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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.

Authors

Charlotte L. Hall charlotte.hall@nottingham.ac.uk

Susan Brown sue.brown@nottingham.ac.uk

Marilyn James marilyn.james@nottingham.ac.uk

Jennifer L. Martin jennifer.martin@nottigham.ac.uk

Nikki Brown nikki.l.brown@sky.com

Kim Selby

Julie Clarke julieclarke2@uhl.nhs.uk

Laura Williams

Kapil Sayal

Chris Hollis

Madeleine J. Groom



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.

Journal Article Type Article
Publication Date Jun 18, 2019
Electronic ISSN 1471-2288
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 19
Article Number 126
Pages 1-13
APA6 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
DOI https://doi.org/10.1186/s12874-019-0772-2
Keywords Protocol development; Expert workshop; QbTest; Medication; Management; Titration; Patient and public involvement
Publisher URL https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-019-0772-2

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