title: Barostat testing of rectal sensation and compliance in humans: comparison of results across two centres and overall reproducibility.
abstract: 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.
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.) Program, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.
authors.forename: F
authors.initials: F
authors.lastname: Cremonini
authors.forename: L A
authors.initials: LA
authors.lastname: Houghton
authors.forename: M
authors.initials: M
authors.lastname: Camilleri
authors.forename: I
authors.initials: I
authors.lastname: Ferber
authors.forename: C
authors.initials: C
authors.lastname: Fell
authors.forename: V
authors.initials: V
authors.lastname: Cox
authors.forename: E J
authors.initials: EJ
authors.lastname: Castillo
authors.forename: D H
authors.initials: DH
authors.lastname: Alpers
authors.forename: O E
authors.initials: OE
authors.lastname: Dewit
authors.forename: E
authors.initials: E
authors.lastname: Gray
authors.forename: R
authors.initials: R
authors.lastname: Lea
authors.forename: A R
authors.initials: AR
authors.lastname: Zinsmeister
authors.forename: P J
authors.initials: PJ
authors.lastname: Whorwell
mesh_terms: D000328:Adult; D003187:Compliance; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D009460:Neurologic Examination; D010147:Pain Measurement; D011312:Pressure; D012002:Rectal Diseases / Q000175:diagnosis; D012007:Rectum / Q000502:physiology*; D015203:Reproducibility of Results; D018401:Sample Size; D012677:Sensation / Q000502:physiology