Medical Technologies Evaluation Research Articles

Feasibility study of the use of a wearable vital sign patch in an intensive care unit setting.

Multiple studies and review papers have concluded that early warning systems have a positive effect on clinical outcomes, patient safety and clinical performances. Despite the substantial evidence affirming the efficacy of EWS applications, persistent barriers hinder their seamless integration into clinical practice. Notably, EWS, such as the National Early Warning Score, simplify multifaceted clinical conditions into singular numerical indices, thereby risking the oversight of critical clinical indicators and nuanced fluctuations in patients' health status. Furthermore, the optimal deployment of EWS within clinical contexts remains elusive. Manual assessment of EWS parameters exacts a significant temporal toll on healthcare personnel. Addressing these impediments necessitates innovative approaches. In this regard, wearable medical technologies emerge as promising solutions capable of continual monitoring of hospitalized patients' vital signs. To overcome the barriers of the use of early warning scores, wearable medical technology has the potential to continuously monitor vital signs of hospitalised patients. However, a fundamental inquiry arises regarding the comparability of their reliability to the current used golden standards. This inquiry underscores the imperative for rigorous evaluation and validation of wearable medical technologies to ascertain their efficacy in augmenting extant clinical practices. This prospective, single-center study aimed to evaluate the accuracy of heart rate and respiratory rate measurements obtained from the Vivalink Cardiac patch in comparison to the ECG-based monitoring system utilized at AZ Maria Middelares Hospital in Ghent. Specifically, the study focused on assessing the concordance between the data obtained from the Vivalink Cardiac patch and the established ECG-based monitoring system among a cohort of ten post-surgical intensive care unit (ICU) patients. Of these patients, five were undergoing mechanical ventilation post-surgery, while the remaining five were not. The study proceeded by initially comparing the data recorded by the Vivalink Cardiac patch with that of the ECG-based monitoring system. Subsequently, the data obtained from both the Vivalink Cardiac patch and the ECG-based monitoring system were juxtaposed with the information derived from the ventilation machine, thereby providing a comprehensive analysis of the patch's performance in monitoring vital signs within the ICU setting. For heart rate, the Vivalink Cardiac patch was on average within a 5% error range of the ECG-based monitoring system during 85.11±10.81% of the measured time. For respiratory rate this was during 40.55±17.28% of the measured time. Spearman's correlation coefficient showed a very high correlation of 8 for heart rate and a moderate correlation of for respiratory rate. In comparison with the ventilated respiratory rate (ventilation machine) the Vivalink and ECG-based monitoring system both had a moderate correlation of A very high correlation was found between the heart rate measured by the Vivalink Cardiac patch and that of the ECG-based monitoring system of the hospital. Concerning respiratory rate the correlation between the data from the Vivalink Cardiac patch, the ECG-based monitoring system and the ventilation machine was found to be moderate.

Sedaconda ACD-S for Sedation with Volatile Anaesthetics in Intensive Care: A NICE Medical Technologies Guidance.

Intensive care unit (ICU) patients receive highly complex care and often require sedation as part of their management. ICU sedation has traditionally been delivered using intravenous (IV) agents due to the impractical use of anaesthetic machines in this setting, which are used to deliver volatile sedation. Sedaconda anaesthetic conserving device (ACD)-S (previously known as AnaConDa-S) is a device which allows for the delivery of volatile sedation via the majority of mechanical ventilators by being inserted in the breathing circuit where the heat and moisture exchanger is normally placed. The National Institute of Health and Care Excellence (NICE), as part of the Medical Technologies Evaluation Programme, considered the potential benefits of using Sedaconda ACD-S compared to standard IV sedation in ICU patients. Here we describe the evidence evaluation undertaken by NICE on this technology, supported by CEDAR. CEDAR considered the evidence present in 21 publications that compared the clinical outcomes of patients receiving Sedaconda ACD-S-delivered sedation and IV sedation, and critiqued the economic model provided by the manufacturer. Clinical expert input during the evaluation process was used extensively to ensure that the relevant clinical evidence was captured and that the economic model was suitable for the UK setting. Due to the uncertainty of the evidence, sensitivity analysis was carried out on the key economic inputs to ensure the reliability of the results. Economic modelling has shown that Sedaconda ACD-S-delivered isoflurane sedation is cost saving on a 30-day horizon compared to IV sedation by £3833.76 per adult patient and by £2837.41 per paediatric patient. Clinical evidence indicated that Sedaconda ACD-S-delivered isoflurane sedation is associated with faster patient wake-up times than standard of care. Consequently, NICE recommended Sedaconda ACD-S as an option for delivering sedation in the ICU setting, but noted that further research should inform whether Sedaconda ACD-S-delivered sedation is of benefit to any particular subgroup of patients.

