Medical Technology Assessment Research Articles

System for evaluating medical technologies in military healthcare

Modern challenges and threats, as well as unprecedented sanctions pressure on the Russian Federation, have contributed to the intensification of research both on the development of innovative medical technologies and on expanding the range of use of existing ones. At the same time, on the one hand, there is an increase in incoming proposals for the use of various medical technologies in military healthcare, and on the other hand, the need to ensure accessibility and improve the quality of medical care for military personnel and other cate- gories of assigned contingents is rapidly increasing. At the same time, in con- ditions of limited resources, the level of requirements for justifying the need to introduce one or another medical technology into the activities of military medical organizations and other medical units of the Armed Forces of the Rus- sian Federation naturally increases. All this predetermines the relevance of the development of a departmental system for assessing medical technologies for effective information support for making rational management decisions. The study examined the main directions of development of the medical tech- nology assessment system in military healthcare. In particular, goals and objectives are defined, the main aspects and possible forms of organizing a departmental system for assessing medical technologies are substantiated. The main elements of the basic model for assessing medical technologies in military healthcare are identified. In addition, the characteristics of the in- formation system for assessing medical technologies in military healthcare are given, its main components are given, as well as the expected effects of implementation. The implementation of the departmental concept for assessing medical tech- nologies in the main directions of development presented in the article on the basis of a specialized information system will not only help increase the availability of effective and safe medical technologies, but also the rational use of funds and other military healthcare resources. In addition, taking into ac- count the results of departmental assessment of medical technologies at the state level will serve as the basis for the formation of priority directions for the strategic development of the domestic medical and pharmaceutical industry in the interests of national defense and state security.

Assessment of Information Technology in Electronic Medical Records Using the Concept Health Technology Assessment at X Jepara Hospital

<div><table cellspacing="0" cellpadding="0" align="left"><tbody><tr><td align="left" valign="top"><p><em>Hospitals as health service providers need to study the equipment used in health services, which is called a Health Technology Assessment. This research aims to determine the assessment of electronic medical record information technology using the Health Technology Assessment concept at regional General Hospital X Jepara. This research uses a qualitative method with a descriptive design. The research was conducted at the regional general hospital X Jepara which was carried out from March to June 2023. There were 13 informants in this research with 9 main informants and 3 triangulation informants. Data collection techniques use in-depth interviews, observation, and document study. Data analysis for this research is data reduction, data presentation, and conclusion. The results of this research on the concept of effectiveness can increase productivity, be more efficient, make it very easy to publish patient medical records in summary and detail, and doctors and nurses can easily access patient data by logging in using their password. Patient privacy is also maintained with limited access to open it. Service is fast and can increase satisfaction and improve hospital services from an economic perspective using health technology assessment methods. The characteristic aspect of using electronic medical records is that it makes hospital services easier. The security aspect of patient data is guaranteed because system access can only be accessed by users with an account, and the rights of each user are guaranteed. The management of the regional general hospital will easily use electronic medical records and improve the service and quality of Regional General Hospital X Jepara.</em></p></td></tr></tbody></table></div> <strong><em>Keywords: Electronic medical record, Effectiveness, Economic, Technical characteristic, Security</em></strong>

Outcome measures for use in trials of paediatric otorrhoea: A systematic review

IntroductionPaediatric otorrhoea (PO) describes a middle ear infection that results in a perforation of the tympanic membrane and ear discharge, in children and young people (CYP). Prolonged infection may be associated with hearing loss and developmental delay. The current management of paediatric otorrhoea is variable, including non-invasive treatments (conservative, oral antibiotics, topical antibiotics) and surgery, reflecting the lack of a sufficiently strong evidence base. Outcome reporting is fundamental to producing reliable and meaningful evidence to inform best practice. ObjectivesPrimary objective: to determine which outcome measures are currently used to evaluate treatment success in studies of non-surgical treatments for paediatric otorrhoea. Secondary objectives: to identify outcome measurement instruments used in the literature and assess their applicability for use in clinical trials of PO. MethodsThis systematic review was registered with PROSPERO (CRD42023407976). Database searches of EMBASE, MEDLINE and Cochrane was performed on June 6, 2023, covering from Jan 1995 to May 2023. Randomised controlled trials or study protocols involving CYP with PO were included following PRISMA guidelines. Risk of bias was assessed with Cochrane's tool. ResultsOf the 377 papers identified, six were included in the systematic review. The primary outcome of five of the studies related to otorrhoea cessation; both time to cessation and proportion recovered at various time points were used as measures. Two measurement instruments were identified: Otitis Media-6 Questionnaire and the Institute for Medical Technology Assessment Productivity Cost Questionnaire. Both were shown to be applicable measurement instruments when used in clinical trials of PO. ConclusionsTo promote homogeneity and facilitate meaningful comparison and combination of studies, we propose that time to cessation of otorrhoea from onset of otorrhoea should be used as the primary outcome in future studies. Further research is needed to establish if this is the most important outcome to children and their caregivers.

