Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Apr 29, 2020
Date Accepted: Sep 22, 2020
Date Submitted to PubMed: Oct 8, 2020
Development and evaluation of smart data-collection and its compliance for the assessment of treatment effects in irritable bowel syndrome: an observational study.
ABSTRACT
Background:
End-of-day symptom diaries are considered the gold standard to assess treatment response in patients with irritable bowel syndrome (IBS). We developed a smartphone application to measure treatment response.
Objective:
Because the employment of an application to measure treatment response in IBS is relatively new, we aimed to explore patients’ compliance to the diary and characteristics associated with compliance.
Methods:
A smartphone application was developed to serve as a symptom diary. IBS patients (Rome-IV) were instructed to fill out end-of-day diary questionnaires during the eight-week treatment. Additional online questionnaires assessed demographics, IBS symptom severity, and psychosocial comorbidities. Compliance rate to the diary was defined as the percentage of days completed out of total days. Compliance to the additional web-based questionnaires was also assessed.
Results:
Overall, 189 patients were analyzed (mean age 34.0±13.3 years, 77.8% female). The mean compliance rate to the diary was 87.9±9.4%. However, compliance to the diary decreased over time (P<.001). No significant association was found between compliance and age, gender, educational level, while higher anxiety scores were associated with lower compliance (P=.03). Compliance to the online questionnaires was also high (>99%). Missingness due to technical issues was limited.
Conclusions:
The use of a smartphone application as a symptom diary to assess treatment response resulted in high patient compliance. The data-collection framework described led to standardized data-collection with excellent completeness and can be used for future RCTs. Due to the slight decrease in compliance to the diary throughout the study, this method might be less suitable for longer trials. Clinical Trial: NCT02716285.
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