186,310 research outputs found

    Clinical trial design in adult reflux disease: a methodological workshop

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    Background: The development of well-tolerated acid suppressant drugs has stimulated substantial growth in the number of trials assessing therapy options for gastro-oesophageal reflux disease (GERD). Aim: To develop consensus statements to inform clinical trial design in adult patients with GERD. Methods: Draft statements were developed employing a systematic literature review. A modified Delphi process including three rounds of voting was used to reach consensus. Between voting, statements were revised based on feedback from the Working Group and additional literature reviews. The final vote was at a face-to-face meeting that included discussion time. Voting was conducted using a six-point scale. Results: At the last vote, 93% of the final 102 statements achieved consensus (defined a priori as being supported by ‡75% of the votes). The Working Group strongly supported the development of validated patientreported outcome instruments. Symptom assessments carried out by the investigator were considered unacceptable. There was agreement that exclusion from clinical trials should be minimized to improve generalizability, that prospective evaluation ideally requires electronic timed ⁄ dated methods and that endoscopists should be blinded to patient symptom status. Conclusions: Implementation of the consensus statements will improve the quality and comparability of trials, and make them compatible with regulatory requirements.J . Dent, P. J . Kahrilas, N. Vakil, S. Veldhuyzen Van Zanten, P. Bytzer, B. Delaney, K. Haruma, J. Hatlebakk, E. McColl, P. Moayyedi, V. Stanghellini, J . Tack and M. Vaezihttp://www3.interscience.wiley.com/journal/120088380/issu

    A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation (IBS-C).

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    BACKGROUND: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent and effective upon repeated use. AIMS: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health-economic measures. PATIENTS: Women (>/=18 years of age) with IBS-C according to the Rome II criteria. METHODS: Prospective, double-blind, placebo- controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg b.i.d. or placebo for 1 month. Patients with at least a partial response entered a treatment-free interval. Upon symptom recurrence, tegaserod-treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention-to-treat. RESULTS: 2,660 patients and 1,191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% vs 24.2% responders respectively for relief of IBS symptoms and 31.3% vs 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% vs 28.7%, and 42.4% vs 27.1%, all p<0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity and improved quality of life than placebo (p<0.05). CONCLUSION: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment

    Oral hypoglycaemic drugs and gastrointestinal symptoms in diabetes mellitus

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    The definitive version is available at www.blackwell-synergy.com Article first published online: 7 JUL 2008Background: Gastrointestinal symptoms are commonly reported as side-effects of oral hypoglycaemic drugs. It may be very difficult to distinguish between spontaneous and truly drug-related symptoms due to the high background incidence of gastrointestinal symptoms. Gastrointestinal symptoms in diabetic patients have also been linked to factors associated with long-standing disease and suboptimal control. Aim: To explore the association between gastrointestinal symptoms and treatment with oral hypoglycaemic drugs in a large cohort of subjects with type 2 diabetes. Patients and methods: 956 subjects with type 2 diabetes participated in the study. All subjects completed a validated, self-administered questionnaire on gastrointestinal symptoms, diabetes, drug use and various potential risk factors for gastrointestinal symptoms. The association between oral hypoglycaemics and nine gastrointestinal symptom groups was assessed based on logistic regression. Results: 405 of the 956 patients used oral hypoglycaemic drugs. Metformin use was independently associated with chronic diarrhoea (odds ratio 3.08, 95% CI: 1.29–7.36, P < 0.02) and with faecal incontinence (odds ratio 1.95, 95% CI: 1.10–3.47, P < 0.05). Use of sulphonylureas was associated with less abdominal pain, but not with any other gastrointestinal symptom. Conclusions: Troublesome gastrointestinal symptoms do not appear to be caused by oral hypoglycaemics, except for diarrhoea and faecal incontinence, which are strongly and independently associated with metformin useP. Bytzer, N. J. Talley, M. P. Jones & M. Horowit

    Going Beyond Counting First Authors in Author Co-citation Analysis

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    The present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed

    Appropriate Similarity Measures for Author Cocitation Analysis

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    We provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis

    Withdrawn by Author

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    Dispelling the Myths Behind First-author Citation Counts

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    We conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more sophisticated methods

    Dr. Edward P. Wimberly, ITC, July 2011

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    This video is a conversation with Dr. Edward P. Wimberly. Dr. Wimberly talks about his book, "No Shame in Wesley's Gospel: A Twenty-First Century Pastoral Gospel". Brad Ost, AUC Woodruff Library, is the interviewer

    Author Rights and Scholarly Publishing

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    Originally posted at http://blog.library.gsu.edu/2014/10/24/author-rights-and-scholarly-publishing/</p
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