A Smartphone App to Support Self-Management for People Living With Sjögren's Syndrome: Qualitative Co-Design Workshops.

BACKGROUND: Sjögren's syndrome (SS) is the second most common autoimmune rheumatic disease, and the range of symptoms includes fatigue, dryness, sleep disturbances, and pain. Smartphone apps may help deliver a variety of cognitive and behavioral techniques to support self-management in SS. However, app-based interventions must be carefully designed to promote engagement and motivate behavior change. OBJECTIVE: We aimed to explore self-management approaches and challenges experienced by people living with SS and produce a corresponding set of design recommendations that inform the design of an engaging, motivating, and evidence-based self-management app for those living with SS. METHODS: We conducted a series of 8 co-design workshops and an additional 3 interviews with participants who were unable to attend a workshop. These were audio recorded, transcribed, and initially thematically analyzed using an inductive approach. Then, the themes were mapped to the Self-Determination Theory domains of competency, autonomy, and relatedness. RESULTS: Participants experienced a considerable demand in the daily work required in self-managing their SS. The condition demanded unrelenting, fluctuating, and unpredictable mental, physical, and social efforts. Participants used a wide variety of techniques to self-manage their symptoms; however, their sense of competency was undermined by the complexity and interconnected nature of their symptoms and affected by interactions with others. The daily contexts in which this labor was occurring revealed ample opportunities to use digital health aids. The lived experience of participants showed that the constructs of competency, autonomy, and relatedness existed in a complex equilibrium with each other. Sometimes, they were disrupted by tensions, whereas on other occasions, they worked together harmoniously. CONCLUSIONS: An SS self-management app needs to recognize the complexity and overlap of symptoms and the complexities of managing the condition in daily life. Identifying techniques that target several symptoms simultaneously may prevent users from becoming overwhelmed. Including techniques that support assertiveness and communication with others about the condition, its symptoms, and users' limitations may support users in their interactions with others and improve engagement in symptom management strategies. For digital health aids (such as self-management apps) to provide meaningful support, they should be designed according to human needs such as competence, autonomy, and relatedness. However, the complexities among the 3 Self-Determination Theory constructs should be carefully considered, as they present both design difficulties and opportunities.

Navigating uncharted territory with a borrowed map: lessons from setting up the BATH-OUT-2 randomised controlled trial in adult social care and housing services in English local authorities.

Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services.Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service (NHS). However, adult social care and local authorities are relatively uncharted territory for trials. BATH-OUT-2 is one of the first clinical trials currently underway within adult social care and housing adaptations services in six English local authorities. It provides an opportunity to explore how the clinical trial road map fares in these settings.Whilst setting up BATH-OUT-2, we encountered challenges with securing funding for the trial, lack of non-NHS intervention costs, using research and support costs as intended, gaining approvals, identifying additional trial sites, and including people who lack the mental capacity to provide informed consent. Overall, our experience has been like navigating uncharted territory with a borrowed map. In the UK, the clinical trial road map was developed for medical settings. Its key features are integrated within the NHS landscape but have been largely absent, unfamiliar, inaccessible, or irrelevant in social care and wider local authority terrain. Navigating the set-up of a clinical trial outside the NHS has been a complicated and disorientating journey.BATH-OUT-2 highlights how local authorities generally and adult social care specifically are a relatively new and certainly different type of setting for trials. Whilst this poses a challenge for conducting trials, it also presents an opportunity to question longstanding assumptions within trials practices, reimagine the conventional clinical trial road map, and take it in new directions. As the UK research landscape moves forward and becomes better primed for randomised evaluations in local authorities, we propose several suggestions for building on recent progress and advancing trials within adult social care and across health and care systems.

Bathing Adaptations in the Homes of Older Adults (BATH-OUT-2): study protocol for a randomised controlled trial, economic evaluation and process evaluation.

