Evidence map›Paper›PMID 24438227›Full record

ArticleBMC medical research methodology2014

Comparison of two data collection processes in clinical studies: electronic and paper case report forms.

Anaïs Le Jeannic, Céline Quelen, Corinne Alberti, Isabelle Durand-Zaleski, CompaRec Investigators

Abstract readComparative Study
In one paragraph

Article in BMC medical research methodology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
–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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  8. Evaluation of electronic patient-reported outcome assessment in inpatient cancer care: a feasibility study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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  16. [Technical aspects of quality assurance for intravitreal injections (IVI)].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2020
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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

5 authors.

Anaïs Le Jeannic
Céline Quelen
Corinne AlbertiAP-HP, Hôpital Robert Debré, Unité d'Épidémiologie clinique, Groupe Hospitalier Robert Debré, 48, Bld Sérurier, F-75019 Paris, France. corinne.alberti@inserm.fr.
Isabelle Durand-Zaleski
CompaRec Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElectronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs.

methodsOur objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 2001 and 2011 were included. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression.

resultsThe total cost per patient was 374€ ±351 with eCRFs vs. 1,135€ ±1,234 with pCRFs. Time between the opening of the first center and the database lock was 31.7 months Q1 = 24.6; Q3 = 42.8 using eCRFs, vs. 39.8 months Q1 = 31.7; Q3 = 52.2 with pCRFs (p = 0.11). Electronic CRFs were globally preferred by all (31/72 vs. 15/72 for paper) for easier monitoring and improved data quality.

conclusionsThis study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. The first ones are more advantageous in large, low-risk studies and gain support from a majority of stakeholders.

Indexed as

AdultCost-Benefit AnalysisDatabases, FactualData CollectionElectronic Health RecordsFemaleHealth PersonnelHumansMaleSurveys and QuestionnairesTime Management

Identifiers

PMID24438227
PMCPMC3909932

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.