Evidence map›Paper›PMID 39175005›Full record

Trial reportTrials2024

Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial.

Muram El-Nayir, Rohan Wijesurendra, David Preiss, Marion Mafham, Leandros Tsiotos, Sadman Islam, Anne Whitehouse, Sophia Wilkinson, Hannah Freeman, Ryonfa Lee and 14 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. 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

24 authors.

Muram El-Nayir *Clinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Rohan Wijesurendra *Clinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK. rohan.wijesurendra@ndph.ox.ac.uk.ORCID http://orcid.org/0000-0002-8261-8343
David PreissClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Marion MafhamClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Leandros TsiotosClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Sadman IslamClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Anne WhitehouseClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Sophia WilkinsonClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Hannah FreemanClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Ryonfa LeeClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Wojciech BrudloClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Genna BobbyClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Bryony JenkinsClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Robert HumphreyClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Amy MallorieClinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Andrew ToalPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Elnora C BarkerPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Dianna MoylanPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Graeme ThomsonPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Firoza DaviesPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Hameed KhanPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Ian AlloteyPublic Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
Susan Dickie *Public Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.
John Roberts *Public Advisory Group; ASCEND PLUS Clinical Trial, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionASCEND PLUS is a randomised controlled trial assessing the effects of oral semaglutide on the primary prevention of cardiovascular events in around 20,000 individuals with type 2 diabetes in the UK. The trial's innovative design includes a decentralised direct-to-participant invitation, recruitment, and follow-up model, relying on self-completion of online forms or telephone or video calls with research nurses, with no physical sites. Extensive patient and public involvement and engagement (PPIE) was essential to the design and conduct of ASCEND PLUS.

aimTo report the process and conduct of PPIE activity in ASCEND PLUS, evaluate effects on trial design, reflect critically on successes and aspects that could have been improved, and identify themes and learning relevant to implementation of PPIE in future trials.

methodsPPIE activity was coordinated centrally and included six PPIE focus groups and creation of an ASCEND PLUS public advisory group (PAG) during the design phase. Recruitment to these groups was carefully considered to ensure diversity and inclusion, largely consisting of adults living with type 2 diabetes from across the UK. Two members of the PAG also joined the trial Steering Committee. Steering Committee meetings, focus groups, and PAG meetings were conducted online, with two hybrid workshops to discuss PPIE activity and aspects of the trial.

resultsPPIE activity was critical to shaping the design and conduct of ASCEND PLUS. Key examples included supporting choice for participants to either complete the screening/consent process independently online, or during a telephone or video call interview with a research nurse. A concise 'initial information leaflet' was developed to be sent with the initial invitations, with the 'full' information leaflet sent later to those interested in joining the trial. The PAG reviewed the content and format of participant- and public-facing materials, including written documents, online screening forms, animated videos, and the trial website, to aid clarity and accessibility, and provided input into the choice of instruments to assess quality of life.

conclusionsPPIE is integral in ASCEND PLUS and will continue throughout the trial. This involvement has been critical to optimising the trial design, successfully obtaining regulatory and ethical approval, and conducting the trial.

Indexed as

Diabetes Mellitus, Type 2Patient ParticipationResearch DesignAdministration, OralCardiovascular DiseasesCommunity ParticipationGlucagon-Like PeptidesHumansHypoglycemic AgentsPatient SelectionSemaglutideStakeholder ParticipationTreatment OutcomeUnited KingdomGlucagon-Like PeptidesHypoglycemic AgentsSemaglutideClinical trialDiabetesPatient and public involvement and engagementPPIE

Identifiers

PMID39175005
PMCPMC11340079

What OpenQuestion holds

Texttitle and abstract
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Registered trials

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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.