BACKGROUND: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations. METHODS: BATH-OUT-2 is a multicentre, two-arm, parallel-group RCT. Adults aged 60 and over who are referred to their local authority for an accessible level access shower will be randomised, using pairwise randomisation, 1:1, to receive either an expedited provision of an accessible shower via the local authority or a usual care control waiting list. Participants will be followed up for a maximum of 12 months and will receive up to four follow-ups in this duration. The primary outcome will be the participant's physical well-being, assessed by the Physical Component Summary score of the Short Form-36 (SF-36), 4 weeks after the intervention group receives the accessible shower. The secondary outcomes include the Mental Component Summary score of the SF-36, self-reported falls, health and social care resource use, health-related quality of life (EQ-5D-5L), social care-related quality of life (Adult Social Care Outcomes Toolkit (ASCOT)), fear of falling (Short Falls Efficacy Scale), independence in bathing (Barthel Index bathing question), independence in daily activities (Barthel Index) and perceived difficulty in bathing (0-100 scale). A mixed-methods process evaluation will comprise interviews with stakeholders and a survey of local authorities with social care responsibilities in England. DISCUSSION: The BATH-OUT-2 trial is designed so that the findings will inform future decisions regarding the provision of bathing adaptations for older adults. This trial has the potential to highlight, and then reduce, health inequalities associated with waiting times for bathing adaptations and to influence policies for older adults. TRIAL REGISTRATION: ISRCTN Registry ISRCTN48563324. Prospectively registered on 09/04/2021.

Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study.

Background: Early rehabilitation and mobilisation encompass patient-tailored interventions, delivered within intensive care, but there are few studies in children and young people within paediatric intensive care units. Objectives: To explore how healthcare professionals currently practise early rehabilitation and mobilisation using qualitative and quantitative approaches; co-design the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual of early rehabilitation and mobilisation interventions, with primary and secondary patient-centred outcomes; explore feasibility and acceptability of implementing the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual within three paediatric intensive care units. Design: Mixed-methods feasibility with five interlinked studies (scoping review, survey, observational study, codesign workshops, feasibility study) in three phases. Setting: United Kingdom paediatric intensive care units. Participants: Children and young people aged 0-16 years remaining within paediatric intensive care on day 3, their parents/guardians and healthcare professionals. Interventions: In Phase 3, unit-wide implementation of manualised early rehabilitation and mobilisation. Main outcome measures: Phase 1 observational study: prevalence of any early rehabilitation and mobilisation on day 3. Phase 3 feasibility study: acceptability of early rehabilitation and mobilisation intervention; adverse events; acceptability of study design; acceptability of outcome measures. Data sources: Searched Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, PEDro, Open grey and Cochrane CENTRAL databases. Review methods: Narrative synthesis. Results: In the scoping review we identified 36 full-text reports evaluating rehabilitation initiated within 7 days of paediatric intensive care unit admission, outlining non-mobility and mobility early rehabilitation and mobilisation interventions from 24 to 72 hours and delivered twice daily. With the survey, 124/191 (65%) responded from 26/29 (90%) United Kingdom paediatric intensive care units; the majority considered early rehabilitation and mobilisation a priority. The observational study followed 169 patients from 15 units; prevalence of any early rehabilitation and mobilisation on day 3 was 95.3%. We then developed a manualised early rehabilitation and mobilisation intervention informed by current evidence, experience and theory. All three sites implemented the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual successfully, recruited to target (30 patients recruited) and followed up the patients until day 30 or discharge; 21/30 parents consented to complete additional outcome measures. Limitations: The findings represent the views of National Health Service staff but may not be generalisable. We were unable to conduct workshops and interviews with children, young people and parents to support the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual development due to pandemic restrictions. Conclusions: A randomised controlled trial is recommended to assess the effectiveness of the manualised early rehabilitation and mobilisation intervention. Future work: A definitive cluster randomised trial of early rehabilitation and mobilisation in paediatric intensive care requires selection of outcome measure and health economic evaluation. Study registration: The study is registered as PROSPERO CRD42019151050. The Phase 1 observational study is registered Clinicaltrials.gov NCT04110938 (Phase 1) (registered 1 October 2019) and the Phase 3 feasibility study is registered NCT04909762 (Phase 3) (registered 2 June 2021). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/21/06) and is published in full in Health Technology Assessment; Vol. 27, No. 27. See the NIHR Funding and Awards website for further award information.

