Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology.
Br J Clin Pharmacol
; 83(9): 1880-1895, 2017 Sep.
Article
en En
| MEDLINE
| ID: mdl-28276585
ABSTRACT
AIMS:
Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underused despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research.METHODS:
The review used PubMed and the Institute of Electrical and Electronic Engineers library. Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas Institute of Electrical and Electronic Engineers is technology based. The review focuses on electronic case report forms and electronic data capture, but briefly considers other relevant topics; consent, ethics and security.RESULTS:
There were 1126 papers found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorized 17 contained study data; 40 observational data; 27 anecdotal data; 47 covering methodology or design of systems; one case study; one literature review; two feasibility studies; and one cost analysis.CONCLUSION:
Electronic case report forms, electronic data capture and IT in general are viewed with enthusiasm and are seen as a cost-effective means of improving research efficiency, educating participants and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practises are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_sistemas_informacao_saude
Asunto principal:
Recolección de Datos
/
Ensayos Clínicos como Asunto
/
Farmacoepidemiología
/
Registros Electrónicos de Salud
Tipo de estudio:
Guideline
Aspecto:
Ethics
Límite:
Humans
Idioma:
En
Revista:
Br J Clin Pharmacol
Año:
2017
Tipo del documento:
Article
País de afiliación:
Reino Unido