Patient, carer and healthcare professional perspectives on increasing calorie intake in Amyotrophic Lateral Sclerosis.

OBJECTIVES: Research suggests that higher Body Mass Index is associated with improved survival in people with Amyotrophic Lateral Sclerosis (pwALS). Yet, understanding of the barriers and enablers to increasing calorie intake is limited. This study sought to explore these issues from the perspective of pwALS, informal carers, and healthcare professionals. METHODS: Interviews with 18 pwALS and 16 informal carers, and focus groups with 51 healthcare professionals. Data were analysed using template analysis and mapped to the COM-B model and Theoretical Domains Framework (TDF). RESULTS: All three COM-B components (Capability, Opportunity and Motivation) are important to achieving high calorie diets in pwALS. Eleven TDF domains were identified: Physical skills (ALS symptoms); Knowledge (about high calorie diets and healthy eating); Memory, attention, and decision processes (reflecting cognitive difficulties); Environmental context/resources (availability of informal and formal carers); Social influences (social aspects of eating); Beliefs about consequences (healthy eating vs. high calorie diets); Identity (interest in health lifestyles); Goals (sense of control); Reinforcement (eating habits); and Optimism and Emotion (low mood, poor appetite). DISCUSSION: To promote high calorie diets for pwALS, greater clarity around the rationale and content of recommended diets is needed. Interventions should be tailored to patient symptoms, preferences, motivations, and opportunities.

Understanding the current nutritional management for people with amyotrophic lateral sclerosis - A mapping review.

BACKGROUND & AIMS: Poor nutritional outcomes are observed in people with Amyotrophic Lateral Sclerosis (pwALS) including weight loss and poor dietary intake. Surveys of healthcare professionals have highlighted the lack of evidence and knowledge regarding nutritional management of ALS throughout the disease course. Furthermore, national evidence-based guidance is lacking. This mapping review aims to understand the structure and input of nutritional management services for pwALS. METHODS: Systematic searches were conducted across eight electronic databases to identify qualitative and quantitative research on structure and input of nutritional care in ALS. Supplementary searches included grey literature, citation and reference list searching of included studies and key reviews, web searching and contacting experts and organisations that provide ALS services to identify guidelines. Study selection and data extraction were undertaken independently by at least two reviewers. Data was synthesised using a narrative approach. RESULTS: One hundred and nine documents were identified. These consisted of journal articles, guidelines and related documents that contributed evidence towards mapping of nutritional management of pwALS. No evidence on commissioning of nutritional care was identified. Guidelines provided high-level overviews and gave general guidance or recommendations for care; however, these typically focused on gastrostomy with limited guidance on broader aspects, including oral nutrition support. Evidence from primary studies found nutritional care delivery in ALS consisted of multiple types of nutritional management, at different time points during the disease course and involving a range of professionals. There was little evidence relating to proactive nutritional care. Details of healthcare setting, number of professionals involved in care, team composition and how services were delivered in community settings were sparse. Although the role of the speech and language therapist in swallowing assessment and provision of advice on the management of swallowing difficulties was consistent; there was limited evidence on care provided by dietitians. In addition, a small number of studies reported on the use of screening tools. Overall, evidence was consistent that weight management, including monitoring of weight change by professionals and patients, was central and recommended that this should be part of nutritional assessment and follow-up. CONCLUSIONS: The evidence identified in this mapping review has highlighted the requirement for further primary research providing specific details on how nutritional management of pwALS is structured and delivered.

The nutritional management of people living with amyotrophic lateral sclerosis: A national survey of dietitians.

BACKGROUND: People living with amyotrophic lateral sclerosis (ALS) face many challenges with respect to taking adequate nutrition. Growing evidence links weight loss with negative prognostic outcomes. We aimed to explore the practice of dietitians in the UK with regard to the nutritional management of ALS. METHODS: A national online survey was disseminated via professional groups, social media and newsletters to UK healthcare professionals between September and November 2018. The survey examined the nutritional management of ALS. Dietitian responses are reported in the present study. RESULTS: In total, 130 dietitians responded to the survey. Two-thirds reported that ALS comprised less than 20% of their total patient caseload. Forty-two percent reported that nutritional screening took place in their organisation. One-half of dietitians reported that patients were referred for dietetic assessment at 'about the right time', although 44% reported referrals were made too late. The majority (83%) of dietitians used resting energy expenditure predictive equations not validated in ALS. When setting weight goals, dietitians reported most frequently recommending weight maintenance if the patient's body mass index was 18.5-25 kg m-2 (72%), 25-30 kg m-2 (98%), and > 30 kg m-2 (79%). In addition, 43% reported that people with ALS were not weighed sufficiently frequently. CONCLUSIONS: Although the importance of early nutritional assessment is recognised, the timeliness of dietetic input and on-going monitoring of nutritional status in ALS care might not currently be ideal. Dietitians report using energy requirement predictive equations and setting weight goals that may not promote positive outcomes. Further research is required to understand the optimal nutritional management of ALS.

