A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults.

AIMS: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. METHODS: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods. DISCUSSION: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open 2021;2(3):150-163.

The Evidence-Based Development of an Intervention to Improve Clinical Health Literacy Practice.

Low health literacy is an issue with high prevalence in the UK and internationally. It has a social gradient with higher prevalence in lower social groups and is linked with higher rates of long-term health conditions, lower self-rated health, and greater difficulty self-managing long-term health conditions. Improved medical services and practitioner awareness of a patient's health literacy can help to address these issues. An intervention was developed to improve General Practitioner and Practice Nurse health literacy skills and practice. A feasibility study was undertaken to examine and improve the elements of the intervention. The intervention had two parts: educating primary care doctors and nurses about identifying and enhancing health literacy (patient capacity to get hold of, understand and apply information for health) to improve their health literacy practice, and implementation of on-screen 'pop-up' notifications that alerted General Practitioners (GPs) and nurses when seeing a patient at risk of low health literacy. Rapid reviews of the literature were undertaken to optimise the intervention. Four General Practices were recruited, and the intervention was then applied to doctors and nurses through training followed by alerts via the practice clinical IT system. After the intervention, focus groups were held with participating practitioners and a patient and carer group to further develop the intervention. The rapid literature reviews identified (i) key elements for effectiveness of doctors and nurse training including multi-component training, role-play, learner reflection, and identification of barriers to changing practice and (ii) key elements for effectiveness of alerts on clinical computer systems including 'stand-alone' notification, automatically generated and prominent display of advice, linkage with practitioner education, and use of notifications within a targeted environment. The findings from the post-hoc focus groups indicated that practitioner awareness and skills had improved as a result of the training and that the clinical alerts reminded them to incorporate this into their clinical practice. Suggested improvements to the training included more information on health literacy and how the clinical alerts were generated, and more practical role playing including initiating discussions on health literacy with patients. It was suggested that the wording of the clinical alert be improved to emphasise its purpose in improving practitioner skills. The feasibility study improved the intervention, increasing its potential usefulness and acceptability in clinical practice. Future studies will explore the impact on clinical care through a pilot and a randomised controlled trial.

Cognitive stimulation therapy in dementia care: exploring the views and experiences of service providers on the barriers and facilitators to implementation in practice using Normalization Process Theory.

BACKGROUND: Cognitive stimulation therapy (CST) is an evidence-based, cost-effective psychosocial intervention for people with dementia but is currently not a standard part of post-diagnostic care. This qualitative study explored the views and experiences of dementia care providers on the barriers and facilitators to its implementation in usual care. METHOD: Thirty four semi-structured interviews (24 participants) were conducted across four dementia care sites in the North of England; ten were follow-up interviews. Data were analyzed using thematic analysis and then mapped to the Normalization Process Theory framework. RESULTS: Participants considered CST a "good fit" with their "preferred" ways of working and goals of dementia care namely the provision of person-centered services. For facilitators delivering the intervention, compared to other behavioral interventions, CST was seen to offer benefits to their work and was easy to understand as an intervention. Training in CST and seeing benefits for clients were important motivators. Time and resources were crucial for the successful implementation of CST. Participants were keen to objectively measure benefits to participants but unsure how to do this. CONCLUSIONS: CST is a cost-effective psychosocial intervention for people with dementia, recommended by national guidance. Despite our findings which show that, using the NPT framework, there are more facilitators than barriers to the implementation of CST, it is still not a standard part of post-diagnostic dementia care. Further research is needed to explore the reasons for this implementation gap in ensuring evidence-based care in translated into practice.

A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers.