PP127 Early Health Technology Assessment (HTA) Of Medical Technologies To Inform Subsidy Decision-making In Singapore

IntroductionMedical technologies are evolving rapidly, with many new and expensive technologies entering the market constantly, challenging the sustainability of the public healthcare system. Early health technology assessment (HTA) to inform subsidy decision for innovative medical technologies, before they diffuse into the public healthcare system, may drive appropriate early adoption or curtail inappropriate use. This abstract describes the Agency for Care Effectiveness (ACE)’s experience in conducting early HTAs and key challenges faced.MethodsDuring ACE’s 2021 topic prioritization exercise, ACE took a proactive approach by considering medical technologies identified from horizon scanning (HS) for subsidy evaluation. Two topics were shortlisted from HS. Standard HTA evaluation framework and local clinician consultation were used to define the evaluation scope and clinical pathways. Literature search and appraisal were conducted for safety, effectiveness, and economic evidence. Budget impact estimations and organizational feasibility assessment were additional domains considered for subsidy decision-making by the Ministry of Health Medical Technology Advisory Committee (MTAC).ResultsMTAC did not recommend subsidy for the two technologies due to weak evidence base, largely due to a lack of comparative evidence, small samples, short-term follow-ups, or heterogeneity of population. Additional considerations included potentially high budget impact or organizational feasibility issues such as substantial capital and maintenance cost and infrastructure reconfiguration required. During the evaluation, key challenges of assessing such technologies in their early diffusion within the healthcare system were: (i) differing clinical opinions on whether the technology meets an unmet need; (ii) uncertain place in the clinical management algorithm for the relevant indications; (iii) sparse and weak evidence; (iv) uncertain financial implications to the healthcare system due to a lack of available local costs.ConclusionsEarly HTA on medical technologies identified from HS can be a useful tool to guide subsidy decisions; however, several challenges exist. Careful selection of technologies and timing of evaluation are critical. Seeking stakeholder inputs earlier would ensure shortlisting appropriate technologies with greater clinical need for HTA.

OP125 How Can Health Technology Assessment Evolve To Better Consider Benefits For Patients, Their Families, And Carers?

IntroductionIn Australia, technical guidelines for the health technology assessment (HTA) of medical technologies do not formally include broader societal benefits in the base case economic evaluation; they are considered supplementary analyses. If what matters to patients is relevant and valuable, then why shouldn’t these broader benefits play a more important role? This presentation will consider the challenges and opportunities for HTA guidelines to change to allow this, and the broader implications for decision makers.MethodsA targeted literature review was undertaken to assess whether economic evaluation methods and their application in HTA are well positioned to assess what matters to patients. Practical challenges for this will be considered, particularly from the perspective of decision makers having a full understanding of broader societal benefits.ResultsPreliminary findings from the literature review suggested that taking a broader societal perspective in economic evaluations used in HTA has the potential to enable more informed decisions for policy makers. However, there are practical considerations regarding consistent approaches to assessing broader societal and patient benefits.ConclusionsFor decision makers to be fully informed on the impact of their decisions beyond healthcare budgets alone, explicit consideration of a societal perspective is necessary. However, for decisions to be equitable across different patient groups, there must be consistency in methodological approaches. Fixing this current limitation should not prevent HTA from giving what matters to patients a central role now, and refining methods on an ongoing basis.

