Trial reportBMC medical research methodology2017
Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.
Trial report in BMC medical research methodology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02649907 (Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Analysis of the Variability of Appetite and Energy Regulating Hormones to an Acute Nutritive Stimulation by Different Combinations of Macronutrients
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Electronic Data Capture Versus Conventional Data Collection Methods in Clinical Pain Studies: Systematic Review and Meta-Analysis.Journal of medical Internet research · 2020Pooled it
- Efficacy of a low-FODMAP diet in children with irritable bowel syndrome and functional abdominal pain-not otherwise specified: a randomized controlled trial with early termination.Frontiers in pediatrics · 2026Article
- Comparison of precision of a paperless electronic input method versus the conventional paper form in an andrology laboratory: a prospective study.Basic and clinical andrology · 2025Article
- Mobile health technology in quality assessment of pediatric ileocolonoscopy: Results of the SIGENP national program.Endoscopy international open · 2025Article
- A Comprehensive Investigation: Developing the Pharmaceutical Industry through Artificial Intelligence.Current drug discovery technologies · 2025Review
- Standardized Usage of Electronic Patient-Reported Outcome Measurements is Time-Efficient and Feasible.Journal of personalized medicine · 2024Article
- An Overview of Data Management in Human Subjects Research.Respiratory care · 2024Review
- ISO/TS 21564:2019- based Evaluation of a Semantic Map between Variables in the ISARIC Freestanding Follow Up Survey and ORCHESTRA Studies.Journal of medical systems · 2023Article
- Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe).Annals of medicine · 2022Article
- The association between research funding status and clinical research papers' citation impact in Japan: A cross-sectional bibliometric study.Frontiers in medicine · 2022Article
- The efficacy and safety of Jin's three-needle therapy vs. placebo acupuncture on anxiety symptoms in patients with post-stroke anxiety: A study protocol for a randomized controlled trial.Frontiers in psychiatry · 2022Article
- The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study.JMIR formative research · 2021Article
- Usability Evaluation of an Offline Electronic Data Capture App in a Prospective Multicenter Dementia Registry (digiDEM Bayern): Mixed Method Study.JMIR formative research · 2021Article
- A look to the future: Pandemic-induced digital technologies in vascular surgery.Seminars in vascular surgery · 2021Review
- Adaptation of a quality improvement approach to implement eScreening in VHA healthcare settings: innovative use of the Lean Six Sigma Rapid Process Improvement Workshop.Implementation science communications · 2021Article
- Applicability of care quality indicators for women with low-risk pregnancies planning hospital birth: a retrospective study of medical records.Scientific reports · 2020Article
- Article
- Implementing eScreening technology in four VA clinics: a mixed-method study.BMC health services research · 2019Article
- Improving the Efficacy of the Data Entry Process for Clinical Research With a Natural Language Processing-Driven Medical Information Extraction System: Quantitative Field Research.JMIR medical informatics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRegulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity.
methodsThis study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics.
resultsAll randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F
conclusionsThis is the first study to prove in direct comparison that using eCRFs instead of pCRFs increases time efficiency of data collection in clinical trials, irrespective of item quantity or patient age, and improves data quality.
trial registrationClinical Trials NCT02649907 .
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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.