Rhodium catalysed intermolecular chelation controlled hydroacylation

EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance

Background Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. Methods The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)—GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Results Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Conclusions Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of any community-based complex intervention is paramount. The appropriateness and viability of inclusion criteria also require careful consideration as does use of a targeted advertising strategy

Offloading devices for the prevention of heel pressure ulcers: a realist evaluation

Background Heel pressure ulcers can cause pain, reduce mobility, lead to longer hospital stays and in severe cases can lead to sepsis, amputation, and death. Offloading boots are marketed as heel pressure ulcer prevention devices, working by removing pressure to the heel, yet there is little good quality evidence about their clinical effectiveness. Given that evidence is not guiding use of these devices, this study aims to explore, how, when, and why these devices are used in hospital settings. Objective To explore how offloading devices are used to prevent heel pressure ulcers, for whom and in what circumstances. Methods A realist evaluation was undertaken to explore the contexts, mechanisms, and outcomes that might influence how offloading devices are implemented and used in clinical practice for the prevention of heel pressure ulcers in hospitals. Eight Tissue Viability Nurse Specialists from across the UK (England, Wales, and Northern Ireland) were interviewed. Questions sought to elicit whether, and in what ways, initial theories about the use of heel pressure ulcers fitted with interviewee's experiences. Results Thirteen initial theories were refined into three programme theories about how offloading devices are used by nurses ‘proactively’ to prevent heel pressure ulcers, ‘reactively’ to treat and minimise deterioration of early-stage pressure ulcers, and patient factors that influence how these devices are used. Conclusions Offloading devices were used in clinical practice by all the interviewees. It was viewed that they were not suitable to be used by every patient, at every point in their inpatient journey, nor was it financially viable. However, the interviewees thought that identifying suitable ‘at risk’ patient groups that can maintain use of the devices could lead to proactive and cost-effective use of the devices. This understanding of the contexts and mechanisms that influence the effective use of offloading devices has implications for clinical practice and design of clinical trials of offloading devices. Tweetable abstract How, for whom, and in what circumstances do offloading devices work to prevent heel pressure ulcers? Tissue viability nurses' perspectives

Process evaluation in intellectual disability research: A case study and the need for adaptation of frameworks

Background: Involving adults with cognitive impairments, and specifically intellectual disability, in research is critical to developing appropriate and effective interventions but is highly challenging. Our aim was to examine where complexities lie in delivering research in underrepresented and hard to reach populations using an exemplar process evaluation conducted as part of a drug reduction trial. Methods: Quantitative methods were used to assess recruitment, adherence to the intervention and safety data. Qualitative interviews examined non-efficacy based barriers to drug reduction in clinical practice. Results: Feasibility of carrying out a drug reduction trial was limited by a lack of exploration of acceptability. Barriers to successful delivery included concerns around wider care team co-operation and consent procedures. Conclusions: It is important to consider interventions involving adults with cognitive impairment, and particularly intellectual disability, as complex. Current process evaluation frameworks require further adaptation to guide research and innovation in these populations

Development of a quality of life questionnaire for patients with pancreatic neuroendocrine tumours (the PANNET module)

Gastrinoma; Insulinoma; Pancreatic neuroendocrine tumourGastrinoma; Insulinoma; Tumor neuroendocrino pancreáticoGastrinoma; Insulinoma; Tumor neuroendocrí pancreàticPancreatic neuroendocrine tumours (panNET) are heterogeneous neoplasms usually characterised by slow growth and secretion of hormones, which often cause symptoms. The effect of these symptoms on quality of life (QoL) has not previously been examined in detail. EORTC (European Organisation for Research and Treatment of Cancer) guidelines were followed in phases 1–3 to produce a potential module of questions usable for trials in panNET, focusing on three common types of panNET. For two less common types, a list of symptoms was constructed. Following an extensive literature search and phase 1a interviews with patients and healthcare workers, a long list of potential issues (169) was obtained. This list was shown to 12 patients from three countries in phase 1b interviews to check that no items were missed. The list was reduced to 57 issues. The list of issues was converted to questions, mainly from existing validated questions within the EORTC item library. The list of questions was then used in a phase 3 international study in eight countries using seven languages. A provisional module of 24 items is presented for use in nonfunctioning panNET, gastrinoma and insulinoma. This module increases knowledge concerning QoL in this condition and may be a useful adjunct in clinical trials. A phase 4 trial is being considered for validation of this questionnaire

Who’s challenging who? : a co-produced approach for training staff in learning disability services about challenging behaviour

Purpose The purpose of this paper is to outline the development, piloting and evaluation of the Who’s Challenging Who? (WCW) training intervention for social care staff to improve their empathy and attitudes towards people with learning disabilities (LD) and challenging behaviour (CB). Design/methodology/approach A phased approach was taken to the development and testing of the intervention. Initially, the existing literature was reviewed, the theoretical background of the intervention was developed, and then the intervention was designed. A pilot study was undertaken, followed by further development, and a large-scale randomised controlled trial (RCT). Findings WCW had a small positive effect on staff empathy 20 weeks after the intervention, and small to moderate effects for other staff reported outcomes (e.g. positive empowerment attitudes and positive work motivation). Being trained by people with LD and CB encouraged staff to reflect on the impact they have on the people they support. The trainers with LD valued their role, and saw benefits beyond this (e.g. friendships). Research limitations/implications It is possible to carry out high-quality RCT evaluations of social care practice, and research should continue to generate evidence in this way, as in healthcare settings. However, there were difficulties in retaining participants. Practical implications People with LD can be actively involved in the co-production and delivery of social care training. Social implications Employment and a fair wage can increase the confidence and empowerment of people with LD. Originality/value This is the first large-scale RCT of an intervention that aimed to improve empathy/change attitudes in social care staff who work with people with LD and CB

Current practices in clinical neurofeedback with functional MRI—Analysis of a survey using the TIDieR checklist

Background: A core principle of creating a scientific evidence base is that results can be replicated in independent experiments and in health intervention research. The TIDieR (Template for Intervention Description and Replication) checklist has been developed to aid in summarising key items needed when reporting clinical trials and other well designed evaluations of complex interventions in order that findings can be replicated or built on reliably. Neurofeedback (NF) using functional MRI (fMRI) is a multicomponent intervention that should be considered a complex intervention. The TIDieR checklist (with minor modification to increase applicability in this context) was distributed to NF researchers as a survey of current practice in the design and conduct of clinical studies. The aim was to document practice and convergence between research groups, highlighting areas for discussion and providing a basis for recommendations for harmonisation and standardisation. Methods: The TIDieR checklist was interpreted and expanded (21 questions) to make it applicable to neurofeedback research studies. Using the web-based Bristol Online Survey (BOS) tool, the revised checklist was disseminated to researchers in the BRAINTRAIN European research collaborative network (supported by the European Commission) and others in the fMRI-neurofeedback community. Results: There were 16 responses to the survey. Responses were reported under eight main headings which covered the six domains of the TIDieR checklist: What, Why, When, How, Where and Who. Conclusions: This piece of work provides encouraging insight into the ability to be able to map neuroimaging interventions to a structured framework for reporting purposes. Regardless of the considerable variability of design components, all studies could be described in standard terms of diagnostic groups, dose/duration, targeted areas/signals, and psychological strategies and learning models. Recommendations are made which include providing detailed rationale of intervention design in study protocols. Keywords: Psychiatric disorder; Neuroimaging; fMRI