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

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Tutton, Elizabeth, Achten, Juul, Lamb, S. E. (Sallie E.), Willett, Keith and Costa, Matthew L. (2018) Participation in a trial in the emergency situation : a qualitative study of patient experience in the UK WOLLF trial. Trials, 19 (1). 328. doi:10.1186/s13063-018-2722-4

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Official URL: https://doi.org/10.1186/s13063-018-2722-4

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Abstract

Background

Patients 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).

Methods

The 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.

Results

The 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.

Conclusions

Patients 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.

Item Type: Journal Article
Subjects: R Medicine > RD Surgery
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Faculty of Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing
Library of Congress Subject Headings (LCSH): Leg -- Fractures -- Treatment, Fractures -- Patients -- Interviews
Journal or Publication Title: Trials
Publisher: Biomed Central
ISSN: 1745-6215
Official Date: 26 June 2018
Dates:
DateEvent
26 June 2018Published
6 June 2018Accepted
Volume: 19
Number: 1
Article Number: 328
DOI: 10.1186/s13063-018-2722-4
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
UNSPECIFIED[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
Related URLs:
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Contributors:
ContributionNameContributor ID
Research GroupUK WOLLF research collaborators, UNSPECIFIED
Research team memberBruce, J. (Julie)33523

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