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

Zsa Zsa R. M. Weerts; Koert G. E. Heinen; Ad A. M. Masclee; Amber B. A. Quanjel; Bjorn Winkens; Lisa Vork; Paula E. L. M. Rinkens; Daisy M. A. E. Jonkers; Daniel Keszthelyi

doi:10.2196/19696

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

Zsa Zsa R. M. Weerts^*, Koert G. E. Heinen, Ad A. M. Masclee, Amber B. A. Quanjel, Bjorn Winkens, Lisa Vork, Paula E. L. M. Rinkens, Daisy M. A. E. Jonkers, Daniel Keszthelyi

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Article number	19696
Number of pages	12
Journal	Journal of Medical Internet Research
Volume	8
Issue number	11
DOIs	https://doi.org/10.2196/19696
Publication status	Published - 2 Nov 2020

Keywords

irritable bowel syndrome
digital diary
smartphone application
mobile phone application
mhealth
e-health
compliance
electronic case report file
patient reported outcome measures
peppermint oil
PERSUADE study
ELECTRONIC DIARIES
PAPER
PAIN
TRIAL
EFFICACY
12-WEEK

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10.2196/19696Licence: CC BY

1 Erratum / corrigendum / retractions

Correction: Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study
Weerts, Z. Z. R. M., Heinen, K. G. E., Masclee, A. A. M., Quanjel, A. B. A., Winkens, B., Vork, L., Rinkens, P. E. L. M., Jonkers, D. M. A. E. & Keszthelyi, D., 15 Feb 2021, In: JMIR mHealth and uHealth. 9, 2, 1 p., e27998.
Research output: Contribution to journal › Erratum / corrigendum / retractions › Academic

Open Access

Cite this

Weerts, Z. Z. R. M., Heinen, K. G. E., Masclee, A. A. M., Quanjel, A. B. A., Winkens, B., Vork, L., Rinkens, P. E. L. M., Jonkers, D. M. A. E., & Keszthelyi, D. (2020). Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study. Journal of Medical Internet Research, 8(11), Article 19696. https://doi.org/10.2196/19696

@article{01e00f65a75444a6905aa15436b98b91,

title = "Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study",

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.",

keywords = "irritable bowel syndrome, digital diary, smartphone application, mobile phone application, mhealth, e-health, compliance, electronic case report file, patient reported outcome measures, peppermint oil, PERSUADE study, ELECTRONIC DIARIES, PAPER, PAIN, TRIAL, EFFICACY, 12-WEEK",

author = "Weerts, {Zsa Zsa R. M.} and Heinen, {Koert G. E.} and Masclee, {Ad A. M.} and Quanjel, {Amber B. A.} and Bjorn Winkens and Lisa Vork and Rinkens, {Paula E. L. M.} and Jonkers, {Daisy M. A. E.} and Daniel Keszthelyi",

note = "Funding Information: We thank all patients who participated in the PERSUADE study; staff members of the PERSUADE team in the 4 participating centers (Maastricht UMC: A Bours, N Aendekerk, D Janssen, G Van Hooff; Hospital Gelderse Vallei: B Witteman, G Homans, A Van de Vendel; Alrijne hospital Leiden: C Clemens, M Oosterveer; Medical Center Leeuwarden: A Westendorp-Ijdema, A de Ruiter-van der Ploeg, G Tack-Blokker, H Lebbink); other members of the PERSUADE study team (J Brouwers, J Tack, H Frijlink, N de Wit, J Muris, B Essers); staff members of Center for Data and Information Management at Maastricht University (D Veldman, J Pisters, L Linden, D de Jong); the Dutch IBS patient federation; and Will Pharma SA employees (K Bouwens, AH Verhage, F Bunel, K Abildayeva). Funding Information: AAMM and DK have received a ZonMw, The Netherlands Organization for Health Research and Development (Dutch government) health care efficiency grant for the execution of the PERSUADE study (grant number 836031017). AAMM and DK have received an unrestricted research grant from Will Pharma SA, which also supported ZZRMW and LV in attending a scientific meeting. The study design, data collection, analysis, and interpretation were performed by the academic authors without industry involvement. The employer of DK and AAMM have an agreement with Will Pharma SA regarding the exploitation of a potential market authorization of the ileocolonic formulation of peppermint oil for IBS. AAMM and DK have received research funding from Allergan and Gr{\"u}nenthal involving a different smartphone app for IBS. KGEH, ABAQ, BW, and PELMR have no conflicts of interest. Part of the work of DJ is financed by Grant Top Knowledge Institute (Well on Wheat), the Carbokinetics program as part of the NOWO-CCC Partnership program, and H2020 848228/DISCOvERIE. Publisher Copyright: {\textcopyright} Zsa Zsa R M Weerts, Koert G E Heinen, Ad A M Masclee, Amber B A Quanjel, Bjorn Winkens, Lisa Vork, Paula E L M Rinkens, Daisy M A E Jonkers, Daniel Keszthelyi. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org),02.11.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.",

