Evidence map›Paper›PMID 28388937›Full record

ReviewTrials2017

Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses.

Lauralie Richard, Donella Piper, Wayne Weavell, Rosemary Callander, Rick Iedema, John Furler, David Pierce, Kali Godbee, Jane Gunn, Victoria J Palmer

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

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

  1. Pooled it
  2. Trial
  3. Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.Health expectations : an international journal of public participation in health care and health policy · 2020
    Trial
  4. Trial
  5. The Influence of Relationships Within Behavioral Weight Management Interventions: An Overview.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Recommendations to encourage participation of individuals from diverse backgrounds in psychiatric genetic studies.American journal of medical genetics. Part B, Neuropsychiatric genetics : the official publication of the International Society of Psychiatric Genetics · 2022
    Review
  11. Article
  12. Optimising co-design with ethnic minority consumers.International journal for equity in health · 2021
    Article
  13. Review
  14. Review
  15. Gender differences in caregiving among a schizophrenia population.Psychology research and behavior management · 2019
    Article
  16. Article
  17. Review
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

10 authors.

Lauralie RichardThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
Donella PiperSchool of Health, University of New England, Armidale, Australia.
Wayne WeavellThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
Rosemary CallanderThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
Rick IedemaMonash Centre for Health Research and Implementation, Monash University, Clayton, Australia.
John FurlerThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
David PierceDepartment of Rural Health, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia.
Kali GodbeeThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
Jane GunnThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
Victoria J PalmerThe Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia. v.palmer@unimelb.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEngagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researched and understood, and models of engagement are rarely informed by theory. This article describes an innovative methodological approach for the development and application of a relational model of engagement in a stepped wedge designed cluster randomised controlled trial (RCT), the CORE study. The purpose of the model is to embed engagement across the continuum of the trial which will test if an experience-based co-design intervention improves psychosocial recovery for people affected by severe mental illness.

methodsThe model was developed in three stages and used a structured iterative approach. A context mapping assessment of trial sites was followed by a literature review on recruitment and retention of hard-to-reach groups in complex interventions and RCTs. Relevant theoretical and philosophical underpinnings were identified by an additional review of literature to inform model development and enactment of engagement activities.

resultsPolicy, organisational and service user data combined with evidence from the literature on barriers to recruitment provided contextual information. Four perspectives support the theoretical framework of the relational model of engagement and this is organised around two facets: the relational and continuous. The relational facet is underpinned by relational ethical theories and participatory action research principles. The continuous facet is supported by systems thinking and translation theories. These combine to enact an ethics of engagement and evoke knowledge mobilisation to reach the higher order goals of the model.

conclusionsEngagement models are invaluable for trials research, but there are opportunities to advance their theoretical development and application, particularly within stepped wedge designed studies where there may be a significant waiting period between enrolment in a study and receipt of an intervention.

Indexed as

Patient ParticipationPatient SelectionHumansMental DisordersRandomized Controlled Trials as TopicResearch SubjectsSeverity of Illness IndexWorkflowCluster randomised controlled trialComplex interventionsEngagement modelExperience-based co-designStepped wedge design

Identifiers

PMID28388937
PMCPMC5385022

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.