1. Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study
- Author
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Koert G. E. Heinen, Daniel Keszthelyi, Lisa Vork, Zsa Zsa R. M. Weerts, Bjorn Winkens, Ad A.M. Masclee, Paula E. L. M. Rinkens, Daisy Jonkers, Amber B. A. Quanjel, Interne Geneeskunde, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Maag Darm Lever (9), FHML Methodologie & Statistiek, RS: CAPHRI - R6 - Promoting Health & Personalised Care, and MEMIC
- Subjects
Adult ,Male ,medicine.medical_specialty ,020205 medical informatics ,peppermint oil ,Health Informatics ,02 engineering and technology ,Smartphone application ,ELECTRONIC DIARIES ,compliance ,mobile phone application ,Irritable Bowel Syndrome ,03 medical and health sciences ,0302 clinical medicine ,Smart data ,Surveys and Questionnaires ,0202 electrical engineering, electronic engineering, information engineering ,medicine ,Humans ,smartphone application ,mHealth ,Irritable bowel syndrome ,Original Paper ,business.industry ,PAIN ,medicine.disease ,EFFICACY ,Mobile Applications ,Corrigenda and Addenda ,mhealth ,12-WEEK ,Diaries as Topic ,PERSUADE study ,electronic case report file ,patient reported outcome measures ,Physical therapy ,PAPER ,Quality of Life ,e-health ,Patient Compliance ,030211 gastroenterology & hepatology ,Observational study ,TRIAL ,Female ,business ,digital diary - Abstract
Background End-of-day symptom diaries are recommended by drug regulatory authorities to assess treatment response in patients with irritable bowel syndrome. We developed a smartphone app to measure treatment response. Objective Because the employment of an app to measure treatment response in irritable bowel syndrome is relatively new, we aimed to explore patients’ adherence to diary use and characteristics associated with adherence. Methods A smartphone app was developed to serve as a symptom diary. Patients with irritable bowel syndrome (based on Rome IV criteria) were instructed to fill out end-of-day diary questionnaires during an 8-week treatment. Additional online questionnaires assessed demographics, irritable bowel syndrome symptom severity, and psychosocial comorbidities. Adherence rate to the diary was defined as the percentage of days completed out of total days. Adherence to the additional web-based questionnaires was also assessed. Results Overall, 189 patients were included (age: mean 34.0 years, SD 13.3 years; female: 147/189, 77.8%; male: 42/189, 22.2%). The mean adherence rate was 87.9% (SD 9.4%). However, adherence to the diary decreased over time (P99%). Missing data due to technical issues were limited. Conclusions The use of a smartphone app as a symptom diary to assess treatment response resulted in high patient adherence. The data-collection framework described led to standardized data collection with excellent completeness and can be used for future randomized controlled trials. Due to the slight decrease in adherence to diary use throughout the study, this method might be less suitable for longer trials.
- Published
- 2020