Assessment of medical technologies in the formation of government programs to assist patients with rare metabolic diseases

The aim: carrying out an assessment of the technologies of nutritional and pharmacological therapy of phenylketonuria (PKU) to justify a set of measures for the implementation of the government program to support patients with rare diseases (RD). Materials and methods: scientific publications, regulatory acts, treatment protocols, statistical data, epidemiological indicators, results of patient questionnaires, marketing information, data from the electronic procurement system "ProZorro" were used in the research process. The research was conducted using the methodology of health technology assessment (HTA), methods of marketing analysis, questionnaire survey, document analysis, comparison, systematization and generalization of data. Research results. An analysis of the evaluation of modern approaches to the treatment of hereditary rare metabolic disease (PKU) was carried out. According to clinical protocols, the main technology for the treatment of PKU is nutritional therapy - a diet (diet-for-life) with restriction of the use of phenylalanine (Phe) and the use of food products for special medical purposes (Special low protein foods for phenylketonuria - SLPF-PKU). Innovative drugs "Kuvan" and "Palynziq" are recommended in the case of atypical PKU. For RD, specific and innovative cost-effective medical technologies (MT) are usually used, which have insufficient evidence due to limited experience, low availability, and small patient populations. Centralized procurement and managed entry agreements (MEA) make it possible to expand the availability of MT to patients and obtain real data on their safety and effectiveness. Integration into the global information space, participation in international projects, joint clinical assessment (JCA) in accordance with Regulation (EU) 2021/2282 on HTA, cooperation with Orphanet, EURORDIS, other professional and patient organizations are extremely important. The key components of HTA for RD are socio-economic and organizational and legal aspects, in particular the special status of MT, which provides certain preferences. The foreign experience of providing orphan patients (in particular, reimbursement) is summarized. The legal framework for RD is systematized. Based on the results of the analysis of PKU prevalence indicators, modelling and budget impact calculations were carried out, considering that SLPF-PKU products are purchased from local budgets. An analysis of prescriptions, assortment, and prices of SLPF-PKU was carried out using data from the ProZorro procurement system. A survey of 156 patients with PKU made it possible to identify unmet needs and formulate recommendations for expanding the SLPF-PKU food basket. Conclusions: Conducting the HTA made it possible to identify key problems, as well as to justify a set of measures for the development and implementation of the government program to support patients with rare diseases, based on the obtained results

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase.

Quantitatively assessing the level of readiness of medical technology improves its chance of successfully transfer from research to industry but remains a challenge. As many innovative medical devices are associated with or incorporate software, this article presents a methodology for evaluating the software maturity of a "Software-driven Medical Technology" (SdMT) during the research phase. A technological maturity model is developed by methodologically extracting relevant terms from the ISO/IEC 62304 standard, the main industry standard for medical device software, and results in a list of required software engineering artifacts. This list and the relative weight of the artifacts are used to establish a software maturity score for SdMT and the corresponding assessment questionnaire. The consistency of the model is demonstrated by analyzing the obtained score system relatively with the standard. The maturity score of a SdMT can be assessed during the research phase and depends on the number and importance of the artifacts already present at the time of evaluation.Clinical relevance- The proposed quantitative maturity score can help the medical technology innovation actors (clinicians, researchers and industrials) to better identify, improve and fasten the readiness of technology for clinical investigation and technology transfer.

The economic and societal burden associated with adolescent idiopathic scoliosis: A burden-of-disease study protocol

