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Record W3126908388 · doi:10.1186/s13063-021-05061-7

Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

2021· article· en· W3126908388 on OpenAlexafffundabout
Jeffrey P. Hau, Penelope M. A. Brasher, Amber Cragg, Serena S Small, Maeve E. Wickham, Corinne M. Hohl

Bibliographic record

VenueTrials · 2021
Typearticle
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmacovigilance and Adverse Drug Reactions
Canadian institutionsVancouver General HospitalVancouver Coastal Health Research InstituteUniversity of British ColumbiaVancouver Coastal Health
FundersCanadian Institutes of Health ResearchMichael Smith Health Research BC
KeywordsMedicineAdverse effectRandomized controlled trialCulpritProtocol (science)DocumentationClinical trialEmergency medicinePharmacyAlternative medicineIntensive care medicineMedical emergencyFamily medicineInternal medicine

Abstract

fetched live from OpenAlex

BACKGROUND: Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE's implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. METHODS: We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial's primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial's primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. DISCUSSION: These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04568668 , NCT04574648 . Registered on 1 October 2020.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.028
metaresearch head score (Gemma)0.037
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.069
Threshold uncertainty score0.231

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0280.037
Meta-epidemiology (narrow)0.0060.003
Meta-epidemiology (broad)0.0120.006
Bibliometrics0.0020.003
Science and technology studies0.0030.003
Scholarly communication0.0050.004
Open science0.0030.002
Research integrity0.0070.007
Insufficient payload (model declined to judge)0.0690.009

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.403
GPT teacher head0.608
Teacher spread0.205 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations9
Published2021
Admission routes3
Has abstractyes

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