Assessment of the quality of online patient information resources for patients considering parastomal hernia treatment.

AIM: The aim was to examine the quality of online patient information resources for patients considering parastomal hernia treatment. METHODS: A Google search was conducted using lay search terms for patient facing sources on parastomal hernia. The quality of the content was assessed using the validated DISCERN instrument. Readability of written content was established using the Flesch-Kincaid score. Sources were also assessed against the essential content and process standards from the National Institute for Health and Care Excellence (NICE) framework for shared decision making support tools. Content analysis was also undertaken to explore what the sources covered and to identify any commonalities across the content. RESULTS: Fourteen sources were identified and assessed using the identified tools. The mean Flesch-Kincaid reading ease score was 43.61, suggesting that the information was difficult to read. The overall quality of the identified sources was low based on the pooled analysis of the DISCERN and Flesch-Kincaid scores, and when assessed against the criteria in the NICE standards framework for shared decision making tools. Content analysis identified eight categories encompassing 59 codes, which highlighted considerable variation between sources. CONCLUSIONS: The current information available to patients considering parastomal hernia treatment is of low quality and often does not contain enough information on treatment options for patients to be able to make an informed decision about the best treatment for them. There is a need for high-quality information, ideally co-produced with patients, to provide patients with the necessary information to allow them to make informed decisions about their treatment options when faced with a symptomatic parastomal hernia.

Healthcare professionals' views on the most important outcomes for non-infectious uveitis of the posterior segment: A qualitative study.

BACKGROUND: Uveitis comprises a range of conditions that result in intraocular inflammation. Most sight-threatening uveitis falls into the broad category known as Non-infectious Posterior Segment-Involving Uveitis (PSIU). To evaluate treatments, trialists and clinicians must select outcome measures. The aim of this study was to understand healthcare professionals' perspectives on what outcomes are important to adult patients with PSIU and their carers. METHODS: Twelve semi-structured telephone interviews were undertaken to understand the perspectives of healthcare professionals. Interviews were audio recorded, transcribed and thematically analysed. Findings were compared with the views of patients and carers and outcomes abstracted from a previously published systematic review. RESULTS: Eleven core domains were identified as important to healthcare professionals: (1) visual function, (2) symptoms, (3) functional ability, (4) impact on relationships, (5) financial impact, (6) psychological morbidity and emotional well-being (7) psychosocial adjustment to uveitis, (8) doctor / patient / interprofessional relationships and access to health care, (9) treatment burden, (10) treatment side effects, (11) disease control. Healthcare professionals recognised a similar range of domains to patients and carers but placed more emphasis on certain outcomes, particularly in the disease control domain. In contrast the range of outcomes identified via the systematic review was limited. CONCLUSION: Healthcare professionals recognise all of the published outcome domains as patients/carers in the previous publication but with subtly differing emphasis within some domains and with a priority for certain types of measures. Healthcare professionals discussed the disease control and side effects/complications to a greater degree than patients and carers in the focus groups.

Focusing a realist evaluation of peer support for paediatric mental health.

OBJECTIVE: Mental health problems are a leading and increasing cause of health-related burden in children across the world. Peer support interventions are increasingly used to meet this need using the lived experience of people with a history of mental health problems. However, much of the research underpinning this work has focused on adults, leaving a gap in knowledge about how these complex interventions may work for different children in different circumstances. Realist research may help us to understand how such complex interventions may trigger different mechanisms to produce different outcomes in children. This paper reports on an important first step in realist research, namely the construction of an embryonic initial programme theory to help 'focus' realist evaluation exploring how children's peer support services work in different contexts to produce different outcomes in the West Midlands (UK). METHODS: A survey and preliminary semi-structured realist interviews were conducted with 10 people involved in the delivery of peer support services. Realist analysis was carried out to produce context-mechanism-outcome configurations (CMOC). RESULTS: Analysis produced an initial programme theory of peer support for children's mental health. This included 12 CMOCs. Important outcomes identified by peer support staff included hope, service engagement, wellbeing, resilience, and confidence; each generated by different mechanisms including contextualisation of psychoeducation, navigating barriers to accessing services, validation, skill development, therapeutic relationship, empowerment, and reducing stigma. CONCLUSION: These data lay the groundwork for designing youth mental health realist research to evaluate with nuance the complexities of what components of peer support work for whom in varying circumstances.