BackgroundAdolescent idiopathic scoliosis (AIS) has an estimated general population prevalence of 2% to 3%. The impact of adolescent idiopathic scoliosis (AIS) on the patients’ experienced quality of life and psychological well-being and the resulting societal burden are increasingly recognized. However, there is limited knowledge on the economic burden of AIS. This cross-sectional, prevalence-based, bottom-up approach burden of disease study aims to determine the impact associated with adolescent idiopathic scoliosis in terms of the cost-of-illness and health-related quality of life from a societal perspective in the Netherlands. MethodsPersons diagnosed with AIS or parents of a child with AIS that are willing and able to answer the questionnaires will be eligible to participate. Patients will be included consecutively between June until January 2023. Costs and self-perceived health-related quality of life will be estimated using 3 steps: identification, measurement and valuation. To assess the costs associated with AIS the institute for Medical Technology Assessment - Medical Consumption Questionnaire and the institute for Medical Technology Assessment – Productivity Cost Questionnaire will be used. To assess the HRQoL of adult AIS patients the EuroQol 5-dimensions or EuroQol 5-dimensions Youth questionnaire for children under the age of 12 and the Scoliosis Research Society-22 revised questionnaire will be considered. DiscussionThis is the first study in this field. It will help raise awareness for AIS and wider support for both the patient community and informal care takers among healthcare professionals and policymakers. Major strengths of this study will be the use of mostly validated, standardized questionnaires. Limitations include the cross-sectional and retrospective nature of the study design.

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations

ABSTRACT Introduction The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US). Areas Covered Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored. Expert Opinion Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers’ evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

MP16-02 WORK PRODUCTIVITY OF PATIENTS UNDERGOING TRIAL OF PASSAGE FOR URETERAL STONES

You have accessJournal of UrologyCME1 Apr 2023MP16-02 WORK PRODUCTIVITY OF PATIENTS UNDERGOING TRIAL OF PASSAGE FOR URETERAL STONES Ian Berger, Alexandria Spellman, Vishnukamal Golla, Michael Lipkin, Gary Faerber, Jodi Antonelli, Charles Scales, and Deborah Kaye Ian BergerIan Berger More articles by this author , Alexandria SpellmanAlexandria Spellman More articles by this author , Vishnukamal GollaVishnukamal Golla More articles by this author , Michael LipkinMichael Lipkin More articles by this author , Gary FaerberGary Faerber More articles by this author , Jodi AntonelliJodi Antonelli More articles by this author , Charles ScalesCharles Scales More articles by this author , and Deborah KayeDeborah Kaye More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003236.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Ureteral stones affect patients of working age and disrupt daily activities. Patient reported outcomes during trial of passage are understudied which hinders counseling and expectation setting. We sought to characterize work productivity losses for patients with a ureteral stone undergoing a trial of passage. METHODS: We identified employed, English speaking patients aged 18-64 years and discharged from Duke University Health System EDs with unilateral ureteral stones on CT scan from February-October 2022. Patients were contacted by phone 4 weeks after discharge and administered the Institute for Medical Technology Assessment Productivity Cost Questionnaire which evaluates three domains of productivity loss over a four-week period: absenteeism (missed work), presenteeism (decreased productivity at work), and volunteerism (help with unpaid work or domestic tasks). Patients were designated as reporting passage of their stone if they noticed it in the toilet or identified a day with symptom resolution that did not return. RESULTS: We enrolled 64 patients who completed the survey. 71% (46/64) had distal stones and 14% (9/64) had symptoms at the time of the survey. 73% (47/64) of patients missed work after discharge (Figure 1), missing a median of 2 days (interquartile range [IQR] 1.0-4.0). 58% (37/64) had pain at work, with a median of 3 days of pain (IQR 1.5-6.5) and a median of 40% reduction in productivity (IQR 20%-50%) on symptomatic days. 38% (24/64) required help with unpaid work for a median of 2.5 days (IQR 1.0-5.8) and median of 3.5 hours per day (IQR 2.0-5.0). 58% (37/64) of patients passed their stone with a median passage time of 3.5 days (IQR 2.0-7.8). Of patients who passed their stone, 68% (25/37) missed work, with a median of 2 days missed (IQR 1-2) or 50% of work days until their stone passed (IQR 21%-83%). Of patients who reported not passing their stone, 74% (20/27) missed work for a median of 4.5 days (IQR 1-7). This was a median of 14% (IQR 3%-22%) of days until surgery or survey completion. CONCLUSIONS: The majority of patients miss work during passage of a ureteral stone. While time off work is less than published rates after ureteroscopy, it is common to miss half of work days until the stone passes. This information may aid patient counselling and help to prevent return ED visits. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e201 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ian Berger More articles by this author Alexandria Spellman More articles by this author Vishnukamal Golla More articles by this author Michael Lipkin More articles by this author Gary Faerber More articles by this author Jodi Antonelli More articles by this author Charles Scales More articles by this author Deborah Kaye More articles by this author Expand All Advertisement PDF downloadLoading ...

