Evidence map›Paper›PMID 41398434›Full record

ReviewNPJ digital medicine2025

Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trials.

Florence D Mowlem, Jeremiah J Trudeau, Jill V Platko, Jos Bloemers, Emuella Flood, Jessica L Abel, Kelly Dumais, Paul O'Donohoe, Sabrina Grant, Ryan Naville-Cook and 16 more

Erratum issuedAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in NPJ digital medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Florence D MowlemuMotif, London, UK. florence.mowlem@umotif.com.
Jeremiah J TrudeauEli Lilly and Company, Indianapolis, IN, USA.
Jill V PlatkoSuvoda, Conshohocken, PA, USA.
Jos BloemersUCB, Brussels, Belgium.
Emuella FloodAstraZeneca, Gaithersburg, MD, USA.
Jessica L AbelAbbVie, Florham Park, NJ, USA.
Kelly DumaisClario, Philadelphia, PA, USA.
Paul O'DonohoeMedidata Solutions, London, UK.
Sabrina GrantParexel International, London, UK.
Ryan Naville-CookEli Lilly and Company, Indianapolis, IN, USA.
Onyekachukwu IllohU.S. Food and Drug Administration, Rockville, MD, USA.
Shannon D KeithGSK, Collegeville, PA, USA.
Jing JuU.S. Food and Drug Administration, Rockville, MD, USA.
Megan FitterU.S. Food and Drug Administration, Rockville, MD, USA.
Dorothee OberdhanOtsuka Pharmaceutical Development & Commercialization, Inc, Rockville, MD, USA.
Randall WinnetteNovartis Services Inc, East Hanover, NJ, USA.
Manuela BossiSignant Health, Blue Bell, PA, USA.
Naomi SuminskiParexel International, London, UK.
Sonya EremencoCritical Path Institute, Tucson, AZ, USA.
Lindsay HughesIQVIA, New York, NY, USA.
Amy FasiczkaMedrio, San Francisco, CA, USA.
Luisana RojasAbbVie, Florham Park, NJ, USA.
Michelle CampbellU.S. Food and Drug Administration, Rockville, MD, USA.
Scottie KernCritical Path Institute, Tucson, AZ, USA.
Electronic Clinical Outcome Assessment Consortium
Patient-Reported Outcome Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Based on the literature and collective experience and consensus of the authors, this article provides a definition for an event-driven electronic diary (EDeD), outlines considerations for the use of EDeDs, and provides best practice recommendations for their design and implementation in clinical trials. This is a much-needed resource to optimize data quality in clinical trials and to support a necessary level of standardization using this form of data capture.

Identifiers

PMID41398434
PMCPMC12706038

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.