The Growth Hormone Deficiency (GHD) Reversal Trial: effect on final height of discontinuation versus continuation of growth hormone treatment in pubertal children with isolated GHD-a non-inferiority Randomised Controlled Trial (RCT).

BACKGROUND: Growth hormone deficiency (GHD) is the commonest endocrine cause of short stature and may occur in isolation (I-GHD) or combined with other pituitary hormone deficiencies. Around 500 children are diagnosed with GHD every year in the UK, of whom 75% have I-GHD. Growth hormone (GH) therapy improves growth in children with GHD, with the goal of achieving a normal final height (FH). GH therapy is given as daily injections until adult FH is reached. However, in many children with I-GHD their condition reverses, with a normal peak GH detected in 64-82% when re-tested at FH. Therefore, at some point between diagnosis and FH, I-GHD must have reversed, possibly due to increase in sex hormones during puberty. Despite increasing evidence for frequent I-GHD reversal, daily GH injections are traditionally continued until FH is achieved. METHODS/DESIGN: Evidence suggests that I-GHD children who re-test normal in early puberty reach a FH comparable to that of children without GHD. The GHD Reversal study will include 138 children from routine endocrine clinics in twelve UK and five Austrian centres with I-GHD (original peak GH < 6.7 mcg/L) whose deficiency has reversed on early re-testing. Children will be randomised to either continue or discontinue GH therapy. This phase III, international, multicentre, open-label, randomised controlled, non-inferiority trial (including an internal pilot study) will assess whether children with early I-GHD reversal who stop GH therapy achieve non-inferior near FH SDS (primary outcome; inferiority margin 0.55 SD), target height (TH) minus near FH, HRQoL, bone health index and lipid profiles (secondary outcomes) than those continuing GH. In addition, the study will assess cost-effectiveness of GH discontinuation in the early retesting scenario. DISCUSSION: If this study shows that a significant proportion of children with presumed I-GHD reversal generate enough GH naturally in puberty to achieve a near FH within the target range, then this new care pathway would rapidly improve national/international practice. An assumed 50% reversal rate would provide potential UK health service cost savings of £1.8-4.6 million (€2.05-5.24 million)/year in drug costs alone. This new care pathway would also prevent children from having unnecessary daily GH injections and consequent exposure to potential adverse effects. TRIAL REGISTRATION: EudraCT number: 2020-001006-39.

Peer support for carers and patients with inflammatory bowel disease: a systematic review.

BACKGROUND: The support provided by people with the same condition, including inflammatory bowel diseases (IBD), has the potential to improve a range of psychosocial outcomes by allowing people with the disease to receive emotional support as well as to learn coping strategies from more experienced peers. The aim of this systematic review was to summarise the evidence on peer support interventions and their effectiveness on people with IBD. METHODS: Bibliographic databases, conference proceedings, grey literature, and clinical trial registers were searched from inception to November 2021. Comparative and single-arm studies that evaluated interventions that were solely or contained in part peer support, for people with IBD and/or their carers of any age and in any setting were included. Effectiveness was evaluated using outcomes relating to physical and psychosocial function, disease control and healthcare utilisation. Data for each outcome were tabulated and presented in a narrative synthesis. Study design specific tools were used to assess risk of bias. Study selection and risk of bias assessment were undertaken by two reviewers independently. RESULTS: Fourteen completed studies and five ongoing studies met the inclusion criteria. Substantial heterogeneity was observed in the studies in relation to the intervention type and peer support was usually part of a wider intervention. All but one study analysed the total effect of the intervention, so it was not possible to fully isolate the effect of the peer support alone. The appropriateness of outcomes and outcome measurement tools for the assessment of effects was a further key issue. As such, overall, no significant evidence of beneficial effects of peer support interventions on quality of life and other psychosocial outcomes was found. CONCLUSIONS: New randomised controlled trials designed to isolate the effects of peer support are needed to evaluate the (net) effects of peer support only. Agreement on the outcomes to be targeted, and the choice of reliable and validated measurement tools for standalone peer support interventions would provide a focus for further intervention design and evaluation. SYSTEMATIC REVIEW REGISTRATION: The protocol was accepted in the international prospective register of systematic reviews (PROSPERO CRD42020168817).

