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Summary: Background: Crohn's disease requires effective patient‐clinician communication for successful illness and medication management. Shared decision making (SDM) has been suggested to improve communication around early intensive therapy. However, effective evidence‐based SDM interventions for Crohn's disease are lacking, and the impact of SDM on Crohn's disease decision making and choice of therapy is unclear. Aim: To test the impact of SDM on choice of therapy, quality of the decision and provider trust compared to standard Crohn's disease care. Methods: We conducted a multi‐site cluster randomised controlled trial in 14 diverse gastroenterology practices in the US. Results: A total of 158 adult patients with Crohn's disease within 15 years of their diagnosis, with no prior Crohn's disease complications, and who were candidates to receive immunomodulators or biologics, participated in the study. Among these, 99 received the intervention and 59 received standard care. Demographics were similar between groups, although there were more women assigned to standard care, and a slightly shorter disease duration among those in the intervention group. Participants in the intervention group more frequently chose combination therapy (25% versus 5% control, p < 0.001), had a significantly lower decisional conflict (p < 0.05) and had greater trust in their provider (p < 0.05). Conclusions: With rapidly expanding medication choices for Crohn's disease and slow uptake of early intensive therapy, SDM can personalise treatment strategies and has the potential to move the field of Crohn's disease management forward with an ultimate goal of consistently treating this disease early and intensively in appropriate patients. Trial Registration: Evaluating a Shared Decision Making Program for Crohn's Disease, ClinicalTrials.gov Identifier NCT02084290 https://clinicaltrials.gov/ct2/show/NCT02084290. [ABSTRACT FROM AUTHOR]

Background: Inflammatory bowel disease (IBD) treatment paradigms recommend objective disease activity assessment and reactive therapeutic drug monitoring (TDM) prior to changes in biologic therapy. We aimed to describe objective marker and TDM assessment in routine clinical practice prior to biologic therapeutic changes in adult IBD patients.Methods: TARGET-IBD is a prospective longitudinal cohort of over 2100 IBD patients receiving usual care at 34 US academic or community centers enrolled between June 2017 and October 2019 who received biologic therapy and had a dose change or biologic discontinuation for lack of efficacy. Objective markers of disease activity within 12 weeks prior included fecal calprotectin, C-reactive protein (CRP), endoscopy, computed tomography (CT) and magnetic resonance imaging (MRI). TDM data for infliximab or adalimumab was obtained.Results: 525 patients (71.4% Crohn's disease [CD], 28.6% ulcerative colitis [UC]) receiving biologic therapy underwent dose change (55.6%) or discontinuation (44.4%) for lack of efficacy. The majority were Caucasian (85.7%), 18-39 years old (52.2%), privately insured (81.5%), and at academic centers (73.7%). For dose changes, 67.5% had at least one objective disease activity assessment or TDM in the 12 weeks prior (CD 67.9%, UC 66.2%; P = 0.79). The most common objective marker was CRP in both CD (39.1%) and UC (54.5%). CRP and calprotectin were used significantly more in UC (P = 0.02 and P = 0.03). TDM was obtained in 30.7% (28.8% UC, 31.4% CD; P = 0.72) prior to dose change. For biologic discontinuation, 79.4% patients underwent objective assessment or TDM prior. In CD, CRP (46.3%) was most common, and CT (P = 0.03) and MRI (P < 0.001) were significantly more frequent than in UC. TDM was performed in 40.1% of patients (43.5% UC, 38.0% CD, P = 0.49) prior to discontinuation. Among all participants with dose change or discontinuation, endoscopy was performed in 29.3% with CD and 31.3% with UC. Academic care setting was associated with objective assessment before therapy change (OR 1.59, 95% CI 1.01-2.50).Conclusion: Nearly one-third of patients undergoing a biologic dose change or discontinuation do not undergo objective disease activity assessment or TDM. Assessment choice differs by disease. Future studies assessing the impact of such practices on long-term outcomes are needed. [ABSTRACT FROM AUTHOR]

