Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.


Journal

AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science
ISSN: 2153-4063
Titre abrégé: AMIA Jt Summits Transl Sci Proc
Pays: United States
ID NLM: 101539486

Informations de publication

Date de publication:
2024
Historique:
medline: 3 6 2024
pubmed: 3 6 2024
entrez: 3 6 2024
Statut: epublish

Résumé

To automatically populate the case report forms (CRFs) for an international, pragmatic, multifactorial, response-adaptive, Bayesian COVID-19 platform trial. The locations of focus included 27 hospitals and 2 large electronic health record (EHR) instances (1 Cerner Millennium and 1 Epic) that are part of the same health system in the United States. This paper describes our efforts to use EHR data to automatically populate four of the trial's forms: baseline, daily, discharge, and response-adaptive randomization. Between April 2020 and May 2022, 417 patients from the UPMC health system were enrolled in the trial. A MySQL-based extract, transform, and load pipeline automatically populated 499 of 526 CRF variables. The populated forms were statistically and manually reviewed and then reported to the trial's international data coordinating center. We accomplished automatic population of CRFs in a large platform trial and made recommendations for improving this process for future trials.

Identifiants

pubmed: 38827056
pii: 2413
pmc: PMC11141839

Types de publication

Journal Article

Langues

eng

Pagination

276-284

Informations de copyright

©2024 AMIA - All rights reserved.

Auteurs

Andrew J King (AJ)

University of Pittsburgh, Pittsburgh, PA, USA.

Lisa Higgins (L)

Monash University, Melbourne, VIC, Australia.

Carly Au (C)

Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.

Salim Malakouti (S)

University of Pittsburgh, Pittsburgh, PA, USA.

Edvin Music (E)

University of Pittsburgh, Pittsburgh, PA, USA.

Kyle Kalchthaler (K)

UPMC Department of Clinical Analytics, Pittsburgh, PA, USA.

Gilles Clermont (G)

University of Pittsburgh, Pittsburgh, PA, USA.

William Garrard (W)

UPMC Department of Clinical Analytics, Pittsburgh, PA, USA.

David T Huang (DT)

University of Pittsburgh, Pittsburgh, PA, USA.

Bryan J McVerry (BJ)

University of Pittsburgh, Pittsburgh, PA, USA.

Christopher W Seymour (CW)

University of Pittsburgh, Pittsburgh, PA, USA.

Kelsey Linstrum (K)

University of Pittsburgh, Pittsburgh, PA, USA.

Amanda McNamara (A)

University of Pittsburgh, Pittsburgh, PA, USA.

Cameron Green (C)

Monash University, Melbourne, VIC, Australia.

India Loar (I)

University of Pittsburgh, Pittsburgh, PA, USA.

Tracey Roberts (T)

Global Coalition for Adaptive Research (GCAR), Larkspur, CA, USA.

Oscar Marroquin (O)

UPMC Department of Clinical Analytics, Pittsburgh, PA, USA.

Derek C Angus (DC)

University of Pittsburgh, Pittsburgh, PA, USA.

Christopher M Horvat (CM)

University of Pittsburgh, Pittsburgh, PA, USA.

Classifications MeSH