Protocol of a feasibility randomised controlled trial of Empowered Conversations: training family carers to enhance their relationships and communication with people living with dementia.

Background: Communication difficulties can cause frustration, low mood, and stress for people living with dementia and their carer. Carers should be offered training on adapting their communication skills. However, it is not common for skills-based education to examine emotional aspects of care and the effect of dementia on relationships. The Empowered Conversations (EC) training course was developed in response to a gap in service provision and has been adapted to a virtual format (Zoom). It addresses the specific psychological, relationship, and communication needs of informal and family dementia carers. The primary aim of the study is to investigate the feasibility of conducting a multi-centre randomised controlled evaluation trial of EC. Secondary aims include exploring the acceptability of delivering the intervention online and examining the optimum way of establishing cost-effectiveness. Methods: The feasibility trial uses a pragmatic data-collector blind parallel two-group RCT design with two arms (EC intervention plus treatment as usual, and treatment as usual waitlist control). There will be a 2:1 allocation in favour of the EC-training intervention arm. 75 participants will complete baseline outcome measures exploring their role as a carer, including their physical and mental health, attitudes to caring, quality of life, and use of health and social care services. These will be repeated after six-months. Participants allocated to the treatment group who complete the course will be invited to participate in a qualitative interview discussing their experience of EC. Conclusions: The study will investigate recruitment pathways (including facilitators and barriers to recruitment), estimate retention levels and response rates to questionnaires, obtain additional evidence regarding proof of concept, and consider the most appropriate primary outcome measures and methods for evaluating cost-effectiveness. The results of the feasibility study will be used to inform the development of a multicentre randomised controlled trial in the United Kingdom. Registration: ISRCTN15261686 (02/03/2022).

There are 700,000 family and informal carers for people living with dementia in the UK alone. Sixty-four percent of informal carers in England say they have limited support for the range of psychological and social needs they experience. It can be difficult to keep communicating well due to thinking and memory changes that caused by dementia. This can lead to frustration, low-mood and stress for both people living with dementia and their carers. The 6-session online Empowered Conversations course is designed to enable carers to maintain and improve good communication and relationships with those they support. Course facilitators are trained to provide specific communication techniques, ways of managing conflicts, and working with difficult emotions. The course has been tried out over the last 4-years and changes made. Feedback from informal carers indicates it is in an optimum form and we are ready to test it further in a large trial. Before this is done, it is necessary to complete a smaller 'feasibility' trial to check whether such a larger trial is possible. This article explains how the feasibility trial will be carried out. Our 'feasibility' trial will check several things. We want to make sure that carers would be willing to have an only 66% chance of receiving the course straight away, because it is essential to have a comparison group. The remaining 33% of carers would be offered the course 6-months later. We want to ensure that our design is good enough to identify any improvement in carers' well-being, relationships and communication. We will also ask carers to take part in a one-to-one interview about their experiences of the course, including their views on the course being delivered on Zoom.

The incidence of pancytopenia in patients taking leflunomide alone or with methotrexate.

PURPOSE: To estimate the incidence of pancytopenia in patients taking leflunomide with or without methotrexate in Australia. METHODS: Review of spontaneous reports to the Australian Adverse Drug Reactions Advisory Committee (ADRAC); estimation of incidence using national prescription reimbursement data; concomitant exposure to methotrexate was estimated using three sources of information. RESULTS: ADRAC received 11 reports of pancytopenia (meeting predefined criteria) associated with the use of leflunomide during its first 31 months of marketing. In nine reports, the patients were also taking methotrexate. Estimates of incidence in patients taking leflunomide alone ranged from 1 in 3698 to 1 in 4582 patients exposed; for patients also taking methotrexate the estimates ranged from 1 in 575 to 1 in 822. CONCLUSIONS: Use of methotrexate with leflunomide increases the risk of pancytopenia compared with use of leflunomide alone. The haematological toxicity of the combination requires further study.

The effect of single set resistance training on strength and functional fitness in pulmonary rehabilitation patients.

PURPOSE: The primary goal of pulmonary rehabilitation (PR) is for patients to achieve and maintain their maximum level of independence and functioning in the community. Traditional PR uses a predominantly aerobic/endurance approach to rehabilitation with little or no inclusion of exercises to increase strength. Few studies have investigated the impact of resistance training on PR despite growing evidence supporting its efficacy to improve physical function (functional fitness) in both healthy individuals and those with chronic disease. The purpose of this study was to investigate the effect of single-set resistance training on strength and functional fitness outcomes in PR patients. METHODS: Twenty PR patients, 60 to 81 years old, were randomly assigned to an 8-week endurance-based PR program (ET) or an ET plus resistance training program (RT). RESULTS: Strength increased in RT (P < .05) and decreased in ET for both upper and lower body. Functional fitness improved (P < .05) in 5 of 7 tests for RT compared with 2 tests for ET. CONCLUSIONS: Single set RT can elicit significant improvements in both strength and functional fitness, which is not obtained by traditional PR alone. Our results are comparable to other studies with similar outcomes using multiple-set RT protocols. These findings may have important implications for program design, application, and adherence in PR.

Cardiac rehabilitation patient versus proxy quality-of-life perceptions.

Spousal perceptions and/or attitudes to their patient partners' capabilities have been shown to affect the effectiveness of the cardiac rehabilitation (CR) process. The purpose of this study was (a) to assess differences between patient and proxy responses to the Medical Outcomes Survey-Short Form 36 (SF36)and (b) suggest how such information may contribute to enhancing rehabitation outcomes. Fifty-eight patients completed the SF36 prior to entering Phase II CR. Patient spouses completed a proxy version of the same questionnaire. The authors found that spouses' perceptions of their patient partners physical functioning (PF) was approximately 10% lower than patients' perceptions of their own PF (p < .04). Implications for the appropriate application of such data are discussed.