Rapid Health Technology Assessment of Argatroban in the Treatment of Acute Ischemic Stroke

Objective: Application of rapid health technology to evaluate the effectiveness, safety, and efficacy of Agatroban Injection in the treatment of acute ischemic stroke, providing evidence-based reference for selecting clinical treatment plans. Method: Retrieve Chinese and English medical databases and health technology evaluation websites. Two researchers independently screened and extracted literature based on inclusion and exclusion criteria, evaluated the quality of the literature, and summarized and evaluated the results. Method: A total of 12 articles were included, of which 8 were used for systematic evaluation and meta-analysis, and 4 were used for pharmacoeconomics research. Effectiveness analysis shows that the use of Agatroban injection can improve overall clinical efficacy, as well as improve neurological deficit scores and daily living activity scores. Safety analysis shows that the use of agatroban injection does not increase the risk of bleeding, and the safety is relatively high. The economic analysis results indicate that the use of agatroban injection has specific economic advantages. Conclusion: Agatroban injection has good efficacy, safety, and economic advantages in the treatment of acute ischemic stroke

Economic Burden of Invasive Meningococcal Infection in Children in the Republic of Belarus

Relevance Invasive meningococcal infection (IMI) is a significant clinical problem and is associated with a high probability of severe complications and death. Vaccination programs against meningococcus can achieve significant clinical effectiveness and require significant financial costs. This makes it relevant to study the economic burden of meningococcal infection in the conditions of modern healthcare in order to obtain basic data for subsequent research in the field of evaluation of medical technologies.Aims. To assess the economic burden of IMI in children in the conditions of healthcare in the Republic of BelarusMaterial and methods: a retrospective study using the "cost of illness" method was conducted for 22 children hospitalized in the city children's infectious clinical diseases hospital in 2018-2019. All values are presented in belarusian rubles. The average ± standard deviation, minimum – maximum values, median [Q1, Q3], cost shares (%) are calculated for the cost values. The minimum– maximum values and median [Q1, Q3] were calculated for the age of the patients.Results: taking into account the costs of treatment in healthcare organizations of all patients studied, the share of direct costs of hospitalization was 29.0%, the share of direct costs of diagnosis – 7.2%, the share of direct costs of pharmacotherapy - 8.3%. A significant part of the costs accounted for observations after discharge and amounted to 55.4%.Conclusion: a retrospective study of the economic burden of MI in the Republic of Belarus using the "cost of illness" method in patients hospitalized in a public health organization demonstrates a significant economic burden of this disease, which in the long term is primarily due to the presence of complications in the patient, as well as the impact of the patient's death on the value of total costs. The data obtained can be used in conducting national research on the evaluation of medical technologies.