Exploration of the uptake of asymptomatic COVID-19 lateral flow testing in Birmingham, UK: survey and qualitative research.

AIM: To examine public perspectives on lateral flow testing (LFT) for COVID-19. DESIGN: Online survey with nested semi-structured interviews. SETTING: Birmingham, UK. PARTICIPANTS: 220 Birmingham residents, 21 of whom took part in an interview. RESULTS: Fifty-six per cent of respondents had taken an LFT. Reasons for not testing included adherence to other government COVID-19 guidance, having had a vaccination and not thinking LFTs were accurate. In 16% of households with children nobody, including children, was testing. In households where children were testing, their parents or other adults were often not. Those who were testing and eligible for workplace and school testing were more likely to be testing twice weekly. In other settings, respondents were more likely to be testing on a one-off or ad hoc basis. Approximately half of respondents said that they were likely to visit friends and family after a negative test result and 10% that they were unlikely to self-isolate following a positive test result. In interviews, participants who were testing described the peace of mind that testing afforded them prior to activities or interactions with family and friends, including those they considered to be vulnerable. Interviewees who were not testing described concerns about test accuracy and also cited a lack of face-to-face interaction with others precluding the need to test. Participants were often testing flexibly according to circumstances and perceived risk of COVID-19 transmission. CONCLUSIONS: While some choose not to test, others are doing so in order to provide peace of mind to engage in personal interactions they might otherwise have avoided. This peace of mind may be a necessary pre-requisite for some to more fully re-engage in pre-pandemic activities. Despite clear concerns about test accuracy among those not testing, those who are testing held generally positive attitudes towards the continued use of LFTs.

Peer support for people with chronic conditions: a systematic review of reviews.

BACKGROUND: People with chronic conditions experience functional impairment, lower quality of life, and greater economic hardship and poverty. Social isolation and loneliness are common for people with chronic conditions, with multiple co-occurring chronic conditions predicting an increased risk of loneliness. Peer support is a socially driven intervention involving people with lived experience of a condition helping others to manage the same condition, potentially offering a sense of connectedness and purpose, and experiential knowledge to manage disease. However, it is unclear what outcomes are important to patients across the spectrum of chronic conditions, what works and for whom. The aims of this review were to (1) collate peer support intervention components, (2) collate the outcome domains used to evaluate peer support, (3) synthesise evidence of effectiveness, and (4) identify the mechanisms of effect, for people with chronic conditions. METHODS: A systematic review of reviews was conducted. Reviews were included if they reported on formal peer support between adults or children with one or more chronic condition. Data were analysed using narrative synthesis. RESULTS: The search identified 6222 unique publications. Thirty-one publications were eligible for inclusion. Components of peer support were organised into nine categories: social support, psychological support, practical support, empowerment, condition monitoring and treatment adherence, informational support, behavioural change, encouragement and motivation, and physical training. Fifty-five outcome domains were identified. Quality of life, and self-efficacy were the most measured outcome domains identified. Most reviews reported positive but non-significant effects. CONCLUSIONS: The effectiveness of peer support is unclear and there are inconsistencies in how peers are defined, a lack of clarity in research design and intervention reporting, and widely variable outcome measurement. This review presents a range of components of peer support interventions that may be of interest to clinicians developing new support programmes. However, it is unclear precisely what components to use and with whom. Therefore, implementation of support in different clinical settings may benefit from participatory action research so that services may reflect local need.

At home parent-administered dressing changes in paediatric burns aftercare: Interviews on parents' experiences of treatment.

