Evidence map›Paper›PMID 25928269›Full record

ArticleBMC medical research methodology2015

Efficiency and effectiveness evaluation of an automated multi-country patient count cohort system.

Iñaki Soto-Rey, Benjamin Trinczek, Yannick Girardeau, Eric Zapletal, Nadir Ammour, Justin Doods, Martin Dugas, Fleur Fritz

Abstract read
In one paragraph

Article in BMC medical research methodology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Clinical Research Informatics: a Decade-in-Review.Yearbook of medical informatics · 2024
    Review
  2. Article
  3. Article
  4. Clinical Research Informatics Contributions from 2015.Yearbook of medical informatics · 2016
    Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Iñaki Soto-ReyInstitute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1/A11, D-48149, Münster, Germany. Inaki.SotoRey@uni-muenster.de.
Benjamin TrinczekInstitute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1/A11, D-48149, Münster, Germany. Benjamin.Trinczek@uni-muenster.de.
Yannick GirardeauDépartement d'Informatique Hospitalière, AP-HP, Hôpital Européen Georges Pompidou, 75015, Paris, France. yannick.girardeau@egp.aphp.fr.
Eric ZapletalDépartement d'Informatique Hospitalière, AP-HP, Hôpital Européen Georges Pompidou, 75015, Paris, France. eric.zapletal@egp.aphp.fr.
Nadir AmmourSanofi-Aventis R&D, 1 avenue Pierre Brossolette, F-91380, Chilly-Mazarin, France. nadir.ammour@sanofi.com.
Justin DoodsInstitute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1/A11, D-48149, Münster, Germany. Justin.Doods@uni-muenster.de.
Martin DugasInstitute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1/A11, D-48149, Münster, Germany. Martin.Dugas@uni-muenster.de.
Fleur FritzInstitute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1/A11, D-48149, Münster, Germany. Fleur.Fritz@uni-muenster.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith the increase of clinical trial costs during the last decades, the design of feasibility studies has become an essential process to reduce avoidable and costly protocol amendments. This design includes timelines, targeted sites and budget, together with a list of eligibility criteria that potential participants need to match. The present work was designed to assess the value of obtaining potential study participant counts using an automated patient count cohort system for large multi-country and multi-site trials: the Electronic Health Records for Clinical Research (EHR4CR) system.

methodsThe evaluation focuses on the accuracy of the patient counts and the time invested to obtain these using the EHR4CR platform compared to the current questionnaire based process. This evaluation will assess the patient counts from ten clinical trials at two different sites. In order to assess the accuracy of the results, the numbers obtained following the two processes need to be compared to a baseline number, the "alloyed" gold standard, which was produced by a manual check of patient records.

resultsThe patient counts obtained using the EHR4CR system were in three evaluated trials more accurate than the ones obtained following the current process whereas in six other trials the current process counts were more accurate. In two of the trials both of the processes had counts within the gold standard's confidence interval. In terms of efficiency the EHR4CR protocol feasibility system proved to save approximately seven calendar days in the process of obtaining patient counts compared to the current manual process.

conclusionsAt the current stage, electronic health record data sources need to be enhanced with better structured data so that these can be re-used for research purposes. With this kind of data, systems such as the EHR4CR are able to provide accurate objective patient counts in a more efficient way than the current methods. Additional research using both structured and unstructured data search technology is needed to assess the value of unstructured data and to compare the amount of efforts needed for data preparation.

Indexed as

AlgorithmsBiomedical ResearchClinical ProtocolsClinical Trials as TopicCohort StudiesElectronic Health RecordsFeasibility StudiesInternationalityMulticenter Studies as TopicPatient DropoutsPatient Selection

Identifiers

PMID25928269
PMCPMC4423123

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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.