328 research outputs found
Participation in a trial in the emergency situation : a qualitative study of patient experience in the UK WOLLF trial
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 patientâs 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 2012âJuly 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
Making sense of it: Intensive care patients' phenomenological accounts of story construction
Background
Patients entering intensive care encounter physical and psychological stress which may lead to psychological morbidity such as depression, anxiety and post-traumatic stress. It has been suggested that constructing a story may assist psychological recovery however this has been minimally investigated in the intensive care patient.
Aim
The aim of this paper is to examine the process of story construction in patientsâ phenomenological accounts of being a patient in the technological environment of intensive care.
Study design
The study design was informed by Heideggerian phenomenology.
Methods
Semi-structured interviews were conducted in nineteen patients who had been in intensive care for at least four days. Interviews were digitally recorded, transcribed and analysed utilising Van Manenâs framework for thematic analysis.
Findings
Making sense of their experiences in ICU appeared to be fundamental to story construction. Themes that arose were: âWhy am I here?â, âFilling in the gapsâ, âSorting the real from the unrealâ and âSearching for familiarityâ. These themes describe how participants sought temporal and causal coherence in order to construct their integrated and understandable story. Families appeared to play a critical role in assisting participants in filling in the gaps, sorting the real from the unreal and their subsequent psychological recovery.
Conclusions and relevance to clinical practice
The importance of early support from health care professionals to facilitate patientsâ story construction is highlighted. The study also emphasizes the role of families in supporting patients in making sense of their experiences and the associated psychological recovery process. Further research to evaluate methods of facilitating story construction such as nurse-led de-briefing, patient diaries, is recommended. In addition investigation of familiesâ perceptions of their role in assisting patients to construct their story may facilitate health care professionals in developing strategies to effectively support families in their role
Patientsâ experiences of technology and care in adult intensive care
Aims
To investigate patientsâ experiences of technology in an adult intensive care unit
Background
Technology is fundamental to support physical recovery from critical illness in Intensive Care Units. As well as physical corollaries, psychological disturbances are reported in critically ill patients at all stages of their illness and recovery. Nurses play a key role in the physical and psychological care of patients, however there is a suggestion in the literature that the presence of technology may dehumanise patient care and distract the nurse from attending to patients psychosocial needs. Little attention has been paid to patientsâ perceptions of receiving care in a technological environment.
Design
This study was informed by Heideggerian phenomenology.
Methods
The research took place in 2009-2011 in a university hospital in England. Nineteen participants who had been patients in ICU were interviewed guided by an interview topic prompt list. Interviews were transcribed verbatim and analysed using Van Manenâs framework.
Findings
Participants described technology and care as inseparable and presented their experiences as a unified encounter. The theme âGetting on with itâ described how participants endured technology by âBeing Goodâ and âBeing Invisibleâ. âGetting over itâ described why participants endured technology by âBowing to Authorityâ and viewing invasive technologies as a âNecessary Evilâ.
Conclusion
Patients experienced technology and care as a series of paradoxical relationships: alienating yet reassuring, uncomfortable yet comforting, impersonal yet personal. By maintaining a close and supportive presence and providing personal comfort and care nurses may minimise the invasive and isolating potential of technology
A qualitative study of cliniciansâ experience of a clinical trial for displaced distal radius fractures
Aims:Â The aim of this study was to explore cliniciansâ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures.
Methods:Â Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis.
Results:Â Analysis of the findings identified the overarching theme of âovercoming obstaclesâ, which described the challenge of alleviating staff concerns about the use of non-surgical casting and recruiting families where there was treatment uncertainty. In order to embed and recruit to the Childrenâs Radius Acute Fracture Fixation Trial (CRAFFT), staff needed to fit the study within clinical practice, work together, negotiate treatment decisions, and support families.
Conclusion:Â Recruiting families to this RCT was challenging because staff were uncertain about longer-term patient outcomes, and the difficulties were exacerbated by interdisciplinary tensions. Strong family and clinician beliefs, coupled with the complex nature of emergency departments and patient pathways that differed site-by-site, served as barriers to recruitment. Cementing a strong research culture, and exploring familiesâ treatment preferences, helped to overcome recruitment obstacles
Being recovered: a qualitative study of parentsâ experience of their childâs recovery up to a year after a displaced distal radius fracture
Aims
The aim of this study was to explore parentsâ experience of their childâs recovery, and their thoughts about their decision to enrol their child in a randomized controlled trial (RCT) of surgery versus non-surgical casting for a displaced distal radius fracture.
Methods
A total of 20 parents of children from 13 hospitals participating in the RCT took part in an interview five to 11 months after injury. Interviews were informed by phenomenology and analyzed using thematic analysis.
Results
Analysis of the findings identified the theme âbeing recoveredâ, which conveyed: 1) parentsâ acceptance and belief that their child received the best treatment for them; 2) their memory of the psychological impact of the injury for their child; and 3) their pride in how their child coped with their cast and returned to activities. The process of recovery was underpinned by three elements of experience: accepting the treatment, supporting their child through challenges during recovery, and appreciating their childâs resilience. These findings extend our framework that highlights parentsâ desire to protect their child during early recovery from injury, by making the right decision, worrying about recovery, and comforting their child.