OBJECTIVE: Paediatric burn injuries present physical and psychosocial effects for children and their parents, including disruption to family life. Some burns services in the UK enable parents to administer dressing changes at home to reduce the number of hospital visits. To date, there is no research on parents' experiences of administering dressing changes. The aim of this study was to describe parents' experiences of administering dressing changes in paediatric burns aftercare. METHODS: Semi-structured research interviews were conducted with a purposive sample of parents recruited from a paediatric burns centre in the UK. The interview addressed the initial offer of at-home dressing changes by clinicians; parental decision-making in relation to dressing changes; training and support received; and the experience of administering dressing changes, including practical and emotional considerations. Thematic analysis of the data was informed by the framework approach, including associative analysis using demographic and clinical characteristics. RESULTS: Seventeen participants were interviewed. Three themes of parents' experiences of administering dressing changes were identified including (1) Parental Identity concerning the newly undertaken responsibility and the impact on the parental role; (2) Challenges, physical or emotional, confronted or lessened by administering dressing changes; and (3) Reassurance provided by healthcare professionals and others to support parents to adopt and maintain parent-administered dressing changes. CONCLUSION: The qualitative data reported here indicates that parents want to be involved in their child's care by administering dressing changes at home, provided they receive sufficient reassurance that they are able to manage the severity of their child's burn. Parents' concerns about the effectiveness of their dressing changes lacks empirical basis, and this study provides preliminary data to support the development and evaluation of best practice guidance for parent-administered dressing changes in paediatric burns aftercare.

Establishment of a core outcome set for burn care research: development and international consensus.

Objective: To develop a core outcome set for international burn research. Design: Development and international consensus, from April 2017 to November 2019. Methods: Candidate outcomes were identified from systematic reviews and stakeholder interviews. Through a Delphi survey, international clinicians, researchers, and UK patients prioritised outcomes. Anonymised feedback aimed to achieve consensus. Pre-defined criteria for retaining outcomes were agreed. A consensus meeting with voting was held to finalise the core outcome set. Results: Data source examination identified 1021 unique outcomes grouped into 88 candidate outcomes. Stakeholders in round 1 of the survey, included 668 health professionals from 77 countries (18% from low or low middle income countries) and 126 UK patients or carers. After round 1, one outcome was discarded, and 13 new outcomes added. After round 2, 69 items were discarded, leaving 31 outcomes for the consensus meeting. Outcome merging and voting, in two rounds, with prespecified thresholds agreed seven core outcomes: death, specified complications, ability to do daily tasks, wound healing, neuropathic pain and itch, psychological wellbeing, and return to school or work. Conclusions: This core outcome set caters for global burn research, and future trials are recommended to include measures of these outcomes.

At home parent-administered dressing changes in paediatric burns aftercare: A survey of burns centres?" practice.

OBJECTIVE: Following paediatric burn injury, dressings are initially changed in outpatient clinics, necessitating regular visits with substantial burden for parents, children and services. This can potentially be lessened if some parents go on to administer dressing changes for their child at home. However, a lack of data regarding support for parent-administered dressing changes is present. The aim of this study was to describe current practice and views regarding at-home parent-administered dressing changes (PAD) in the UK. METHODS: An online survey was distributed to 20 paediatric burns services in England and Wales. The survey used fixed and free-text responses to collect data on whether PAD is offered and the reasons for this; patient and parent eligibility criteria; training and support; and respondents?" views on the advantages and disadvantages of PAD. Analysis comprised simple descriptive statistics and simple content analysis of free-text responses. RESULTS: Thirteen responses were received (response rate = 65%). Eleven respondents indicated their service offers PAD. Two respondents reported their service does not offer PAD due to alternative nurse outreach appointments (n = 1), and service resource limitations (n = 1), though another respondent indicated service cost savings. Twelve respondents regard PAD positively (n = 8) or very positively (n = 4). Most respondents reported that 10% or fewer parents refuse PAD when offered (n = 7). Perceived advantages of PAD included reduced travel burden (n = 9), patient better able to cope with dressing changes (n = 8), better school and work attendance for child and parent respectively (n = 6), and reduced financial impact on families (n = 4). No formal eligibility criteria for PAD are extant, though 5 respondents described informal criteria in place in their service, predominantly involving dressing frequency (n = 5), and size or complexity of wound (n = 4). CONCLUSION: The survey indicates that most paediatric burns services support PAD. However, the absence of formal eligibility criteria, and informal criteria open to interpretation, risks inequity of support received by children and their families. Further research should evaluate whether this inequity extends to variable clinical outcomes to determine what works for who and under what circumstances when supporting parents in paediatric burns aftercare.

Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT2R2 score-guided strategy in anticoagulant-naïve Thai patients with atrial fibrillation (TREATS-AF): a study protocol.

