EmpRess: an eHealth implementation readiness checklist for dementia developed through an interview study of stakeholder needs.

OBJECTIVE: This study aimed to create a tool to assess eHealth interventions for dementia by adapting an existing implementation readiness (ImpRess) checklist that assessed manualised interventions. METHODS: In Part 1, online semi-structured interviews with individual stakeholders (N = 9) with expertise in eHealth and dementia were conducted (response rate 83%). The Nonadoption, Abandonment, and challenges to the Scale-Up, Spread, and Sustainability of Health and care technologies (NASSS) framework was applied, both to guide the construction of the interview guide, as well as to use its subdomains as codes in the deductive qualitative thematic analysis. Respondents were industry professionals (n = 3), researchers (n = 3), policy officers (n = 2), and a clinician (n = 1). In Part 2, the items of the original ImpRess checklist were supplemented by items that covered determinants discussed in the interviews, that were not included in the original checklist. RESULTS: The main findings from the interviews included: Participants' preference for a non-dementia-specific, more general approach to the checklist; the importance of searching for shared values with implementers; and the need for more systematic monitoring of implementation. CONCLUSIONS: The EmpRess checklist applies an inclusive design approach. The checklist will help evaluate the implementation determinants of eHealth interventions for dementia and provide up-to-date information on what is, and is not, working in eHealth for dementia care.

Use and uptake of technology by people with dementia and their supporters during the COVID-19 pandemic.

OBJECTIVE: This rapid review aims to identify the types of technologies used by people with dementia and their supporters during the COVID-19 pandemic, and the issues which influenced technology adoption within their usual care routines. METHODS: PubMed, PsychInfo, Scopus, and Cochrane COVID reviews were searched to identify peer-review studies published since 2020. A total of 18 studies were included and synthesised thematically. RESULTS: Of these, most were conducted in the community (n = 15) with people with dementia only (n = 11) and involved qualitative methods (n = 11). The majority (n = 12) focused on digital off-the-shelf and low-cost solutions, such as free video conferencing platforms, to access care, socialise or take part in interventions. Whilst often well-accepted and associated with positive outcomes (such as improved social connectedness), lack of digital literacy or support to use technologies, limited access to appropriate technology, individuals' physical, cognitive, or sensory difficulties, were highlighted and likely to threaten the adoption of these solutions. The quality of the evidence was mixed, neither very robust nor easily generalisable which may be attributed to the challenges of conducting research during the pandemic or the need to rapidly adapt to a new reality. CONCLUSION: While COVID-19 has fast-tracked the adoption of technology, its use is likely to continue beyond the pandemic. We need to ensure this technology can leverage dementia support and care and that people with dementia are enabled and empowered to use it.

A systematic literature review and meta-analysis on digital health interventions for people living with dementia and Mild Cognitive Impairment.

OBJECTIVES: Digital health interventions enable services to support people living with dementia and Mild Cognitive Impairment (MCI) remotely. This literature review gathers evidence on the effectiveness of digital health interventions on physical, cognitive, behavioural and psychological outcomes, and Activities of Daily Living in people living with dementia and MCI. METHODS/DESIGN: Searches, using nine databases, were run in November 2021. Two authors carried out study selection/appraisal using the Critical Appraisal Skills Programme checklist. Study characteristics were extracted through the Cochrane handbook for systematic reviews of interventions data extraction form. Data on digital health interventions were extracted through the template for intervention description and replication (TIDieR) checklist and guide. Intervention effectiveness was determined through effect sizes. Meta-analyses were performed to pool data on intervention effectiveness. RESULTS: Twenty studies were included in the review, with a diverse range of interventions, modes of delivery, activities, duration, length, frequency, and intensity. Compared to controls, the interventions produced a moderate effect on cognitive abilities (SMD = 0.36; 95% CI = -0.03 to 0.76; I2  = 61%), and a negative moderate effect on basic ADLs (SMD = -0.40; 95% CI = -0.86 to 0.05; I2  = 69%). Stepping exergames generated the largest effect sizes on physical and cognitive abilities. Supervised training produced larger effect sizes than unsupervised interventions. CONCLUSION: Supervised intervention delivery is linked to greatest benefits. A mix of remote and face-to-face delivery could maximise benefits and optimise costs. Accessibility, acceptability and sustainability of digital interventions for end-users must be pre-requisites for the development of future successful services.

Design decisions and data completeness for experience sampling methods used in psychosis: systematic review.

BACKGROUND: The experience sampling method (ESM) is an intensive longitudinal research method.  Participants complete questionnaires at multiple times about their current or very recent state. The design of ESM studies is complex. People with psychosis have been shown to be less adherent to ESM study protocols than the general population. It is not known how to design studies that increase adherence to study protocols. A lack of typology makes it is hard for researchers to decide how to collect data in a way that allows for methodological rigour, quality of reporting, and the ability to synthesise findings. The aims of this systematic review were to characterise the design choices made in ESM studies monitoring the daily lives of people with psychosis, and to synthesise evidence relating the data completeness to different design choices. METHODS: A systematic review was conducted of published literature on studies using ESM with people with psychosis. Studies were included if they used digital technology for data collection and reported the completeness of the data set. The constant comparative method was used to identify design decisions, using inductive identification of design decisions with simultaneous comparison of design decisions observed. Weighted regression was used to identify design decisions that predicted data completeness. The review was pre-registered (PROSPERO CRD42019125545). RESULTS: Thirty-eight studies were included. A typology of design choices used in ESM studies was developed, which comprised three superordinate categories of design choice: Study context, ESM approach and ESM implementation. Design decisions that predict data completeness include type of ESM protocol used, length of time participants are enrolled in the study, and if there is contact with the research team during data collection. CONCLUSIONS: This review identified a range of design decisions used in studies using ESM in the context of psychosis. Design decisions that influence data completeness were identified. Findings will help the design and reporting of future ESM studies. Results are presented with the focus on psychosis, but the findings can be applied across different mental health populations.

Internalized Weight Stigma, Psychological Well-Being, and Sleep in Women.

BACKGROUND: Many women internalize negative attitudes regarding body shape and size because of the societal standards for women's ideal body shapes and sizes. Internalized weight stigma is related to poorer physical and psychological health. A growing body of research has documented the links between other forms of internalized stigma (e.g., HIV-stigma) and poor sleep quality; however, little research examines the links between internalized weight stigma and sleep or the mechanisms that explain this relationship. Internalized weight stigma may be associated with poor sleep through increases in psychological distress. This study hypothesized that the links between internalized weight stigma and sleep would be mediated by higher levels of depression and anxiety. METHODS: About 257 women were recruited via social media, word of mouth, and an undergraduate participant pool. Participants completed an online survey assessing various aspects of weight stigma and health through self-report questionnaires. Most women were non-Hispanic White (86.8%) and had a mean age of 31.40. RESULTS: The indirect effects of internalized weight stigma on poorer global sleep quality and daily disturbances through depression and anxiety were significant. In contrast, depressive symptoms but not anxiety explained the links between internalized weight stigma and perceived sleep quality and neither depressive symptoms nor anxiety explained the link between internalized weight stigma and sleep efficiency. CONCLUSIONS: Internalized weight stigma is linked to poorer sleep quality, and these links may be explained by psychological well-being. Understanding the mechanisms by which internalized weight stigma is associated with sleep quality can inform the psychological interventions employed.

Estimating the Economic Value of Automated Virtual Reality Cognitive Therapy for Treating Agoraphobic Avoidance in Patients With Psychosis: Findings From the gameChange Randomized Controlled Clinical Trial.

BACKGROUND: An automated virtual reality cognitive therapy (gameChange) has demonstrated its effectiveness to treat agoraphobia in patients with psychosis, especially for high or severe anxious avoidance. Its economic value to the health care system is not yet established. OBJECTIVE: In this study, we aimed to estimate the potential economic value of gameChange for the UK National Health Service (NHS) and establish the maximum cost-effective price per patient. METHODS: Using data from a randomized controlled trial with 346 patients with psychosis (ISRCTN17308399), we estimated differences in health-related quality of life, health and social care costs, and wider societal costs for patients receiving virtual reality therapy in addition to treatment as usual compared with treatment as usual alone. The maximum cost-effective prices of gameChange were calculated based on UK cost-effectiveness thresholds. The sensitivity of the results to analytical assumptions was tested. RESULTS: Patients allocated to gameChange reported higher quality-adjusted life years (0.008 QALYs, 95% CI -0.010 to 0.026) and lower NHS and social care costs (-£105, 95% CI -£1135 to £924) compared with treatment as usual (£1=US $1.28); however, these differences were not statistically significant. gameChange was estimated to be worth up to £341 per patient from an NHS and social care (NHS and personal social services) perspective or £1967 per patient from a wider societal perspective. In patients with high or severe anxious avoidance, maximum cost-effective prices rose to £877 and £3073 per patient from an NHS and personal social services perspective and societal perspective, respectively. CONCLUSIONS: gameChange is a promising, cost-effective intervention for the UK NHS and is particularly valuable for patients with high or severe anxious avoidance. This presents an opportunity to expand cost-effective psychological treatment coverage for a population with significant health needs. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17308399; https://www.isrctn.com/ISRCTN17308399. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-031606.

Health Care Professionals' Views on Using Remote Measurement Technology in Managing Central Nervous System Disorders: Qualitative Interview Study.

BACKGROUND: Remote measurement technologies (RMT) can be used to collect data on a variety of bio-behavioral variables, which may improve the care of patients with central nervous system disorders. Although various studies have explored their potential, prior work has highlighted a knowledge gap in health care professionals' (HCPs) perceptions of the value of RMT in clinical practice. OBJECTIVE: This study aims to understand HCPs' perspectives on using RMT in health care practice for the care of patients with depression, epilepsy, or multiple sclerosis (MS). METHODS: Semistructured interviews were conducted with 26 multidisciplinary primary and secondary care HCPs who care for patients with epilepsy, depression, or MS. Interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: A total of 8 main themes emerged from the analysis: (1) potential clinical value of RMT data; (2) when to use RMT in care pathways; (3) roles of health care staff who may use RMT data; (4) presentation and accessibility of data; (5) obstacles to successful use of RMT; (6) limits to the role of RMT; (7) empowering patients; and (8) considerations around alert-based systems. CONCLUSIONS: RMT could add value to the system of care for patients with central nervous system disorders by providing clinicians with graphic summaries of data in the patient record. Barriers of both technical and human nature should be considered when using these technologies, as should the limits to the benefits they can offer.

In vitro microvessels for the study of angiogenesis and thrombosis.

Microvascular networks support metabolic activity and define microenvironmental conditions within tissues in health and pathology. Recapitulation of functional microvascular structures in vitro could provide a platform for the study of complex vascular phenomena, including angiogenesis and thrombosis. We have engineered living microvascular networks in three-dimensional tissue scaffolds and demonstrated their biofunctionality in vitro. We describe the lithographic technique used to form endothelialized microfluidic vessels within a native collagen matrix; we characterize the morphology, mass transfer processes, and long-term stability of the endothelium; we elucidate the angiogenic activities of the endothelia and differential interactions with perivascular cells seeded in the collagen bulk; and we demonstrate the nonthrombotic nature of the vascular endothelium and its transition to a prothrombotic state during an inflammatory response. The success of these microvascular networks in recapitulating these phenomena points to the broad potential of this platform for the study of cardiovascular biology and pathophysiology.

Usability of web-based tools designed for communication and decision-making in dementia: Systematic review and design brief.

INTRODUCTION: There is an increased number of web-based tools designed for people with dementia and their family caregivers and addressing communication and decision-making. The loss of cognitive functions associated with dementia can impact individuals' experiences and use of web-based tools. There is a need for high quality and user-friendly web-based tools that support communication and decision-making for people with dementia and their family caregivers. OBJECTIVE: To identify usability requirements, usability testing methods, and design suggestions from studies focusing on web-based tools for communication and decision-making support in dementia care. METHODS: We conducted a systematic review with narrative synthesis. Five databases were systematically searched in February 2023. The quality of the included studies was assessed using the Mixed Methods Appraisal Tool. RESULTS: A total of 1,032 articles were identified and 7 fulfilled inclusion criteria. Web-based tools addressed technology usage, health promotion, home modification information, shared decision-making facilitation, information needs and social isolation. Methods to test usability included surveys, interviews, focus groups, cognitive walkthroughs and think-aloud procedures. Findings suggested reducing cognitive load, enhancing readability, providing clear language, and emphasising the need for additional support for people with dementia. Design recommendations include optimising information delivery and presentation, enhancing visual elements, streamlining navigation, providing concrete examples, using clear language, and offering training and tailored support. CONCLUSION: Usability requirements ranged from visual appearance and navigation to delivery of content and support needed. This review contributes to efforts to improve design and development of web-based tools targeting communication and decision-making in dementia care. Further research should address tailored support to enhance usability for people with dementia.

Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial.

BACKGROUND: Randomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have reported improved anxiety and depression symptoms; however, no adequately powered sham-controlled trials in major depression are available. We investigated whether active Alpha-Stim AID is superior to sham Alpha-Stim AID in terms of clinical effectiveness for depression symptoms in major depression. METHODS: The Alpha-Stim-D trial was a multicentre, parallel group, double-blind, randomised controlled trial, recruiting participants from 25 primary care centres in two regions in England, UK. Eligible participants were aged 16 years or older with a current diagnosis of primary major depression, a score of 10-19 on the nine-item Patient Health Questionnaire, and had been offered or prescribed and reported taking antidepressant medication for at least 6 weeks in the previous 3 months. Main exclusion criteria were contraindications to Alpha-Stim AID device use, having persistent suicidal ideation or self-harm, neurological conditions, a substance use disorder or dependence, an eating disorder, bipolar disorder, or non-affective psychosis, or receiving psychological treatment in the past 3 months. Eligible participants were randomly assigned (1:1, minimised by region, anxiety disorder, and antidepressant use) to 1 h daily use of active (100 µA) or sham Alpha-Stim AID treatment for 8 weeks. Randomisation was via an independent web-based system, with participants, outcome assessors, and data analyst masked to treatment assignment. The primary outcome was change from baseline in score on the 17-item Hamilton Depression Rating Scale (HDRS-17, GRID version) at 16 weeks after randomisation, with participants analysed by intention to treat (ITT; all randomly assigned participants). Safety was assessed in all randomly assigned participants. The trial is registered with the ISRCTN registry (ISRCTN11853110); status completed. FINDINGS: Between Sept 8, 2020, and Jan 14, 2022, 236 eligible participants were randomly assigned to active or sham Alpha-Stim AID (n=118 each). 156 (66%) participants were women, 77 (33%) were men, and three (1%) self-reported as other gender; 200 (85%) were White British or Irish; and the mean age was 38·0 years (SD 15·3; range 16-83). 102 (86%) participants in the active Alpha-Stim AID group and 98 (83%) in the sham group were followed up 16 weeks after randomisation. In the ITT population, mean change in GRID-HDRS-17 at 16 weeks was -5·9 (95% CI -7·1 to -4·8) in the active Alpha-Stim AID group and -6·5 (-7·7 to -5·4) in the sham group (mean change difference -0·6 [95% CI -1·0 to 2·2], p=0·46). Among the 236 participants, 17 adverse events were reported in 17 (7%) participants (nine [8%] participants in the active Alpha-Stim AID group; and eight [7%] participants in the sham group). One serious adverse event of suicidal ideation leading to hospitalisation was reported in the sham group, which was judged to be unrelated to the device. INTERPRETATION: Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression. FUNDING: National Institute for Health Research Applied Research Collaboration East Midlands and Electromedical Products International.

Developing a prototype digital risk mitigation pathway for children and young people admitted to acute paediatric NHS care in mental health crisis: Protocol of the Safety Assessment in Paediatric healthcare Environments (SAPhE) pathway study.

Background: Globally, there are increasing numbers of Children and young people (CYPs) experiencing a mental health crisis requiring admission to acute paediatric inpatient care. These CYPs can often experience fluctuating emotional states accompanied by urges to self-harm or attempt to end their life, leading to reduced safety and poorer experiences. Currently, in the UK National Health Service (NHS) there are no standardised, evidence-based interventions in acute paediatric care to mitigate or minimise immediate risk of self-harm and suicide in CYP admitted with mental health crisis. Objective: To outline the protocol for the SAPhE Pathway study which aims to: 1) identify and prioritise risk mitigation strategies to include in the digital prototype, 2) understand the feasibility of implementing a novel digital risk mitigation pathway in differing NHS contexts, and 3) co-create a prototype digital risk mitigation pathway. Methods: This is a multi-centre study uses a mixed-methods design. A systematic review and exploratory methods (interviews, surveys, and focus groups) will be used to identify the content and feasibility of implementing a digital risk mitigation pathway. Participants will include healthcare professionals, digital experts and CYP with experience of mental health conditions. Data will be collected between January 2022 and March 2023 and analysed using content and thematic analysis, case study, cross-case analysis for qualitative data and descriptive statistics for quantitative data. Findings will inform the experience-based co-design workshops. Ethics and Dissemination: The study received full ethical approval from NHS REC [Ref: 22/SC/0237 and 22/WM/0167]. Findings will be made available to all stakeholders using multiple approaches.

c-kit expression identifies cardiovascular precursors in the neonatal heart.

Directed differentiation of embryonic stem cells indicates that mesodermal lineages in the mammalian heart (cardiac, endothelial, and smooth muscle cells) develop from a common, multipotent cardiovascular precursor. To isolate and characterize the lineage potential of a resident pool of cardiovascular progenitor cells (CPcs), we developed BAC transgenic mice in which enhanced green fluorescent protein (EGFP) is placed under control of the c-kit locus (c-kit(BAC)-EGFP mice). Discrete c-kit-EGFP(+) cells were observed at different stages of differentiation in embryonic hearts, increasing in number to a maximum at about postnatal day (PN) 2; thereafter, EGFP(+) cells declined and were rarely observed in the adult heart. EGFP(+) cells purified from PN 0-5 hearts were nestin(+) and expanded in culture; 67% of cells were fluorescent after 9 days. Purified cells differentiated into endothelial, cardiac, and smooth muscle cells, and differentiation could be directed by specific growth factors. CPc-derived cardiac myocytes displayed rhythmic beating and action potentials characteristic of multiple cardiac cell types, similar to ES cell-derived cardiomyocytes. Single-cell dilution studies confirmed the potential of individual CPcs to form all 3 cardiovascular lineages. In adult hearts, cryoablation resulted in c-kit-EGFP(+) expression, peaking 7 days postcryolesion. Expression occurred in endothelial and smooth muscle cells in the revascularizing infarct, and in terminally differentiated cardiomyocytes in the border zone surrounding the infarct. Thus, c-kit expression marks CPc in the neonatal heart that are capable of directed differentiation in vitro; however, c-kit expression in cardiomyocytes in the adult heart after injury does not identify cardiac myogenesis.

Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops.

BACKGROUND: With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. METHODS: A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. RESULTS: The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one. CONCLUSION: This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE.

Perceptions of Cognitive Training Games and Assessment Technologies for Dementia: Acceptability Study With Patient and Public Involvement Workshops.

BACKGROUND: Cognitive training and assessment technologies offer the promise of dementia risk reduction and a more timely diagnosis of dementia, respectively. Cognitive training games may help reduce the lifetime risk of dementia by helping to build cognitive reserve, whereas cognitive assessment technologies offer the opportunity for a more convenient approach to early detection or screening. OBJECTIVE: This study aims to elicit perspectives of potential end users on factors related to the acceptability of cognitive training games and assessment technologies, including their opinions on the meaningfulness of measurement of cognition, barriers to and facilitators of adoption, motivations to use games, and interrelationships with existing health care infrastructure. METHODS: Four linked workshops were conducted with the same group, each focusing on a specific topic: meaningful improvement, learning and motivation, trust in digital diagnosis, and barriers to technology adoption. Participants in the workshops included local involvement team members acting as facilitators and those recruited via Join Dementia Research through a purposive selection and volunteer sampling method. Group activities were recorded, and transcripts were analyzed using thematic analysis with a combination of a priori and data-driven themes. Using a mixed methods approach, we investigated the relationships between the categories of the Capability, Opportunity, and Motivation-Behavior change model along with data-driven themes by measuring the φ coefficient between coded excerpts and ensuring the reliability of our coding scheme by using independent reviewers and assessing interrater reliability. Finally, we explored these themes and their relationships to address our research objectives. RESULTS: In addition to discussions around the capability, motivation, and opportunity categories, several important themes emerged during the workshops: family and friends, cognition and mood, work and hobbies, and technology. Group participants mentioned the importance of functional and objective measures of cognitive change, the social aspect of activities as a motivating factor, and the opportunities and potential shortcomings of digital health care provision. Our quantitative results indicated at least moderate agreement on all but one of the coding schemes and good independence of our coding categories. Positive and statistically significant φ coefficients were observed between several coding themes between categories, including a relatively strong positive φ coefficient between capability and cognition (0.468; P<.001). CONCLUSIONS: The implications for researchers and technology developers include assessing how cognitive training and screening pathways would integrate into existing health care systems; however, further work needs to be undertaken to address barriers to adoption and the potential real-world impact of cognitive training and screening technologies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1007/978-3-030-49065-2_4.

Baseline Aerobic Fitness in High School and College Football Players: Critical for Prescribing Safe Exercise Regimens.

BACKGROUND: Nontraumatic fatalities occur on a regular basis in high school (HS) and college football athletes, primarily in obese linemen performing high-intensity exercise. One contributing factor to these deaths may be a mismatch between baseline aerobic (cardiorespiratory) fitness and exercise regimens. HYPOTHESIS: There is a wide range of aerobic fitness in HS and college football players. Body mass index (BMI) is a safe and simple method for estimating baseline aerobic fitness. STUDY DESIGN: Retrospective cohort study. LEVEL OF EVIDENCE: Level 3. METHODS: A retrospective review was performed on 79 HS football athletes who had VO2Peak (mL·kg-1·min-1) measured during the offseason. Multivariate regression analysis was used to determine if BMI (obese, overweight, and normal; kg/m2), position played (linemen vs other), year in school (freshmen vs other), and/or race (African American vs White) were risk factors for poor aerobic fitness. A separate cohort of 135 (48 HS; 87 college) football athletes performed a 6-minute run test to determine speed (miles/min), extrapolate VO2Max, and calculate reference values for suggested upper threshold safe starting speeds (85% of maximum) for aerobic training based on BMI. The relationship between BMI and VO2Peak was assessed. The exercise regimens (speeds) of 2 collegiate football fatalities from the public domain were used to predict their VO2Max values. RESULTS: Mean VO2Peak (mL·kg-1·min-1) was 38.5 ± 8.6 (range 19.1-60.6); when grouped by BMI, low scores (<40) were found in 87.5% of obese (32.4 ± 7.7), 47.8% of overweight (40.8 ± 7.6), and 45.2% of normal (41.4 ± 7.8) athletes. VO2Peak was significantly lower in linemen (32.8 ± 6.4; P = 0.007) compared with nonlineman (41.8 ± 7.9), and in obese players (by BMI; 32.4; P = 0.019) compared with nonobese players (41.4 ± 7.6), but did not differ by age, year in school, or race. Means for speed (min/mile) and extrapolated VO2Max (mL·kg-1·min-1) for the 6-minute run test by BMI groups were both significantly different (P = 0.001) for normal (7.0 ± 0.6; 51.1 ± 2.6), overweight (7.6 ± 0.8; 46.5 ± 3.2), and obese (8.9 ± 1.5; 36.8 ± 5.9) athletes. There was a significant negative correlation (r = -0.551; P = 0.001; R2 = 0.304) between VO2Peak and BMI. Safe starting speed recommendations for running 1 mile range from 7.3 to 12.1 min/mile for BMIs 20 to 40 kg/m2 for HS and college athletes. For the 2 fatalities (mean, BMI of 36.5 kg/m2) repetitive sprint speeds were 49 and 89% higher than our safe starting speeds for their BMI. CONCLUSION: A large spectrum of baseline aerobic fitness was noted in HS and college football players. Obese players and linemen had statistically lower baseline aerobic fitness, a major risk factor for possible heat illness. BMI is an acceptable surrogate for VO2Peak and can be employed to develop safe training regimens without the need for a maximum fitness test, which can place the athlete at risk for a medical event. CLINICAL RELEVANCE: Knowledge of BMI provides an estimate of baseline aerobic fitness and a foundation for prescribing safe, individualized exercise regimens.

Insights on conducting digital patient and public involvement in dementia research during the COVID-19 pandemic: supporting the development of an "E-nabling digital co-production" framework.

BACKGROUND: The rapid transition to digital working, accelerated due to the response to the COVID-19 pandemic, has impacted the involvement of patients and public in research. This paper presents experiences of engaging in digital Patient and Public Involvement (e-PPI) in dementia research since the lockdowns, offering recommendations regarding future digital and hybrid working. Furthermore, it introduces a co-produced framework for researchers, PPI coordinators and public contributors to identify and discuss challenges and opportunities provided by e-PPI. METHODS: Two online workshops and one individual interview were performed with a group of researchers and PPI coordinators with experience in PPI in dementia research, and with an existing dementia PPI group having some experience of working online during the pandemic. The project was constructed as a PPI activity, with the MindTech Involvement Team (PPI group) involved in the entire process, and a collaborative data analysis process was adopted. RESULTS: After refinement of the coding structure, the MindTech Involvement Team and Project Leaders identified four main themes, resulting in the 'E-nabling Digital Co-production' Framework. During this framework development, different positions were expressed, associated with the transition to digital working. Two main themes were shared by the participating groups regarding e-PPI: wider potential reach without geographical constraints, and the perception of more business-like sessions with reduced opportunities for social interactions and communication. Specifically for dementia research, whilst e-PPI may allow public contributors to attend more meetings, potentially mutually supportive environments provided by face-to-face meetings could be diminished, with carers experiencing a possible reduction in informal respite opportunities. CONCLUSIONS: Through involving public contributors, researchers, and PPI coordinators with a focus on digital PPI in dementia research, we were able to further refine and co-produce the 'E-nabling Digital Co-production' Framework. Demonstrating potential for analysis of benefits and limitations within e-PPI, it was possible to identify both general insights and those specific to dementia research. However, the most significant contribution of the framework is the potential to support local journeys of co-production in ongoing digital and hybrid public involvement activities.

The COVID-19 pandemic has impacted the engagement of patients and the public in research. Lockdowns, social distancing, and reduced physical contact have affected the involvement of public contributors in research studies. In particular, the pandemic triggered a rapid transition to digital working, increasing the use of Information and Communication Technologies such as video conferencing on computers and mobile devices. With little time to reflect on the consequences of digital working in PPI and with a continuing legacy of hybrid or blended approaches to involvement, this project highlights the challenges and potential for e-PPI approaches (electronic/digital PPI) within the context of dementia research. In addition to examining the transition to digital working in this area, we present a co-produced framework for researchers, PPI coordinators and public contributors.

A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial).

BACKGROUND: Major depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation. METHODS: The aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions. DISCUSSION: This study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms. TRIAL REGISTRATION: ISRTCN ISRCTN11853110 . Registered on 14 August 2020.

This is Me: Evaluation of a boardgame to promote social engagement, wellbeing and agency in people with dementia through mindful life-storytelling.

Receiving a dementia diagnosis is a difficult experience for most people and often affects their wellbeing negatively. To support people's wellbeing, in a therapeutic context, life-storytelling, reminiscence and mindfulness are used with people with dementia. In an everyday context, traditional games are used as a resource for stimulating memory, cognition and social activity. While an increasing number of creative strategies are available to support people with dementia, the area of board games design and their effect on wellbeing is underexplored. This paper reports on the evaluation of the This is Me (TIM) mindful life-storytelling board game by the European project MinD. Using a co-design methodology, TIM was developed with and for people with mild to moderate dementia to support their wellbeing by enhancing self-empowerment and social engagement. A focus group methodology was used to evaluate TIM with 50 people with dementia and 19 carers across four countries. TIM was evaluated with regard to the usability and experience of the design as well as people's emotional wellbeing, social engagement and agency. The thematic analysis demonstrated that the combination of life-storytelling and mindfulness allowed players to engage in meaningful social interaction and, as a result, they reported enjoyment, learning, more acceptance of the past and present situation, and that they perceived looking forward into the future together with others as helpful. The study demonstrates that design can be a useful means to support people with dementia in aspects of emotional wellbeing, social engagement and a sense of agency.

The role of the user within the medical device design and development process: medical device manufacturers' perspectives.

BACKGROUND: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. METHODS: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. RESULTS: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. CONCLUSIONS: Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised.