Evidence map›Paper›PMID 30018100›Full record

ArticleBMJ open2018

Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes.

Catherine Henshall, Parth Narendran, Robert C Andrews, Amanda Daley, Keith A Stokes, Amy Kennedy, Sheila Greenfield

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

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

8 citing papers in PubMed, 25 citations in OpenAlex.

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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

7 authors at 7 institutions in 3 countries.

Catherine HenshallOxford Brookes University, Oxford, UK.ORCID 0000-0001-5659-3296
Parth NarendranInstitute or Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
Robert C AndrewsUniversity of Exeter Medical School, Exeter, UK.
Amanda DaleySchool of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.
Keith A StokesDepartment for Health, University of Bath, Bath, UK.
Amy KennedyDepartment of Diabetes & Endocrinology, Royal Stoke University Hospital, University Hospitals of North Midlands, Stoke-on-Trent, UK.
Sheila GreenfieldInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Institute of Immunology · HRLoughborough University · GBOxford Brookes University · GBRoyal Stoke University Hospital · GBUniversity of Bath · GBUniversity of Birmingham · GBUniversity of Exeter · GB

Funding

Department of Health PB-PG-0609-19093
6 · The paper itself

Abstract

objectivesRegular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.

designQualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method.

settingThe study took place at five participating UK hospitals.

participantsTwenty participants, aged 19-55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4).

resultsParticipants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention.

conclusionsTo our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

Indexed as

Clinical Trials as TopicExerciseResearch SubjectsRetention in CareAdultDiabetes Mellitus, Type 1EmploymentFemaleHumansMaleMiddle AgedPatient SelectionQualitative ResearchSocial SupportTime FactorsUnited Kingdomclinical trialsexerciseparticipantsphysical activitytrial retentiontype 1 diabetes

Identifiers

PMID30018100
PMCPMC6059261
OpenAlexW2884147798

What OpenQuestion holds

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LicenceCC BY-NC
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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.