Evidence map›Paper›PMID 31133076›Full record

ArticleTrials2019

Ambassadors of hope, research pioneers and agents of change-individuals' expectations and experiences of taking part in a randomised trial of an innovative health technology: longitudinal qualitative study.

Julia Lawton, Maxine Blackburn, Jenna P Breckenridge, Nina Hallowell, Conor Farrington, David Rankin

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02523131 (An Open-label, Multi-centre, Randomised, Single-period, Parallel Design Study to Assess the Efficacy, Safety, Utility and Psychosocial Effect of 12 Week Day and Night Automated Closed Loop Glucose Control Combined With Pump Suspend Feature Compared to Sensor Augmented Insulin Pump Therapy in Youth and Adults With Type 1 Diabetes With Sub-optimal Glucose Control Under Free Living Conditions), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% of its field
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.

NCT02523131 nacompletednot on this map

An Open-label, Multi-centre, Randomised, Single-period, Parallel Design Study to Assess the Efficacy, Safety, Utility and Psychosocial Effect of 12 Week Day and Night Automated Closed Loop Glucose Control Combined With Pump Suspend Feature Compared to Sensor Augmented Insulin Pump Therapy in Youth and Adults With Type 1 Diabetes With Sub-optimal Glucose Control Under Free Living Conditions

TypeinterventionalSponsorUniversity of CambridgeRan2016 to 2018Enrolled84ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System DiseasesArmsFlorenceM, Medtronic insulin pump 640G
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  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

6 authors at 4 institutions in 1 country.

Julia LawtonUsher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK. J.Lawton@ed.ac.uk.ORCID http://orcid.org/0000-0002-8016-7374
Maxine BlackburnUsher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.
Jenna P BreckenridgeUsher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.
Nina HallowellWellcome Centre for Ethics and Humanities and the Ethox Centre, Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK.
Conor FarringtonCambridge Centre for Health Services Research, University of Cambridge, Cambridge, UK.
David RankinUsher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.
University of Edinburgh · GBUniversity of Cambridge · GBUniversity of Dundee · GBUniversity of Oxford · GB

Funding

Wellcome TrustWellcome Trust 100574/Z/12/Z
6 · The paper itself

Abstract

backgroundWhile a growing body of research has explored why people take part in clinical trials, this research has not considered how people's understandings, motivations and agendas might influence their conduct during a trial. This is an important area of enquiry because it is now widely recognised that an intervention might lead to different clinical outcomes when delivered as part of a trial than when implemented in routine clinical practice; however, the reasons for this are not fully understood. METHODS/

designWe interviewed 24 individuals who took part in a trial of an innovative health technology under development for people with type 1 diabetes which automatically regulates blood glucose: the closed-loop system. Participants were interviewed following randomisation to a closed-loop and at trial closeout.

resultsParticipants provided complex agendas for taking part in which altruistic and self-interested considerations were often inseparable. Many described belonging to a wider diabetes community and being beneficiaries of others' participation in research and how this had given rise to attendant citizenship obligations. Participants also shared the excitement and pride they experienced from contributing to research which situated them at the forefront of technological innovation and enabled them to present themselves to others, by virtue of their trial participation, as ambassadors of hope and research pioneers. Given their desire to support the progression of a potentially life-changing technology, and be part of that innovation, participants, at follow-up, described having made extra effort during the trial. Specifically, participants described having been more focused on their diabetes management to help create conditions in which the closed-loop could work most effectively to optimize their blood glucose control.

conclusionsOur findings contribute a new dimension to understandings of trial effects; specifically, we argue that, to aid interpretation of trial outcomes, participants' understandings and motivations for participation need to be considered. We highlight the potential pertinence of our findings in the contemporary era of bio-citizenship where, increasingly, people are driving research agendas and see themselves as co-producers of knowledge. We also recommend a new concept be introduced into the literature-'the altruselfish agenda'-to recognise potential inseparability of self-interested and altruistic motivations.

trial registrationClinicalTrials.gov, NCT02523131 . Registered on 14 August 2015.

Indexed as

Biomedical TechnologyRandomized Controlled Trials as TopicAdolescentAdultAgedDiabetes Mellitus, Type 1FemaleHumansLongitudinal StudiesMaleMiddle AgedMotivationPatient ParticipationQualitative ResearchClinical trialDiabetesMedical deviceQualitative researchTechnologyTrial effectsTrial participation

Identifiers

PMID31133076
PMCPMC6537378
OpenAlexW2947524601

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.