ArticleJMIR research protocols2018
A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.
Article in JMIR research protocols, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02465931 (Decisional Capacity and Informed Consent in Fragile X Syndrome), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled 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.
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.
Decisional Capacity and Informed Consent in Fragile X Syndrome
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Responsible inclusion: A systematic review of consent to social-behavioral research with adults with intellectual disability in the US.Disability and health journal · 2024Pooled it
- Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.Journal of medical Internet research · 2020Pooled it
- Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool.JMIR formative research · 2025Observational
- Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations.Medical devices (Auckland, N.Z.) · 2025Article
- Development of web- and mobile-based shared decision-making tools in the neurological intensive care unit.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Review
- Identifying the capabilities for creating next-generation registries: a guide for data leaders and a case for "registry science".Journal of the American Medical Informatics Association : JAMIA · 2024Article
- Applications to augment patient care for Internal Medicine specialists: a position paper from the EFIM working group on telemedicine, innovative technologies & digital health.Frontiers in public health · 2024Review
- Toward Inclusive Approaches in the Design, Development, and Implementation of eHealth in the Intellectual Disability Sector: Scoping Review.Journal of medical Internet research · 2023Article
- Making Pain Research More Inclusive: Why and How.The journal of pain · 2022Review
- Article
- The Application of Human-Centered Design Approaches in Health Research and Innovation: A Narrative Review of Current Practices.JMIR mHealth and uHealth · 2021Review
- Development of a decision support intervention for family members of adults who lack capacity to consent to trials.BMC medical informatics and decision making · 2021Article
- Design Requirements for a Digital Aid to Support Adults With Mild Learning Disabilities During Clinical Consultations: Qualitative Study With Experts.JMIR rehabilitation and assistive technologies · 2019Article
- Article
- Article
- A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2018Article
- The Use of Web-Based Technologies in Health Research Participation: Qualitative Study of Consumer and Researcher Experiences.Journal of medical Internet research · 2018Article
- Approaching differential diagnosis and decisional capacity assessment in the context of COVID-19 conspiracy beliefs: A narrative review and clinical discussion.General hospital psychiatryReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundChallenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial.
objectiveWe describe the design and development process of a tablet-based decision support tool.
methodsOur development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles.
resultsWe used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice.
conclusionsThe informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources.
trial registrationClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW).
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What OpenQuestion holds
Registered trials
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.