Patient-reported outcomes, such as validated symptom-based questionnaires, are commonly used in healthcare. In the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS), many questionnaires have been validated for paper-based administration.  As technology is incorporated into delivery of medical care and research, it is important to consider whether administration of questionnaires via electronic rather than paper format impacts their validity. In this study, we tested our hypothesis that responses on electronically administered (web–based or smartphone) validated instruments of pelvic floor dysfunction would be comparable to responses on those same instruments when administered on paper.

Subjects presenting for care of pelvic floor disorders were prospectively enrolled at 5 FPMRS clinic sites and invited to complete 4 validated pelvic floor disorder questionnaires (PFDI-20, PFIQ-7, PISQ-12, Bristol Stool Scale) in both paper and electronic formats, two weeks apart, with the order of administration being randomized. Participants who planned intervention in the two weeks between initial instrument completion and repeat instrument completion were excluded from the study. Participants could complete the questionnaires electronically on the internet via REDCap or using the Pelvic Matters App on a smartphone or tablet. As this was a psychometric validation study, prior validation metrics of the PFIQ-7 and PFDI-20 short forms compared to the long forms (Reference 1) were used to calculate that 36 subjects in each arm (108 total) would be needed to detect an effect size of 0.50 or greater, with 80% power and a 2-tailed alpha of 0.05.  Continuous variables were compared with t-test and categorical values with chi-square. Correlation coefficients were calculated using Pearson’s and Spearman’s depending on the distribution of data.

234 subjects were enrolled and 132 subjects (56%) completed both sets of questionnaires.  This group was 58 (+-15) years-old, with BMI 28 (+-6), parity 2 (1,3), 77% white, 6% African American, 7% Asian, and 10% other. Presenting complaints were classified as 58% urinary, 37% prolapse, and 5% defecatory. There was no difference in overall demographic information between those who completed the second round of questionnaires and those who didn’t. Correlation coefficients between the paper and electronic total and sub-scales are shown in the table and range from 0.5 to 0.8.

Overall the paper and electronic versions of the PFDI-20 and the PISQ were strongly correlated with r values of 0.74 and 0.86 respectively.  The paper and electronic versions of the PFIQ-7 and Bristol Stool Scale demonstrated moderate correlation with r values of 0.63 and 0.58.

We demonstrated moderate to strong reliability between scales of pelvic floor dysfunction when administered electronically compared to the paper version.  Our results are similar to those of prior authors (Reference 2) demonstrating strong correlation between paper-based and electronic administration of the PFDI-20 and PFIQ-7.  However our study is unique in that it also demonstrates correlation between paper-based and electronic administration of the PISQ and BSS.  Further, our electronic validation included both web-based administration (REDCap) and administration on a smartphone platform (Pelvic Matters App).  Electronic questionnaires are an acceptable alternative to paper based forms in research studies and clinical practice and will reliably provide required information.

Barber et al. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). AJOG  (2005) 193, 103–13.
Handa et al. Paper versus web-based administration of the pelvic floor distress inventory-20 and pelvic floor impact questionnaire-7 Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct; 19(10):1331–1335.