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.
Highlights
Patients can struggle to make sense of trials in emergency situations
In the UK WOLLF trial if a patient lacked capacity a personal or nominated consultee was asked to advise the team regarding the patient’s participation in the trial, Tutton et al Trials (2018) 19:328 and patient consent was gained for continued enrolment in the study when they were well enough [1]
This study was embedded in a clinical trial comparing standard wound management with Negative Pressure Wound Therapy (NPWT)
Summary
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). The second is reported here and describes the patient experience of being part of a trial in the context of emergency interventions The vehicle for this was the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT) [5, 7]. In order to understand trial participation within their overall experience, a methodological approach was used that enabled patients to present their experience of what it was like being in a wound-dressing trial in emergency circumstances How they made sense of the trial was situated in relation to other aspects of their experience. This patient-informed evidence could be used in the education of future practitioners involved in consenting patients to emergency trials in musculoskeletal injury
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