scholarly journals Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study

10.2196/19696 ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. e19696
Author(s):  
Zsa Zsa R M Weerts ◽  
Koert G E Heinen ◽  
Ad A M Masclee ◽  
Amber B A Quanjel ◽  
Bjorn Winkens ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Data Collection ◽  
Treatment Response ◽  
Patient Adherence ◽  
Education Level ◽  
Adherence Rate ◽  
Smartphone App ◽  
Assess Treatment Response ◽  
Irritable Bowel ◽  
Symptom Diary

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 (P<.001). No significant association was found between adherence and gender (P=.84), age (P=.22), or education level (lower education level: P=.58, middle education level: P=.46, versus high education level), while higher anxiety scores were associated with lower adherence (P=.03). Adherence to the online questionnaires was also high (>99%). 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.

scholarly journals Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study (Preprint)

2020 ◽  
Author(s):  
Zsa Zsa R M Weerts ◽  
Koert G E Heinen ◽  
Ad A M Masclee ◽  
Amber B A Quanjel ◽  
Bjorn Winkens ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Data Collection ◽  
Treatment Response ◽  
Patient Adherence ◽  
Education Level ◽  
Adherence Rate ◽  
Smartphone App ◽  
Assess Treatment Response ◽  
Irritable Bowel ◽  
Symptom Diary

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 (<i>P</i>&lt;.001). No significant association was found between adherence and gender (<i>P</i>=.84), age (<i>P</i>=.22), or education level (lower education level: <i>P</i>=.58, middle education level: <i>P</i>=.46, versus high education level), while higher anxiety scores were associated with lower adherence (<i>P</i>=.03). Adherence to the online questionnaires was also high (&gt;99%). 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.

Tolerability of FODMAP – reduced diet in irritable bowel syndrome – efficacy, adherence, and body weight course

2019 ◽  
Vol 57 (06) ◽  
pp. 740-744 ◽  
Author(s):  
Thomas Frieling ◽  
Jürgen Heise ◽  
Britta Krummen ◽  
Corinna Hundorf ◽  
Sigrid Kalde
Keyword(s):  
Weight Loss ◽  
Irritable Bowel Syndrome ◽  
Patient Adherence ◽  
Significant Weight Loss ◽  
Global Improvement ◽  
Validated Questionnaire ◽  
Stool Form ◽  
Irritable Bowel ◽  
A Prospective Study ◽  
Therapy Strategies

Abstract Background FODMAP reduced diet (fermentable oligo-, di-, monosaccharide, and polyols) belongs to the established therapy strategies in irritable bowel syndrome (IBS). However, disadvantages of this diet are significant and may lead to weight loss and insufficient patient adherence. Reports from Germany are not available yet. Material and methods In a prospective study, 93 patients with IBS according to Rom III were investigated. Sixty-three patients were recruited for the study and received standardized investigation, informed consent, and structured dietary instructions about the FODMAP reduced diet. Patients complaints were documented by a validated questionnaire and a standardized Lickert scale before and 8 weeks after the start of the diet. Stool characteristics were documented by the Bristol stool form scale. Results Patients adherence was low because 30 patients (47 %) stopped the diet. Of the remaining 33 patients, 36 % (n = 12) developed significant weight loss during the FODMAP therapy. Patients completing the study reported significant global improvement of symptoms in 79 % of cases (abdominal pain 85 %, meteorism 79 %, flatulence 69 %, borbogymi 69 %, nausea 46 %, fatigue 69 %). In addition, the severity of symptoms was significantly reduced. Fourteen patients developed changes of their stool characteristics according to the Bristol stool form scale, 11 of whom improved diarrhea and 3 improved constipation. Conclusion FODMAP reduced diet is an efficient therapy in IBS. However, adherence of the patients is poor and the therapy bears the risk of significant weight loss.

scholarly journals Correction: Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study (Preprint)

2021 ◽  
Author(s):  
Zsa Zsa R M Weerts ◽  
Koert G E Heinen ◽  
Ad A M Masclee ◽  
Amber B A Quanjel ◽  
Bjorn Winkens ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Data Collection ◽  
Observational Study ◽  
Treatment Effects ◽  
Smart Data ◽  
Irritable Bowel ◽  
Assessment Of Treatment Effects

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