Recovery and Renewal of Co-Design Approaches in Health: Protocol for a Realist Synthesis.

BACKGROUND: The COVID-19 pandemic significantly transformed the landscape of work and collaboration, impacting design research methodologies and techniques. Co-design approaches have been both negatively and positively affected by the pandemic, prompting a need to investigate and understand the extent of these impacts, changes, and adaptations, specifically in the health sector. Despite the challenges that the pandemic imposed on conducting co-design and related projects, it also encouraged a re-evaluation of co-design practices, leading to innovative solutions and techniques. Designers and researchers have explored alternative ways to engage stakeholders and end users, leveraging digital workshops and participatory digital platforms. These adaptations have the potential to enhance inclusivity, allowing for a wider range of individuals to contribute their perspectives and insights through co-design and thus contribute to healthcare change. OBJECTIVE: This study aims to explore the impacts of the pandemic on co-design and related practices, focusing on co-design practices in healthcare that have been gained, adapted, or enhanced, with a specific focus on issues of equity, diversity, and inclusion. METHODS: The study uses a realist synthesis methodology to identify and analyze the effects of the pandemic on co-design approaches in health, drawing on a range of sources including first-person experiences, gray literature, and academic literature. A community of practice in co-design in health will be engaged to support this process. RESULTS: By examining the experiences and insights of professionals, practitioners, and communities who were actively involved in co-design and have navigated the challenges and opportunities of the pandemic, we can gain a deeper understanding of the strategies, tools, and techniques that have facilitated effective co-design during the pandemic, contributing to building resilience and capacity in co-design in health beyond the pandemic. CONCLUSIONS: By involving community partners, community of practice (research), and design practitioners, we expect closer proximity to practice with capacity building occurring through the realist process, thus enabling rapid adoption and refinement of new techniques or insights that emerge. Ultimately, this research will contribute to the advancement of co-design methodologies and inform the future of co-design in health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58318.

Using policy codesign to achieve multi-sector alignment in adolescent behavioral health: a study protocol.

BACKGROUND: Policymaking is quickly gaining focus in the field of implementation science as a potential opportunity for aligning cross-sector systems and introducing incentives to promote population health, including substance use disorders (SUD) and their prevention in adolescents. Policymakers are seen as holding the necessary levers for realigning service infrastructure to more rapidly and effectively address adolescent behavioral health across the continuum of need (prevention through crisis care, mental health, and SUD) and in multiple locations (schools, primary care, community settings). The difficulty of aligning policy intent, policy design, and successful policy implementation is a well-known challenge in the broader public policy and public administration literature that also affects local behavioral health policymaking. This study will examine a blended approach of coproduction and codesign (i.e., Policy Codesign), iteratively developed over multiple years to address problems in policy formation that often lead to poor implementation outcomes. The current study evaluates this scalable approach using reproducible measures to grow the knowledge base in this field of study. METHODS: This is a single-arm, longitudinal, staggered implementation study to examine the acceptability and short-term impacts of Policy Codesign in resolving critical challenges in behavioral health policy formation. The aims are to (1) examine the acceptability, feasibility, and reach of Policy Codesign within two geographically distinct counties in Washington state, USA; (2) examine the impact of Policy Codesign on multisector policy development within these counties using social network analysis; and (3) assess the perceived replicability of Policy Codesign among leaders and other staff of policy-oriented state behavioral health intermediary organizations across the USA. DISCUSSION: This study will assess the feasibility of a specific approach to collaborative policy development, Policy Codesign, in two diverse regions. Results will inform a subsequent multi-state study measuring the impact and effectiveness of this approach for achieving multi-sector and evidence informed policy development in adolescent SUD prevention and treatment.

Development of the Preferred Components for Co-Design in Research Guideline and Checklist: Protocol for a Scoping Review and a Modified Delphi Process.

