Implementation of clinical research trials using web-based and mobile devices: challenges and solutions.
BMC Med Res Methodol
; 17(1): 43, 2017 03 17.
Article
em En
| MEDLINE
| ID: mdl-28302050
ABSTRACT
BACKGROUND:
With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature.RESULTS:
The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy.CONCLUSION:
We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Linhas Diretas
/
Segurança Computacional
/
Telemedicina
/
Confidencialidade
/
Internet
/
Cardiopatias Congênitas
/
Obesidade
Tipo de estudo:
Guideline
Limite:
Adolescent
/
Child
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
BMC Med Res Methodol
Assunto da revista:
MEDICINA
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Canadá