Application trends of the systemic paradigm in pharmaceutical research

Pharmacists use systematic knowledge to study the regularities of complex, multilevel systems with a considerable number of variable, feedback connections between them in order to find or make rational management decisions. However, the level and direction of application of the system paradigm of knowledge in pharmacy remain to the end do not determine. The aim of our research is to identify trends in the application of a systemic paradigm in modern pharmaceutical research to outline promising directions in pharmaceutical science for raising the level of pharmaceutical assistance to the population. Materials and methods. The research material was publications of fundamental and applied research of domestic and foreign scientists on the raised issue, scientific and methodical publications, dissertations on the repositions of medical and pharmaceutical universities of Ukraine, and database PubMed for the last 20 years. Results. The research, analysis, and systematization of 59 scientific works of domestic scientists on the application of system paradigms in pharmaceutical research by different applied values were carried out. Namely this pharmaceutical provision for diseases of different nosology, management of pharmaceutical organizations (including regulation, logistics), assessment of medical technologies, social pharmacy (including patient-centered model), pharmaceutical marketing (including pricing, information support), and systems architecture. Conclusions. The developed array of information sources showed the significant spread of system methodology, approach, and system method. However, the issue of a coordinated and integral definition of the pharmaceutical system remains open. Perspective has seen the application of system analysis and modeling of pharmaceutical systems with modern computer technologies with the further realization of results in the patient’s health care system to increase the level of pharmaceutical care.

PP70 Enhancing HTA Processes In The Maltese System For Introducing New Medicines

IntroductionMost European countries use Health Technology Assessment (HTA) as input for decisions on reimbursement of (new) medicines. In 2018, following the approval of European Social Funding, the Directorate for Pharmaceutical Affairs (DPA) within the Malta Ministry for Health led a specific Work Package aimed at enhancing knowledge, skills and HTA processes to inform reimbursement decisions.MethodsSince the start of the project, the Institute for Medical Technology Assessment (iMTA) and the National Health Care Institute of the Netherlands (ZIN) collaborate in providing guidance and training to DPA on relative effectiveness assessments (REAs) and pharmacoeconomic assessments (PEAs) of pharmaceuticals. Several activities were organized: site visits, face-to face interviews with stakeholders, a qualitative assessment of the core process of the Maltese system, health economics training and tutorials, meetings introducing the European Network for Health Technology Assessment (EUnetHTA) and Dutch HTA processes, development of a new framework for assessment, and a shadow assessment.ResultsOur assessment identified important methodological challenges and crucial processes interdependencies to optimize within the Maltese system. Based on the learnings, DPA created a template based on the EUnetHTA REA assessment format. IMTA created a template to perform PEAs. Currently, a shadow assessment is ongoing in which DPA performs the REA and PEA of a pharmaceutical using the new templates. ZIN and iMTA will provide feedback to DPA on several aspects, including, but not limited to, the PICO, assessment of therapeutic efficacy and safety, identifying uncertainties, input costs and effects, and formulating a clear discussion of the assessment. If necessary, the templates will be adapted during the process. The project will be evaluated and finalized in 2022.ConclusionsWith the guidance and training provided by iMTA and ZIN, DPA structured and aligned their REA and PEA to enhance their assessment process and to improve the presentation of their HTA report to the two appraisal committees. This project emphasizes the importance of international collaboration to enhance HTA processes within the

HTA216 Assessment of Key Drivers of Economic Evaluations for Digital Health and Medical Technologies: Insights and Lessons From Review of NICE Medical Technology Assessment Reports (2010-2022)

HTA216 Assessment of Key Drivers of Economic Evaluations for Digital Health and Medical Technologies: Insights and Lessons From Review of NICE Medical Technology Assessment Reports (2010-2022)

Value Insider Season 1 Episode 4: How are Costs Measured, and How are CEAs Constructed and Used? (CEA) [Podcast