INTRODUCTION: The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TT2R2 score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF. METHODS AND ANALYSIS: Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TT2R2 score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients' knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention. ETHICS AND DISSEMINATION: The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication. TRIAL REGISTRATION NUMBER: TCTR20180711003.

Exploring patients' perceptions and experiences of treatments for the prevention of variceal bleeding: a qualitative study.

BACKGROUND: The most common fatal complication of liver cirrhosis is haemorrhaging caused by variceal rupture. The prevention of the first variceal bleed is, therefore, an important clinical goal. Little is known about patients' experience of treatments geared towards this, or of their perceptions of treatments prior to being exposed to them. AIMS: To explore the factors impacting patient preference for, and actual experience of carvedilol and variceal band ligation. METHODS: Semistructured interviews were conducted with 30 patients from across the UK at baseline, prior to random allocation to either carvedilol or variceal band ligation. Twenty patients were interviewed a second time at 6-month follow-up. Five patients who declined the trial were also interviewed. Data were analysed using thematic analysis. RESULTS: There was no clear preference for either treatment pathway at baseline. Key factors reported by patients to influence their treatment preference included: negative experiences with key treatment processes; how long-term or short-term treatment was perceived to be; treatment misconceptions; concerns around polypharmacy and worries around treatment adherence. Patient treatment experience was influenced by their perceptions of treatment effectiveness; clinical surveillance; clinician interaction and communication, or lack thereof. Carvedilol-specific experience was also influenced by the manifestation of side effects and patient dosage routine. Variceal band ligation-specific experience was positively influenced by the use of sedation, and negatively influenced by the procedure recovery period. CONCLUSIONS: These data do not support a view that the patient experience of beta-blockade for prevention of variceal bleeds is likely to be superior to variceal band ligation.

Patient experience of scar assessment and the use of scar assessment tools during burns rehabilitation: a qualitative study.

BACKGROUND: Scar assessment plays a key role during burns aftercare, to monitor scar remodelling and patients' psychosocial well-being. To aid assessment, subjective scar assessment scales are available that use health-care professionals' and patients' opinions to score scar characteristics. The subjective scales are more widely used in clinical practice over objective scar measures. To date, there is no research that considers patients' views on scar assessment and the role of subjective and objective assessment tools. Therefore, the aim of this qualitative study was to explore patients' perspectives on scar assessment and the utility of scar assessment tools during burns rehabilitation. METHODS: Semi-structured interviews were conducted with 10 adult burn patients who were being reviewed in clinic for scarring. Participants were recruited via their clinical care team and research nurses at the Queen Elizabeth Hospital, Birmingham, UK. Topics covered during interview included patient experience of scar assessment, the use of scar assessment tools and discussion surrounding important factors to be addressed when assessing scars. A thematic analysis using the Framework Method was conducted. RESULTS: Participants identified key subthemes that contribute towards the overarching theme of patient-centred scar assessment. These are: patient-led care; continuity in care; learning how to self-manage scarring; and psychological assessment. Links were demonstrated between these subthemes and the remaining themes that describe scar assessment strategies, indicating their potential patient-centred contributions. The subjective opinions of clinicians were found to be valued above the use of subjective or objective scar assessment tools. Scar assessment scales were perceived to be a beneficial method for self-reflection in relation to psychosocial functioning. However, minimal feedback and review of completed assessment scales led to uncertainty regarding their purpose. Patients perceived objective tools to be of primary use for health-care professionals, though the measures may aid patients' understanding of scar properties. CONCLUSIONS: Scar assessment tools should be used to support, rather than replace, health-care professionals' subjective judgements of scarring. Adapting the way in which clinicians introduce and use scar assessment tools, according to patient needs, can support a patient-centred approach to scar assessment.

Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment.

PURPOSE: To develop an agreed upon set of outcomes known as a "core outcome set" (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials. DESIGN: Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting. PARTICIPANTS: Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners. METHODS: A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of "include," "exclude," or "for discussion" that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS. MAIN OUTCOME MEASURE: Items recommended for inclusion in the COS for NIU-PS. RESULTS: A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control. CONCLUSIONS: This study builds on international work across the clinical trials community and our qualitative research to construct the world's first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development.

Ensuring that the outcome domains proposed for use in burns research are relevant to adult burn patients: a systematic review of qualitative research evidence.

