title: Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder.
abstract: This observational study compared data values, reliability, consistency and compliance collected by electronic and paper diaries of differing durations.
  
  
  
  Subjects ≥18 years with overactive bladder (OAB) on stable antimuscarinic treatment for ≥12 weeks were assigned to one of five, 15-week diary schedules in this randomized, parallel-group observational study. Sample size was sufficient to assess reliability and consistency of diary data with adequate precision. Reliability was assessed via intraclass correlation coefficients, variability with ANCOVAs, and consistency using Cronbach's alpha.
  
  
  
  Demographic characteristics of randomized subjects were representative of OAB trial populations. For mean volume voided, reliability was comparable across diary groups. For incontinence, reliability improved with increasing diary duration. For micturition frequency, electronic 7-day diary results had highest reliability and lowest variability. Lowest overall reliability was observed in the 3-day paper diary. Consistency was highest in the electronic continuous groups; Cont A (daily measurements throughout the study period [fully Continuous]) and Cont B (daily measurements for some but not all endpoints of interest [Partially Continuous]). Compliance was generally high; across groups ≥90% of diaries had at least one entry per day. There was no significant change in average micturition frequency with diary duration, suggesting no diary fatigue. One-third of subjects in the electronic Cont B group also reported micturitions as incontinence when they only needed to report incontinence; they also reported lowest satisfaction with the study. The electronic 7-day and electronic Cont A schedules (who reported incontinence and micturitions throughout the study) had lowest residual errors.
  
  
  
  For future OAB trials, 7-day or continuous electronic diaries may improve accuracy and reliability of micturition and incontinence frequency data compared with shorter collection periods and paper diaries. Neurourol. Urodynam. 35:743-749, 2016. © 2015 Wiley Periodicals, Inc.
authors.affiliation: Southmead Hospital, Bristol Urological Institute, Southmead Road, Bristol, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Abrams
authors.affiliation: Quintiles, Skyline Drive, Hawthorne, New York.
authors.forename: Jean
authors.initials: J
authors.lastname: Paty
authors.affiliation: University of Leicester, University Road, Leicester, United Kingdom, (formerly of Astellas Pharma Europe BV, Netherlands).
authors.forename: Reynaldo
authors.initials: R
authors.lastname: Martina
authors.affiliation: Astellas Pharma BV, Leiden, Netherlands.
authors.forename: Donald T
authors.initials: DT
authors.lastname: Newgreen
authors.affiliation: Astellas Pharma BV, Leiden, Netherlands.
authors.forename: Rob
authors.initials: R
authors.lastname: van Maanen
authors.affiliation: Astellas Pharma BV, Leiden, Netherlands.
authors.forename: Asha
authors.initials: A
authors.lastname: Paireddy
authors.affiliation: Astellas Pharma BV, Leiden, Netherlands.
authors.forename: Trudy
authors.initials: T
authors.lastname: Kuipers-deGroot
authors.affiliation: Astellas Pharma BV, Leiden, Netherlands.
authors.forename: Arwin
authors.initials: A
authors.lastname: Ridder
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D003625:Data Collection / Q000379:methods; D018727:Muscarinic Antagonists / Q000494:pharmacology / Q000627:therapeutic use; D015203:Reproducibility of Results; D053201:Urinary Bladder, Overactive / Q000188:drug therapy / Q000503:physiopathology; D014549:Urinary Incontinence / Q000188:drug therapy / Q000503:physiopathology; D014554:Urination / Q000187:drug effects / Q000502:physiology; D064804:Urological Agents / Q000494:pharmacology / Q000627:therapeutic use; D011897:Random Allocation
chemical_list: D018727:Muscarinic Antagonists; D064804:Urological Agents
keywords: electronic diary; overactive bladder; paper diary