Conclusion
By one year after injury, parents in both treatment groups considered their child ârecoveredâ. They had overcome early concerns about healing, the appearance of the wrist, and coping after cast removal. Greater educational support for families during recovery would enable parents and their child to cope with the uncertainty of recovery, particularly addressing the loss of confidence, worry about reinjury, and the appearance of their wrist
Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb : UK wound management of open lower limb fractures (UK WOLFF)
Introduction:
Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures.
Methods and analysis:
All adult patients presenting with an open lower limb fracture, with a Gustilo and Anderson (G&A) grade 2/3, will be considered for inclusion. 460 consented patients will provide 90% power to detect a difference of eight points in the Disability Rating Index (DRI) score at 12â
months, at the 5% level. A randomisation sequence, stratified by trial centre and G&A grade, will be produced and administered by a secure web-based service. A qualitative substudy will assess patientsâ experience of giving consent for the trial, and acceptability of trial procedures to patients and staff. Patients will have clinical follow-up in a fracture clinic up to a minimum of 12â
months as per standard National Health Service (NHS) practice. Functional and quality of life outcome data will be collected using the DRI, SF12 and EQ-5D questionnaires at 3, 6, 9 and 12â
months postoperatively. In addition, information will be requested with regards to resource use and any late complications or surgical interventions related to their injury. The main analysis will investigate differences in the DRI score at 1â
year after injury, between the two treatment groups on an intention-to-treat basis. Tests will be two sided and considered to provide evidence for a significant difference if p values are less than 0.05.
Ethics and dissemination:
Ethical approval was given by NRES Committee West MidlandsâCoventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences
Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study
Introduction Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.
The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6âmonth follow-up.
Methods and analysis A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.
Ethics and dissemination Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.
Trial registration number ISRCTN1661233
Effect of negative pressure wound therapy vs standard wound management on 12-month disability among adults with severe open fracture of the lower limb : the WOLLF randomised clinical trial
Importance
Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing.
Objectives
To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound.
Design, Setting, and Participants
Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires.
Interventions
NPWT (nâ=â226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (nâ=â234).
Main Outcomes and Measures
Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to â0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months.
Results
Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patientsâ Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, â3.9 [95% CI, â8.9 to 1.2]; Pâ=â.13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0% [95% CI, â4.2% to 6.3%]; Pâ=â.64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, â0.05 to 0.08]; Short Formâ12 Physical Component Score, 0.5 [95% CI, â3.1 to 4.1] and Mental Health Component Score, â0.4 [95% CI, â2.2 to 1.4]).
Conclusions and Relevance
Among patients with severe open fracture of the lower limb, use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months. The findings do not support this treatment for severe open fractures.
Trial Registration isrctn.org Identifier: ISRCTN3375665
Experience of patients and physiotherapists within the AFTER pilot randomised trial of two rehabilitation interventions for people aged 50 years and over post ankle fracture: a qualitative study.
This is the final version. Available from BMJ Publishing via the DOI in this record.âŻData availability statement: Data are available upon reasonable request.OBJECTIVES: To explore patient and staff experience of best-practice rehabilitation advice (one session of face-to-face self-management advice with up to two additional optional sessions) compared with progressive functional exercise (up to six sessions of face-to-face physiotherapy) after ankle fracture. DESIGN: The study drew on phenomenology using interviews and a focus group. SETTING: Participants were from three NHS Trusts in England, UK. PARTICIPANTS: A purposive sample of 20 patients with ankle (malleolar) fractures from the Ankle Fracture Treatment: Enhancing Rehabilitation-pilot trial (now completed) were interviewed (median 50âmin) from May 2019 to January 2020. They were 6 months post injury, over 50 years of age, (median 66, 12 females) and had received surgical or non-surgical treatment (seven internal fixation surgery, seven close contact casting, six walking boot). A focus group of five physiotherapists who had provided the study interventions (2.5âhours) was undertaken. RESULTS: The findings show the acceptability of both interventions through the themes, 'being helped' (for patients) and 'developing expertise' (for staff) with subthemes of choosing and progressing. Progressive exercise added value with a perceived increase in strength, motion, ability to undertake activities and continued use of the workbook. Both staff and patients valued physiotherapy expertise demonstrated through interpersonal skills, advice, individualised exercise plans and active monitoring of progression. Best practice advice was particularly helpful in the early stages of recovery and with the use of mobility aids. CONCLUSION: Both interventions were acceptable but progressive exercise was highly valued by patients. Developing expertise through experiential learning enabled staff to facilitate progression. Adjustments to the workbook and the addition of exercises for continued recovery in the best practice advice would enhance a future study. Research during treatment provision may provide further insights into the challenges of facilitating progression of exercise. TRIAL REGISTRATION: ISRCTN16612336; AFTER-pilot trial).National Institute for Health Researc
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