Factors affecting adolescents' participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project.
BMC Med Res Methodol
; 20(1): 205, 2020 08 03.
Article
em En
| MEDLINE
| ID: mdl-32746862
ABSTRACT
BACKGROUND:
Recruitment of adolescents to intervention studies is a known challenge. For randomized controlled trials (RCT) to be generalizable, reach must be assessed, which means ascertaining how many of the intended population actually participated in the trial. The aim of this study was to evaluate the reach and representativeness of an RCT evaluating the effectiveness of a complex intervention for adolescents with chronic conditions.METHODS:
A mixed methods sequential explanatory design was employed. Firstly, quantitative cross-sectional data from the RCT, patient registries and medical records were collected and analysed regarding baseline differences between participants and non-participants in the trial. Secondly, qualitative data on their reasons for participating or not were collected and analysed with content analysis to explain the quantitative findings.RESULTS:
Participants showed larger differences in effect sizes and a significantly more complex chronic condition than non-participants. No other statistically significant differences were reported, and effect sizes were negligible. Reasons for declining or accepting participation were categorized into three main categories altruistic reasons, personal reasons and external reasons and factors.CONCLUSIONS:
Integration of quantitative and qualitative findings showed that participation in the RCT was affected by disease complexity, the perceived need to give back to healthcare and research and the adolescents' willingness to engage in their illness. To empower adolescents with chronic conditions and motivate them to participate in research, future intervention studies should consider developing tailored recruitment strategies and communications with sub-groups that are harder to reach.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Atenção à Saúde
Tipo de estudo:
Clinical_trials
/
Evaluation_studies
/
Qualitative_research
Limite:
Adolescent
/
Humans
Idioma:
En
Revista:
BMC Med Res Methodol
Assunto da revista:
MEDICINA
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Suécia