BACKGROUND: There is increasing evidence that co-design can lead to more engaging, acceptable, relevant, feasible, and even effective interventions. However, no guidance is provided on the specific designs and associated methods or methodologies involved in the process. We propose the development of the Preferred Components for Co-design in Research (PRECISE) guideline to enhance the consistency, transparency, and quality of reporting co-design studies used to develop complex health interventions. OBJECTIVE: The aim is to develop the first iteration of the PRECISE guideline. The purpose of the PRECISE guideline is to improve the consistency, transparency, and quality of reporting on studies that use co-design to develop complex health interventions. METHODS: The aim will be achieved by addressing the following objectives: to review and synthesize the literature on the models, theories, and frameworks used in the co-design of complex health interventions to identify their common elements (components, values or principles, associated methods and methodologies, and outcomes); and by using the results of the scoping review, prioritize the co-design components, values or principles, associated methods and methodologies, and outcomes to be included in the PRECISE guideline. RESULTS: The project has been funded by the Canadian Institutes of Health Research. CONCLUSIONS: The collective results of this project will lead to a ready-to-implement PRECISE guideline that outlines a minimum set of items to include when reporting the co-design of complex health interventions. The PRECISE guideline will improve the consistency, transparency, and quality of reports of studies. Additionally, it will include guidance on how to enact or enable the values or principles of co-design for meaningful and collaborative solutions (interventions). PRECISE might also be used by peer reviewers and editors to improve the review of manuscripts involving co-design. Ultimately, the PRECISE guideline will facilitate more efficient use of new results about complex health intervention development and bring better returns on research investments. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50463.

Leading co-production in five UK collaborative research partnerships (2008-2018): responses to four tensions from senior leaders using auto-ethnography.

BACKGROUND: Despite growing enthusiasm for co-production in healthcare services and research, research on co-production practices is lacking. Multiple frameworks, guidelines and principles are available but little empirical research is conducted on 'how to do' co-production of research to improve healthcare services. This paper brings together insights from UK-based collaborative research partnerships on leading co-production. Its aim is to inform practical guidance for new partnerships planning to facilitate the co-production of applied health research in the future. METHODS: Using an auto-ethnographic approach, experiential evidence was elicited through collective sense making from recorded conversations between the research team and senior leaders of five UK-based collaborative research partnerships. This approach applies a cultural analysis and interpretation of the leaders' behaviours, thoughts and experiences of co-production taking place in 2008-2018 and involving academics, health practitioners, policy makers and representatives of third sector organisations. RESULTS: The findings highlight a variety of practices across CLAHRCs, whereby the intersection between the senior leaders' vision and local organisational context in which co-production occurs largely determines the nature of co-production process and outcomes. We identified four tensions in doing co-production: (1) idealistic, tokenistic vs realistic narratives, (2) power differences and (lack of) reciprocity, (3) excluding vs including language and communication, (4) individual motivation vs structural issues. CONCLUSIONS: The tensions were productive in helping collaborative research partnerships to tailor co-production practices to their local needs and opportunities. Resulting variation in co-production practices across partnerships can therefore be seen as highly advantageous creative adaptation, which makes us question the utility of seeking a unified 'gold standard' of co-production. Strategic leadership is an important starting point for finding context-tailored solutions; however, development of more distributed forms of leadership over time is needed to facilitate co-production practices between partners. Facilitating structures for co-production can enable power sharing and boost capacity and capability building, resulting in more inclusive language and communication and, ultimately, more credible practices of co-production in research. We provide recommendations for creating more realistic narratives around co-production and facilitating power sharing between partners.

Putting guidelines into practice: Using co-design to develop a complex intervention based on NG48 to enable care staff to provide daily oral care to older people living in care homes.

