ArticleJournal of the American Geriatrics Society2026
Operationalizing a Decision-Making for Adverse Event Reporting Toolkit (DART) for Aging and Serious Illness Research.
Article in Journal of the American Geriatrics Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Operationalizing a Decision-Making for Adverse Event Reporting Toolkit (DART) for Aging and Serious Illness Research.Journal of the American Geriatrics Society · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
introductionMonitoring adverse events (AEs) assures patient safety in clinical trials. Studies involving seriously ill and older adults can have a high volume of AEs related to underlying courses of illness rather than study procedures. Trials not regulated by the Food and Drug Administration (FDA) can incur excessive reporting burden beyond that required for compliance or patient safety assurance. In 2021, a working group proposed an alternative approach to AE evaluation, emphasizing routine, aggregate reporting, and reserving expedited reporting of individual AEs for serious events at least possibly related to study procedures and not aligned with goals of care. Another outcome was a call to operationalize the approach for eventual implementation.
methodsA panel comprising 31 leaders from government agencies, professional organizations, aging and serious illness research communities, research administration, and medical ethics met five times in 2024-2025. The panel advised on deliverables, assessed concept acceptability, and reviewed tools; a multidisciplinary project team generated content and incorporated feedback. Research compliance experts reviewed the final decision algorithm.
resultsThe resulting Decision-Making for Adverse Event Reporting Toolkit Tailored to Social, Behavioral and Health Services Studies involving Seriously Ill and Older Adult Populations (DART) is a novel research tool to support researchers in AE evaluation. The decision algorithm assesses: (1) relatedness, (2) goals of care alignment, (3) seriousness, and (4) greater risk of harm. The toolkit includes a case series, frequently asked questions, and reporting form. Feedback emphasized DART applies to any study population and intervention type not regulated by the FDA.
conclusionsDART provides a novel solution to AE reporting challenges faced by aging and serious illness researchers. While its design centers on seriously ill older adults, DART can likely be applied to research in any population and intervention type not regulated by the FDA. Future pilot testing will inform implementation.
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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.