Clinical Engineering and health policies in Venezuela: challenges and achievements in a changing political context

This article summarizes the evolution of clinical engineering in Venezuela and its interaction with the political environment and health policies. Method: The study consists of a comprehensive review of publications from the Health Technologies Management Unit of Simón Bolívar University throughout 1992-2023, organized into three thematic areas: Technological and Environmental; Relationship with Public Health Policies; and Influence of the Political System. Conclusions: The early history of clinical engineering in Venezuela stands out for its impact on training and technological management to ensure quality and efficiency in the Venezuelan healthcare system. In the first area, it demonstrated the potential for improvement in medical technologies, generating high expectations. The second area focuses on the relationship between technologies and health policies, emphasizing the need to align public policies and technological management. However, challenges identified include the lack of evaluation and selection of appropriate medical technologies and political influence in acquisitions. The third area addresses political influence on the quality of medical care, emphasizing the importance of considering political and technological aspects in decision-making.

OP106 Standing On The Shoulders Of Giants: Adapting Published Health Technology Assessments On Medical Technologies To Singapore’s Context

IntroductionGiven time and resource constraints, health technology assessments (HTAs) should avoid duplicating prior HTAs. This abstract describes the experience of the Agency for Care Effectiveness (ACE) with adapting and building on published HTAs of medical technologies to support efficient decision-making.MethodsUpon defining the scope of an evaluation topic, searches were performed on reference agency websites and HTA networks, such as the International Network of Agencies for Health Technology Assessment, to identify relevant published HTAs. Identified reports were included for evidence synthesis if the inclusion criteria were met. If multiple relevant HTAs were identified, the most recent or comprehensive HTA identified was used as the foundational evidence base and supplemented by additional primary or secondary literature as needed. When deemed necessary, de novo economic models were developed. Where available, reimbursement decisions or recommendations from published HTAs and their applicability to Singapore’s context were also considered. Following ACE’s evaluations, the Ministry of Health Medical Technology Advisory Committee (MTAC) made subsidy recommendations.ResultsTo date, ACE has completed 54 HTA evaluations of medical technologies, 47 (87%) of which incorporated published HTA evidence. Although some MTAC recommendations were aligned with published HTAs, discrepancies were observed that were mainly attributed to evolution of the technology or evidence since publication of HTAs; different local clinical needs or management algorithms; and different local costs of the intervention and comparator. Key challenges in adapting published HTAs included differences in the target population and intervention or comparator in published HTAs, mixed recommendations from published HTAs, and non-English language reports, which may underscore the need to adapt published HTAs to Singapore’s context. To overcome some of these challenges, close consultation with stakeholders is critical to understand local clinical need and care pathways and to gather key information such as costs.ConclusionsPublished HTAs, when used as an evidence base and supplemented by evidence updates and local contextualization, allow for efficient and robust HTA to support decision-making.

HTA112 The NICE Medical Technologies Evaluation Program: An Analysis of Clinical and Economic Evidence Evaluated in Published Medical Technology Guidance

HTA112 The NICE Medical Technologies Evaluation Program: An Analysis of Clinical and Economic Evidence Evaluated in Published Medical Technology Guidance

PP26 Critical Review Of The Reimbursement Process For Software As A Medical Device And Challenges In South Korea

IntroductionThe global artificial intelligence (AI) healthcare market is predicted to grow rapidly. Various technologies for AI-based Software as Medical Device (SaMD) have been developed, and demand for their health insurance reimbursement coverage is increasing. Reimbursement policies for new medical technologies need to be thoroughly examined, despite their role in stimulating the market. The reason is that health insurance finance can have significant impact on the entire country, including patients, providers, and industry.MethodsBased on guidelines for applying Korea’s innovative medical technologies, especially AI-based imaging medical technology, to health insurance, we examined outcome factors such as procedures and benefits. After the guidelines’ publication in 2019, we examined their impact on the medical device market through changes in the number of clinical trials and identified cases in which health insurance was listed.ResultsThe process of registering SaMD’s health insurance occurs in accordance with the existing medical technology evaluation system, and it can take up to 460 days from application to approval. If new technologies, including SaMDs demonstrate significant improvement in diagnostic capabilities and cost-effectiveness compared to existing practices, separate health insurance claims are available. Since the scheme’s announcement in 2019, items approved for SaMD clinical trials have increased (2018: ‘n=4; 2020: n=44; 2021: n=37). However, as of November 2022, only one was listed for health insurance benefits (VUNO Med-DeepBrain®), and one case was not listed on benefits but was recognized for its innovation and entered the market on the premise of suspending the health technology assessment process and accumulating real-world data (VUNO Med-DeepCARS®).™ DeepBrain® is a deep learning-based image reading technology costing about KRW80,000 (USD60) higher than conventional brain-magnetic resonance imaging and readings.ConclusionsThe number of SaMDs attempting clinical trials is increasing, but there is a low number of cases of reimbursement because most technologies are often classified as existing technologies and do not receive additional compensation. Since SaMD continuously is developed by accumulating data and feedback, a flexible system that can reflect this is required.

