Journal Article


The impact of parent treatment preference and other factors on recruitment : lessons learned from a paediatric epilepsy randomised controlled trial

Abstract

Background. In paediatric epilepsy, the evidence of effectiveness of antiseizure treatment is inconclusive for some types of epilepsy. As with other paediatric clinical trials, researchers undertaking paediatric epilepsy clinical trials face a range of challenges that may compromise external validity Main body. In this paper, we critically reflect upon the factors which impacted recruitment to the pilot phase of a phase IV unblinded, randomised controlled 3×2 factorial trial examining the effectiveness of two antiseizure medications (ASMs) and a sleep behaviour intervention in children with Rolandic epilepsy. We consider the processes established to support recruitment, public and patient involvement and engagement (PPIE), site induction, our oversight of recruitment targets and figures, and the actions we took to help us understand why we failed to recruit sufficient children to continue to the substantive trial phase. The key lessons learned were about parent preference, children’s involvement and collaboration in decision-making, potential and alternative trial designs, and elicitation of stated preferences pre-trial design. Despite pre-funding PPIE during the trial design phase, we failed to anticipate the scale of parental treatment preference for or against antiseizure medication (ASMs) and consequent unwillingness to be randomised. Future studies should ensure more detailed and in-depth consultation to ascertain parent and/or patient preferences. More intense engagement with parents and children exploring their ideas about treatment preferences could, perhaps, have helped predict some recruitment issues. Infrequent seizures or screening children close to natural remission were possible explanations for non-consent. It is possible some clinicians were unintentionally unable to convey clinical equipoise influencing parental decision against participation. We wanted children to be involved in decisions about trial participation. However, despite having tailored written and video information to explain the trial to children we do not know whether these materials were viewed in each consent conversation or how much input children had towards parents’ decisions to participate. Novel methods such as parent/patient preference trials and/or discrete choice experiments may be the way forward. Conclusion. The importance of diligent consultation, the consideration of novel methods such as parent/patient preference trials and/or discrete choice experiments in studies examining the effectiveness of ASMs versus no-ASMs cannot be overemphasised even in the presence of widespread clinician equipoise.

Attached files

Authors

Carter, Bernie
Bray, Lucy
al-Najjar, Nadia
Tort Piella, Agnès
Tudur-Smith, Catrin
Spowart, Catherine
Collingwood, Amber
Crudgington, Holly
Currier, Janet
Hughes, Dyfrig A.
Wood, Eifiona
Martin, Rachael
Morris, Christopher
Roberts, Deborah
Rouncefield-Swales, Alison
Sutherland, Heather
Watson, Victoria
Cook, Georgia
Wiggs, Luci
Gringras, Paul
Pal, Deb

Oxford Brookes departments

Department of Psychology, Health and Professional Development

Dates

Year of publication: 2023
Date of RADAR deposit: 2023-01-06


Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License


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