Usability testing of the Norwegian PFDI-20 and PFIQ-7 e-PROMs. (Preprint)

<sec> <title>BACKGROUND</title> Patient-Reported Outcomes Measurements (PROMS) are commonly used in healthcare in Norway. Today, the Norwegian PROMs PFDI-20 and PFIQ-7 have been validated for paper-based administration assessing pelvic organ prolapse symptoms and impact on quality of life and are used in several hospitals in Norway. However, as information technology in Norway is becoming an established part of the delivery of patient care and research clinicians need to consider how to obtain data electronically while ensuring the usability of ePROM systems is assessed during development to ensure they are fit for purpose. </sec> <sec> <title>OBJECTIVE</title> Aim: The aim of this study is to provide evidence to support usability and satisfaction, of the Norwegian Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) electronic Patient Reported Outcome Measures (ePROMs). </sec> <sec> <title>METHODS</title> The electronic PFDI-20 and PFIQ-7 Patient Reported Outcome Measurements (ePROMs) were pilot-tested on women with symptomatic Pelvic Organ Prolapse (POP) undergoing surgery at a department of obstetrics and gynaecology at a tertiary centre. Usability was the primary outcome. The level of usability was tested through usability testing followed by cognitive debriefing. The secondary outcomes included level of satisfaction using Patient Reported Experience Measurements (PREMs) and level of ease of use of the electronic compared to the paper version. The patients were invited to fill in the electronic and paper-based versions of the PFDI-20 and PFIQ-7 during the preoperative phase followed by a semi-structured interview 4-21 days after surgery. </sec> <sec> <title>RESULTS</title> Of 74 Norwegian women who were invited to participate in the pilot test, 28 (38%) completed the paper-based version and electronic PFDI-20 and PFIQ-7 versions using a web-based form pre-operatively. The median age of the sample was 55 years (range, 37–80 years). All participants reported that they had a computer at home and/or work and used the internet for email, banking and social activities. A total of 27/28 (96%) of the patients had a median score of 3 or higher on the usability test. Notably, 26/28 participants reported that the electronic version was easier to fill in compared to the paper version and 28/28 reported a high level of satisfaction while filling out the electronic versions. </sec> <sec> <title>CONCLUSIONS</title> The usability study suggests that women with symptomatic POP and pelvic floor dysfunction found that the PFDI-20 and PFIQ-7 ePROMs were acceptable and easy to use. Furthermore, all patients reported that they were satisfied filling in the electronic versions of the PFDI-20 and PFIQ-7. The majority of patients reported that the electronic version was easier to fill in compared to the paper version. </sec> <sec> <title>CLINICALTRIAL</title> The Research Ethics Committee, Akershus University Hospital has approved of this study (number 2019-101). </sec>