How is a cost-effectiveness analysis constructed and used? In this episode of the Value Insider podcast, host Mike Chambers speaks with Prof. Maureen Rutten-van Mölken about economic evaluations in healthcare and how value is considered in these evaluations. Prof. Rutten-van Mölken is professor of Economic Evaluation of Innovations for Health at the Erasmus University Rotterdam in the Netherlands. She leads the Erasmus HTA department and is Scientific Director of the Institute for Medical Technology Assessment (iMTA). Prof Rutten-van Mölken explains how comparative assessments can help us understand which treatments offer the best value-for-money as reimbursement can only be allocated to a selection of all possible treatments.

Economic assessment of the high-tech and primary health care technologies for coronary heart disease according to personalized accounting of medical care for compulsory health insurance

Background. The assessment of medical technologies based on digital information is prompt and accurate, but it is currently not widely used, and analysis methods for this have not been developed, which became the basis for this study.
 Aim. To economically evaluate the technologies of reperfusion therapy and dispensary observation in coronary heart disease using electronic data on medical care.
 Material and methods. 586 patients with myocardial infarction treated in 2016 in two vascular centers of the Orenburg region were identified according to the registers-accounts of the compulsory health insurance fund. Among them were 349 patients with reperfusion therapy (main group) and 237 without it (control group). In the groups, the cost-effectiveness indicator, the cost of inpatient treatment of myocardial infarction and treatment in the postinfarction period were determined. Also, according to the registers-accounts for 2016, 17 225 patients with angina pectoris were identified. Among them, 13 208 patients, who applied to polyclinics for dispensary purposes during 20162017, and 4017 patients who did not apply, were registered the main and control groups. Between groups, the total cost of outpatient, emergency, emergency hospital care and the cost-effectiveness ratio were compared. When processing the data, linear statistics methods and parametric comparison methods (Student's t-test and z-test) were used.
 Results. The cost-effectiveness indicator in the group with reperfusion therapy was 425 879, without it 643 069 rubles/unit, 1.5 times more in the control group. In the postinfarction period, the cost of treatment in the main group was lower than in the control group, 1223.6619.04 and 1321.1121.15 rubles, respectively, for outpatient care (p=0.001), 35 138.91299.85 and 51 189.64903.15 rubles for inpatient care (p=0.002), 4093.058.98 and 5428.652.95 rubles for an ambulance (p=0.001). The cost of angina treatment in the main group was 2.1 times less than in the control group, 6541.385.58 and 13 671.492.12 rubles (p=0.001). The cost-effectiveness indicator in the main group was 6867, in the control group it was 15 293 rubles/unit, 2.2 times more in the control group.
 Conclusion. The use of reperfusion therapy and dispensary observation in coronary heart disease is economically feasible.

Effects of Video-Based Patient Education and Consultation on Unplanned Health Care Utilization and Early Recovery After Coronary Artery Bypass Surgery (IMPROV-ED): Randomized Controlled Trial.

BackgroundHealth care utilization after coronary artery bypass graft (CABG) surgery is high and is partly of an unplanned nature. eHealth applications have been proposed to reduce care consumption, which involve and assist patients in their recovery. In this way, health care expenses could be reduced and quality of care could be improved.ObjectiveThe aim of this study was to evaluate if an eHealth program can reduce unplanned health care utilization and improve mental and physical health in the first 6 weeks after CABG surgery.MethodsA single-blind randomized controlled trial was performed, in which patients scheduled for nonacute CABG surgery were included from a single center in the Netherlands between February 2020 and October 2021. Participants in the intervention group had, alongside standard care, access to an eHealth program consisting of online education videos and video consultations developed in conjunction with the Dutch Heart Foundation. The control group received standard care. The primary outcome was the volume and costs of a composite of unplanned health care utilization, including emergency department visits, outpatient clinic visits, rehospitalization, patient-initiated telephone consultations, and visits to a general practitioner, measured using the Medical Technology Assessment Medical Consumption Questionnaire. Patient-reported anxiety and recovery were also assessed. Intention-to-treat and “users-only” analyses were used.ResultsDuring the study period, 280 patients were enrolled and randomly allocated at a 1:1 ratio to the intervention or control group. The intention-to-treat analysis consisted of 136 and 135 patients in the intervention and control group, respectively. At 6 weeks, the primary endpoint had occurred in 43 of 136 (31.6%) patients in the intervention group and in 61 of 135 (45.2%) patients in the control group (hazard ratio 0.56, 95% CI 0.34-0.92). Recovery was faster in the intervention group, whereas anxiety was similar between study groups. “Users-only” analysis yielded similar results.ConclusionsAn eHealth strategy comprising educational videos and video consultations can reduce unplanned health care utilization and can aid in faster patient-reported recovery in patients following CABG surgery.Trial RegistrationNetherlands Trial Registry NL8510; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8510International Registered Report Identifier (IRRID)RR2-10.1007/s12471-020-01508-9

