Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders

Hall, Charlotte L.; Brown, Susan; James, Marilyn; Martin, Jennifer L.; Brown, Nikki; Selby, Kim; Clarke, Julie; Williams, Laura; Sayal, Kapil; Hollis, Chris; Groom, Madeleine J.

Abstract

Background
The study design and protocol that underpin a randomised controlled trial (RCT) are critical for the ultimate success of the trial. Although RCTs are considered the gold standard for research, there are multiple threats to their validity such as participant recruitment and retention, identifying a meaningful change, and non-adherence to the protocol. For clinical RCTs, involving patients and clinicians in protocol design provides the opportunity to develop research protocols that are meaningful to their target audience and may help overcome some of the inherent threats in conducting RCTs. However, the majority of protocols do not describe the methodology underpinning their development, limiting the amount of learned experience shared between research groups.

Method
With the purpose of reporting a collaborative approach towards developing a protocol, we present the findings from three sequential workshops that were conducted with the aim of developing a protocol to investigate the feasibility of adding a computerised test of attention, impulsivity and activity (QbTest) to medication management of children and young people with Attention deficit hyperactivity disorder (ADHD). Based on previous qualitative interviews with clinicians and families, each workshop prioritised topics for focused discussion. Information from the workshops was fed back to the participants for reflection in advance of the next workshop.

Results
The workshops involved 21 multi-disciplinary ADHD experts, including clinicians, patient and public involvement (PPI) members, parents of young people with ADHD and researchers. The consensus workshops addressed key research issues such as: the most relevant outcome measures/ resource drivers; methods and time points for data collection; and the clinical protocol for utilising the QbTest, including when best to use this within the medication management process. The resulting protocol details a feasibility RCT design describing these factors.

Conclusion
Protocols which are co-developed may help overcome some of the risks associated with RCT completion (e.g. recruitment, retention, protocol adherence) and help prioritise outcomes of greater relevance to the populations under study. The methodology has potential value for researchers and organisations developing clinical guidelines, and offers insights into the valuable impact of PPI upon trial design.

Citation

Hall, C. L., Brown, S., James, M., Martin, J. L., Brown, N., Selby, K., …Groom, M. J. (2019). Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders. BMC Medical Research Methodology, 19, 1-13. https://doi.org/10.1186/s12874-019-0772-2

• Journal Article Type: Article
• Acceptance Date: Jun 9, 2019
• Online Publication Date: Jun 18, 2019
• Publication Date: Jun 18, 2019
• Deposit Date: Jun 14, 2019
• Publicly Available Date: Jun 24, 2019
• Journal: BMC Medical Research Methodology
• Electronic ISSN: 1471-2288
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Article Number: 126
• Pages: 1-13
• DOI: https://doi.org/10.1186/s12874-019-0772-2
• Keywords: Protocol development; Expert workshop; QbTest; Medication; Management; Titration; Patient and public involvement
• Public URL: https://nottingham-repository.worktribe.com/output/2188467
• Publisher URL: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-019-0772-2
• Additional Information: Received: 12 September 2018; Accepted: 9 June 2019; First Online: 18 June 2019; : The paper presents the methodological development of the protocol created by a steering group. Members were not recruited by public recruitment in the NHS nor were the activities considered ‘data collection’ or ‘research’ (but rather, involvement in shaping the research design) and thus ethical approval for the workshops was not sought; this was agreed by the study Sponsor (Nottinghamshire Healthcare NHS Foundation Trust; Ref: Groom050917). Nonetheless, although not required by an ethics committee, all members of the workshops were adults who provided their verbal consent to participate. The resulting protocol that stemmed from the process described in this manuscript did receive Ethical approval: QUOTA protocol (v1.1) approved by West of Scotland REC 1 (REC reference 17/WS/0209) on 7th November 2017.; : Not applicable.; : On behalf of all authors, the corresponding author declares no conflicts of interests.