Evidence map›Paper›PMID 31215440›Full record

ArticleBMC medical research methodology2019

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

Charlotte L Hall, Susan Brown, Marilyn James, Jennifer L Martin, Nikki Brown, Kim Selby, Julie Clarke, Laura Williams, Kapil Sayal, Chris Hollis and 1 more

Registry-linked trialAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical research methodology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03368573 (Optimising Medication Management in Children and Young People With Attention Deficit Hyperactivity Disorder), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03368573 nacompletednot on this map

Optimising Medication Management in Children and Young People With Attention Deficit Hyperactivity Disorder (ADHD) Using an Objective Measure of Attention, Impulsivity and Activity (QbTest): a Feasibility Study

TypeinterventionalSponsorNottinghamshire Healthcare NHS TrustRan2017 to 2018Enrolled43ConditionsADHDArmsQbTest
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Charlotte L HallDivision of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK. charlotte.hall@nottingham.ac.uk.ORCID 0000-0002-5412-6165
Susan BrownDivision of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Marilyn JamesDivision of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
Jennifer L MartinDivision of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Nikki BrownDivision of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Kim SelbyDepartment of Community Paediatrics, Medway NHS Foundation Trust, Kent, UK.
Julie ClarkeActing Consultant Community Paediatrics, Grantham and District Hospital, United Lincolnshire Hospitals NHS Trust, Grantham, UK.
Laura WilliamsDivision of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Kapil SayalChild and Adolescent, Developmental Psychiatry, School of Medicine, University of Nottingham and CANDAL (Centre for ADHD and Neuro-developmental Disorders across the Lifespan), Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Chris HollisDevlopmental Psychiatry Queens Medical Centre, School of Medicine, and MindTech, Institute of Mental, University of Nottingham, Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Madeleine J GroomDivision of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.

Funding

Department of Health PB-PG-1215-20026
6 · The paper itself

Abstract

backgroundThe 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.

methodWith 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.

resultsThe 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.

conclusionProtocols 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.

trial registrationClinicaltrials.gov NCT03368573, 11th December 2017 (retrospectively registered).

Indexed as

Attention Deficit Disorder with HyperactivityRandomized Controlled Trials as TopicResearch DesignAdolescentChildClinical Trial Protocols as TopicFemaleHumansMaleOutcome Assessment, Health CarePractice Guidelines as TopicExpert workshopManagementMedicationPatient and public involvementProtocol developmentQbTestTitration

Identifiers

PMID31215440
PMCPMC6582552

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.