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Comparison of two data collection processes in clinical studies: electronic and paper case report forms
- Source :
- BMC Medical Research Methodology, BMC Medical Research Methodology, BioMed Central, 2014, 14 (1), pp.7. ⟨10.1186/1471-2288-14-7⟩
- Publication Year :
- 2014
- Publisher :
- Springer Science and Business Media LLC, 2014.
-
Abstract
- Background Electronic 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. Methods Our 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. Results The 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. Conclusions This 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Databases, Factual
020205 medical informatics
Epidemiology
Cost-Benefit Analysis
Health Personnel
MEDLINE
Health Informatics
02 engineering and technology
Logistic regression
Electronic data collection
03 medical and health sciences
0302 clinical medicine
Surveys and Questionnaires
Statistics
0202 electrical engineering, electronic engineering, information engineering
Electronic Health Records
Humans
Medicine
Medical physics
Time management
030212 general & internal medicine
Duration (project management)
Work satisfaction
[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology
Data collection
Cost–benefit analysis
business.industry
Data Collection
Time Management
Costs
[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie
Data quality
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Female
Job satisfaction
business
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Research Article
Subjects
Details
- ISSN :
- 14712288
- Volume :
- 14
- Database :
- OpenAIRE
- Journal :
- BMC Medical Research Methodology
- Accession number :
- edsair.doi.dedup.....9d688eb6bc2fe1316ffda7ab3e82d37a