Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis

Trials

Review

Hugo Pedder¹  Daisy M. Gaunt¹  Esther Crawley¹  Cat Papastavrou Brooks¹  Chris Metcalfe²  Jeremy Horwood³ 

[1] Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, BS8 2PS, Bristol, UK;Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, BS8 2PS, Bristol, UK;Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, BS8 1NU, Bristol, UK;Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, BS8 2PS, Bristol, UK;NIHR Applied Research Collaboration West, 9th Floor, Whitefriars, Lewins Mead, BS1 2NT, Bristol, UK;

关键词: Systematic review;    Meta-analysis;    Paediatric;    Randomised controlled trials;    Attrition;    Retention;   

DOI  :  10.1186/s13063-023-07333-w

 received in 2023-01-04, accepted in 2023-04-28,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more challenging due to child developmental stages, involving additional participants, and proxy-reporting of outcomes. This systematic review and meta-analysis explores the factors which may influence retention in paediatric trials.MethodsUsing the MEDLINE database, paediatric randomised controlled trials published between 2015 and 2019 were identified from six general and specialist high-impact factor medical journals. The review outcome was participant retention for each reviewed trial’s primary outcome. Context (e.g. population, disease) and design (e.g. length of trial) factors were extracted. Retention was examined for each context and design factor in turn, with evidence for an association being determined by a univariate random-effects meta-regression analysis.ResultsNinety-four trials were included, and the median total retention was 0.92 (inter-quartile range 0.83 to 0.98). Higher estimates of retention were seen for trials with five or more follow-up assessments before the primary outcome, those less than 6 months between randomisation and primary outcome, and those that used an inactive data collection method. Trials involving children aged 11 and over had the higher estimated retention compared with those involving younger children. Those trials which did not involve other participants also had higher retention, than those where they were involved. There was also evidence that a trial which used an active or placebo control treatment had higher estimated retention, than treatment-as-usual. Retention increased if at least one engagement method was used. Unlike reviews of trials including all ages of participants, we did not find any association between retention and the number of treatment groups, size of trial, or type of treatment.ConclusionsPublished paediatric RCTs rarely report the use of specific modifiable factors that improve retention. Including multiple, regular follow-ups with participants before the primary outcome may reduce attrition. Retention may be highest when the primary outcome is collected up to 6 months after a participant is recruited. Our findings suggest that qualitative research into improving retention when trials involve multiple participants such as young people, and their caregivers or teachers would be worthwhile. Those designing paediatric trials also need to consider the use of appropriate engagement methods.Research on Research (RoR) registryhttps://ror-hub.org/study/2561

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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