours and faster colonic transit slope compared to the 95th percentile of the sham group.Conclusions and InferencesAlthough there were no group differences between VIBRANT and sham capsule treatment on colonic transit, at least one (and possibly three) of 12 patients receiving the VIBRANT capsule had faster colonic transit. The vibration parameters to accelerate colonic transit in patients with functional constipation require further optimization.

Patient-centered cognitive support has been shown to be critically important to facilitate the effective use of health information technologies (HIT). There is a well-documented need to better understand HIT-mediated clinical workflow. Current technologies can burden clinicians’ cognitive resources, which is associated with patient safety risks and medical errors. We sought to employ a distributed cognition approach to examine how information flows across the activity system to support clinicians’ problem-solving. Specifically, we studied the propagation of representational states across media, conversations, actors and time in the coordination of patient-care processes. We examined multiple instances of work and information flow in a real-world setting, revealing problems in information flow: a) use of paper artifacts has limitations to facilitating coordination of care, b) clinicians challenged in developing shared awareness, c) responsibility of representing patient states is distributed across documents, d) clinical reasoning that informed care plans was absent from documents. Findings surface a challenge to automated monitoring of care goals; much of the information is present only in clinicians’ minds and in informal documents.

AbstractBackgroundSynthetic human ghrelin accelerates gastric emptying, reduces gastric accommodation, and results in numerical increases in postprandial symptom scores. The ghrelin receptor agonist, relamorelin, accelerates gastric emptying in patients with diabetic gastroparesis.AimTo measure pharmacological effects of relamorelin on gastric accommodation, distal antral motility, and satiation in healthy volunteers.MethodsIn a placebo‐controlled, double‐blind, randomized study of 16 healthy volunteers, we compared effects of 30 μg subcutaneous (s.c.) relamorelin to placebo on: (i) gastric volumes measured by single photon emission computed tomography, (ii) 1‐h postprandial distal antral motility index (MI) by 15‐lumen perfusion gastroduodenal manometry, and (iii) satiation tested by Ensure nutrient drink test. Primary endpoints were: fasting and postprandial gastric volumes, distal antral phasic pressure activity (number of contractions, mean amplitude, and MI), and maximum tolerated volume. Results were normally distributed and the two treatment groups were compared using t‐test.Key ResultsRelamorelin, 30 μg s.c., significantly increased the number of contractions in the distal antrum during 0–60 min postmeal when compared to placebo (p = 0.022); this was also observed in the first two 15‐min periods (p = 0.005 and 0.015 for number of contractions 0–15 and 16–30). There was borderline increase in MI0‐15 (p = 0.055) and numerically increased MI0‐60 (p = 0.139) and MI16‐30 (p = 0.116). The amplitude of contractions was not significantly increased. Relamorelin did not significantly alter fasting or postprandial gastric volumes, gastric accommodation, or satiation volumes and symptoms.Conclusions & InferencesRelamorelin increases frequency of distal antral motility contractions without significant effects on amplitude of contractions. The lack of inhibition of accommodation and absence of increase in satiation symptoms support relamorelin for the treatment of symptomatic gastroparesis (ClinicalTrials.gov NCT02466711).

AbstractBackgroundThis study compared prucalopride, a selective, prokinetic, 5‐HT4 receptor agonist, with polyethylene glycol 3350 + electrolytes (PEG3350), an osmotic laxative, on colonic motility parameters, primarily high‐amplitude propagating contractions (HAPCs) in patients with chronic constipation.MethodsThis randomized, cross‐over, reader‐blinded study was conducted at a single site in the USA. The study was open to men and women aged 18–75 years who met study inclusion criteria. Colonic manometry catheters were inserted the day before investigation. On the investigation days, patients received oral 2 mg prucalopride or 2 × 13.8 g PEG3350 in solution. The primary endpoint was HAPC count (threshold: mean amplitude ≥100 mmHg, propagation ≥20 cm [HAPC1]) in the 12 h after treatment administration. Analyses were also conducted at two co‐primary thresholds: mean amplitude ≥75 mmHg, propagation ≥20 cm (HAPC2); and mean amplitude ≥75 mmHg, propagation ≥10 cm (HAPC3). Secondary endpoints included HAPC area under the curve (AUC), contraction force, amplitude, duration, and propagation velocity.Key ResultsThirteen women were enrolled, with 12 completing the study. Significantly more HAPC1 (8.7 ± 2.06 vs 2.9 ± 2.06; p = 0.012) and HAPC2 (9.0 ± 2.11 vs 3.3 ± 2.11; p = 0.017) were observed in the 12‐h periods with prucalopride than with PEG3350. Prucalopride significantly increased mean propagation distance and velocity (HAPC2) and mean AUC, force, and amplitude (HAPC3) compared with PEG3350. Adverse events were mild or moderate.Conclusions & InferencesPrucalopride was superior to PEG3350 in inducing HAPCs in patients with chronic constipation.ClinicalTrials.gov number NCT01707667.

