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Research article
Factors affecting adolescents’ participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project
Markus Saarijärvi
Goteborgs Universitet
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7053-6930
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Medical Research Methodology.
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.
Keywords
Adolescent, Chronic Disease, Mixed method, Process evaluation, Randomized Controlled Trial, Transition of care
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CURRENT STATUS: Published
Published
On 03 Aug, 2020
No community comments so far
Submission checks complete
On 28 Jul, 2020
Editorial decision: Accept
On 27 Jul, 2020
Version 2
Posted 08 Jul, 2020
No comments provided
Editorial decision: Minor revision
On 22 Jul, 2020
Reviewers invited
Invitations sent on 10 Jul, 2020
Editor assigned
On 07 Jul, 2020
Submission checks complete
On 06 Jul, 2020
Editor invited
On 06 Jul, 2020
No comments provided
Editorial decision: Major revision
On 24 Jun, 2020
Review #2 received
Received 05 Jun, 2020
Review #1 received
Received 05 Jun, 2020
Reviewers invited
Invitations sent on 29 May, 2020
Reviewer #1 agreed
On 29 May, 2020
Reviewer #2 agreed
On 29 May, 2020
Submission checks complete
On 22 May, 2020
Editor invited
On 19 May, 2020
Editor assigned
On 18 May, 2020
First submitted
On 15 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Health Economics & Outcomes Research
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This preprint is under consideration at BMC Medical Research Methodology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Factors affecting adolescents’ participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project
Markus Saarijärvi
Goteborgs Universitet
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7053-6930
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Published
On 03 Aug, 2020
No community comments so far
Submission checks complete
On 28 Jul, 2020
Editorial decision: Accept
On 27 Jul, 2020
Version 2
Posted 08 Jul, 2020
No comments provided
Editorial decision: Minor revision
On 22 Jul, 2020
Reviewers invited
Invitations sent on 10 Jul, 2020
Editor assigned
On 07 Jul, 2020
Submission checks complete
On 06 Jul, 2020
Editor invited
On 06 Jul, 2020
No comments provided
Editorial decision: Major revision
On 24 Jun, 2020
Review #2 received
Received 05 Jun, 2020
Review #1 received
Received 05 Jun, 2020
Reviewers invited
Invitations sent on 29 May, 2020
Reviewer #1 agreed
On 29 May, 2020
Reviewer #2 agreed
On 29 May, 2020
Submission checks complete
On 22 May, 2020
Editor invited
On 19 May, 2020
Editor assigned
On 18 May, 2020
First submitted
On 15 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Health Economics & Outcomes Research
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Medical Research Methodology.
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.
Figure 1
Figure 2