Simplification of Validated Patient-Reported Outcome Instruments in Inflammatory Bowel Disease

Abstract

Introduction: Patient-reported outcomes (PROs), such as health-related quality of life (HRQoL), pain and sleep quality, are aspects of well-being and health status that are meaningful to patients and are reported by patients to providers. Traditionally, PROs in inflammatory bowel disease (IBD) patients have been assessed using periodically-administered surveys which are time-consuming and limited by reliance on subjective recall. We aimed to determine the feasibility and reliability of simplified daily HRQoL and sleep quality data collection in patients with IBD using mobile technologies. Methods: This was a four week prospective study. Outpatients and inpatients with IBD downloaded a proprietary smartphone app (developed by Litmus Health, Austin, TX) for completion of daily and bi-weekly surveys. Daily surveys included a visual analog scale (VAS) to assess QoL and sleep quality and Wong-Baker Faces Pain Rating Scale to assess pain. The VAS is a linear sliding scale in which patients select between “very bad” and “great.” At days 1, 14, and 28, patients completed the validated Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Pittsburgh Sleep Quality Index (PSQI). Mean VAS and Wong-Baker scores were obtained for each patient over two weeks. Pearson correlation coefficients were calculated to assess the agreement between mean daily survey scores and validated questionnaires. Results: 100 patients were enrolled. 57% were male, 72% had Crohn's disease, 24% had clinically active disease, and 59% reported poor sleep based on PSQI score at baseline. Overall patient compliance with daily survey completion was 65.4%. The correlation between mean QoL VAS scores over two weeks and SIBDQ scores at day 14 was moderate among patients in remission (r=0.44) and strong among patients with active disease (r=0.76). The correlation between mean Wong-Baker pain score and SIBDQ was moderate among patients in remission (r=-0.57) and with active disease (r=0.61). The correlation between mean sleep VAS scores over two weeks and PSQI scores at day 14 was weak for patients in remission (r=-0.37) yet very strong for patients with active disease (r=-0.80). Conclusion: Daily assessments of HRQoL and sleep quality using mobile technologies in patients with IBD reliably correlate with validated periodic questionnaires, especially among patients with active disease. These results inform a longitudinal study incorporating wearable technologies to monitor health status in IBD patients.