BACKGROUND: Tools to support clinical or patient decision-making in the treatment/management of a health condition are used in a range of clinical settings for numerous preference-sensitive healthcare decisions. Their impact in clinical practice is largely dependent on their quality across a range of domains. We critically analysed currently available tools to support decision making or patient understanding in the treatment of acute ischaemic stroke with intravenous thrombolysis, as an exemplar to provide clinicians/researchers with practical guidance on development, evaluation and implementation of such tools for other preference-sensitive treatment options/decisions in different clinical contexts. METHODS: Tools were identified from bibliographic databases, Internet searches and a survey of UK and North American stroke networks. Two reviewers critically analysed tools to establish: information on benefits/risks of thrombolysis included in tools, and the methods used to convey probabilistic information (verbal descriptors, numerical and graphical); adherence to guidance on presenting outcome probabilities (IPDASi probabilities items) and information content (Picker Institute Checklist); readability (Fog Index); and the extent that tools had comprehensive development processes. RESULTS: Nine tools of 26 identified included information on a full range of benefits/risks of thrombolysis. Verbal descriptors, frequencies and percentages were used to convey probabilistic information in 20, 19 and 18 tools respectively, whilst nine used graphical methods. Shortcomings in presentation of outcome probabilities (e.g. omitting outcomes without treatment) were identified. Patient information tools had an aggregate median Fog index score of 10. None of the tools had comprehensive development processes. CONCLUSIONS: Tools to support decision making or patient understanding in the treatment of acute stroke with thrombolysis have been sub-optimally developed. Development of tools should utilise mixed methods and strategies to meaningfully involve clinicians, patients and their relatives in an iterative design process; include evidence-based methods to augment interpretability of textual and probabilistic information (e.g. graphical displays showing natural frequencies) on the full range of outcome states associated with available options; and address patients with different levels of health literacy. Implementation of tools will be enhanced when mechanisms are in place to periodically assess the relevance of tools and where necessary, update the mode of delivery, form and information content.

Clinical research without consent in adults in the emergency setting: a review of patient and public views.

BACKGROUND: In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. METHODS: Seven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded. RESULTS: Considering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did not agree generally with RWC, though paradoxically, a higher percentage would personally take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol. CONCLUSION: There are too few data to evaluate whether the rules and regulations permitting RWC protects - or is acceptable to - the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.

A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial.

OBJECTIVE: To determine the efficacy of a computerised decision aid in patients with atrial fibrillation making decisions on whether to take warfarin or aspirin therapy. DESIGN: Two-armed open exploratory randomised controlled trial. SETTING: Two research clinics deriving participants from general practices in Northeast England. PARTICIPANTS: 109 patients with atrial fibrillation aged over 60. INTERVENTIONS: Computerised decision aid applied in shared decision-making clinic compared to evidence-based paper guidelines applied as direct advice. MAIN OUTCOME MEASURES: Primary outcome measure was the decision conflict scale. Secondary outcome measures included anxiety, knowledge, decision-making preference, treatment decision, use of primary and secondary care services and health outcomes. RESULTS: Decision conflict was lower in the computerised decision aid group immediately after the clinic; mean difference -0.18 (95% CI -0.34 to -0.01). Participants in this group not already on warfarin were much less likely to start warfarin than those in the guidelines arm (4/16, 25% compared to the guidelines group 15/16, 93.8%, RR 0.27, 95% CI 0.11 to 0.63). CONCLUSIONS: Decision conflict was lower immediately following the use of a computerised decision aid in a shared decision-making consultation than immediately following direct doctor-led advice based on paper guidelines. Furthermore, participants in the computerised decision aid group were significantly much less likely to start warfarin than those in the guidelines arm. The results show that such an approach has a positive impact on decision conflict comparable to other studies of decision aids, but also reduces the uptake of a clinically effective treatment that may have important implications for health outcomes.

'I just keep thinking I haven't got it because I'm not yellow': a qualitative study of the factors that influence the uptake of Hepatitis C testing by prisoners.

BACKGROUND: Hepatitis C viral (HCV) infection is a significant public health problem. In the UK, an estimated 200,000 individuals have active HCV infection, most of whom are injecting drug users (IDUs). Many IDUs spend time within the prison system therefore screening for HCV infection in this setting is important. However, uptake of testing within prisons is very low. METHODS: Qualitative interview study. 30 interviews with 25 male and 5 female prisoners with a history of injecting drug use. RESULTS: Personal and institutional barriers to uptake of testing for HCV were identified. Personal barriers included: prisoners' fears and lack of knowledge about HCV, low motivation for testing, lack of awareness about the testing procedure, and concerns about confidentiality and stigma. Institutional barriers included: the prisons' applications procedure for testing, inadequate pre- and post-test discussion, lack of pro-active approaches to offering testing, and lack of continuity of care on discharge and transfer. CONCLUSION: This study highlights potential areas of development in the management of HCV in prisons. Further research is needed to evaluate care pathways for HCV in the prison setting and to develop and assess interventions to improve the uptake of testing for HCV by prisoners.