OBJECTIVES: (1) Explore the challenges of providing daily oral care in care homes; (2) understand oral care practices provided by care home staff; (3) co-design practical resources supporting care home staff in these activities. METHODS: Three Sheffield care homes were identified via the "ENRICH Research Ready Care Home Network," and three to six staff per site were recruited as co-design partners. Design researchers led three co-design workshops exploring care home staff's experiences of providing daily oral care, including challenges, coping strategies and the role of current guidelines. New resources were prototyped to support the use of guidelines in practice. The design researchers developed final resources to enable the use of these guidelines in-practice-in-context. FINDINGS: Care home staff operate under time and resource constraints. The proportion of residents with dementia and other neurodegenerative conditions is rapidly increasing. Care home staff face challenges when residents adopt "refusal behaviours" and balancing daily oral care needs with resident and carer safety becomes complex. Care home staff have developed many coping strategies to navigate "refusal behaviours." Supporting resources need to "fit" within the complexities of practice-in-context. CONCLUSIONS: The provision of daily oral care practices in care homes is complex and challenging. The co-design process revealed care home staff have a "library" of context-specific practical knowledge and coping strategies. This study offers insights into the process of making guidelines usable for professionals in their contexts of practice, exploring the agenda of implementing evidence-based guidelines.

Co-production practice and future research priorities in United Kingdom-funded applied health research: a scoping review.

BACKGROUND: Interest in and use of co-production in healthcare services and research is growing. Previous reviews have summarized co-production approaches in use, collated outcomes and effects of co-production, and focused on replicability and reporting, but none have critically reflected on how co-production in applied health research might be evolving and the implications of this for future research. We conducted this scoping review to systematically map recent literature on co-production in applied health research in the United Kingdom to inform co-production practice and guide future methodological research. METHODS: This scoping review was performed using established methods. We created an evidence map to show the extent and nature of the literature on co-production and applied health research, based on which we described the characteristics of the articles and scope of the literature and summarized conceptualizations of co-production and how it was implemented. We extracted implications for co-production practice or future research and conducted a content analysis of this information to identify lessons for the practice of co-production and themes for future methodological research. RESULTS: Nineteen articles reporting co-produced complex interventions and 64 reporting co-production in applied health research met the inclusion criteria. Lessons for the practice of co-production and requirements for co-production to become more embedded in organizational structures included (1) the capacity to implement co-produced interventions, (2) the skill set needed for co-production, (3) multiple levels of engagement and negotiation, and (4) funding and institutional arrangements for meaningful co-production. Themes for future research on co-production included (1) who to involve in co-production and how, (2) evaluating outcomes of co-production, (3) the language and practice of co-production, (4) documenting costs and challenges, and (5) vital components or best practice for co-production. CONCLUSION: Researchers are operationalizing co-production in various ways, often without the necessary financial and organizational support required and the right conditions for success. We argue for accepting the diversity in approaches to co-production, call on researchers to be clearer in their reporting of these approaches, and make suggestions for what researchers should record. To support co-production of research, changes to entrenched academic and scientific practices are needed. Protocol registration details: The protocol for the scoping review was registered with protocols.io on 19 October 2021: https://dx.doi.org/10.17504/protocols.io.by7epzje .

Improving the oral health of older people in care homes (TOPIC): a protocol for a feasibility study.

BACKGROUND: Evidence for interventions promoting oral health amongst care home residents is weak. The National Institute for Health and Care Excellence (NICE) guideline NG48 aims to maintain and improve the oral health of care home residents. A co-design process that worked with residents and care home staff to understand how the NG48 guideline could be best implemented in practice has been undertaken to refine a complex intervention. The aim of this study is to assess the feasibility of the intervention to inform a future larger scale definitive trial. METHODS: This is a protocol for a pragmatic cluster randomised controlled trial with a 12-month follow-up that will be undertaken in 12 care homes across two sites (six in London, six in Northern Ireland). Care homes randomised to the intervention arm (n = 6) will receive the complex intervention based on the NG48 guideline, whilst care homes randomised to the control arm (n = 6) will continue with routine practice. The intervention will include a training package for care home staff to promote knowledge and skills in oral health promotion, the use of the Oral Health Assessment Tool on residents by trained care home staff, and a 'support worker assisted' daily tooth-brushing regime with toothpaste containing 1500 ppm fluoride. An average of ten residents, aged 65 years or over who have at least one natural tooth, will be recruited in each care home resulting in a recruited sample of 120 participants. Assessments will be undertaken at baseline, 6 months and 12 months, and will include a dental examination and questionnaires on general health and oral health administered by a research assistant. A parallel process evaluation involving semi-structured interviews will be undertaken to explore how the intervention could be embedded in standard practice. Rates of recruitment and retention, and intervention fidelity will also be recorded. A cost-consequence model will determine the relevance of different outcome measures in the decision-making context. DISCUSSION: The study will provide valuable information for trialists, policymakers, clinicians and care home staff on the feasibility and associated costs of oral health promotion in UK care homes. TRIAL REGISTRATION: ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613 .

