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Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder
Author(s) -
Abrams Paul,
Paty Jean,
Martina Reynaldo,
Newgreen Donald T,
van Maanen Rob,
Paireddy Asha,
KuipersdeGroot Trudy,
Ridder Arwin
Publication year - 2016
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22800
Subject(s) - overactive bladder , medicine , intraclass correlation , observational study , urination , reliability (semiconductor) , cronbach's alpha , urinary incontinence , randomized controlled trial , physical therapy , urinary system , urology , psychometrics , clinical psychology , power (physics) , physics , alternative medicine , pathology , quantum mechanics
Aims This observational study compared data values, reliability, consistency and compliance collected by electronic and paper diaries of differing durations. Methods 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. Results 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. Conclusions 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.