AbstractBackgroundGastrointestinal (GI) and non‐GI disorders are associated with altered intestinal permeability, which can be measured in vivo by urinary excretion after oral lactulose and mannitol ingestion. Inadvertent dietary consumption of 12Carbon (12C, regular) mannitol in food or from other sources may interfere with the test's interpretation. 13Carbon (13C) constitutes 1% of carbon in nature and 13C mannitol is a stable isotope. Our aim was to determine the performance of 13C mannitol for measurement of intestinal permeability.MethodsTen healthy volunteers underwent intestinal permeability assay using coadministered 12C mannitol, 13C mannitol and lactulose, followed by timed urine collections. Urinary sugar concentrations were measured using tandem high performance liquid chromatography–mass spectrometry.Key resultsWe found that 13C mannitol can be distinguishable from 12C mannitol on tandem mass spectrometry. In addition, 13C mannitol had ~20‐fold lower baseline contamination compared to 12C mannitol. We describe here the 13C mannitol assay method for the measurement of intestinal permeability.Conclusions & InferencesIn conclusion, 13C mannitol is superior to 12C mannitol for measurement of intestinal permeability. It avoids issues with baseline contamination and erratic excretions during the testing period.

Introduction: Our study assesses the utility of telemetry in identifying decompensation in patients with documented cardiopulmonary arrest. Methods: A retrospective review of inpatients who experienced a cardiopulmonary arrest from May 1, 2008, until June 30, 2014, was performed. Telemetry records 24 hours prior to and immediately preceding cardiopulmonary arrest were reviewed. Patient subanalyses based on clinical demographics were made as well as analyses of survival comparing patients with identifiable rhythm changes in telemetry to those without. Results: Of 242 patients included in the study, 75 (31.0%) and 110 (45.5%) experienced telemetry changes at the 24-hour and immediately preceding time periods, respectively. Of the telemetry changes, the majority were classified as nonmalignant (n = 50, 66.7% and n = 66, 55.5% at 24 hours prior and immediately preceding, respectively). There was no difference in telemetry changes between intensive care unit (ICU) and non-ICU patients and among patients stratified according to the American Heart Association telemetry indications. There was no difference in survival when comparing patients with telemetry changes immediately preceding and at 24 hours prior to an event (n = 30, 27.3% and n = 15, 20.0%) to those without telemetry changes during the same periods (n = 27, 20.5% and n = 42, 25.2%; P = .22 and .39). Conclusion: Telemetry has limited utility in predicting clinical decompensation in the inpatient setting.

ABSTRACTBackgroundThe panelists of the Joint National Committee recently published new recommendations for the management of hypertension. Our study aims to evaluate how current practice compares.HypothesisCurrent practice likely deviates from the recent JNC 8 panelists' recommendations.MethodsA survey was sent to cardiology providers at 3 academic medical centers: Mayo Clinic, Jacksonville, Florida; Mayo Clinic, Scottsdale, Arizona; and Mayo Clinic, Rochester, Minnesota. Providers were asked to select which blood‐pressure goal would be deemed appropriate in various cases based on individual practice in both the maintenance of patients already on therapy as well as threshold of when to initiate therapy. Comparisons with current recommendations were made, as well as geographic location and level of experience.ResultsA total of 251 survey requests were sent (May 2014), and 77 responses (30.7%) were received. Cardiologists tended not to practice according to the new guidelines, with most variation seen in patients age >60 years without comorbidities on active treatment. Providers' selection of initial pharmacologic agents in non–African American patients, African American patients, and patients with diabetes mellitus reflected congruency with guidelines.ConclusionsOur study found that clinical practice does not correlate well with the new blood‐pressure goal recommendations published by the Joint National Committee 8 panelists, particularly in patients age >60 years. Practitioners are likely to follow the recommendations in regard to pharmacologic management.