Réducteur de sinus coronaire : revue de littérature et enjeux autour du registre France Reducer

Coronary sinus Reducer implantation is a percutaneous technique used to treat patients suffering from refractory angina pectoris. The device narrows the coronary sinus, increases the back pressure in the myocardial venous system and forces redistribution of coronary blood flow from less ischemic subepicardium to the more ischemic subendocardium. Multiple clinical studies had proven its efficacy to alleviate myocardial ischemia and related symptoms, and to improve the quality of life of patients with refractory symptomatic chronic coronary artery disease for whom coronary revascularization is deemed unsuitable. This literature review aims to expose the device design, its mechanisms of action, and the clinical data supporting its use.Since November 2021 Reducer's reimbursement has been granted in France by the national health authority. It is the first device to be approved under a newly established reimbursement approval process. A transitional coverage is provided with opportunities for renewal before applying for full-time reimbursement. To fulfill the requirements of the National Commission for Evaluation of Medical Devices and Health Technologies, the French Society of Cardiology has been creating the France Reducer registry. This clinical registry has been collecting data from patients undergoing coronary sinus Reducer implantation regarding their clinical situation, periprocedural information, and one-year follow-up. It is crucial for the future of this emerging therapeutic option in France. To date, 215 patients from 28 centers have been included between June 2022 and September 2023.

Evaluation of Medical Technologies Used to Manage Malaria in Efoulan Health District of Yaounde-Cameroon

Purpose: This study aimed at evaluating medical technologies used to manage malaria at Efoulan health’s district. Problem: With almost 3 million of confirmed cases per year, malaria is the disease that most affects Cameroonians. From March 2020, Cameroon witnessed the advent of massive cases of COVID-19, whose symptoms almost coincide with those of malaria, causing a mix of medical technologies meanwhile, populations and medical personnel are required not to get confused between malaria and Covid-19. Methods: We conducted a retrospective cross-sectional qualitative study for analytical purposes at three levels of comparative analyzes (Malaria protocol, Malaria equipment, and Malaria drugs) using Anova and Pearson correlation. Results: Our study revealed that Malaria protocol in hospitals was moderately and positively correlated to WHO (2023) [1] guidelines at 41.8% [r(30) = .41.8, 95%, p = .019]. Malaria equipment found within the community were statistically significantly different (F(2, 96) = [10.688], p = 0.00) from those recommended by Long (2009) [2] (p = 0.001, 95% C.I. = [-2.01, -0.41]). Antimalarial drugs used within the community and in hospitals were respectively moderately positively correlated at 43.5% [r(20) = .435, 95%, p = .043] and highly positively correlated at 53.3% [r(20) = .533, 95%, p = .011] to WHO (2023) [1] guidelines. Conclusion: To strengthen malaria control, health education on complete malaria protocol must be carried out, first aid medical centers must be better equipped, drugs must be prescribed according to patient’s histories and pre-referral treatments must be applied within the community while integrating traditional concoctions into modern medicine.