year = "2020",

month = nov,

day = "2",

doi = "10.2196/19696",

language = "English",

volume = "8",

journal = "Journal of Medical Internet Research",

issn = "1439-4456",

publisher = "JMIR Publications Inc.",

number = "11",

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TY - JOUR

T1 - Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome

T2 - Observational Study

AU - Weerts, Zsa Zsa R. M.

AU - Heinen, Koert G. E.

AU - Masclee, Ad A. M.

AU - Quanjel, Amber B. A.

AU - Winkens, Bjorn

AU - Vork, Lisa

AU - Rinkens, Paula E. L. M.

AU - Jonkers, Daisy M. A. E.

AU - Keszthelyi, Daniel

N1 - Funding Information: We thank all patients who participated in the PERSUADE study; staff members of the PERSUADE team in the 4 participating centers (Maastricht UMC: A Bours, N Aendekerk, D Janssen, G Van Hooff; Hospital Gelderse Vallei: B Witteman, G Homans, A Van de Vendel; Alrijne hospital Leiden: C Clemens, M Oosterveer; Medical Center Leeuwarden: A Westendorp-Ijdema, A de Ruiter-van der Ploeg, G Tack-Blokker, H Lebbink); other members of the PERSUADE study team (J Brouwers, J Tack, H Frijlink, N de Wit, J Muris, B Essers); staff members of Center for Data and Information Management at Maastricht University (D Veldman, J Pisters, L Linden, D de Jong); the Dutch IBS patient federation; and Will Pharma SA employees (K Bouwens, AH Verhage, F Bunel, K Abildayeva). Funding Information: AAMM and DK have received a ZonMw, The Netherlands Organization for Health Research and Development (Dutch government) health care efficiency grant for the execution of the PERSUADE study (grant number 836031017). AAMM and DK have received an unrestricted research grant from Will Pharma SA, which also supported ZZRMW and LV in attending a scientific meeting. The study design, data collection, analysis, and interpretation were performed by the academic authors without industry involvement. The employer of DK and AAMM have an agreement with Will Pharma SA regarding the exploitation of a potential market authorization of the ileocolonic formulation of peppermint oil for IBS. AAMM and DK have received research funding from Allergan and Grünenthal involving a different smartphone app for IBS. KGEH, ABAQ, BW, and PELMR have no conflicts of interest. Part of the work of DJ is financed by Grant Top Knowledge Institute (Well on Wheat), the Carbokinetics program as part of the NOWO-CCC Partnership program, and H2020 848228/DISCOvERIE. Publisher Copyright: © Zsa Zsa R M Weerts, Koert G E Heinen, Ad A M Masclee, Amber B A Quanjel, Bjorn Winkens, Lisa Vork, Paula E L M Rinkens, Daisy M A E Jonkers, Daniel Keszthelyi. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org),02.11.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.

PY - 2020/11/2

Y1 - 2020/11/2

N2 - 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.

AB - 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.

KW - irritable bowel syndrome

KW - digital diary

KW - smartphone application

KW - mobile phone application

KW - mhealth

KW - e-health

KW - compliance

KW - electronic case report file

KW - patient reported outcome measures

KW - peppermint oil

KW - PERSUADE study

KW - ELECTRONIC DIARIES

KW - PAPER

KW - PAIN

KW - TRIAL

KW - EFFICACY

KW - 12-WEEK

U2 - 10.2196/19696

DO - 10.2196/19696

M3 - Article

C2 - 33030150

SN - 1439-4456

VL - 8

JO - Journal of Medical Internet Research

JF - Journal of Medical Internet Research

IS - 11

M1 - 19696

ER -

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

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Keywords

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

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