Context and the evidence-based paradigm: The potential for participatory research and systems thinking in oral health.

The implementation of research evidence to promote oral health is critical, given the intransigent and emerging challenges for policymakers at a population level. Despite this, little attention has been paid to implementation research within the evidence-based paradigm. This is important as getting research evidence into clinical practice is not a linear path that consists of simple sequential steps. In this article, we argue that we need to consider a broader range of conceptual and methodological approaches to increase the value of information generated. This should be undertaken either in parallel with empirical and experimental designs, or in some cases, instead of. This is important if we are going to understand the complexity and contextual knowledge of the 'system', within which interventions are implemented. Involving key stakeholders alongside empirical and experimental designs is one helpful approach. Examples of these approaches include Patient and Public Involvement and the development of Core Outcome Sets, where the views of those that will be potentially affected by the research, are included. The use of theoretical frameworks and process evaluations alongside trials are also important, if they are fully integrated into the approach taken to address the research question. A more radical approach is using participatory designs and 'systems thinking'. Participatory approaches include subject matter 'experts by experience'. These include patients, their families, carers, healthcare professionals, services managers, policymakers, commissioners and researchers. Participatory approaches raise important questions about who facilitates the process, when it should happen and how the diverse actors become meaningfully engaged so that their involvement is active, democratic and ongoing. We argue that the issues of control, power and language are central to this and represent a paradigmatic shift to conventional approaches. Systems thinking captures the idea that public health problems commonly involve multiple interdependent and interconnected factors, which interact with each other dynamically. This approach challenges the simplicity of the hierarchy of evidence and linear sequential logic, when it does not account for context. In contrast, systems thinking accepts complexity de novo and emphasizes the need to understand the whole system rather than its individual component parts. We conclude with the idea that participatory and systems thinking help to unpack the diverse agents that are often involved in the generation and translation of evidence into clinical dental practice. It moves our conception of research away from a simple exchange between 'knowledge producers' and 'knowledge users' and raises both methodological and epistemological challenges.

Training using a simulation-based workshop reduces inaccuracies in estimations of testicular volume.

OBJECTIVES: Measuring testicular volume (TV) by orchidometer is routine in the clinic when staging male puberty. We have developed a simulation model for TV estimation and investigated whether training medical students, using a workshop with simulation models, could improve the accuracy and reliability of TV estimation. METHODS: All participating medical students watched a video representing standard undergraduate training in male pubertal assessment. Volunteers were then randomised directly to assessment or to attend a workshop consisting of a further video and four stations contextualising and practising the skills required for TV estimation, prior to assessment. Three child mannequins displaying testes of 3 mL, 4 mL (twice), 5, 10 and 20 mL were used for assessment. Participants were asked to return a fortnight later for repeat assessment to assess intra-observer reliability, the effect of repeated examinations on accuracy and time on skill retention. RESULTS: Ninety students participated (55F), 46 attended the workshop and were considered "trained". There was no difference between the groups in numbers of correct estimations (29% trained, 27% untrained, p=0.593). However, the trained group's estimations were closer to the true volume, with more from the trained group one bead away (p=0.002) and fewer more than three beads away from the true volume (p<0.001), compared to the untrained group. Trained participants were more accurate at the second assessment (n=80) (p<0.001) and had greater intra-observer reliability (p=0.004). CONCLUSIONS: Overall TV estimation accuracy was poor. Workshop-style training improved accuracy, reliability and retention of skill acquisition and could be considered as a useful learning tool.

