COMPARISON OF THE PERFORMANCE AND DATA QUALITY OF ELECTRONIC AND PAPER DIARIES FOR BENIGN PROSTATIC HYPERPLASIA (BPH)
Author(s)
Bushnell DM1, Martin ML1, Hareendran A2, Abraham L2 , 1Health Research Associates, Inc, Mountlake Terrace, WA, USA; 2Pfizer Ltd, Sandwich, United Kingdom
OBJECTIVE: Use of electronic data capture (EDC) in the assessment of patient status is increasing, however it must be determined how data collected electronically correlates with similar data collected using the standard "paper" method. Our objective was to compare paper and electronic administrations of a urinary voiding and symptom diary for use in a population with benign prostatic hyperplasia (BPH). METHODS: Using a crossover design, men aged 45-85 with a diagnosis of BPH and IPSS scores of 8 or greater were recruited from clinics. Subjects completed either the paper or electronic version of the diary (depending on randomized arm) for 7 consecutive days and then the opposing version for the following 7 consecutive days. Data quality was assessed for both versions. Intraclass correlation coefficients (ICC) and t-test comparisons were calculated to compare EDC and paper versions for the mean number of urinary events, symptoms, and severity of urgency. Ease of use, preference, and demographic items were also collected. RESULTS: A total of 28 subjects were assessed with 14 in each group. Mean age and IPSS for the total sample was 63.8 and 17.3, respectively. Data quality concerns were minimal with both versions. Mean differences in urinary events, symptoms and severity were not significantly different (p-values > 0.29, ICC > 0.70). Participants who took the electronic version first thought the paper version was considerably less convenient to keep with them and more difficult to use. The majority of the sample (64%) would prefer, if given a choice, the computerized version of the diary compared with 29% opting for the paper version (7% indicated no real preference for either). CONCLUSION: As in previous studies comparing electronic to paper assessments, this study revealed statistical evidence to support the use of EDC of a patient urinary diary. While some difficulties existed, the electronic version produced good data with low data management burden.
Conference/Value in Health Info
2003-11, ISPOR Europe 2003, Barcelona, Spain
Value in Health, Vol. 6, No. 6 (November/December 2003)
Code
PUK13
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Urinary/Kidney Disorders