The impact of parent treatment preference and other factors on recruitment: lessons learned from a paediatric epilepsy randomised controlled trial
dc.contributor.author | Carter, B | |
dc.contributor.author | Bray, L | |
dc.contributor.author | al-Najjar, N | |
dc.contributor.author | Piella, AT | |
dc.contributor.author | Tudur-Smith, C | |
dc.contributor.author | Spowart, C | |
dc.contributor.author | Collingwood, A | |
dc.contributor.author | Crudgington, H | |
dc.contributor.author | Currier, J | |
dc.contributor.author | Hughes, DA | |
dc.contributor.author | Wood, E | |
dc.contributor.author | Martin, R | |
dc.contributor.author | Morris, C | |
dc.contributor.author | Roberts, D | |
dc.contributor.author | Rouncefield-Swales, A | |
dc.contributor.author | Sutherland, H | |
dc.contributor.author | Watson, V | |
dc.contributor.author | Cook, G | |
dc.contributor.author | Wiggs, L | |
dc.contributor.author | Gringras, P | |
dc.contributor.author | Pal, D | |
dc.date.accessioned | 2023-02-07T09:30:55Z | |
dc.date.issued | 2023-02-06 | |
dc.date.updated | 2023-02-07T07:03:05Z | |
dc.description.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. | en_GB |
dc.description.sponsorship | National Institute for Health Research (NIHR) | en_GB |
dc.identifier.citation | Vol. 24(1), article 83 | en_GB |
dc.identifier.doi | https://doi.org/10.1186/s13063-023-07091-9 | |
dc.identifier.grantnumber | RP-PG-0615-20007 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/132429 | |
dc.identifier | ORCID: 0000-0002-9916-507X (Morris, Christopher) | |
dc.identifier | ScopusID: 7401472396 (Morris, Christopher) | |
dc.language.iso | en | en_GB |
dc.publisher | BMC | en_GB |
dc.rights | © The Author(s) 2023. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | en_GB |
dc.subject | Parent treatment preference | en_GB |
dc.subject | Recruitment | en_GB |
dc.subject | Consent | en_GB |
dc.subject | Patient and public involvement | en_GB |
dc.subject | Randomised trial design | en_GB |
dc.title | The impact of parent treatment preference and other factors on recruitment: lessons learned from a paediatric epilepsy randomised controlled trial | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2023-02-07T09:30:55Z | |
exeter.article-number | 83 | |
dc.description | This is the final version. Available on open access from BMC via the DOI in this record | en_GB |
dc.description | Availability of data and materials: The CASTLE trial was terminated after the pilot. The datasets used and/or analysed during the CASTLE pilot as well as select trial materials are available from the corresponding author (DP) on reasonable request (see also pages 53-54 of the attached protocol). The information from the consultation with the health professionals is not available as this is not research data. | en_GB |
dc.identifier.eissn | 1745-6215 | |
dc.identifier.journal | Trials | en_GB |
dc.relation.ispartof | Trials, 24(1) | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | en_GB |
dcterms.dateAccepted | 2022-12-30 | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2023-02-06 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2023-02-07T09:29:07Z | |
refterms.versionFCD | VoR | |
refterms.dateFOA | 2023-02-07T09:31:57Z | |
refterms.panel | A | en_GB |
refterms.dateFirstOnline | 2023-02-06 |
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Except where otherwise noted, this item's licence is described as © The Author(s) 2023. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.