Innovative solutions to enhance safe and green environments for ageing well using co-design through patient and public involvement.

BACKGROUND: There is a need to develop innovative solutions to enhance safe and green physical environments, which optimise health, wellbeing and community participation among older adults. To develop solutions that meet the needs of a diverse ageing population, an interdisciplinary approach is needed. Our aim was to identify the needs of older people in relation to ageing well in the environment by bringing together knowledge from different perspectives using Patient and Public Involvement. METHODS: An international consortium (Retrofit living For ageing well through Understanding and Redesign of Built environments consortium: ReFURB) was established in April 2018, including ten core members, to (i) explore cutting-edge solutions to safe living for ageing populations and (ii) develop innovative approaches to everyday physical environments, which bring about health benefits. We used a co-design, interdisciplinary framework involving older adults, carers, physiotherapists, geriatricians, engineers, human movement experts, geographers and psychologists from the UK and Australia. This engaged people in a 1 day workshop that comprised a series of presentations from international speakers on urban design, social connectedness, hazards and injury prevention, and the physical environment. Small group discussions (facilitated by consortium members) followed presentations to consider the opportunities, challenges and barriers encountered with ageing, which included the use of creative engagement activities (LEGO® Serious Play, mind maps, poster gallery walk), to help participants share personal stories and reflect on the issues raised. Thematic coding was used to synthesise the outputs of the small group work. RESULTS: Five themes were identified across the workshops: access and transport; involvement of the whole community; restoration rather than redesign; assistive and digital technology; and intergenerational approaches. These dimensions related to the physical, social and nature-based qualities of everyday environments, as they pertain to ageing well. CONCLUSIONS: Co-design was a valuable tool that helped understand the perceptions of participants and essential to develop effective interventions and solutions. Participants highlighted several issues affecting people as they age and key environmental considerations to promote wellbeing, activity, and participation. The consortium identified gaps in the existing evidence base and are now planning activities to further develop research ideas in collaboration with our co-design participants.

Re-Framing the Knowledge to Action Challenge Through NIHR Knowledge Mobilisation Research Fellows Comment on "CIHR Health System Impact Fellows: Reflections on 'Driving Change' Within the Health System".

The ambition of the Canadian Institutes for Health Research Health System Impact (HSI) Fellowship initiative to modernise the health system is impressive. Embedded researchers who work between academia and non-academic settings offer an opportunity to reframe the problem of evidence uptake as a product of a gap between those who produce knowledge and those who use it. As such, there has been an increasing interest in the potential of people in embedded research roles to work with stakeholders in the co-production of knowledge to address service challenges. In this commentary, we draw on research and experiential evidence of an embedded researcher initiative, which has similar intentions to the HSI Fellowships programme: the National Institute for Health Research (NIHR) Knowledge Mobilisation Research Fellowship (KMRF) scheme. We outline the similarities and differences between the two schemes, and then consider the work, characteristics and skills, and organisational arrangements evident in operationalising these types of roles.

Promoting co-production in the generation and use of research evidence to improve service provision in special care dentistry.

Special care dentistry (SCD) provides holistic oral service provision for people with complex health and care needs. These can include physical, sensory, intellectual, mental, medical, emotional or social impairment or disability or, more often, a combination of these factors. The level of disability within these population groups can vary, and a proportion of people will have multiple and overlapping impairments and/or medical conditions. This paper explores a number of possible research methods that may better reflect the diversity and challenges of this population group, where the emphasis is placed on co-production and co-design.

A simulation study assessing the accuracy and reliability of orchidometer estimation of testicular volume.