BACKGROUND: There have been several attempts to define core outcome domains for use in research focused on adult burns. Some have been based in expert opinion, whilst others have used primary qualitative research to understand patients' perspectives on outcomes. To date there has not been a systematic review of qualitative research in burns to identify a comprehensive list of patient-centred outcome domains. We therefore conducted a systematic review of qualitative research studies in adult burns. METHODS: We searched multiple databases for English-language, peer-reviewed, qualitative research papers. We used search strategies devised using the SPIDER tool for qualitative synthesis. Our review utilized an iterative three-step approach: (1) outcome-focused coding; (2) development of descriptive accounts of outcome-relevant issues; and (3) revisiting studies and the broader theoretical literature in order to frame the review findings. RESULTS: Forty-one articles were included. We categorized papers according to their primary focus. The category with the most papers was adaptation to life following burn injury (n = 13). We defined 19 outcome domains across the 41 articles: (1) sense of self; (2) emotional and psychological morbidity; (3) sensory; (4) scarring and scar characteristics; (5) impact on relationships; (6) mobility and range of joint motion; (7) work; (8) activities of daily living and self-care; (9) treatment burden; (10) engagement in activities; (11) wound healing and infection; (12) other physical manifestations; (13) financial impact; (14) impact on spouses and family members; (15) analgesia and side effects; (16) cognitive skills; (17) length of hospital stay; (18) access to healthcare; and (19) speech and communication. We suggest that sense of self is a core concern for patients that, to date, has not been clearly conceptualized in the burns outcome domain literature. CONCLUSIONS: This outcome domain framework identifies domains that are not covered in previous attempts to outline core outcome domains for adult burn research. It does so with reference to existing theoretical perspectives from the sociology and psychology of medicine. We propose that this framework can be used as a basis to ensure that outcome assessment is patient-centred. Sense of self requires further consideration as a core outcome domain.

Development of a core outcome set for use in community-based bipolar trials-A qualitative study and modified Delphi.

BACKGROUND: A core outcome set (COS) is a standardised collection of outcomes to be collected and reported in all trials within a research area. A COS can reduce reporting bias and facilitate evidence synthesis. This is currently unavailable for use in community-based bipolar trials. This research aimed to develop such a COS, with input from a full range of stakeholders. METHODS: A co-production approach was used throughout. A longlist of outcomes was derived from focus groups with people with a bipolar diagnosis and carers, interviews with healthcare professionals and a rapid review of outcomes listed in bipolar trials on the Cochrane database. An expert panel with personal and/or professional experience of bipolar participated in a modified Delphi process and the COS was finalised at a consensus meeting. RESULTS: Fifty participants rated the importance of each outcome. Sixty-six outcomes were included in Round 1 of the questionnaire; 13 outcomes were added by Round 1 participants and were rated in Round 2. Seventy-six percent of participants (n = 38) returned to Round 2 and 60 outcomes, including 4 outcomes added by participants in Round 1, received a rating of 7-9 by >70% and 1-3 by <25% of the sample. Fourteen participants finalised a COS containing 11 outcomes at the consensus meeting: personal recovery; connectedness; clinical recovery of bipolar symptoms; mental health and wellbeing; physical health; self-monitoring and management; medication effects; quality of life; service outcomes; experience of care; and use of coercion. CONCLUSIONS: This COS is recommended for use in community-based bipolar trials to ensure stakeholder-relevant outcomes, facilitate data synthesis, and transparent reporting. The COS includes guidance notes for each outcome to allow the identification of suitable measurement instruments. Further validation is recommended for use with a wide range of communities and to achieve standardised measurement.

Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study.