Healthcare Applications Using Blockchain Technology: Motivations and Challenges

Blockchain technology is one of the most important inventions and creative advancements that play a crucial role in today's business world. Blockchain technology is heading in the direction of systematic innovation and revolution. It is a digital ledger of transactions, and every block contains information of transactions linked by cryptographic references. Every block covers information and maintains trust among people based on how far they are. Blockchain is a system used for storing data, and it ensures the security of the system. The resurgence in blockchain technology has encouraged scholars and specialists over the past couple of years to carefully examine new ways of implementing blockchain technology with a wide range in the domain of healthcare. This rapid increase in blockchain technology has generated many endless possibilities. In this article, we provide a review of blockchain technology in healthcare. We present a detailed introduction, history, technical information, and types of blockchain technology. Motivations behind this technology and top healthcare projects completed using this technology are also discussed. This article is classified into three groups based on blockchain applications with their use cases. The evaluation of medical care technologies and relevant applications based on blockchain technology, such as sharing electronic medical records, remote patient monitoring, and supply chain management, are also discussed. In revolutionizing the healthcare industry, we illustrate the potential of blockchain technology. We have also focused on identifying the limitations of previous approaches. Finally, this article is concluded with some open research issues and future research direction.

Strong Sustainability of Medical Technologies: A Medical Taboo? The Case of Disposable Endoscopes.

This paper aims to question the sustainability of biomedical engineering practices. The strong sustainability framework is applied to the evaluation and development of medical technologies through the definition of clinical sustainability. A roadmap for developing and evaluating medical technologies in this respect is derived from this framework, as a first step toward a multidisciplinary evaluation tool. On this basis, the current trend towards disposable endoscopes is analyzed and discussed. This highlights the subtle balance between economic, clinical, social, and environmental factors, the lack of evidence at these multiple levels, and the need for multidisciplinarity. This paper concludes with the need to assess all aspects of sustainability and identify and quantify the trade-offs, instead of focusing on one or two key indicators, to have more relevant information in order to make better and more effective decisions. Towards sustainable healthcare, we outline two paths of action: (1) providing evidence that is lacking on the environmental impact of existing or currently developed medical technologies and (2) clarifying the premises and visions underlying our practices.Clinical Relevance- This work provides insights regarding the strong sustainability of medical technologies. This clinical framework may help clinicians and developers in decision-making to reduce indirect negative ecological, social, and health impacts.

ЗАРУБІЖНИЙ ДОСВІД УПРАВЛІННЯ НОВОВВЕДЕННЯМИ В ОРГАНІЗАЦІЇ СФЕРИ ОХОРОНИ ЗДОРОВ’Я

The article examines the foreign experience of innovation management on the example of EU and OECD countries. The relevance of this problem is due to the fact that the state of the country's economy depends on the quality level of its productive forces, the main component of which are people who need to receive highquality medical services. In this regard, it is necessary to apply managerial approaches to the formation of favourable conditions for achieving a balanced development of a holistic innovative system of health care institutions. Emphasis is placed on the fact that the current managerial approaches to innovations do not allow overcoming innovative passivity and fully implementing and using innovations of various types. The use of information and communication technologies in health care institutions of the countries of the world is considered. One of the main points of the "anticipatory market initiative" of the EU regarding electronic medicine is: determination of the volume of products and services of the electronic medicine market; recommendations for a new approach to policy coordination based on improving the balance between supply and demand both between EU member states and within these countries in specific target areas of e-medicine; elements of evaluation by external stakeholders. It is noted that in the OECD countries considerable attention is paid to the mechanism of evaluation of innovative medical technologies. The development of the health care system of the OECD countries is characterized by a shift in priority from saving costs for the provision of medical services to the implementation and use of the most effective methods of resource allocation. One of the methods of solving this task is the creation of restrictive lists of medical services, drugs and products, the costs of which are reimbursed from the health care budgets of different levels. The leading element of the assessment is the clinical and economic analysis. This assessment involves the selection of optimal technologies and products that provide the maximum benefit for the health of the population at a given level of costs. The key directions for the further development of the innovation management system in domestic health care institutions have been identified, including: the total transition of the entire field of health care and infrastructural organizations of the medical services market to electronic document management with legal confirmation of its priority in the collection, processing, storage and transmission of data of a medical nature; creation, promotion and development of electronic services and medical services; increasing the digital literacy of medical personnel, followed by the provision of the necessary equipment; reduction of the number of personal visits of patients in medical institutions for the implementation of simple, typical and repetitive actions, and others.

