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 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

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 patients’ 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 Manen’s framework for thematic analysis. Findings Making sense of their experiences in ICU appeared to be fundamental to story construction. Themes that arose were: “Why am I here?”, “Filling in the gaps”, “Sorting the real from the unreal” and “Searching for familiarity”. 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 patients’ 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 families’ 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

Patients’ experiences of technology and care in adult intensive care

Aims To investigate patients’ 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 patients’ 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 Manen’s framework. Findings Participants described technology and care as inseparable and presented their experiences as a unified encounter. The theme ‘Getting on with it’ described how participants endured technology by ‘Being Good’ and ‘Being Invisible’. ‘Getting over it’ described why participants endured technology by ‘Bowing to Authority’ and viewing invasive technologies as a ‘Necessary Evil’. 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

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 12 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 patients’ 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 12 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 12 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 1 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 Midlands—Coventry & 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

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 (n = 226) 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 (n = 234). 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 −0.59 [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 patients’ 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, −3.9 [95% CI, −8.9 to 1.2]; P = .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, −4.2% to 6.3%]; P = .64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, −0.05 to 0.08]; Short Form–12 Physical Component Score, 0.5 [95% CI, −3.1 to 4.1] and Mental Health Component Score, −0.4 [95% CI, −2.2 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

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 6 month 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

Protecting my injured child: a qualitative study of parents' experience of caring for a child with a displaced distal radius fracture

BACKGROUND: Childhood fractures can have a significant impact on the daily lives of families affecting children’s normal activities and parent’s work. Wrist fractures are the most common childhood fracture. The more serious wrist fractures, that can look visibly bent, are often treated with surgery to realign the bones; but this may not be necessary as bent bones straighten in growing children. The children’s radius acute fracture fixation trial (CRAFFT) is a multicentre randomised trial of surgery versus a cast without surgery for displaced wrist fractures. Little is known about how families experience these wrist fractures and how they manage treatment uncertainty. This study aimed to understand families’ experience of this injury and what it is like to be asked to include their child in a clinical trial. METHODS: Nineteen families (13 mothers, 7 fathers, 2 children) from across the UK participated in telephone interviews. Interviews were audio recorded, transcribed and analysed using reflexive thematic analysis. RESULTS: Our findings highlight parents’ desire to be a good parent through the overarching theme “protecting my injured child”. To protect their child after injury, parents endeavoured to make the right decisions about treatment and provide comfort to their child but they experienced ongoing worry about their child’s recovery. Our findings show that parents felt responsible for the decision about their child’s treatment and their child’s recovery. They also reveal the extent to which parents worried about the look of their child’s wrist and their need for reassurance that the wrist was healing. CONCLUSION: Our findings show that protecting their child after injury can be challenging for parents who need support to make decisions about treatment and confidently facilitate their child’s recovery. They also highlight the importance of providing information about treatments, acknowledging parents’ concerns and their desire to do the right thing for their child, reassuring parents that their child’s wrist will heal and ensuring parents understand what to expect as their child recovers

Have we seen the geneticisation of society? Expectations and evidence

Abby Lippman’s geneticization thesis, of the early 1990s, argued and anticipated that with the rise of genetics, increasing areas of social and health related activities would come to be understood and defined in genetic terms leading to major changes in society, medicine and health care. We review the considerable literature on geneticization and consider how the concept stands both theoretically and empirically across scientific, clinical, popular and lay discourse and practice. Social science scholarship indicates that relatively little of the original claim of the geneticization thesis has been realised, highlighting the development of more complex and dynamic accounts of disease in scientific discourse and the complexity of relationships between bioscientific, clinical and lay understandings. This scholarship represents a shift in social science understandings of the processes of sociotechnical change, which have moved from rather simplistic linear models to an appreciation of disease categories as multiply understood. Despite these shifts, we argue that a genetic imaginary persists, which plays a performative role in driving investments in new gene-based developments. Understanding the enduring power of this genetic imaginary and its consequences remains a key task for the social sciences, one which treats ongoing genetic expectations and predictions in a sceptical yet open way

The ethics of uncertainty for data subjects

Modern health data practices come with many practical uncertainties. In this paper, I argue that data subjects’ trust in the institutions and organizations that control their data, and their ability to know their own moral obligations in relation to their data, are undermined by significant uncertainties regarding the what, how, and who of mass data collection and analysis. I conclude by considering how proposals for managing situations of high uncertainty might be applied to this problem. These emphasize increasing organizational flexibility, knowledge, and capacity, and reducing hazard