OBJECTIVE: Uveitis, a group of disorders characterised by intraocular inflammation, causes 10%-15% of total blindness in the developed world. The most sight-threatening forms of non-infectious uveitis are those affecting the posterior segment of the eye, collectively known as posterior segment-involving uveitis (PSIU). Numerous different clinical outcomes have been used in trials evaluating treatments for PSIU, but these may not represent patients' and carers' concerns. Therefore, the aims of this study were to understand the impact of PSIU on adult patients' and carers' lives and to explore what outcomes of treatment are important to them. METHODS AND ANALYSIS: Four focus group discussions were undertaken to understand the perspectives of adult patients (=18) and carers (10) with PSIU. Participants were grouped according to whether or not their uveitis was complicated by the sight-threatening condition uveitic macular oedema. Discussions were audio-recorded, transcribed and analysed using the framework analytical approach. Outcomes were identified and grouped into outcome domains. RESULTS: Eleven core domains were identified as important to patients and carers undergoing treatment for PSIU, comprising (1) visual function, (2) symptoms, (3) functional ability, (4) impact on relationships, (5) financial impact, (6) psychological morbidity and emotional well-being, (7) psychosocial adjustment to uveitis, (8) doctor/patient/interprofessional relationships and access to healthcare, (9) treatment burden, (10) treatment side effects, and (11) disease control. CONCLUSION: The domains identified represent patients' and carers' experience and perspectives and can be used to reflect on outcomes assessed in PSIU. They will directly inform the development of a core outcome set for PSIU clinical trials.

STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis.

INTRODUCTION: Imbalance of the gut microbiome is key to the pathogenesis of ulcerative colitis (UC). Faecal microbiota transplant (FMT) is the transfer of homogenised and filtered faeces from a healthy individual to the gastrointestinal tract of a patient with disease. Published datasets show a positive signal for the use of FMT to treat UC, but the optimal route and dose of FMT remain unanswered. METHODS AND ANALYSIS: This prospective, multi-centre open-label, randomised pilot study will assess two possible routes of FMT delivery, via the nasogastric (NG) route or by delivery to the COLON, in 30 patients with active UC recruited from three sites in the UK. Stool will be collected from healthy screened donors, processed, frozen and stored under a Medicines and Healthcare products Regulatory Agency (MHRA) "specials" manufacturing licence held at the University of Birmingham Microbiome Treatment Centre. Thawed FMT samples will be administered to patients either via eight nasogastric infusions given initially over 4 days starting on the day of randomisation, and then again for 4 days in week 4 for foregut delivery (total of 240 g of stool) or via one colonoscopic infusion followed by seven weekly enemas according to the hindgut protocol (total of 360 g of stool). Patients will be followed up weekly for 8 weeks, and then at 12 weeks. The aims of this pilot study are (1) to determine which FMT administration route (NG or COLON) should be investigated in a randomised double-blind, placebo-controlled trial and (2) to determine if a full randomised controlled trial is feasible. The primary outcome will be a composite assessment of both qualitative and quantitative data based on efficacy (clinical response), acceptability and safety. At the end of the pilot study, decisions will be made regarding the feasibility of a full randomised double-blind, placebo-controlled trial and, if deemed feasible, which route of administration should be used in such a study. ETHICS AND DISSEMINATION: Ethical approval for this study has been obtained from the East Midlands-Nottingham Research Ethics Committee (REC 17/EM/0274). At the end of the study, findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN74072945.

Dressing use issues in primary abdominal wounds: a qualitative study of health staff and patient views.

Primary surgical abdominal wounds are usually covered with a dressing. However, little is known about the practical issues and costs around these dressings. This study aimed to provide an in-depth description of patients' and health professionals' perspectives on the clinical and practical issues associated with standard and novel dressing (glue-as-a-dressing) use on primary surgical wounds, and to establish whether and how their experience compares with these perspectives. During semi-structured interviews, patients and health professionals discussed their positive experience of glue-as-a-dressing and no dressing around six themes: wound contamination and infection, wound healing, wound care, physical protection afforded by simple dressings, the potential psychological impact of an exposed wound, and ability to carry out everyday tasks. Current views on the practice of dressings for primary abdominal wounds are influenced by ingrained clinical practice. These views can be challenged when exposed to novel dressing strategies or as new evidence of the clinical effect of dressing strategies emerges.

Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.

BACKGROUND: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. OBJECTIVE: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. DESIGN: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. SETTING: Usual NHS care. PARTICIPANTS: Patients undergoing elective/non-elective abdominal surgery, including caesarean section. INTERVENTIONS: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'. MAIN OUTCOME MEASURES: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. DATA SOURCES: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals. RESULTS: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. LIMITATIONS: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. CONCLUSIONS: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks. TRIAL REGISTRATION: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.