Evidence map›Paper›PMID 33030150›Full record

Observational studyJMIR mHealth and uHealth2020

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

Erratum issuedOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in JMIR mHealth and uHealth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Zsa Zsa R M WeertsDivision Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0001-7522-9916
Koert G E HeinenMEMIC Center for Data and Information Management, Maastricht University, Maastricht, Netherlands.ORCID 0000-0001-6374-6086
Ad A M MascleeDivision Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0001-5819-0116
Amber B A QuanjelDivision Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0002-5116-7420
Bjorn WinkensDepartment of Methodology and Statistics, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0002-6747-6228
Lisa VorkDivision Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0001-7316-3191
Paula E L M RinkensMEMIC Center for Data and Information Management, Maastricht University, Maastricht, Netherlands.ORCID 0000-0003-0964-7655
Daisy M A E JonkersDivision Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0001-8981-8965
Daniel KeszthelyiDivision Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, Netherlands.ORCID 0000-0001-9856-9980
Maastricht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnd-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.

objectiveBecause 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.

methodsA 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.

resultsOverall, 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.

conclusionsThe 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.

Indexed as

Diaries as TopicIrritable Bowel SyndromeMobile ApplicationsAdultFemaleHumansMalePatient ComplianceQuality of LifeSurveys and Questionnairescompliancedigital diarye-healthelectronic case report fileirritable bowel syndromemhealthmobile phone applicationpatient reported outcome measurespeppermint oilPERSUADE study.smartphone application

Identifiers

PMID33030150
PMCPMC7669448
OpenAlexW3203352194

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.