Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study
Background: Research in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing imple...
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doaj-9d969712f4a14cf1b20d3b835f4e50ce2021-04-27T18:17:00ZengRoyal College of General PractitionersBJGP Open2398-37952021-04-015210.3399/bjgpopen20X101154Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort studyAnouk AH Weghorst0Gea A Holtman1Pien I Wolters2Heleen A Russchen3Freek Fickweiler4Henkjan J Verkade5Johan Post6Karin M Vermeulen7Boudewijn J Kollen8Irma J Bonvanie9Marjolein Y Berger10Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of Paediatrics, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of Out-Of-Hours Service Groningen, Groningen, The NetherlandsDepartment of Epidemiology, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The NetherlandsBackground: Research in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing implementation has become common in pragmatic randomised controlled trials (RCTs) set in primary care. Aim: To describe how the informed consent procedure affects study inclusion and to assess how off-protocol medication prescribing affects participant selection in a paediatric RCT. Design & setting: A pragmatic RCT evaluating the cost-effectiveness of oral ondansetron in children diagnosed with acute gastroenteritis (AGE) in primary care out-of-hours services and a parallel cohort study. Method: Consecutive children aged 6 months to 6 years attending primary care out-of-hours services with AGE were evaluated to assess the feasibility of obtaining informed consent, the off-protocol use of ondansetron, and other inclusion and exclusion criteria. Results: The RCT's feasibility was reduced by the informed consent procedure because 39.0% (n = 325/834) of children were accompanied by only one parent. GPs prescribed ondansetron off-protocol to 34 children (4.1%) of which 19 children were eligible for the RCT. RCT-eligible children included in the parallel cohort study had fewer risk factors for dehydration than children in the RCT despite similar dehydration assessments by GPs. Conclusion: The informed consent procedure and off-protocol use of study medication affect the inclusion rate, but had little effect on selection. A parallel cohort study alongside the RCT can help evaluate selection bias, and a pilot study can reveal potential barriers to inclusion.https://bjgpopen.org/content/5/2/bjgpopen20X101154primary careinformed consentoff-protocolselection biaschildrenrandomised controlled trialcohort |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Anouk AH Weghorst Gea A Holtman Pien I Wolters Heleen A Russchen Freek Fickweiler Henkjan J Verkade Johan Post Karin M Vermeulen Boudewijn J Kollen Irma J Bonvanie Marjolein Y Berger |
spellingShingle |
Anouk AH Weghorst Gea A Holtman Pien I Wolters Heleen A Russchen Freek Fickweiler Henkjan J Verkade Johan Post Karin M Vermeulen Boudewijn J Kollen Irma J Bonvanie Marjolein Y Berger Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study BJGP Open primary care informed consent off-protocol selection bias children randomised controlled trial cohort |
author_facet |
Anouk AH Weghorst Gea A Holtman Pien I Wolters Heleen A Russchen Freek Fickweiler Henkjan J Verkade Johan Post Karin M Vermeulen Boudewijn J Kollen Irma J Bonvanie Marjolein Y Berger |
author_sort |
Anouk AH Weghorst |
title |
Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study |
title_short |
Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study |
title_full |
Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study |
title_fullStr |
Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study |
title_full_unstemmed |
Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study |
title_sort |
recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study |
publisher |
Royal College of General Practitioners |
series |
BJGP Open |
issn |
2398-3795 |
publishDate |
2021-04-01 |
description |
Background: Research in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing implementation has become common in pragmatic randomised controlled trials (RCTs) set in primary care. Aim: To describe how the informed consent procedure affects study inclusion and to assess how off-protocol medication prescribing affects participant selection in a paediatric RCT. Design & setting: A pragmatic RCT evaluating the cost-effectiveness of oral ondansetron in children diagnosed with acute gastroenteritis (AGE) in primary care out-of-hours services and a parallel cohort study. Method: Consecutive children aged 6 months to 6 years attending primary care out-of-hours services with AGE were evaluated to assess the feasibility of obtaining informed consent, the off-protocol use of ondansetron, and other inclusion and exclusion criteria. Results: The RCT's feasibility was reduced by the informed consent procedure because 39.0% (n = 325/834) of children were accompanied by only one parent. GPs prescribed ondansetron off-protocol to 34 children (4.1%) of which 19 children were eligible for the RCT. RCT-eligible children included in the parallel cohort study had fewer risk factors for dehydration than children in the RCT despite similar dehydration assessments by GPs. Conclusion: The informed consent procedure and off-protocol use of study medication affect the inclusion rate, but had little effect on selection. A parallel cohort study alongside the RCT can help evaluate selection bias, and a pilot study can reveal potential barriers to inclusion. |
topic |
primary care informed consent off-protocol selection bias children randomised controlled trial cohort |
url |
https://bjgpopen.org/content/5/2/bjgpopen20X101154 |
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