Validation of electronic data capture of the Irritable Bowel Syndrome--Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol.
OBJECTIVE
To assess the comparability, reliability, and subject acceptability of electronic data capture (EDC) versions of Irritable Bowel Syndrome-Quality of Life (IBS-QOL), EuroQoL (EQ-5D) and Work Productivity and Activity Impairment (WPAI:IBS) instruments.


METHODS
Comparability of EDC and paper questionnaires was evaluated in 72 subjects with IBS who completed a baseline EDC or paper questionnaire, a crossover questionnaire 24 hours later, and a retest of the crossover version at 1 week. The EDC version was presented on a hand-held device. Comparability was assessed using paired t-test statistics, intraclass correlation coefficients (ICC) and tests for internal consistency (Cronbach's alpha).


RESULTS
No significant differences were found between scores obtained by paper questionnaire and EDC at the baseline and crossover assessments. ICCs between baseline and crossover assessments ranged from 0.83 to 0.96 for the IBS-QOL scores, 0.82 to 0.96 for the WPAI:IBS scores, and 0.77 to 0.82 for the EQ-5D. Internal consistency was comparable for the two data collection methods for the IBS-QOL overall score (0.96) and subscales and the EQ-5D Index (0.70 vs. 0.74). Retest statistics (ICC) were generally comparable between the EDC and paper versions for all scores. Ease of use was comparable for the two modes of administration, but more patients preferred EDC (47.2%) than the paper questionnaire (23.6%).


CONCLUSIONS
EDC versions of the IBS-QOL, EQ-5D, and WPAI:IBS are comparable to paper questionnaires in internal consistency and test-retest reliability, and have greater patient acceptability.
Bushnell
Donald M
DM
Health Research Associates, Inc., Seattle, WA 98043, USA. bushnell@hrainc.net
Reilly
Margaret C
MC
Galani
Carmen
C
Martin
Mona L
ML
Ricci
Jean-François
JF
Patrick
Donald L
DL
McBurney
Christopher R
CR
D000041:Absenteeism; D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001292:Attitude to Computers; D034201:Computers, Handheld; D018592:Cross-Over Studies; D004526:Efficiency; D001330:Electronic Data Processing; D004651:Employment; D005260:Female; D006801:Humans; D007087:Illinois; D043183:Irritable Bowel Syndrome / Q000503:physiopathology / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011594:Psychometrics / Q000295:instrumentation* / Q000379:methods; D011788:Quality of Life; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014861:Washington