ArticleJAMIA open2018
Design and implementation of pragmatic clinical trials using the electronic medical record and an adaptive design.
Article in JAMIA open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed.
- Digital integration of research conduct into clinical care: results of the PROSPECTOR randomised feasibility study.BMJ evidence-based medicine · 2025Trial
- A methodological review of pragmatic designs in acute stroke trials.International journal of stroke : official journal of the International Stroke Society · 2026Review
- Use of EpicClinical trials (London, England) · 2025Article
- Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2024Article
- Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention.Translational behavioral medicine · 2023Article
- Innovative trial design in precision oncology.Seminars in cancer biology · 2022Review
- Personalized public health: An implementation research agenda for the HIV response and beyond.PLoS medicine · 2019Article
- Embedding research recruitment in a community resource e-prescribing system: lessons from an implementation study on Chicago's South Side.Journal of the American Medical Informatics Association : JAMIA · 2019Article
- Bayesian Approaches to Subgroup Analysis and Related Adaptive Clinical Trial Designs.JCO precision oncology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
Abstract
objectivesTo demonstrate the feasibility of pragmatic clinical trials comparing the effectiveness of treatments using the electronic medical record (EMR) and an adaptive assignment design.
methodsWe have designed and are implementing pragmatic trials at the point-of-care using custom-designed structured clinical documentation support and clinical decision support tools within our physician's typical EMR workflow. We are applying a subgroup based adaptive design (SUBA) that enriches treatment assignments based on baseline characteristics and prior outcomes. SUBA uses information from a randomization phase (phase 1, equal randomization, 120 patients), to adaptively assign treatments to the remaining participants (at least 300 additional patients total) based on a Bayesian hierarchical model. Enrollment in phase 1 is underway in our neurology clinical practices for 2 separate trials using this method, for migraine and mild cognitive impairment (MCI).
resultsWe are successfully collecting structured data, in the context of the providers' clinical workflow, necessary to conduct our trials. We are currently enrolling patients in 2 point-of-care trials of non-inferior treatments. As of March 1, 2018, we have enrolled 36% of eligible patients into our migraine study and 63% of eligible patients into our MCI study. Enrollment is ongoing and validation of outcomes has begun. DISCUSSION: This proof of concept article demonstrates the feasibility of conducting pragmatic trials using the EMR and an adaptive design.
conclusionThe demonstration of successful pragmatic clinical trials based on a customized EMR and adaptive design is an important next step in achieving personalized medicine and provides a framework for future studies of comparative effectiveness.
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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.