Early rehabilitation and mobilisation, within the first week of intensive care admission, can improve the speed of recovery from illness or injury in adults. However, there is a lack of evidence about whether critically unwell children benefit from early rehabilitation and mobilisation. We aimed to identify which patients may benefit from early rehabilitation and mobilisation. Also, to develop and test a manual of early rehabilitation and mobilisation using the best evidence and expertise ­ called the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual. Then evaluate whether the manual could be implemented safely in paediatric intensive care units and was acceptable to staff and families. We undertook in respect of early rehabilitation and mobilisation: review of existing research; national survey of practice (124 staff); gathered information about current conduct (15 paediatric intensive care units, 169 patients); spoke to experts (18 people); developed the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual to guide paediatric intensive care unit staff; Tested the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual in three paediatric intensive care units with 30 patients; gathered feedback from healthcare professionals via weekly 'debriefs' (47), interviews (13) and surveys (118), and from parents via parent-completed questionnaires (21) and interviews (14). Despite being regarded as important, currently early rehabilitation and mobilisation practice is inconsistent, not considered 'early' enough and often focuses on low-risk activities conducted on the bed. Introducing the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual as part of a trial was acceptable and feasible and helps standardise delivery to unwell children. Measuring child and parent reported outcomes was acceptable but follow-up at 30 days was incomplete. A larger trial of early rehabilitation and mobilisation, involving more paediatric intensive care units, is feasible and required to demonstrate benefit to children.

Cultural Influences on African Migrant Pregnant and Postnatal Women's Dietary Behaviours and Nutrition Support Needs in the UK.

Black women in the UK face significantly higher risks of overweight and obesity and adverse pregnancy outcomes compared to women from other ethnic groups. Maternal nutrition plays a pivotal role in influencing the health outcomes of women and their children, especially during preconception and pregnancy. Cultural and environmental factors significantly influence the dietary experiences of African women after migration. This study explored the unique nutrition-related challenges faced by African migrant pregnant and postnatal women in the UK, and their nutrition support needs. Interviews were conducted with 23 African migrant women living in the UK, who were either pregnant or had a pregnancy within the past 3 years. These were analysed thematically, resulting in five overarching themes: food rituals and beliefs, pregnancy cravings, limited access to culturally appropriate food, limited access to culturally appropriate and evidence-based nutritional guidance, and the focus on healthy weight. The study identified challenges that African migrant women face in balancing their cultural heritage with the UK food environment and dietary recommendations, including potential implications on their health and pregnancy outcomes. It emphasised the importance of addressing these challenges through culturally sensitive approaches and tailored interventions, to enable informed decision making and enhance health outcomes for these women.

Towards an Implementation-STakeholder Engagement Model (I-STEM) for improving health and social care services.

BACKGROUND: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation-STakeholder Engagement Model (I-STEM) in the context of an international, large-scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I-STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. METHODS: In-depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet-based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first- and third-generation Grounded Theory, including constant comparative method. RESULTS: We conducted 55 interviews and observed 19 implementation-related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I-STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. CONCLUSION: The I-STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I-STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. PATIENT OR PUBLIC CONTRIBUTION: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN-Europe at all stages-from grant development to dissemination. GAMIAN-Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN-Europe was involved in pilot testing the ItFits-toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits-toolkit. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018.

"My gut feeling is ": An Ethnographic Study Exploring Interprofessional Communication About Children and Adolescents With Chronic Musculoskeletal Pain in Paediatric Rheumatology.

Interprofessional communication about inflammatory and non-inflammatory musculoskeletal conditions is an important component of assessment and management in paediatric rheumatology. Chronic pain is a feature of some of these conditions which likely influences the extent and type of communication about pain. Research investigating interprofessional communication about paediatric pain is limited but has found that communication is inclusive of the biopsychosocial context of children/adolescents as well as their families. The aim of this ethnographic study was to explore interprofessional communication about children and adolescents with chronic musculoskeletal pain in paediatric rheumatology. We observed forty-five healthcare professionals recruited from 3 UK paediatric rheumatology teams during thirty multi-disciplinary team meetings. Contemporaneous field notes created during observations were analysed using grounded theory procedures. Core processes identified in interprofessional communication involved describing, making sense of, and managing children/adolescents with pain and their families. Topic areas discussed within these core processes included healthcare professional perceptions about children's and parents' personality characteristics, as well as healthcare professionals' familiarity with families. Underlying diagnoses and possible attributions of pain aetiology were also discussed. Interprofessional narratives included consideration of the potential anxieties and uncertainties about pain within families. Healthcare professionals communicated about strategies for managing expectations about pain. These findings characterise the nuances in interprofessional communication about pain and can be used to inform future work aimed at understanding and optimising the impact of interprofessional communication on clinical decisions and pain outcomes. PERSPECTIVE: This study characterises the processes (series of actions), the function (purpose) and the content (topic areas) of interprofessional communication about paediatric pain in rheumatology settings. These findings should be used to inform interventions targeting both the appropriateness and effectiveness of this communication.

A review of leg ulcerations coverage in the United Kingdom print media: A growing problem for the vulnerable adult.

It is estimated that venous leg ulcers affect 1-1.5% of the industrialised world's population. These can be painful, malodorous and debilitating to the person affected. In this paper we explore, through an analysis of the print media, how journalists translate medical knowledge into lay language and how they represent new directions in treatment. We also show how the term 'leg ulcer' is used as part of the description of vulnerable people at the edge of society, some whom are to be seen as needing our compassion, others as (morally) problematic. Finally, we show how stories around 'leg ulcers' are also used in relation to narratives around austerity in the UK and to show gaps in health and social care. We conclude that journalists, wound care researchers and health professionals should work together to inform the public and persons affected that leg ulceration can be successfully treated.

Patient attitudes to nebulised antibiotics in the treatment of bronchiectasis: a mixed-methods study.

Background: Regular daily nebulised antibiotics are widely used in managing bronchiectasis. This patient population typically has severe bronchiectasis requiring multiple other medications. Given that little is known about patients' views and preferences for such therapies, this was the focus of our study. Methods: To explore patient lived-experience using nebulised antibiotics, focus groups and semi-structured interviews were conducted with patients and carers; these were audio-recorded and transcribed to enable thematic analysis. QSR NVivo software facilitated data management. The themes developed from the qualitative data analysis were then used to co-design a questionnaire to capture attitudes and preferences towards nebulised therapy. Questionnaires were completed by patients and statistical analysis was performed. Ethical approval was obtained (13/WS/0036). Results: The study's focus groups comprised 13 patients and carers, and 101 patients completed the questionnaire. Patients described nebulised therapy as an imposition on their daily routine, in turn affecting reported rates of adherence. Results demonstrated that 10% of all patients using nebulised antibiotics found these hard/very hard to administer. Further, 53% of participants strongly agreed/agreed that they would prefer an antibiotic delivered by an inhaler over a nebuliser, if it were as effective at preventing exacerbations. Notably, only 10% of participants wished to remain on nebulised therapy. Conclusions: Inhaled antibiotics delivered via dry powder devices were deemed quicker and easier to use by patients. Providing they were at least as effective as current nebulised treatments, patients deemed inhaled antibiotics to be a preferable treatment option.

Physical activity in young children across developmental and health states: the ActiveCHILD study.

Background: Evidence about physical activity of young children across developmental and health states is very limited. Using data from an inclusive UK cohort, ActiveCHILD, we investigated relationships between objectively measured physical activity, child development, social context, and health-related quality of life (HRQoL). Methods: Children (12-36 months), purposively sampled across health pathways, developmental abilities, and sociodemographic factors, were recruited through thirteen National Health Service organisations in England. Data were collected from 07/2017 to 08/2019 on: weekly physical activity (3-7 days) using waist-worn accelerometer (ActiGraph 3GTX); sociodemographics, parent actions, child HRQoL, and child development using questionnaires; and child health conditions using clinical records. A data-driven, unsupervised method, called hidden semi-Markov model (HSMM) segmented the accelerometery data and provided estimates of the total time spent active (any intensity) and very active (greater intensity) for each child. Relationships with the explanatory factors were investigated using multiple linear regression. Findings: Physical activity data were obtained for 282 children (56% females, mean age 21 months, 37.5% with a health condition) covering all index of multiple deprivation deciles. The patterns of physical activity consisted of two daily peaks, children spending 6.44 (SD = 1.39) hours active (any intensity), of which 2.78 (SD = 1.38) hours very active, 91% meeting WHO guidelines. The model for total time active (any intensity) explained 24% of variance, with mobility capacity the strongest predictor (ß = 0.41). The model for time spent very active explained 59% of variance, with mobility capacity again the strongest predictor (ß = 0.76). There was no evidence of physical activity explaining HRQoL. Interpretation: The findings provide new evidence that young children across developmental states regularly achieve mainstream recommended physical activity levels and challenges the belief that children with development problems need lower expectations for daily physical activity compared to peers. Advancing the rights of all children to participate in physical activity requires inclusive, equally ambitious, expectations for all. Funding: Niina Kolehmainen, HEE/NIHR Integrated Clinical Academic Senior Clinical Lecturer, NIHR ICA-SCL-2015-01-00, was funded by the NIHR for this research project. Christopher Thornton, Olivia Craw, Laura Kudlek, and Laura Cutler were also funded from this award. Tim Rapley is a member of the NIHR Applied Research Collaboration North East and North Cumbria, with part of his time funded through the related award (NIHR200173). The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR, NHS, or the UK Department of Health and Social Care. The work of Kianoush Nazarpour is supported by Engineering and Physical Sciences Research Council (EPSRC), under grant number EP/R004242/2.

Online comic-based art workshops as an innovative patient and public involvement and engagement approach for people with chronic breathlessness.

BACKGROUND: Talking about breathlessness can be emotionally challenging. People can feel a sense of illegitimacy and discomfort in some research contexts. Comic-based illustration (cartooning) offers an opportunity to communicate in a more creative and inclusive way. We used cartooning in patient and public involvement and engagement (PPIE) work to explore symptoms of breathlessness and their impact on peoples' everyday lives. MAIN BODY: Five, 90-min cartooning workshops were delivered online to members of Breathe Easy Darlington (UK). The workshop series involved 5-10 Breathe Easy members and were facilitated by a professional cartoonist supported by three researchers. The experience of living with breathlessness was represented via illustrations of cartoon characters and ideas explored in subsequent conversations. Cartooning was fun and the majority found it a nostalgic experience. Sharing the experience helped the research team develop new understandings of breathlessness and fostered relationships with the Breathe Easy members. The illustrations showed characters leaning against objects, sweating and sitting down, demonstrating living with the sensation of not being in control. CONCLUSION: Comic-based art, as a fun and innovative PPIE approach. It facilitated the research team becoming embedded in an existing group who will act as PPIE members on a long-term research programme. Illustrations enabled storytelling and fostered novel insights into the lived experiences of people with breathlessness including sensations of a loss of control, disorientation, and unsteadiness. This will impact on work investigating balance in people with chronic obstructive pulmonary disease. This model has potential to be applied in a range of PPIE and research contexts.

Talking about breathlessness can be difficult and cause feelings of anxiety. Involving people with breathlessness in research activities can also be challenging. Research contexts can make people feel uncomfortable as they may struggle to understand and feel like they don't belong. Comic-based illustration (cartooning) offers an opportunity to communicate in a different way. Cartooning was used with members of Breathe Easy Darlington, a support group for people with breathlessness, as a way of helping the research team understand how breathlessness impacts daily lives. Five 90-min cartooning workshops were delivered online and involved 5­10 Breathe Easy members per session. The sessions were led by a professional cartoonist whilst the research team facilitated discussions about breathlessness and related issues. The experience of living with breathlessness was illustrated via cartoon characters and ideas were explored through conversations about the illustrations. People found cartooning fun and sharing the experience with the research team helped them to become part of an existing group who will support a long-term research project directly impacting research investigating balance in people with lung disease. The Breathe Easy members were able to tell their stories via illustrations allowing the research team an insight into different aspects of living with breathlessness. The illustrations showed characters leaning against trees and chairs, sweating and sitting down. The need for physical support caused embarrassment, while people struggled to appear "normal". Conversations about the illustrations revealed that the idea of "balance" aligns with a loss of control, disorientation, and unsteadiness which causes intense fear and shame.