CONTEXT: Measuring testicular volume (TV) by orchidometer is the standard method of male pubertal staging. A paucity of evidence exists as to its inter- and intra-observer reliability and the impact of clinicians' gender, training and experience on accuracy. OBJECTIVE: Prosthetic testicular models were engineered to investigate accuracy and reliability of TV estimation. DESIGN: Simulation study. SETTING: Conducted over three-day 2015 British Society for Paediatric Endocrinology and Diabetes (BSPED) meeting. PARTICIPANTS: Two hundred fifteen meeting delegates (161F, 54M): 50% consultants, 30% trainees, 9% clinical nurse specialists, 11% other professionals. INTERVENTION: Three child-sized mannequins displayed latex scrotum containing prosthetic testicles of 3, 4, 5, 10 and 20 mL. Demographic data, paediatric endocrinology experience, TV examination training, examination technique and TV estimations were collected. Delegates were asked to repeat their measurements later during the meeting. Scrotum order was changed daily. MAIN OUTCOME MEASURES: Accuracy by variance from the simulated TV. Inter- and intra-observer variability. RESULTS: One thousand two hundred eighty four individual estimations were obtained. Eighty-five participants repeated measurements. Delegates measured TV accurately on 33.4% (±2.6) of occasions: overestimations 37% (±2.3), underestimations 28% (±1.8) (Fleiss' Kappa score 0.04). The accuracy of assessing a 4 mL testis was 36%-39%. Observers underestimated the volume when paired with a 3 mL testis and overestimated when paired with a 5 mL testis demonstrating a tendency impose biological symmetry. Intra-observer reliability was lacking; individuals giving different estimations for the same size testicle on 61% (±4.2) of occasions, 20% (±3.5) of estimations were more than 1 size outside the previous measurement. On only 39% (±4.2) of occasions did individuals agree with their previous estimation (irrespective of whether or not it was initially accurate). Training did not impact on results but experience did improve accuracy. CONCLUSIONS: Overall TV estimation accuracy was poor. Considerable variation exists between and within subjects. Seniority slightly improved measurement estimation.

'Collective making' as knowledge mobilisation: the contribution of participatory design in the co-creation of knowledge in healthcare.

The discourse in healthcare Knowledge Mobilisation (KMb) literature has shifted from simple, linear models of research knowledge production and action to more iterative and complex models. These aim to blend multiple stakeholders' knowledge with research knowledge to address the research-practice gap. It has been suggested there is no 'magic bullet', but that a promising approach to take is knowledge co-creation in healthcare, particularly if a number of principles are applied. These include systems thinking, positioning research as a creative enterprise with human experience at its core, and paying attention to process within the partnership. This discussion paper builds on this proposition and extends it beyond knowledge co-creation to co-designing evidenced based interventions and implementing them. Within a co-design model, we offer a specific approach to share, mobilise and activate knowledge, that we have termed 'collective making'. We draw on KMb, design, wider literature, and our experiences to describe how this framework supports and extends the principles of co-creation offered by Geenhalgh et al. [1] in the context of the state of the art of knowledge mobilisation. We describe how collective making creates the right 'conditions' for knowledge to be mobilised particularly addressing issues relating to stakeholder relationships, helps to discover, share and blend different forms of knowledge from different stakeholders, and puts this blended knowledge to practical use allowing stakeholders to learn about the practical implications of knowledge use and to collectively create actionable products. We suggest this collective making has three domains of influence: on the participants; on the knowledge discovered and shared; and on the mobilisation or activation of this knowledge.

A comfort assessment of existing cervical orthoses.

PURPOSE: Identify location and intensity of discomfort experienced by healthy participants wearing cervical orthoses. METHOD: Convenience sample of 34 healthy participants wore Stro II, Philadelphia, Headmaster, and AspenVista® cervical orthoses for four-hour periods. Participants reported discomfort level (scale 0-6) and location. RESULTS: Participants reported mean discomfort for all orthoses over the four-hour test between 'a little discomfort' and 'very uncomfortable' (mean discomfort score = 1.64, SD = 1.50). Seven participants prematurely stopped tests due to pain and six reported maximum discomfort scores. Significant linear increase in discomfort with duration of wear was found for all orthoses. Significantly less discomfort was reported with Stro II than Headmaster and Philadelphia. Age correlated with greater perceived discomfort. Orthoses differed in the location discomfort was experienced. CONCLUSION: Existing cervical orthoses cause discomfort influenced by design and duration of wear with orthoses' design the more significant factor. This work informed the design of a new orthosis and future orthoses developments. Practitioner Summary: The purpose of this study was to gain greater knowledge about the discomfort caused by wearing of existing neck orthoses in order to inform the design and development of a new neck orthosis. This study gathers empirical data from a surrogate population and concludes that orthosis design is more influential than the duration of wear.

"Seeing" the Difference: The Importance of Visibility and Action as a Mark of "Authenticity" in Co-production Comment on "Collaboration and Co-production of Knowledge in Healthcare: Opportunities and Challenges".

The Rycroft-Malone paper states that co-production relies on 'authentic' collaboration as a context for action. Our commentary supports and extends this assertion. We suggest that 'authentic' co-production involves processes where participants can 'see' the difference that they have made within the project and beyond. We provide examples including: the use of design in health projects which seek to address power issues and make contributions visible through iteration and prototyping; and the development of 'actionable outputs' from research that are the physical embodiment of co-production. Finally, we highlight the elements of the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) architecture that enables the inclusion of such collaborative techniques that demonstrate visible co-production. We reinforce the notion that maintaining collaboration requires time, flexible resources, blurring of knowledge producer-user boundaries, and leaders who promote epistemological tolerance and methodological exploration.

Evaluating a novel cervical orthosis, the Sheffield Support Snood, in patients with amyotrophic lateral sclerosis/motor neuron disease with neck weakness.

Current practice and guidelines recommend the use of neck orthoses for people with amyotrophic lateral sclerosis (ALS) to compensate for neck weakness and to provide surrogate neck control. However, available options are frequently described by patients as restrictive and unsuitable and there was a need for a new device that addressed the needs of people with ALS. This project utilized a co-design process to develop a new neck orthosis that was more flexible yet supportive. Following development of a prototype device, a mixed methods cohort study was undertaken with patients and carers, in order to evaluate the new orthosis. Twenty-six patients were recruited to the study, with 20 of these completing all phases of data collection. Participants described the impact of neck weakness on their life and limitations of existing supports. Evaluation of the new orthosis identified key beneficial features: notably, increased support while providing a greater range of movement, flexibility of use, and improved appearance and comfort. In conclusion, the results of this evaluation highlight the value of this alternative option for people with ALS, and potentially other patient groups who require a neck orthosis.

Assessment of the Sheffield Support Snood, an innovative cervical orthosis designed for people affected by neck muscle weakness.

BACKGROUND: This study aimed at quantifying the biomechanical features of the Sheffield Support Snood, a cervical orthosis specifically designed for patients with neck muscle weakness. The orthosis is designed to be adaptable to a patient's level of functional limitation using adjustable removable supports, which contribute support and restrict movement only in desired anatomical planes. METHODS: The snood was evaluated along with two commercially available orthoses, the Vista and Headmaster, in a series of flexion, extension, axial-rotation and lateral flexion movements. Characterization was performed with twelve healthy participants with and without the orthoses. Two inertial-magneto sensors, placed on the forehead and sternum, were used to quantify the neck's range of motion. FINDINGS: In its less supportive configuration, the snood was effective in limiting movements to the desired planes, preserving free movement in other planes. The Headmaster was only effective in limiting flexion. The range of motion achieved with the snood in its rigid configuration was equivalent (P>0.05, effect size<0.4) to that achieved with the Vista, both in trials performed reaching the maximum amplitude (range of motion reduction: 25%-34% vs 24%-47%) and at maximum speed (range of motion reduction: 24%-29% vs 25%-43%). INTERPRETATION: The Sheffield Support Snood is effectively adaptable to different tasks and, in its most supportive configuration, offers a support comparable to the Vista, but providing a less bulky structure. The chosen method is suitable for the assessment of range of motions while wearing neck orthoses and is easily translatable in a clinical context.