Trial reportPatient education and counseling2019
Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.
Trial report in Patient education and counseling, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension.Clinical trials (London, England) · 2026Trial
- Standardising written informed consent forms to improve patient care: a quality improvement project.BMJ open quality · 2026Article
- Structure and legibility of informed consent for clinical practice in Ecuador.Frontiers in medical technology · 2026Article
- Liquid Biopsy for Medical Imaging Analysis in Cancer Diagnosis.Current pharmaceutical design · 2025Review
- Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices.PLOS digital health · 2024Review
- Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods.JCO oncology practice · 2023Article
- Electronic informed consent criteria for research ethics review: a scoping review.BMC medical ethics · 2022Article
- Article
- Shortened consent forms for genome-wide sequencing: Parent and provider perspectives.Molecular genetics & genomic medicine · 2020Article
- Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020Article
- Male Nurses' Dealing with Tensions and Conflicts with Patients and Physicians: A Theoretically Framed Analysis.Journal of multidisciplinary healthcare · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
objectiveTo develop a patient-centered informed consent and assessment tool written at a 6th grade-level that is multimodal, affordable, transportable, and readily modifiable for protocol updates.
methodsThis quality improvement initiative was performed in two phases on an actively-recruiting study at a pediatric diabetes clinic. In phase I, 38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback. Using feedback and the structure of the Plan-Do-Study-Act cycle a multimodal consent and assessment were developed. In phase II, volunteers were randomized to the standard (n = 25) or the multimodal consent (n = 25) and all completed the same comprehension assessment via touch-screen tablet. Primary outcomes were comparison of the individual and total comprehension assessment scores.
resultsTotal comprehension scores were higher in the multimodal versus the standard consent group (p < 0.001) and on the elements of benefits (p < 0.001), risks (p < 0.001), volunteerism (p < 0.012), results (p < 0.001), confidentiality (p < 0.004) and privacy (p < 0.001).
conclusionA multimodal consent and assessment presented sequentially on a touch-screen tablet were patient-centered enhancements to standard consent. PRACTICE IMPLICATIONS: Multimodal standardization of delivery with improved readability may strengthen the informed consent process.
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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.