| Barostat testing of rectal sensation and compliance in humans: comparison of results across two centres and overall reproducibility. | |
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MedLine Citation:
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PMID: 16336496 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We assessed reproducibility of measurements of rectal compliance and sensation in health in studies conducted at two centres. We estimated samples size necessary to show clinically meaningful changes in future studies. We performed rectal barostat tests three times (day 1, day 1 after 4 h and 14-17 days later) in 34 healthy participants. We measured compliance and pressure thresholds for first sensation, urgency, discomfort and pain using ascending method of limits and symptom ratings for gas, urgency, discomfort and pain during four phasic distensions (12, 24, 36 and 48 mmHg) in random order. Results obtained at the two centres differed minimally. Reproducibility of sensory end points varies with type of sensation, pressure level and method of distension. Pressure threshold for pain and sensory ratings for non-painful sensations at 36 and 48 mmHg distension were most reproducible in the two centres. Sample size calculations suggested that crossover design is preferable in therapeutic trials: for each dose of medication tested, a sample of 21 should be sufficient to demonstrate 30% changes in all sensory thresholds and almost all sensory ratings. We conclude that reproducibility varies with sensation type, pressure level and distension method, but in a two-centre study, differences in observed results of sensation are minimal and pressure threshold for pain and sensory ratings at 36-48 mmHg of distension are reproducible. |
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Authors:
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F Cremonini; L A Houghton; M Camilleri; I Ferber; C Fell; V Cox; E J Castillo; D H Alpers; O E Dewit; E Gray; R Lea; A R Zinsmeister; P J Whorwell |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society Volume: 17 ISSN: 1350-1925 ISO Abbreviation: Neurogastroenterol. Motil. Publication Date: 2005 Dec |
Date Detail:
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Created Date: 2005-12-12 Completed Date: 2006-01-17 Revised Date: 2007-11-14 |
Medline Journal Info:
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Nlm Unique ID: 9432572 Medline TA: Neurogastroenterol Motil Country: England |
Other Details:
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Languages: eng Pagination: 810-20 Citation Subset: IM |
Affiliation:
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Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.) Program, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Compliance Endpoint Determination Female Humans Male Neurologic Examination Pain Measurement Pressure Rectal Diseases / diagnosis Rectum / physiology* Reproducibility of Results Sample Size Sensation / physiology |
| Grant Support | |
ID/Acronym/Agency:
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K24-DK02638/DK/NIDDK NIH HHS; R01-DK54681/DK/NIDDK NIH HHS; R01-DK67071/DK/NIDDK NIH HHS; RR00585/RR/NCRR NIH HHS |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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