Sample Size Calculation for Clinical Trials of Medical Decision Support Systems with Binary Outcome.

Currently, software products for use in medicine are actively developed. Among them, the dominant share belongs to clinical decision support systems (CDSS), which can be intelligent (based on mathematical models obtained by machine learning methods or other artificial intelligence technologies) or non-intelligent. For the state registration of CDSSs as software medical products, clinical trials are required, and the protocol of trial is developed jointly by the developer and an authorized medical organization. One of the mandatory components of the protocol is the calculation of the sample size. This article discusses the calculation of the sample size for the most common case, the binary outcome in diagnostic/screening and predictive systems. For diagnostic/screening models, cases of a non-comparative study, comparative study with testing of the superiority hypothesis, comparative study with testing of a hypothesis of non-inferiority in cross-sectional studies are considered. For predictive models, cases of randomized controlled trials of the complex intervention "prediction + prediction-dependent patient management" with testing of the hypothesis of superiority and non-inferiority are considered. It is emphasized that representativeness of the sample and other design components are no less important in clinical trials than sample size. They are even more important since systematic biases in clinical trials are primary, and even the most sophisticated statistical analysis cannot compensate for design defects. The reduction of clinical trials to external validation of models (i.e. evaluation of accuracy metrics on external data) seems completely unreasonable. It is recommended to perform clinical trials with the design adequate to the tasks, so that further clinical and economic analysis and comprehensive assessment of medical technologies are possible. The sample size calculation methods described in the article can potentially be applied to a wider range of medical devices.

Dydrogesterone: assessment of medical technology to preserve pregnancy

The purpose of the work: to identify clinical and pharmacological aspects of the use of dydrogesterone in the practice of a gynecologist.

Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps.

Digital health and mobile medical apps (MMAs) have shown great promise in transforming health care, but their adoption in clinical care has been unsatisfactory, and regulatory guidance and coverage decisions have been lacking or incomplete. A multidimensional assessment framework for regulatory, policymaking, health technology assessment, and coverage purposes based on the MMA lifecycle is needed. A targeted review of relevant policy documents from international sources was conducted to map current MMA assessment frameworks, to formulate 10 recommendations, subsequently shared amongst an expert panel of key stakeholders. Recommendations go beyond economic dimensions such as cost and economic evaluation and also include MMA development and update, classification and evidentiary requirements, performance and maintenance monitoring, usability testing, clinical evidence requirements, safety and security, equity considerations, organizational assessment, and additional outcome domains (patient empowerment and environmental impact). The COVID‐19 pandemic greatly expanded the use of MMAs, but temporary policies governing their use and oversight need consolidation through well‐developed frameworks to support decision‐makers, producers and introduction into clinical care processes, especially in light of the strong international, cross‐border character of MMAs, the new EU medical device and health technology assessment regulations, and the Next Generation EU funding earmarked for health digitalization.

Health Technology Assessment in India: Necessity, Progress and Future Plans

The implementation of a universal healthcare coverage by the Indian government has forced a relook into the existing systems of healthcare decision-making. Health technology assessment (HTA) is being looked at to provide efficient decision-making and helping in priority setting for the policymakers. The Ministry of Health and Family Welfare has, therefore established a Medical Technology Assessment Board as a way of institutionalising the HTA framework and methodology in India. Despite some challenges, the future looks bright for HTA in India.