Evidence map›Paper›PMID 29941030›Full record

Trial reportTrials2018

Participation in a trial in the emergency situation: a qualitative study of patient experience in the UK WOLLF trial.

Elizabeth Tutton, Juul Achten, Sarah E Lamb, Keith Willett, Matthew L Costa, UK WOLLF Research Collaborators

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 16% 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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 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

6 authors at 2 institutions in 1 country.

Elizabeth TuttonWarwick Research in Nursing, Warwick Medical School, University of Warwick, Gibbet Hill Campus, Coventry, CV4 7AL, UK. liz.tutton@warwick.ac.uk.ORCID http://orcid.org/0000-0003-3973-360X
Juul AchtenClinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Campus, Coventry, CV4 7AL, UK.
Sarah E LambClinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Campus, Coventry, CV4 7AL, UK.
Keith WillettKadoorie Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, OX3 9DU, UK.
Matthew L CostaClinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Campus, Coventry, CV4 7AL, UK.
UK WOLLF Research Collaborators
Nuffield Orthopaedic Centre · GBJohn Radcliffe Hospital · GB

Funding

Department of Health 10/57/20Department of Health HTA/14/199/14Medical Research Council G0501681Medical Research Council G0700452NIHR HTA 10/57/20
6 · The paper itself

Abstract

backgroundPatients can struggle to make sense of trials in emergency situations. This study examines patient experience of participating in the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) study, a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT).

methodsThe aim of the study was to understand the patient's lived experience of taking part in a trial of wound dressings. Interviews drawing on Phenomenology were undertaken with a purposive sample of 20 patients, on average 12 days into their hospital stay from July 2012-July 2013.

resultsThe participants were vulnerable due to the emotional and physical impact of injury. They expressed their trial experience through the theme of being compromised identified in categories of being dependent, being trusting, being grateful and being without experience. Participants felt dependent on and trusted the team to make the right decisions for them and not cause them harm. Their hopes for future recovery were also invested within the expertise of the team. Despite often not being well enough to consent to the study prior to surgery, they wished to be involved as much as possible. In agreeing to take part they expressed gratitude for their care, wanted to be helpful to others and considered the trial interventions to be a small component in relation to the enormity of their injury and broader treatment. In making sense of the trial they felt they could not understand the interventions without experience of them but if they received NPWT they developed a strong technological preference for this intervention.

conclusionsPatients prefer to be involved in studies within the limits of their capacity, despite not being able to provide informed consent. A variety of sources of knowledge may enable participants to feel that they have a better understanding of the interventions. Professional staff need to be aware of the situated nature of decision making where participants invest their hopes for recovery in the team.

trial registrationCurrent Controlled Trials, ID: ISRCTN33756652 . Registered on 24 February 2012.

Indexed as

Health Knowledge, Attitudes, PracticeNegative-Pressure Wound TherapyPatient SelectionComprehensionEmergenciesFracture HealingFractures, OpenHumansInformed ConsentQualitative ResearchResearch SubjectsTreatment OutcomeTrustUnited KingdomWound HealingConsentEmergencyExperienceInterviewsQualitativeTrial

Identifiers

PMID29941030
PMCPMC6019785
OpenAlexW2809999542

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.