Abstract NS1: Mobile Health Technology Is Feasible And Effective For Self-management Support Among Underserved Stroke Survivors

Background and Purpose: Self-management Support (SMS) helps stroke survivors control risk factors to prevent second stroke. Little is known about feasibility and effectiveness of using mobile health technology (MHT) for SMS among underserved stroke survivors. The investigators studied feasibility and effectiveness of using a video teleconference mobile application to deliver a SMS program to underserved, hard to reach stroke survivors. Methods: The Video teleconference Self-management TO Prevent stroke (V-STOP) program was evaluated using longitudinal design with measurements at baseline, immediately post intervention (6 weeks), intermediate (12 weeks), and at study end (18 weeks). Medically underserved stroke survivors with uncontrolled stroke risk factors were included. Feasibility was assessed as time in intervention, telehealth satisfaction, stroke knowledge and SMS effectiveness were measured as psychological (depression, PHQ-8; anxiety, GAD-7), social (community integration questionnaire), and stroke self-management (goal attainment) outcomes. Generalized estimating equations were used with site and time in intervention as covariates. Results: V-STOP was successfully delivered to 106 participants using MHT over 2 years. Mean age was 59.3 (±10.9), majority were white (82.1%), males (54.3%), not living alone (85.9%), married (52.8%), with low annual income (<$25,000) ( 58.5%), and health insurance (59.4%). Program feasibility indicated mean number of V-STOP sessions were 4.6 (±1.8), with 4.4 (±2.0) hours of total time for the intervention. Overall satisfaction at 6 weeks with V-STOP (4.8(±0.5)) and telehealth (4.7(±0.5)) was high. Stroke knowledge was high at 12 weeks (9.6(±0.7)). SMS effectiveness indicated improvement in psychological outcomes at 6, 12, and 18 weeks from baseline; depression (18 weeks - β = 0.64 (CI 0.49-0.84)) and anxiety (18 weeks - β = 0.66 (CI 0.51-0.85)). Community integration improved by 18 weeks - β = 1.08 (CI 1.01-1.16) and stroke self-management also improved long term at 12 and 18 weeks (β = 0.92 (CI 0.84-0.99). Conclusion: MHT is feasible to deliver SMS to underserved stroke survivors. It improves psycho-social and self-management goal setting and goal attainment outcomes.

Comparing Two Approaches for Thyroidectomy: A Health Technology Assessment through DMAIC Cycle

Total thyroidectomy is very common in endocrine surgery and the haemostasis can be obtained in different ways across surgery; recently, some devices have been developed to support this surgical phase. In this paper, a health technology assessment is conducted through the define, measure, analyse, improve, and control cycle of the Six Sigma methodology to compare traditional total thyroidectomy with the surgical operation performed through a new device in an overall population of 104 patients. Length of hospital stay, drain output, and time for surgery were considered the critical to qualities in order to compare the surgical approaches which can be considered equal regarding the organizational, ethical, and security impact. Statistical tests (Kolmogorov–Smirnov, t test, ANOVA, Mann–Whitney, and Kruskal–Wallis tests) and visual management diagrams were employed to compare the approaches, but no statistically significant difference was found between them. Considering these results, this study shows that the introduction of the device to perform total thyroidectomy does not guarantee appreciable clinical advantages. A cost analysis to quantify the economic impact of the device into the practice could be a future development. Healthy policy leaders and clinicians who are requested to make decisions regarding the supply of biomedical technologies could benefit from this research.

Does the use of mobile applications or mobile health technology improve diet quality in adults? A protocol for a systematic literature review

Background: Mobile technology has grown at an exceptional rate and is now a huge part of our daily living. This use of mobile technology has opened up new possibilities in treating health, with almost half of the current applications linked to the mHealth sector. In particular, dietary measurement, applications have become very accessible and very popular. As dietary issues have become more prevalent, more mobile and mHealth applications offer various solutions. This systematic review aims to address if the use of such mobile applications or mobile health technology can improve diet quality in adults that interact with them. Methods: A systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. The Cumulative Index to Nursing and Allied Health Literature (Cinahl), The American Psychological Association’s (APA Psycinfo), and PubMed will be searched from January 2010 to November 2021. Primary outcomes will include identifying if adults who use mobile applications and health technology improve their diet quality compared to adults who do not use this technology. Study selection will follow the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines. The methodological appraisal of the studies will be assessed independently by two different reviewers (AS and JR) using the Cochrane Risk-of-Bias Tool for RCTs and the Risk-of Bias In Non-Randomised Studies Tool for NRCTs. Ethics and dissemination: Ethical approval is not essential for this systematic review. Only data from studies that are publically available from previously published studies will be used. The findings of this systematic review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. PROSPERO registration: CRD42021240224 (01/03/2021).