OP36 A Lifecycle Approach In Evaluating Medical Technologies: Insights From The National Institute For Health And Care Excellence Guidance Review Process

IntroductionHealth Technology Reassessment (HTR) is emerging, as the focus of health technology assessment agencies shifts from traditional methods of technology adoption to managing technologies throughout their lifecycle. The National Institute for Health and Care Excellence (NICE) evaluates devices, digital and diagnostic technologies by producing medical technologies guidance, which could recommend for adoption, no adoption, or further research. The desire to move to a lifecycle approach in the evaluation of medical technologies is reflected in the guidance review process, which involves review of the technology every three years or upon notification of significant new evidence. The outcomes of the guidance review can be to amend, update, withdraw, or leave the guidance unchanged.MethodsInformation on all technologies which have undergone guidance review since the commencement of the process was collected, including the recommendation before and after review and the basis for this recommendation. The proportion of guidances which were not changed, amended, updated, and withdrawn was calculated and the trends, including the bases for recommendation change were analyzed.ResultsIn total, 34 medical technology guidance reviews have been performed. During the process, 15 (44%) were amended to reflect minor changes in the economic or clinical evidence, which did not change the recommendation. Ten (29%) were not changed, while three (9%) were updated respectively. Three (9%) were withdrawn. Another three (9%) represent special cases, which entered guidance review, but were paused due to external reasons. Among the guidances that progressed to update, two out of three had a cost increase, whereas one was broadened to reflect evidence for a larger population.ConclusionsHTR is an important mechanism to improve patient care and system efficiency. In NICE’s evaluation of medical technologies, changes in the recommendation stemmed from changes in the technology’s (or standard care’s) cost, the evidence for clinical effectiveness, or the safety profile.

OP76 “Thunderbirds Are Go!” Rapid Response HTA Outputs For COVID-19

IntroductionThe COVID-19 pandemic has highlighted the need for rapid assessment of potential health technologies that can improve health outcomes in COVID-19 patients, as well as helping pressurized health service provision. Medical technologies play a key role in the COVID-19 pandemic, especially diagnostic tests and respiratory technologies. This study evaluates the rapid response work that the medical technology evaluation programme (MTEP) at the National Institute for Health and Care Excellence (NICE) has done in response to the COVID-19 pandemic.MethodsCompanies routinely submit medical technologies for evaluation by NICE through HealthTech Connect, which is an online portal for devices, diagnostics and digital technologies intended for use in the NHS or wider United Kingdom health and care system. During the COVID-19 pandemic, companies were able to use a designated email address if they perceived their technology may benefit the healthcare system regarding the COVID-19 pandemic. This new system bypassed the usual full registration and data submission. All technologies were reviewed that were submitted via HealthTech connect and email between March 2020 and June 2021.ResultsDuring this period, 20 technologies were submitted to MTEP. Most of these technologies were submitted via email. These technologies consisted of a mix of digital, diagnostic, and respiratory technologies. Seven technologies were selected for a rapid COVID-19 MedTech innovation briefing (MIB), with one specifically addressing issues around waiting lists because of knock-on effects of COVID-19 restricting normal clinical work. A further six technologies were not selected because of limited evidence, while one was not selected because it was not perceived as innovative. The other five technologies were progressed as normal MIBs as there was not enough evidence of potential benefits related to COVID-19 to expedite to a rapid COVID-19 MIB. In total, two technologies were selected for medical technology guidance (myCOPD and Anaconda) and are currently in development.ConclusionsMTEP has responded to the COVID-19 pandemic by prioritising and producing rapid COVID-19 MIBs on technologies to improve health and social care.