Delivery of nutritional management services to people with amyotrophic lateral sclerosis (ALS).

OBJECTIVES: The aim of this study was to investigate how nutritional management services for people with Amyotrophic Lateral Sclerosis (pwALS) are structured in the UK, in order to gain insight into current practice and identify key barriers and enablers to delivering and providing services. Methods: A three-part, sequential mixed-methods study was conducted that comprised (i) a thematic analysis of data from five focus groups (with 47 ALS health professionals from 41 UK organizations and four service user representatives), (ii) a nationwide cross-sectional survey (281 ALS healthcare professionals) and (iii) a freedom of information request (251 organizations). Results: UK nutritional management services for pwALS are coordinated from specialist (n = 22) and non-specialist care centers (n = 89), with national variability in the organization and delivery of services. Multidisciplinary working was highlighted to facilitate the coordination of nutritional care. However, the need to provide evidence-based continuing education for HCPs was evident. Overall, the lack of clear guidelines on the nutritional management of people with ALS was identified as a key barrier to the delivery of effective nutritional care, as was the lack of transparency and consistency in the commissioning of nutritional services. Further concerns over the timeliness of the dietetic intervention and equity of access and provision were raised. Conclusions: Our findings suggest that development of guidelines for nutritional management, particularly at diagnosis and pre-gastrostomy, could drive standardization of high quality nutritional care for pwALS. Such guidance has the potential to reduce inequalities in geographical provision by providing clarity for those commissioning specialist nutrition services.

Interventions to promote oral nutritional behaviours in people living with neurodegenerative disorders of the motor system: A systematic review.

BACKGROUND & AIMS: Weight loss is common in people with neurodegenerative diseases of the motor system (NDMS), such as Parkinson's disease and Amyotrophic Lateral Sclerosis, and is associated with reduced quality of life, functional ability and survival. This systematic review aims to identify interventions and intervention components (i.e. behaviour change techniques [BCTs] and modes of delivery [MoDs]) that are associated with increased effectiveness in promoting oral nutritional behaviours that help people with NDMS to achieve a high calorie diet. METHODS: Eight electronic databases including MEDLINE and CINAHL were searched from inception to May 2018. All interventions from included studies were coded for relevant BCTs and MoDs. Methodological quality of studies was assessed using the Cochrane risk of bias tool. RESULTS: Fourteen studies were included. Of these, eight studies reported interventions to assist with swallowing difficulties and six studies reported interventions targeting dietary content. Beneficial effects in managing swallowing difficulties were observed with video assisted swallowing therapy, lung volume recruitment and swallowing management clinics with outpatient support. In contrast, studies reporting effectiveness of chin down posture, use of thickened liquids and respiratory muscle training were inconclusive. Positive effects in interventions targeting dietary content included the use of food pyramid tools, individualised nutritional advice with nutritional interventions, electronic health applications, face-to-face dietary counselling and high fat, high carbohydrate and milk whey protein supplements. Individualised nutritional advice with weekly phone contact did not appear to be effective. Most frequently coded BCTs were 'instructions on how to perform the behaviour', 'self-monitoring' and 'behavioural practice/rehearsal'. Most commonly identified MoDs were 'human, face-to-face' and 'somatic therapy'. However, the robustness of these findings are low due to the small number of studies, small sample sizes and large between-study variability. CONCLUSIONS: Despite the limited evidence, these findings may help inform the development of more effective interventions to promote oral nutritional behaviours in people with NDMS. However, further research is needed to demonstrate which interventions, or intervention components, yield most benefit.

Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT.

BACKGROUND: There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. OBJECTIVE: To evaluate the feasibility of undertaking a definitive trial to evaluate the clinical effectiveness and cost-effectiveness of behavioural activation (BA) compared with usual stroke care for treating post-stroke depression. DESIGN: Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. SETTING: Acute and community stroke services in three sites in England. PARTICIPANTS: Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9 (PHQ-9) or the Visual Analogue Mood Scales 'Sad' item. Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention. RANDOMISATION AND BLINDING: Participants were randomised (1 : 1 ratio) to BA or usual stroke care. Randomisation was conducted using a computer-generated list with random permuted blocks of varying sizes, stratified by site. Participants and therapists were aware of the allocation, but outcome assessors were blind. INTERVENTIONS: The intervention arm received up to 15 sessions of BA over 4 months. BA aims to improve mood by increasing people's level of enjoyable or valued activities. The control arm received usual care only. MAIN OUTCOME MEASURES: Primary feasibility outcomes concerned feasibility of recruitment to the main trial, acceptability of research procedures and measures, appropriateness of baseline and outcome measures, retention of participants and potential value of conducting the definitive trial. Secondary feasibility outcomes concerned the delivery of the intervention. The primary clinical outcome 6 months post randomisation was the PHQ-9. Secondary clinical outcomes were Stroke Aphasic Depression Questionnaire - Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire. RESULTS: Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month. The 25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care. Outcome assessments were completed by 39 (81%) participants (BA, n = 18; usual care, n = 21). Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm. Therapy was delivered as intended. BA was acceptable to participants, carers and therapists. Value-of-information analysis indicates that the benefits of conducting a definitive trial would be likely to outweigh the costs. It is estimated that a sample size of between 580 and 623 participants would be needed for a definitive trial. LIMITATIONS: Target recruitment was not achieved, although we identified methods to improve recruitment. CONCLUSIONS: The Behavioural Activation Therapy for Depression after Stroke trial was feasible with regard to the majority of outcomes. The outstanding issue is whether or not a sufficient number of participants could be recruited within a reasonable time frame for a definitive trial. Future work is required to identify whether or not there are sufficient sites that are able to deliver the services required for a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12715175. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.