How innovation can be defined, evaluated and rewarded in health technology assessment

Background What constitutes innovation in health technologies can be defined and measured in a number of ways and it has been widely researched and published about. However, while many countries mention it as a criterion for pricing or reimbursement of health technologies, countries differ widely in how they define and operationalise it. Methods We performed a literature review, using a snowballing search. In this paper, we explore how innovation has been defined in the literature in relation to health technology assessment. We also describe how a selection of countries (England, France, Italy, Spain and Japan) take account of innovation in their health technology assessment frameworks and explore the key methodologies that can capture it as a dimension of value in a new health technology. We propose a way of coming to, and incorporating into health technology assessment systems, a definition of innovation for health technologies that is independent of other dimensions of value that they already account for in their systems, such as clinical benefit. We use Spain as an illustrative example of how innovation might be operationalised as a criterion for decision making in health technology assessment. Results The countries analysed here can be divided into 2 groups with respect to how they define innovation. France, Japan and Italy use features such as severity, unmet need and therapeutic added value as indicators of the degree of innovation of a health technology, while England, Spain consider the degree of innovation as a separate and additional criterion from others. In the case of Spain, a notion of innovation might be constructed around concepts of `step-change’, `convenience’, `strength of evidence base’ and `impact on future research & development’. Conclusions If innovation is to be used as operational criteria for adoption, pricing and reimbursement of health technologies, the concept must be clearly defined, and it ought to be independent from other value dimensions already captured in their health technology assessment systems.

Health technology assessment-informed pricing negotiation in China: higher negotiated price for more effective targeted anticancer medicines?

Background In China, health technology assessment (HTA) has recently been adopted in pricing negotiation for medicine listing in the National Reimbursement Drug List. At present, how HTA is applied to inform the decision-making process remains underreported. In order to explore how the adoption of HTA was translated into listing and price negotiation results in light of the confidential nature of the negotiating process, this study aimed to compare the negotiated price and the clinical benefit of selected targeted anticancer medicines (TAMs) involved in the 2019 negotiation. Main text Among 16 TAMs successfully negotiated, only four TAMs representing four indication groups had appropriate reference medicines for comparison and were, therefore, included in the analysis. The price and clinical benefit of the four TAMs were compared against one or two reference medicines with the same initial indications. The sales prices for nine TAMs before and after the negotiation were extracted from the centralized medication procurement system. Clinical benefits were evaluated based on evidence from published articles and clinical guidelines. The results suggested that, despite the application of HTA, both rational and irrational decisions had been made about the reimbursement of TAMs in the 2019 negotiation, warranting further investigation. Conclusion While the development and adoption of HTA has seen significant progress in China, actions are needed to ensure that the adoption of HTA is effectively applied in decisions on the reimbursement of medicines.

Ethical and Regulatory Challenges of Emerging Health Technologies

The advances in biotechnology and computer and data sciences opened the way for innovative approaches to human healthcare. Meanwhile, they created many ethical and regulatory dilemmas such as pervasive global inequalities and security and risk to data privacy. The assessment of health technology is a systematic multidisciplinary process that aims to examine the benefits and risks associated with its use including medical, social, economic, and ethical impacts. It is used to inform policy and optimize decision-making. The advance of technology is creating significant challenges to healthcare regulators who strive to balance patient safety to fostering innovation. The FDA and EMA are modernizing their regulatory approaches to foster innovation in digital technology and improve safety and applicability to patients. On the other hand, data analytic technologies have been introduced into regulatory decision processes.

Real-world data from expanded access programmes in health technology assessments: a review of NICE technology appraisals

ObjectivesTo quantify and characterise the usage of expanded access (EA) data in National Institute for Health and Care Excellence (NICE) technology appraisals (TAs). EA offers patients who are ineligible for clinical trials or registered treatment options, access to investigational therapies. Although EA programmes are increasingly used to collect real-world data, it is unknown if and how these date are used in NICE health technology assessments.DesignCross-sectional study of NICE appraisals (2010–2020). We automatically downloaded and screened all available appraisal documentation on NICE website (over 8500 documents), searching for EA-related terms. Two reviewers independently labelled the EA usage by disease area, and whether it was used to inform safety, efficacy and/or resource use. We qualitatively describe the five appraisals with the most occurrences of EA-related terms.Primary outcome measureNumber of TAs that used EA data to inform safety, efficacy and/or resource use analyses.ResultsIn 54.2% (206/380 appraisals), at least one reference to EA was made. 21.1% (80/380) of the TAs used EA data to inform safety (n=43), efficacy (n=47) and/or resource use (n=52). The number of TAs that use EA data remained stable over time, and the extent of EA data utilisation varied by disease area (p=0.001).ConclusionNICE uses EA data in over one in five appraisals. In synthesis with evidence from well-controlled trials, data collected from EA programmes may meaningfully inform cost-effectiveness modelling.