Keeping patient and public partnership at the heart of medical technology development during Covid-19: examples of adaptive practice

NIHR (National Institute for Health Research) Devices for Dignity MedTech Cooperative (D4D) and NIHR Children and Young People MedTech Cooperative (CYPMedTech) have established track records in keeping patient and public involvement (PPI) at the core of medical technology development, evaluation and implementation. The 2020 global COVID-19 pandemic presented significant challenges to maintaining this crucial focus. In this paper we describe prior successful methodologies and share examples of the adaptations made in order to continue to engage with patients and the public throughout the pandemic and beyond. We reflect on learning gained from these experiences, and new areas of scope and focus relating to broadening the reach of engagement and representation, along with associated resource requirements and impact metrics.

MT2 Evidence Levels in Nice Medical Technologies Guidance on Digital Health Technologies

NICE’s evidence standards framework (ESF) for digital health technologies (DHTs) describes expected health technology assessment evidence levels for the commissioning of these technologies in the NHS. NICE's medical technologies evaluation programme (MTEP) develops guidance on medical devices and diagnostics which are claimed to be cost saving for the NHS. Medical technologies guidance has been published on 5 DHTs. Here we present a summary of the evidence for each technology and compare it with the evidence levels suggested in the ESF.

Participants' Perspectives of Their Involvement in Medical Device Trials: A Focus Groups Study.

Medical technologies have the potential to improve quality and efficiency of healthcare. The design of clinical trials should consider participants' perspectives to optimise enrolment, engagement and satisfaction. This study aims to assess patients' perceptions of their involvement in medical device trials, to inform the designs of future medical technology implementation and evaluation. Four focus groups were undertaken with a total of 16 participants who had participated in a study testing hospital inpatient remote monitoring devices. Interviews were audio-recorded, transcribed verbatim and underwent thematic analysis. Four main themes emerged: patients' motivations for participating in medical device research; patients' perceptions of technology in medicine; patients' understanding of trial methodology; and patients' perceptions of the benefits of involvement in medical device trials. The appeal of new technology is a contributing factor to the decision to consent, although concerns remain regarding risks associated with technology in healthcare settings. Perceived benefits of participating in device trials include extra care, social benefits and comradery with other participants seen using the devices, although there is a perceived lack of confidence in using technology amongst older patients. Future device trials should prioritise information sharing with participants both before and after the trial. Verbal and written information alongside practical demonstrations can help to combat a lack of confidence with technology. Randomised trials and those with placebo- or sham-controlled arms should not be considered as barriers to participation. Study results should be disseminated to participants in lay format as soon as possible, subject to participant permission.

Comparative analysis of multicriteria methods based on single-valued neutrosophic numbers for the evaluation of medical technologies

Decision-makers are often faced with complicated decision problems with intangible and conflicting criteria. Many methods are proposed to handle the inclusion of many and varied criteria that allow choosing the best alternative for a decision. The public health sector daily faces numerous complex situations that require the facilities provided by multicriteria methods. This research proposes a comparative analysis of multicriteria methods for the selection of health technologies. With this, it is proposed to check to what extent the selected MCDAs are capable of offering consistent results among themselves. Comparisons are made using the TOPSIS method and a modification of the PROMETHEE method, both in their neutrosophic versions, by using single-valued neutrosophic numbers. The results showed that both methods coincided in the order of preference given to each treatment. However, it is observed that the method based on PROMETHEE yields more detailed information on the elections' interiorities. The effectiveness of the methods used can be verified and their practical and feasible application in complex medical problems.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.