Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial

Background: Functional Strength Training (FST) could enhance recovery late after stroke. The aim of this study was to evaluate the feasibility of a subsequent fully powered, randomized controlled trial. Methods: The study was designed as a randomized, observer-blind trial. Both interventions were provided for up to one hour a day, four days a week, for six weeks. Evaluation points were before randomization (baseline), after six weeks intervention (outcome), and six weeks thereafter (follow-up). The study took place in participants’ own homes. Participants (n = 52) were a mean of 24.4 months after stroke with a mean age of 68.3 years with 67.3% male. All had difficulty using their paretic upper (UL) and lower limb (LL). Participants were allocated to FST-UL or FST-LL by an independent randomization service. The outcome measures were recruitment rate, attrition rate, practicality of recruitment strategies, occurrence of adverse reactions, acceptability of FST, and estimation of sample size for a subsequent trial. Primary clinical efficacy outcomes were the Action Research Arm Test (ARAT) and the Functional Ambulation Categories (FAC). Analysis was conducted using descriptive statistics and thematic analysis of participants’ views of FST. A power calculation used estimates of clinical efficacy variance to estimate sample size for a subsequent trial. Results: The screening process identified 1,127 stroke survivors of whom 52 (4.6%) were recruited. The recruitment rate was higher for referral from community therapists than for systematic identification of people discharged from an acute stroke unit. The attrition rate was 15.5% at the outcome and follow-up time-points. None of the participants experienced an adverse reaction. The participants who remained in the study at outcome had received 68% of the total possible amount of therapy. Participants reported that their experience of FST provided a sense of purpose and involvement and increased their confidence in performing activities. The power calculation provides estimation that 150 participants in each group will be required for a subsequent clinical trial. Conclusions: This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used

Teaching in Focus: The value of implementing a program-specific teaching support project for staff wellbeing and student success

This work is licensed under a Creative Commons Attribution 4.0 Licence. As an open access journal, articles are free to use, with proper attribution, in educational and other non-commercial settings.This paper reports on a program-level teaching support initiative that was implemented in a Health Sciences undergraduate degree with a large and highly casualised teaching team. It has been argued that to improve student retention and success, universities need to consider implementing comprehensive teaching support models that address institutional, program, and individual level needs. We report on the implementation of our project and reflect on participant feedback, which demonstrated the value of the program for improving staff wellbeing. We argue that introducing support strategies for staff at a local level is essential not only for delivery of high quality learning experiences, but also for staff wellbeing which, in turn, has important implications for student success and retention

Consensus Decision Models for Biologics in Rheumatoid and Psoriatic Arthritis: Recommendations of a Multidisciplinary Working Party.

INTRODUCTION: Biologic therapies are efficacious but costly. A number of health economic models have been developed to determine the most cost-effective way of using them in the treatment pathway. These models have produced conflicting results, driven by differences in assumptions, model structure, and data, which undermine the credibility of funding decisions based on modeling studies. A Consensus Working Party met to discuss recommendations and approaches for future models of biologic therapies. METHODS: Our working party consisted of clinical specialists, modelers, and policy makers. Two 1-day meetings were held for members to arrive at consensus positions on model structure, assumptions, and appropriate data sources. These views were guided by clinical aspects of rheumatoid and psoriatic arthritis and the principles of evidence-based medicine. Where opinions differed, we sought to identify a research agenda that would generate the evidence needed to reach consensus. RESULTS: We gained consensus in four areas of model development: initial response to treatment; long-term disease progression; lifetime costs and benefits; and model structure. Consensus was also achieved on some key parameters such as choices of outcome measures, methods for extrapolation beyond trial data, and treatment switching. A research agenda to support further consensus was also identified. CONCLUSION: Consensus guidance that fully reflects current evidence and clinical understanding was gained successfully. In addition, research needs have been identified. Such guidance can be updated as evidence develops and policy questions change and need not be prescriptive as long as deviations from consensus are clearly explained and justified. FUNDING: Arthritis Research UK and the UK Medical Research Council Network of Hubs for Trials Methodology Research

Randomised controlled trial of the effect, cost and acceptability of a bronchiectasis self-management intervention

Background: Patient self-management plans (PSMP) are advised for bronchiectasis but their efficacy is not established. We aimed to determine whether, in people with bronchiectasis, the use of our bronchiectasis PSMP - Bronchiectasis Empowerment Tool (BET), compared to standard care, would improve self-efficacy. Methods: In a multi-centre mixed-methods randomised controlled parallel study, 220 patients with bronchiectasis were randomised to receive standard care with or without the addition of our BET plus education sessions explaining its use. BET comprised an action plan, indicating when to seek medical help based on pictorial represented indications for antibiotic therapy, and four educational support sections. At baseline and after 12 months, patients completed the Self-Efficacy to Manage Chronic Disease Scale (SEMCD), St George’s Respiratory Questionnaire (SGRQ), EQ-5D-3L (to calculate Quality Adjusted Life Years (QALYs) and cost questionnaires. Qualitative data were obtained by focus groups. Results: The recruitment to the study was high (63% of eligible patients agreeing to participate) however completion rate was low (57%). BET had no effect on SEMCD (mean difference (0.14 (95% confidence interval (95%CI) -0.37 to 0.64), p=0.59) or SGRQ, exacerbation rates, overall cost to the NHS or QALYs. Most had developed their own techniques for monitoring their condition and they did not find BET useful as it was difficult to complete. Participant knowledge was good in both groups. Conclusion: The demand for patient support in bronchiectasis was high suggesting a clinical need. However, the BET did not improve self-efficacy, health related quality of life, costs or clinically relevant outcome measures. BET needs to be modified to be less onerous for users and implemented within a wider package of care. Further studies, particularly those evaluating people newly diagnosed with bronchiectasis, are required and should allow for 50% withdrawal rate or utilise less burdensome outcome measures. Clinical trials registration: ISRCTN ISRCTN 18400127. Registered 24 June 2015. Retrospectively Registere

Improving primary care Access in Context and Theory (I-ACT trial): a theory-informed randomised cluster feasibility trial using a realist perspective

Background Primary care access can be challenging for older, rural, socio-economically disadvantaged populations. Here we report the I-ACT cluster feasibility trial which aims to assess the feasibility of trial design and context-sensitive intervention to improve primary care access for this group and so expand existing theory. Methods Four general practices were recruited; three randomised to intervention and one to usual care. Intervention practices received £1500, a support manual and four meetings to develop local, innovative solutions to improve the booking system and transport. Patients aged over 64 years old and without household car access were recruited to complete questionnaires when booking an appointment or attending the surgery. Outcome measures at 6 months included: self-reported ease of booking an appointment and transport; health care use; patient activation; capability; and quality of life. A process evaluation involved observations and interviews with staff and participants. Results Thirty-four patients were recruited (26 female, eight male, mean age 81.6 years for the intervention group and 79.4 for usual care) of 1143 invited (3% response rate). Most were ineligible because of car access. Twenty-nine participants belonged to intervention practices and five to usual care. Practice-level data was available for all participants, but participant self-reported data was unavailable for three. Fifty-six appointment questionnaires were received based on 150 appointments (37.3%). Practices successfully designed and implemented the following context-sensitive interventions: Practice A: a stacked telephone system and promoting community transport; Practice B: signposting to community transport, appointment flexibility, mobility scooter charging point and promoting the role of receptionists; and Practice C: local taxi firm partnership and training receptionists. Practices found the process acceptable because it gave freedom, time and resource to be innovative or provided an opportunity to implement existing ideas. Data collection methods were acceptable to participants, but some found it difficult remembering to complete booking and appointment questionnaires. Expanded theory highlighted important mechanisms, such as reassurance, confidence, trust and flexibility. Conclusions Recruiting older participants without access to a car proved challenging. Retention of participants and practices was good but only about a third of appointment questionnaires were returned. This study design may facilitate a shift from one-size-fits-all interventions to more context-sensitive interventions

Environmental lithium exposure in the north of Chile - Tissue exposure indices

Background: northern Chile has the highest levels of lithium in surface waters in the world which is reflected in very high lithium levels in the plants and animals that depend on these water systems and consequently in the indigenous population. Methods: the lithium tissue burdens in populations from two valleys in the extreme north of Chile have been studied. The bulk of this report is based on analyses of lithium levels in urine, hair, and breast milk in the population of several villages. Data on serum levels, some of which had been previously published, are included for the sake of completeness. Since this paper reports studies by several groups of workers samples were analysed by a variety of methods. These include atomic emission, atomic absorption, other photospectroscopic techniques and mass spectroscopy. Results: in all samples studied the average lithium level (5.3 ppm) was found to be significantly elevated compared to levels reported in the literature and measured in this study for people not exposed to high levels in water and food (0.009-0.228 ppm). Conclusions: the people studied represent a unique longitudinal cohort. The work should provide important insights into the potential neuroprotective effects of lithium also help us set guidelines to assess the risks from high dose environmental exposure

Questions of inclusion in Scotland and Europe

This paper examines inclusion in Scotland and in Europe. It considers some of the uncertainties surrounding inclusion and the questions which are currently being raised by researchers, teachers and their representative unions, parents and children, many of which give cause for concern. The shifting political and policy contexts and recent patterns and trends in Scotland and across Europe, which illustrate key points of exclusion, as well as some of the challenges to these, are reported. A ‘landmark’ challenge to discrimination of Roma children, achieved within the European Convention on Human Rights, is presented as an illustration of the scope for asserting the right to inclusion. The paper ends with a discussion of the prospects and possibilities for inclusion. The significance of the barriers to inclusion is acknowledged and it is argued that there is an urgent need to address the competing policy demands within education and the problems associated with fragmented provision. A call is also made for research involving children, young people and families in order to inform practice

Mathematical modeling and design of layer crystallization in a concentric annulus with and without recirculation [Abstract]

Mathematical modeling and design of layer crystallization in a concentric annulus with and without recirculation [Abstract

Mathematical modeling and design of layer crystallization in a concentric annulus with and without recirculation

A solution layer crystallization process in a concentric annulus is presented that removes the need for filtration. A dynamic model for layer crystallization with and without a recirculation loop is developed in the form of coupled partial differential equations describing the effects of mass transfer, heat transfer, and crystallization kinetics. The model predicts the variation of the temperature, concentration, and dynamic crystal thickness along the pipe length, and the concentration and temperature along the pipe radius. The model predictions are shown to closely track experimental data that were not used in the model's construction, and also compared to an analytical solution that can be used for quickly obtaining rough estimates when there is no recirculation loop. The model can be used to optimize product yield and crystal layer thickness uniformity, with constraints on the supersaturation to avoid bulk nucleation by adjusting cooling temperatures in the core and jacket. © 2013 American Institute of Chemical Engineers