Background: Telithromycin is a ketolide antibiotic approved by the U.S. Food and Drug Administration for acute bacterial infections causing sinusitis, bronchitis, and community-acquired pneumonia. Objective: To describe 3 cases of severe hepatotoxicity in patients receiving telithromycin. Design: Case reports. Setting: A tertiary care medical center. Patients: 3 previously healthy patients who had recently taken telithromycin and took no other prescription medications. Measurements: Serologic, histologic, and liver function tests. Results: Within a few days of receiving telithromycin, the patients presented with acute hepatitis. All had jaundice and markedly abnormal results on liver function tests. Results of viral serologic tests were negative. One patient spontaneously recovered, 1 required orthotopic liver transplantation, and 1 died. Histologic examination in the latter 2 patients showed massive hepatic necrosis. Limitations: Two patients had some history of alcohol use. The frequency of severe telithromycin-related hepatotoxicity cannot be established with case reports. Conclusions: Telithromycin can cause severe hepatotoxicity. Caution is advised in prescribing this drug pending additional postmarketing surveillance data. [ABSTRACT FROM AUTHOR]

During a 44-month period, 105 Medtronic model 6972-58 polyurethane-insulated, bipolar ventricular pacing leads were implanted, of which 16 failed clinically at a mean of 20.5 months post-implant. Pacing dysfunction presented as either intermittent or complete loss of sensing and/or capture and, rarely, oversensing. Thirteen of the 16 patients were asymptomatic, and problems were detected in 11 instances during routine telephonic surveillance. At the time of lead replacement, low or widely fluctuating lead resistance values and high current drain were uniformly observed. The single lead capable of total extraction revealed rupture of both internal and external insulation. A brief summary of the currently much-discussed "polyurethane controversy" is presented, and the issue of patient management is discussed. [ABSTRACT FROM AUTHOR]

Our experience with over one-thousand pacemaker implantations resulting in almost 28.000 patient pacing months is reviewed. Data are presented regarding changing indications for pacing, experience with numerous pacemaker types, patient survival, comparative mortality of sick sinus syndrome and complete heart block, and telephone surveillance. Consistent with some previous reports, there were high one- and two-year post-implant mortality rates, and advanced age at implant was associated with decreased survival. Males had a significantly higher mortality rate. The period reported covers the transition from utilization of mercury-zinc batteries to lithium power cells and other new technology; significant differences were observed in device reliability and patient mortality when comparing these eras. Certain patients evidenced disparate survivals, the most notable difference being seen in those who received their primary implants prior to 1976 and subsequent implants of more modern units. [ABSTRACT FROM AUTHOR]

The capabilities of a mini-computer-oriented permanent pacemaker information system are described. Extensive patient and pacer functional data. are maintained in readily accessible files which may be displayed on a CRT terminal or printed out. Selective sorting of stored information may be accomplished according to any desired set of inclusive or exclusive criteria. Intelligent, comprehensive patient follow-up has been greatly facilitated through application of the system. In view of the rapidly expanding pacemaker population, it is suggested that cooperative regional networks operating with come parable information storage and retrieval structures will provide the only means for adequate patient surveillance and compilation of necessary pacemaker data. [ABSTRACT FROM AUTHOR]

Nausea and vomiting can result from a wide variety of organic and psychogenic disorders. In evaluating these symptoms, a thorough history with careful attention to their duration and relation to meals, as well as to concomitant drug use and underlying chronic medical problems, often will point to the correct diagnosis. A wide variety of diagnostic modalities exist, including radiographic studies, endoscopy, radionuclide methods of assessing gastrointestinal motility, and imaging studies of the central nervous system. These techniques must be used wisely and are not all required to elucidate the etiology in every patient. Treatment can be symptomatic but is directed at the underlying pathological process whenever possible. Recently developed gastrointestinal "prokinetic" agents have helped to improve the course of patients with identifiable motility disorders. [ABSTRACT FROM AUTHOR]

We present here an unusual case of a pancreatic gastrinoma that caused recurrent episodes of clinical pancreatitis secondary to complete obstruction of the main pancreatic duct. The patient did not manifest signs or symptoms of peptic ulcer disease. [ABSTRACT FROM AUTHOR]