Search

Background Knowledge mobilisation is a term used in healthcare research to describe the process of generating, sharing and using evidence. ‘Co’approaches, such as co-production, co-design and co-creation, have been proposed as a way of overcoming the knowledge to practice gap. There is a need to understand why researchers choose to adopt these approaches, how they achieve knowledge mobilisation in the management of health conditions, and the extent to which knowledge mobilisation is accomplished. Methods Studies that explicitly used the terms co-production, co-design or co-creation to mobilise knowledge in the management of health conditions were included. Web of Science, EMBASE via OvidSP, MEDLINE via OvidSP and CINHAL via EBSCO databases were searched up to April 2021. Quality assessment was carried out using the Joanna Briggs Institute qualitative quality assessment checklist. Pluye and Hong’s seven steps for mixed studies reviews were followed. Data were synthesised using thematic synthesis. Results Twenty four international studies were included. These were qualitative studies, case studies and study protocols. Key aspects of ‘co’approaches were bringing people together as active and equal partners, valuing all types of knowledge, using creative approaches to understand and solve problems, and using iterative prototyping techniques. Authors articulated mechanisms of action that included developing a shared understanding, identifying and meeting needs, giving everyone a voice and sense of ownership, and creating trust and confidence. They believed these mechanisms could produce interventions that were relevant and acceptable to stakeholders, more useable and more likely to be implemented in healthcare. Varied activities were used to promote these mechanisms such as interviews and creative workshops. There appeared to be a lack of robust evaluation of the interventions produced so little evidence in this review that ‘co’approaches improved the management of health conditions. Conclusion Those using ‘co’approaches believed that they could achieve knowledge mobilisation through a number of mechanisms, but there was no evidence that these led to improved health. The framework of key aspects and mechanisms of ‘co’approaches developed here may help researchers to meet the principles of these approaches. There is a need for robust evaluation to identify whether ‘co’approaches produce improved health outcomes. Trial Registration PROSPERO CRD42020187463.

Background & Aims\ud \ud 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.\ud \ud \ud \ud Methods\ud \ud 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.\ud \ud \ud \ud Results\ud \ud 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.\ud \ud \ud \ud Conclusions\ud \ud 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.

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.

Background\ud \ud People living with Amyotrophic Lateral Sclerosis (ALS) face many challenges 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 regards the nutritional management of ALS.\ud \ud \ud Methods\ud \ud 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 this paper.\ud \ud \ud Results\ud \ud In total, 130 dietitians responded to the survey. Two thirds reported that ALS comprised less than a 20% of their total patient caseload. Fourty two percent reported that nutritional screening took place in their organisation. 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 patients BMI was 18.5‐25kg/m2 (72%), 25‐30kg/m2 (98%), and over 30kg/m2 (79%). In addition, 43% reported that people with ALS were not weighed frequently enough.\ud \ud \ud Conclusions\ud \ud While 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.

Aims\ud \ud Self‐management programmes for type 1 diabetes, such as the UK’s Dose Adjustment for Normal Eating (DAFNE), improve short‐term clinical outcomes but difficulties maintaining behavioural changes attenuate long‐term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change.\ud \ud \ud \ud Methods\ud \ud A four‐step method was based on the BCW intervention development approach: 1) Identifying self‐management behaviours and barriers/enablers to maintaining them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation‐Behaviour (COM‐B) model. 2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). 3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. 4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co‐designed by stakeholders (diabetologists, psychologists, specialist nurses and dietitians).\ud \ud \ud \ud Results\ud \ud Thirty‐four barriers and five enablers to sustaining self‐management post‐DAFNE, were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. Twenty‐seven BCTs were added, including ‘Habit formation’, ‘Credible source’ and ‘Conserving mental resources’. Fifteen stakeholder‐agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co‐designed components: (1) face‐to‐face group learning course, (2) individual structured follow‐up sessions, (3) technological support, including blood glucose data management.\ud \ud \ud \ud Conclusions\ud \ud This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self‐management behaviours.

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.\ud \ud \ud \ud This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.\ud \ud \ud \ud The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text\ud \ud The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites.\ud \ud “To maximise the benefit to society, you need to not just do research but do it well” Douglas G Altman

Background: 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 three years. As no cure is currently available, symptomatic management is the mainstay of treatment. An important part of this is optimising nutritional intake with evidence that this may positively affect survival and quality of life. Healthcare professionals (HCPs) play a pivotal role in nutritional management of people with MND but, to date, their views on the psychological barriers faced by people with MND have not been explored. Such an exploration may identify ways in which the delivery of nutritional care for people with MND can be optimised.\ud \ud Methods: Five qualitative focus groups were carried out across the UK in June 2018 with 51 participants, including 47 healthcare professionals involved with MND care and four service user representatives. Data were analysed through thematic analysis.\ud \ud 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.\ud \ud Conclusions: The findings suggest that the nutritional management of people with MND 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.

Background: There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression.\ud \ud 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.\ud \ud Design: Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation.\ud \ud Setting: Acute and community stroke services in three sites in England.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud Limitations: Target recruitment was not achieved, although we identified methods to improve recruitment.\ud \ud 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.\ud \ud Trial registration: Current Controlled Trials ISRCTN12715175.\ud \ud 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.

Introduction\ud Health policy promotes living well with dementia. Occupational therapists deliver interventions to support people with dementia and family carers to live well. This study aimed at identifying influences on uptake of a community occupational therapy intervention by people with dementia and carers, as little evidence about this topic exists.\ud \ud Method\ud Seventeen semi-structured, paired interviews with people with dementia and carers were conducted as part of the ‘Valuing Active Life in Dementia’ research programme. A secondary, qualitative analysis of these interviews explored influences on uptake of the intervention.\ud \ud Findings\ud Four main themes were identified: ‘Grabbing at straws and keen to take part’; ‘We’re trying to put a routine in’; ‘We didn’t know what to expect’, and ‘Give it a go’. Factors identified as potentially influencing uptake included whether the intervention was perceived as potentially meeting needs for support and activity, and whether participants were struggling to adjust or cope.\ud \ud Conclusion\ud Despite limited expectations or apprehension, uptake of this intervention was demonstrated. Understanding why people with dementia and carers accept intervention offers can inform what occupational therapists provide and how it is offered. Further research is required to determine the occupational therapy interventions people with dementia and carers might find supportive at different stages of the disease trajectory.

© 2018 Elsevier Inc. Objective: To determine rates of death or neurodevelopmental impairment (NDI) at 2 years corrected age (primary outcome) in children

Background: There is currently insufficient evidence for the clinical and cost-effectiveness of psychological\ud therapies for treating post-stroke depression.\ud \ud Methods/Design: BEADS is a parallel group feasibility multicentre randomised controlled trial with nested\ud qualitative research and economic evaluation. The aim is to evaluate the feasibility of undertaking a full trial\ud comparing behavioural activation (BA) to usual stroke care for 4 months for patients with post-stroke depression.\ud We aim to recruit 72 patients with post-stroke depression over 12 months at three centres, with patients identified\ud from the National Health Service (NHS) community and acute services and from the voluntary sector. They will be\ud randomly allocated to receive behavioural activation in addition to usual care or usual care alone. Outcomes will be\ud measured at 6 months after randomisation for both participants and their carers, to determine their effectiveness.\ud The primary clinical outcome measure for the full trial will be the Patient Health Questionnaire-9 (PHQ-9). Rates of\ud consent, recruitment and follow-up by centre and randomised group will be reported. The acceptability of the\ud intervention to patients, their carers and therapists will also be assessed using qualitative interviews. The economic\ud evaluation will be undertaken from the National Health Service and personal social service perspective, with a\ud supplementary analysis from the societal perspective. A value of information analysis will be completed to identify\ud the areas in which future research will be most valuable.\ud \ud Discussion: The feasibility outcomes from this trial will provide the data needed to inform the design of a\ud definitive multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of behavioural\ud activation for treating post-stroke depression.\ud \ud Trial registration: Current controlled trials ISRCTN12715175