Approximately one-third of stroke patients experience depression, which can have negative effects on recovery and quality of life (QoL). Currently, we do not have sufficient evidence to indicate which psychological interventions are effective and affordable to the NHS for treating post-stroke depression. We aimed to determine whether or not it is feasible to conduct a future large-scale study to evaluate a psychological intervention, called behavioural activation (BA) therapy, for treating post-stroke depression. BA aims to improve mood by identifying what stroke patients enjoy doing and helping them to undertake these activities. BA can be used with all stroke patients with depression, including people with cognitive or communication difficulties. We recruited 48 post-stroke patients who had suffered a stroke between 3 months and 5 years previously. People with dementia or significant aphasia were excluded. Participants were divided into two groups at random. About half of the participants received BA over a 4-month period and the other half did not. Participants received all other available care. After 6 months, participants completed questionnaires about their mood, activity level and QoL. We also interviewed 16 participants and 10 carers about their views on the actual research process and therapy. Although we were able to recruit participants to the study, we recruited fewer than the original target of 72 participants owing to delays in starting recruitment. However, we have identified ways to improve participant recruitment in a future study. We found that it was feasible to deliver BA, and the therapy was found to be acceptable to participants, carers and therapists. The results indicate that the benefits of conducting a large-scale future study would outweigh the costs. However, the main consideration will be whether or not we could identify enough stroke services able to run the study for a long enough period to recruit the large number of participants required.

Health care professionals' views on psychological factors affecting nutritional behaviour in people with motor neuron disease: A thematic analysis.

Motor neuron disease (MND), also known as amyotrophic lateral sclerosis, is a neurodegenerative disorder that causes progressive muscle paralysis and typically leads to death within 3 years. As no cure is currently available, symptomatic management is the mainstay of treatment. An important part of this is optimizing nutritional intake with evidence that this may positively affect survival and quality of life. Health care professionals (HCPs) play a pivotal role in nutritional management of people with MND (pwMND) but, to date, their views on the psychological barriers faced by pwMND have not been explored. Such an exploration may identify ways in which the delivery of nutritional care for pwMND can be optimized. METHODS: Five qualitative focus groups were carried out across the United Kingdom in June 2018 with 51 participants, including 47 HCPs involved with MND care and four service user representatives. Data were analysed through thematic analysis. RESULTS: Four overarching themes were identified: psychological adjustment and patient engagement; nutrition and the need for control; knowledge of nutrition and the complexity of MND; and the psychosocial nature of eating. CONCLUSIONS: The findings suggest that the nutritional management of pwMND should be mindful of factors such as the impact of distress at the time of diagnosis, the availability of clear information on nutrition and MND, as well as the importance of illness perceptions and coping strategies. Moreover, tailored psychological interventions should be considered to mitigate the impact on MND on the experience of eating. Statement of contribution What is already known on this subject? Since weight loss and reduced body mass index (BMI) have been identified as independent risk factors for prognosis and survival in motor neuron disease (MND), nutritional management represents an important component of the symptomatic care of people with MND (pwMND) aimed at prolonging survival and maintaining or improving quality of life. However, the current guidelines and quantitative and qualitative literature on the topic are mainly focused on issues around enteral feeding and gastrostomy insertion, and very little is currently known about potential psychological enablers or barriers to earlier nutritional management, especially from the perspectives of health care professionals (HCPs) involved in the delivery of nutritional care in pwMND. What does this study add? First qualitative investigation of enablers or barriers to nutritional care in pwMND from the perspective of HCPs. New insight into psychological factors (e.g., adjustment, avoidance, loss of control) in nutritional care for pwMND. Practical implications and novel clinical suggestions for HCPs involved in nutritional care of pwMND.

A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial.

BACKGROUND: Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. DESIGN: Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. SETTING: Eight secondary care diabetes centres in the UK. PARTICIPANTS: Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. INTERVENTIONS: Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm® VeoTM (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). MAIN OUTCOME MEASURES: Primary outcome - change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome - proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months - moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. RESULTS: We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was -0.24% [95% confidence interval (CI) -0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of -0.36% (95% CI -0.64% to -0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. LIMITATION: Blinding of pump therapy was not possible, although an objective primary outcome was used. CONCLUSION: Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. RESEARCH PRIORITY: To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61215213. 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. 21, No. 20. See the NIHR Journals Library website for further project information.