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.

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.

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.

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.

Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange).

INTRODUCTION: Many patients with psychosis experience everyday social situations as anxiety-provoking. The fears can arise, for example, from paranoia, hallucinations, social anxiety or negative-self beliefs. The fears lead patients to withdraw from activities, and this isolation leads to a cycle of worsening physical and mental health. Breaking this cycle requires highly active treatment directly in the troubling situations so that patients learn that they can safely and confidently enter them. However patients with psychosis seldom receive such life-changing interventions. To solve this problem we have developed an automated psychological treatment delivered in virtual reality (VR). It allows patients to experience computer simulations of the situations that they find anxiety-provoking. A virtual coach guides patients, using cognitive techniques, in how to overcome their fears. Patients are willing to enter VR simulations of anxiety-provoking situations because they know the simulations are not real, but the learning made transfers to the real world. METHODS AND ANALYSIS: 432 patients with psychosis and anxious avoidance of social situations will be recruited from National Health Service (NHS) secondary care services. In the gameChange trial, they will be randomised (1:1) to the six-session VR cognitive treatment added to treatment as usual or treatment as usual alone. Assessments will be conducted at 0, 6 (post-treatment) and 26 weeks by a researcher blind to allocation. The primary outcome is avoidance and distress in real-life situations, using a behavioural assessment task, at 6 weeks. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention-to-treat. Moderation and mediation will be tested. An economic evaluation will be conducted. ETHICS AND DISSEMINATION: The trial has received ethical approval from the NHS South Central - Oxford B Research Ethics Committee (19/SC/0075). A key output will be a high-quality automated VR treatment for patients to overcome anxious avoidance of social situations. TRIAL REGISTRATION NUMBER: ISRCTN17308399.

Clinical effectiveness and cost minimisation model of Alpha-Stim cranial electrotherapy stimulation in treatment seeking patients with moderate to severe generalised anxiety disorder.

BACKGROUND: Cranial electrotherapy stimulation (CES) is a well-tolerated neuromodulation treatment with demonstrated trial efficacy in anxiety disorders. The aim of the current study was to demonstrate its clinical and cost effectiveness during and after CES in people with generalised anxiety disorder (GAD) who had not responded to low intensity psychological treatment in a routine health service. METHODS: Consecutive sample of eligible patients with GAD waiting for individual cognitive behaviour therapy (CBT) selected from two publicly funded services in England. They received 60 min per day Alpha-Stim CES for 6-12 weeks. Primary outcome was remission on the GAD-7 scale at 12 and 24 weeks. Cost effectiveness was examined using a cost minimisation model of direct health costs. RESULTS: Of 161 patients recruited, 72 (44.7%) and 77 (47.8%) achieved remission on the GAD-7 at 12 and 24 weeks respectively with 122 (75.8%) receiving at least 6 weeks CES. Mean (sd) GAD-7 score at baseline significantly improved from 15.77 (3.21) to 8.92 (5.42) and 8.99 (6.18) at 12 and 24 weeks respectively (p < 0.001). 80 (49.7%) participants required further individual CBT. CES provided a saving of £540.88 per patient (95% CI -£327.12, £648.69). LIMITATIONS: Participants were not randomised and there was no control group. Only 48 (29.9%) participants completed every assessment. CONCLUSION: In patients with generalised anxiety disorder not responding to low intensity psychological treatment, 6-12 weeks daily Alpha Stim CES may be effective after treatment and 3 months later, thereby reducing the need for individual CBT and saving health costs.

Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents-'Online Remote Behavioural Intervention for Tics' (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial.

INTRODUCTION: Tourette syndrome and chronic tic disorder are common, disabling childhood-onset conditions. Guidelines recommend that behavioural therapy should be offered as first-line treatment for children with tics. However, there are very few trained behaviour therapists for tics and many patients cannot access appropriate care. This trial investigates whether an internet-delivered intervention for tics can reduce severity of symptoms. METHODS AND ANALYSIS: This parallel-group, single-blind, randomised controlled superiority trial with an internal pilot will recruit children and young people (aged 9-17 years) with tic disorders. Participants will be randomised to receive 10 weeks of either online, remotely delivered, therapist-supported exposure response prevention behavioural therapy for tics, or online, remotely delivered, therapist-supported education about tics and co-occurring conditions. Participants will be followed up mid-treatment, and 3, 6, 12 and 18 months post randomisation.The primary outcome is reduction in tic severity as measured on the Yale Global Tic Severity Scale total tic severity score. Secondary outcomes include a cost-effectiveness analysis and estimate of the longer-term impact on patient outcomes and healthcare services. An integrated process evaluation will analyse quantitative and qualitative data in order to fully explore the implementation of the intervention and identify barriers and facilitators to implementation. The trial is funded by the National Institute of Health Research (NIHR), Health Technology Assessment (16/19/02). ETHICS AND DISSEMINATION: The findings from the study will inform clinicians, healthcare providers and policy makers about the clinical and cost-effectiveness of an internet delivered treatment for children and young people with tics. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref.: 18/NW/0079). TRIAL REGISTRATION NUMBERS: ISRCTN70758207 and NCT03483493; Pre-results.

Technologies to Support Community-Dwelling Persons With Dementia: A Position Paper on Issues Regarding Development, Usability, Effectiveness and Cost-Effectiveness, Deployment, and Ethics.

BACKGROUND: With the expected increase in the numbers of persons with dementia, providing timely, adequate, and affordable care and support is challenging. Assistive and health technologies may be a valuable contribution in dementia care, but new challenges may emerge. OBJECTIVE: The aim of our study was to review the state of the art of technologies for persons with dementia regarding issues on development, usability, effectiveness and cost-effectiveness, deployment, and ethics in 3 fields of application of technologies: (1) support with managing everyday life, (2) support with participating in pleasurable and meaningful activities, and (3) support with dementia health and social care provision. The study also aimed to identify gaps in the evidence and challenges for future research. METHODS: Reviews of literature and expert opinions were used in our study. Literature searches were conducted on usability, effectiveness and cost-effectiveness, and ethics using PubMed, Embase, CINAHL, and PsycINFO databases with no time limit. Selection criteria in our selected technology fields were reviews in English for community-dwelling persons with dementia. Regarding deployment issues, searches were done in Health Technology Assessment databases. RESULTS: According to our results, persons with dementia want to be included in the development of technologies; there is little research on the usability of assistive technologies; various benefits are reported but are mainly based on low-quality studies; barriers to deployment of technologies in dementia care were identified, and ethical issues were raised by researchers but often not studied. Many challenges remain such as including the target group more often in development, performing more high-quality studies on usability and effectiveness and cost-effectiveness, creating and having access to high-quality datasets on existing technologies to enable adequate deployment of technologies in dementia care, and ensuring that ethical issues are considered an important topic for researchers to include in their evaluation of assistive technologies. CONCLUSIONS: Based on these findings, various actions are recommended for development, usability, effectiveness and cost-effectiveness, deployment, and ethics of assistive and health technologies across Europe. These include avoiding replication of technology development that is unhelpful or ineffective and focusing on how technologies succeed in addressing individual needs of persons with dementia. Furthermore, it is suggested to include these recommendations in national and international calls for funding and assistive technology research programs. Finally, practitioners, policy makers, care insurers, and care providers should work together with technology enterprises and researchers to prepare strategies for the implementation of assistive technologies in different care settings. This may help future generations of persons with dementia to utilize available and affordable technologies and, ultimately, to benefit from them.

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.

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.