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

Early Years Physical Activity and Motor Skills Intervention-A Feasibility Study to Evaluate an Existing Training Programme for Early Years Educators.

A lack of fundamental motor skills (FMS) in the early years can lead to lower engagement with physical activity (PA), and track into adulthood. This study aimed to test the feasibility of an existing intervention for Early Years Educators ("Educators") designed to increase knowledge, confidence and the ability to increase PA and FMS of children in a deprived area of England. Non-randomised design with wait-list control. Sixty-seven settings in Middlesbrough, North East England were invited. Recruitment target: 10 settings, 2 Educators per setting, four children per Educator. INTERVENTION: one-day training course "Physical Literacy in the Early Years", an age-appropriate theoretical and practical training course to support the development of physical literacy. PRIMARY OUTCOMES: recruitment, retention, acceptability of intervention and outcome measures. SECONDARY OUTCOMES: change in Educators' knowledge, intentions and behaviour, and change in children's BMI z-score, PA and FMS. Eight settings were recruited; all Intervention Educators completed the training. Six settings participated at follow-up (four Intervention, two Control). The target for Educator recruitment was met (two per setting, total n = 16). Questionnaires were completed by 80% of Intervention Educators at baseline, 20% at follow-up. Control Educators completed zero questionnaires. No Educators took part in a process evaluation interview. Forty-eight children participated at baseline, 28 at follow-up. The intervention was deemed acceptable. The recruitment, retention and acceptability of measurements were insufficient to recommend proceeding. Additional qualitative work is needed to understand and surmount the challenges posed by the implementation of the trial.

Normative puzzles for local government: Managing the introduction of single-handed care in England.

A crisis in social care is apparent across the developed world as ageing populations put unprecedented demand on understaffed social care workforces. A recent popular response to this 'care crisis' within the UK involves the 'innovation' of single-handed care (SHC). SHC involves a care package with two or more homecare workers being reduced to one worker using advanced equipment and new moving and handling techniques. In this article, we explore how SHC is rendered in 245 documents from 52 local authorities in England. Using Actor Network Theory as an interpretative lens, we suggest documents attempt to satisfy three 'duties of care': to the individual wellbeing of citizens, morally and fiscally to the collective and to innovation. Each appeal to different stakeholder groups necessary for SHC to work, but the combination of duties can pose problems in enabling coherent stories of SHC. Duties can be kept apart in different documents, but at times they must be brought together in certain textual spaces to enact SHC as a coherent enterprise. Here, the potential tensions that emerge are routinely orientated to as (merely) problems of process that can and should be managed in and through a more refined approach to change management.

Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT.

BACKGROUND: Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care. DESIGN: Placebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded. SETTING: Nine NHS head and neck cancer sites in England and Wales. PARTICIPANTS: A total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy. INTERVENTION: Random allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20-30 spots per session. Sham low-level laser therapy was delivered in an identical manner. MAIN OUTCOME MEASURE: The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome. RESULTS: A total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm. LIMITATIONS: The trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient's mouth. CONCLUSIONS: This trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services. FUTURE WORK: Further well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research. TRIAL REGISTRATION: This trial is registered as ISRCTN14224600. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information.

Around 9 out of 10 head and neck cancer patients undergoing treatment experience pain, swelling and sores in their mouth (oral mucositis). This can lead to weight loss, painful ulcers, difficulty talking, eating and drinking, and even hospitalisation. Current care includes helping patients to keep their mouth and teeth clean, encouraging them to have a healthy diet and prescribing mouthwashes, painkillers and mouth-coating gels. However, these treatments give limited help in preventing or treating this condition. The LiTEFORM trial looked at whether or not low-level laser therapy could be used to prevent and treat oral mucositis. Patients were allocated to one of two arms at random: active laser or fake (sham) laser. Neither the patients nor the hospital staff knew which laser was being used. Eighty-seven people joined the study during the time allowed (44 received low-level laser therapy and 43 received sham treatment); however, this was a smaller number than the planned target of 380 people. As a result, no meaningful conclusion can be drawn from the results about whether the therapy is beneficial or cost-effective. People receiving the low-level laser therapy reported slightly more soreness in their mouth than those receiving the sham laser, but this could be down to chance. The number of participants is too small to draw conclusions about whether or not the low-level laser is helpful. Some patients found the laser treatment sessions to be difficult. Setting up a new service delivering laser therapy at the same time as cancer treatments was more complicated than originally anticipated. Problems included the scheduling of appointments, finding suitable rooms and having enough trained staff with time to deliver laser therapy. However, this study has provided us with knowledge on how best to set up a laser therapy service in the NHS as part of the cancer treatment pathway and the costs involved. These findings could help future studies looking into low-level laser therapy for those with head and neck cancer.

Advancing cluster randomised trials in children's therapy: a survey of the acceptability of trial behaviours to therapists and parents.

BACKGROUND: Randomised controlled trials of non-pharmacological interventions in children's therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users. METHODS: A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children's therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary. RESULTS: A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children's therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%). CONCLUSIONS: Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy.

Early mobilisation and rehabilitation in the PICU: a UK survey.

OBJECTIVE: To understand the context and professional perspectives of delivering early rehabilitation and mobilisation (ERM) within UK paediatric intensive care units (PICUs). DESIGN: A web-based survey administered from May 2019 to August 2019. SETTING: UK PICUs. PARTICIPANTS: A total of 124 staff from 26 PICUs participated, including 22 (18%) doctors, 34 (27%) nurses, 28 (23%) physiotherapists, 19 (15%) occupational therapists and 21 (17%) were other professionals. RESULTS: Key components of participants' definitions of ERM included tailored, multidisciplinary rehabilitation packages focused on promoting recovery. Multidisciplinary involvement in initiating ERM was commonly reported. Over half of respondents favoured delivering ERM after achieving physiological stability (n=69, 56%). All age groups were considered for ERM by relevant health professionals. However, responses differed concerning the timing of initiation. Interventions considered for ERM were more likely to be delivered to patients when PICU length of stay exceeded 28 days and among patients with acquired brain injury or severe developmental delay. The most commonly identified barriers were physiological instability (81%), limited staffing (79%), sedation requirement (73%), insufficient resources and equipment (69%), lack of recognition of patient readiness (67%), patient suitability (63%), inadequate training (61%) and inadequate funding (60%). Respondents ranked reduction in PICU length of stay (74%) and improvement in psychological outcomes (73%) as the most important benefits of ERM. CONCLUSION: ERM is gaining familiarity and endorsement in UK PICUs, but significant barriers to implementation due to limited resources and variation in content and delivery of ERM persist. A standardised protocol that sets out defined ERM interventions, along with implementation support to tackle modifiable barriers, is required to ensure the delivery of high-quality ERM.

'Single-handed care' initiatives and reviews of double-handed homecare packages: A survey of practices in English local authorities with adult social care responsibilities.

International health and social care systems are experiencing unprecedented pressure and demand. 'Single-handed care' initiatives seek to identify whether all or part of a homecare package involving more than one care worker can be safely reduced to a single worker. Little is known about these initiatives across local authorities. The aim of this study was to identify, describe and explain current processes and practices for single-handed care initiatives and double-handed homecare reviews. An electronic survey link was sent to each local authority with social care responsibilities in England. The questions covered a range of areas in relation to single-handed care processes and included a combination of pre-coded and free-text responses. Responses were received from 76 (50%) local authorities. Findings were that over 12,000 reviews were reported within a year with a median of 141 (IQR 45-280) from 53 authorities that provided figures. Reviews were usually led by a local authority occupational therapist. On average, 540 min was spent per review, including conducting and organising the review, documentation, and travel. In nearly half the authorities, double handed care remained at least partially in place following at least 80% of the reviews and remained wholly in place following at least 60%. Local authorities also reported some resistance from homecare providers when implementing single-handed care. The findings have confirmed anecdotal evidence that reviews of double-handed homecare packages are common practice within local authorities. Given the amount of time taken with these reviews, and paucity of evidence on outcomes for people receiving them, further research should evaluate this.

Translational framework for implementation evaluation and research: Protocol for a qualitative systematic review of studies informed by Normalization Process Theory (NPT) [version 1; peer review: 2 approved].

Background: Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions. Methods: We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed. This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software. Other: We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated.