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Abstract 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.

Abstract 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.

BackgroundEpilepsy, multiple sclerosis (MS), and depression are chronic conditions where technology holds potential in clinical monitoring and self-management. Over 5 years, the Remote Assessment of Disease and Relapse - Central Nervous System (RADAR-CNS) consortium has explored the application of remote measurement technology (RMT) to the management and self-management of patients in these clinical areas. The consortium is large and includes clinical and nonclinical researchers as well as a patient advisory board. ObjectiveThis formative development study aimed to understand how consortium members viewed the potential of RMT in epilepsy, MS, and depression. MethodsIn this qualitative survey study, we developed a methodological tool, universal points of care (UPOC), to gather views on the potential use, acceptance, and value of a novel RMT platform across 3 chronic conditions (MS, epilepsy, and depression). UPOC builds upon use case scenario methodology, using expert elicitation and analysis of care pathways to develop scenarios applicable across multiple conditions. After developing scenarios, we elicited views on the potential of RMT in these different scenarios through a survey administered to 28 subject matter experts, consisting of 16 health care practitioners; 5 health care services researchers; and 7 people with lived experience of MS, epilepsy, or depression. Survey results were analyzed thematically and using an existing framework of factors describing links between design and context. ResultsThe survey elicited potential beneficial applications of the RADAR-CNS RMT system as well as patient, clinical, and nonclinical requirements of RMT across the 3 conditions of interest. Potential applications included recognition of early warning signs of relapse from subclinical signals for MS, seizure precipitant signals for epilepsy, and behavior change in depression. RMT was also thought to have the potential to overcome the problem of underreporting, which is especially problematic in epilepsy, and to allow the capture of secondary symptoms that are not generally collected in MS, such as mood. ConclusionsRespondents suggested novel and unanticipated uses of RMT, including the use of RMT to detect emerging side effects of treatment, enable behavior change for sleep regulation and activity, and offer a way to include family and other carers in a care network, which could assist with goal setting. These suggestions, together with others from this and related work, will inform the development of the system for its eventual application in research and clinical practice. The UPOC methodology was effective in directing respondents to consider the value of health care technologies in condition-specific experiences of everyday life and working practice.

BackgroundRemote 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. ObjectiveThis 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). MethodsSemistructured 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. ResultsA 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. ConclusionsRMT 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.

BackgroundDigital tools have the potential to support patient activation and shared decision making in the face of increasing levels of mental health problems in young people. There is a need for feasibility trials of digital interventions to determine the usage and acceptability of interventions. In addition, there is a need to determine the ability to recruit and retain research participants to plan rigorous effectiveness trials and, therefore, develop evidence-based recommendations for practice. ObjectiveThis study aimed to determine the feasibility of undertaking a cluster randomized controlled trial to test the effectiveness of a smartphone app, Power Up, co-designed with young people to support patient activation and shared decision making for mental health. MethodsOverall, 270 young people were screened for participation and 52.5% (142/270) were recruited and completed baseline measures across 8 specialist child mental health services (n=62, mean age 14.66 (SD 1.99) year; 52% [32/62] female) and 2 mainstream secondary schools (n=80; mean age 16.88 [SD 0.68] years; 46% [37/80] female). Young people received Power Up in addition to management as usual or received management as usual only. Posttrial interviews were conducted with 11 young people from the intervention arms (specialist services n=6; schools n=5). ResultsUsage data showed that there were an estimated 50 (out of 64) users of Power Up in the intervention arms. Findings from the interviews indicated that young people found Power Up to be acceptable. Young people reported (1) their motivation for use of Power Up, (2) the impact of use, and (3) barriers to use. Out of the 142 recruited participants, 45.0% (64/142) completed follow-up measures, and the approaches to increase retention agreed by the steering group are discussed. ConclusionsThe findings of this study indicate that the app is acceptable, and it is feasible to examine the effectiveness of Power Up in a prospective cluster randomized controlled trial. Trial RegistrationClinicalTrials.gov NCT02552797; https://clinicaltrials.gov/ct2/show/NCT02552797 (Archived by WebCite at http://www.webcitation.org/6td6MINP0)

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

BackgroundGuidelines in the United Kingdom recommend that medication titration for attention deficit hyperactivity disorder (ADHD) should be completed within 4-6 weeks and include regular reviews. However, most clinicians think that weekly clinic contact is infeasible, and audits have shown that this timeline is rarely achieved. Thus, a more effective monitoring and review system is needed; remote monitoring technology (RMT) may be one way to improve current practice. However, little is known about whether patients with ADHD, their families, and clinicians would be interested in using RMT. ObjectiveTo explore patients’, parents’, and health care professionals’ views and attitudes toward using digital technology for remote monitoring during titration for ADHD. MethodsThis was a qualitative study, and data were collected through 11 focus groups with adults and young people with ADHD, parents of children with ADHD, and health care professionals (N=59). ResultsAll participant groups were positive about using RMT in the treatment of ADHD, but they were also aware of barriers to its use, especially around access to technology and integrating RMT into clinical care. They identified that RMT had the most potential for use in the ongoing management and support of ADHD, rather than during the distinct titration period. Participants identified features of RMT that could improve the quality of consultations and support greater self-management. ConclusionsRMT has the potential to augment support and care for ADHD, but it needs to go beyond the titration period and offer more to patients and families than monitoring through outcome measures. Developing and evaluating an mHealth app that incorporates the key features identified by end users is required.

Background: Multiple sclerosis (MS), epilepsy, and depression are chronic central nervous system conditions in which remote measurement technology (RMT) may offer benefits compared with usual assessment. We previously worked with clinicians, patients, and researchers to develop 13 use cases for RMT: 5 in epilepsy (seizure alert, seizure counting, risk scoring, triage support, and trend analysis), 3 in MS (detecting silent progression, detecting depression in MS, and donating data to a biobank), and 5 in depression (detecting trends, reviewing treatment, self-management, comorbid monitoring, and carer alert). Objective: In this study, we aimed to evaluate the use cases and related implementation issues with an expert panel of clinicians external to our project consortium. Methods: We used a Delphi exercise to validate the use cases and suggest a prioritization among them and to ascertain the importance of a variety of implementation issues related to RMT. The expert panel included clinicians from across Europe who were external to the project consortium. The study had 2 survey rounds (n=23 and n=17) and a follow-up interview round (n=9). Data were analyzed for consensus between participants and for stability between survey rounds. The interviews explored the reasons for answers given in the survey. Results: The findings showed high stability between rounds on questions related to specific use cases but lower stability on questions relating to wider issues around the implementation of RMT. Overall, questions on wider issues also had less consensus. All 5 use cases for epilepsy (seizure alert, seizure counting, risk scoring, triage support, and trend analysis) were considered beneficial, with consensus among participants above the a priori threshold for most questions, although use case 3 (risk scoring) was considered less likely to facilitate or catalyze care. There was very little consensus on the benefits of the use cases in MS, although this may have resulted from a higher dropout rate of MS clinicians (50%). Participants agreed that there would be benefits for all 5 of the depression use cases, although fewer questions on use case 4 (triage support) reached consensus agreement than for depression use cases 1 (detecting trends), 2 (reviewing treatment), 3 (self-management), and 5 (carer alert). The qualitative analysis revealed further insights into each use case and generated 8 themes on practical issues related to implementation. Conclusions: Overall, these findings inform the prioritization of use cases for RMT that could be developed in future work, which may include clinical trials, cost-effectiveness studies, and the commercial development of RMT products and services. Priorities for further development include the use of RMT to provide more accurate records of symptoms and treatment response than is currently possible and to provide data that could help inform patient triage and generate timely alerts for patients and carers. [ABSTRACT FROM AUTHOR]