Telemedical Intervention and Its Effect on Quality of Life in Chronic Heart Failure Patients: The Results from the Telemedicine and e-Health Solution Pilot Program.

(1) Background: Heart failure (HF) is not only a common cardiovascular disease with a poor prognosis. Its prevalence in developed countries equals 1-2% of the general population of adults, while in Poland HF, patients constitute 3.2% of the total population. Modern heart failure treatment should be focused not only on reducing the risk of death and the number of readmissions due to HF exacerbation but quality of life as well. Telemedicine has been suggested as a viable tool for enhancing HRQL. Therefore, we present the results of telemedical intervention in a group of HF patients and its effect on quality of life in chronic heart failure patients from a pilot study dedicated to reducing social inequalities in health through the use of telemedicine and e-health solutions. (2) Method: The project was a multicenter, open, non-controlled trial conducted by the University of Rzeszów, Poland. The data points were collected in the June 2023-December 2023 period from fourteen primary care units from five voivodeships, mostly considered social exclusion areas. A total of 52.7% of the patients recruited were Podkarpackie Voivodeship inhabitants. The result and discussion are presented based on the Chronic Heart Failure Questionnaire (CHFQ) and the EuroQol Visual Analogue Scale (EQVAS). (3) Results: During the program, a total of over 100,000 telemedicine examinations were conducted in the form of body weight measurement, heart rate, blood pressure tests, and 7-day Holter or 14-day event Holter assessment. Over the course of this study, coordinating the pilot program medical staff has ordered 570 changes in the patient's pharmacotherapy, confirming the positive impact on quality of life in the study group. (4) Conclusions: A comprehensive telemedical intervention can contribute to an improvement in the quality of life of patients with HF beyond what was achieved with the basic standard of care in the group of HF patients from the social exclusion region. It is now unclear if the result of the basic telemedical intervention would be constant after discontinuation of the mentioned pilot program.

Systematic reviews of machine learning in healthcare: a literature review.

INTRODUCTION: The increasing availability of data and computing power has made machine learning (ML) a viable approach to faster, more efficient healthcare delivery. METHODS: A systematic literature review (SLR) of published SLRs evaluating ML applications in healthcare settings published between1 January 2010 and 27 March 2023 was conducted. RESULTS: In total 220 SLRs covering 10,462 ML algorithms were reviewed. The main application of AI in medicine related to the clinical prediction and disease prognosis in oncology and neurology with the use of imaging data. Accuracy, specificity, and sensitivity were provided in 56%, 28%, and 25% SLRs respectively. Internal and external validation was reported in 53% and less than 1% of the cases respectively. The most common modeling approach was neural networks (2,454 ML algorithms), followed by support vector machine and random forest/decision trees (1,578 and 1,522 ML algorithms, respectively). EXPERT OPINION: The review indicated considerable reporting gaps in terms of the ML's performance, both internal and external validation. Greater accessibility to healthcare data for developers can ensure the faster adoption of ML algorithms into clinical practice.

Population norms of health-related quality of life in Moscow, Russia: the EQ-5D-5L-based survey.

PURPOSE: To develop population norms for the EQ-5D-5L questionnaire based on a representative sample of Moscow citizens. METHODS: We used quota sampling accounting for sex, age group and administrative district of residence. Respondents in randomly selected outdoor and indoor locations were surveyed with the official Russian paper-and-pencil version of the EQ-5D-5L questionnaire and a set of socio-demographic questions. We estimated four types of EQ-5D results: the distribution of limitations according to EQ-5D-5L dimensions, the perception of the health-related quality of life (HRQoL) with a visual analogue scale (EQ VAS), the unweighted score for a respondent's health state (Level Sum Score, LSS) and the Russian health preferences-based weighted score (EQ index). In order to estimate the EQ-5D-5L index, we used a newly developed Russian EQ-5D-3L value set, together with EuroQol Group cross-over methodology. RESULTS: A total of 1020 respondents (18-93 years old) from the general Moscow adult population completed the EQ-5D-5L questionnaire. HRQoL domains with the largest number of identified health limitations were pain/discomfort (48.6%) and anxiety/depression (44.1%). Two hundred seventy-nine respondents (27.0%) did not report any health restrictions. The mean EQ VAS and EQ-5D-5L index were 74.1 (SD 17.3) and 0.907 (0.106) respectively. Multivariate analysis showed that female sex, advanced age and lack of access to the Internet had a negative influence on HRQoL, whereas residence in certain districts had a positive impact. CONCLUSIONS: The study provides population norms of health-related quality of life in Moscow, measured according to the EQ-5D-5L questionnaire. These reference values can be used to optimise the effectiveness of resource allocation in healthcare.

EQ-5D-Derived Health State Utility Values in Hematologic Malignancies: A Catalog of 796 Utilities Based on a Systematic Review.

OBJECTIVES: We performed a systematic review of health state utility values (HSUVs) obtained using the EQ-5D questionnaire for patients with hematologic malignancies. METHODS: The following databases were searched up to September 2018: MEDLINE, EMBASE, The Cochrane Library, and the EQ-5D publications database on the EuroQol website. Additional references were extracted from reviewed articles. Only studies presenting EQ-Index results were incorporated. In view of the heterogeneity across the included publications, we limited ourselves to a narrative synthesis of original HSUVs found. RESULTS: Fifty-nine studies (described in 63 articles) met the inclusion criteria. Data from 21 635 respondents provided 796 HSUV estimates for hematologic malignancy patients. EQ-Index scores ranged from -0.025 to 0.980. The most represented area was multiple myeloma (4 studies, 11 112 patients, and 249 HSUVs). In clinical areas such as chronic myeloid leukemia, acute myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, and mantle cell lymphoma, we described over 50 health utilities in each. In contrast, we identified only 13 HSUVs (based on 4 studies and the data of 166 patients) for Hodgkin lymphoma. Areas without EQ-5D-based health utilities comprised: polycythemia vera, primary myelofibrosis, essential thrombocythemia, mastocytosis, myeloid sarcoma, chronic myelomonocytic, eosinophilic leukemia, and neutrophilic leukemia. CONCLUSIONS: There is a wide range of HSUVs available for hematologic cancer patients with different indications. The review provides a catalog of utility values for use in cost-effectiveness models for hematologic malignancies.

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges.

Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence. Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020. Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs. Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.

[Policy developments of health technology assessment in the European Union]. / Rozwój wspólpracy w zakresie oceny technologii medycznych w krajach Unii Europejskiej.

The purpose of the note below is to familiarize readers with the current status and future initiatives of cooperation in the field of health technology assessment (HTA) in the European Union (EU). The European Commission is trying to create a framework for efficient collaboration between member states of EU in the field of HTA and is gradually working on strengthening it. The following initiatives, projects and programs have already been implemented: - Project on Coordination and Development of Health Care Technology Assessment in Europe - The European Collaboration for Assessment of Health Interventions and Technology - European Network for Health Technology Assessment - Beneluxa Initiative, The Valletta Declaration, FINOSE and Fair and Affordable Pricing - European Network for Health Technology Assessment Currently there is an ongoing proposal for an HTA Regulation of the European Parliament and the Council, which is the measurable result of this cooperation. A key element of the proposed regulation is a centralized joint clinical assessment (for HTA purposes) of the efficacy of the medicinal product/medical device.

A Review of Rare Disease Policies and Orphan Drug Reimbursement Systems in 12 Eurasian Countries.

Background: Despite international initiatives on collaboration within the field of rare diseases, patient access to orphan medicinal products (OMPs) and healthcare services differ greatly between countries. This study aimed to create a comprehensive and in-depth overview of rare diseases policies and reimbursement of OMPs in a selection of 12 countries in the Western Eurasian region: Armenia, France, Germany, Kazakhstan, Latvia, The Netherlands, Poland, Romania, Russia, Turkey, Ukraine, and the United Kingdom. Methods: A systematic literature review was performed and an analysis of publicly available legislative and rare disease health policy data was undertaken in five focus areas: rare disease definition, newborn screening, registries, national plans, access to/reimbursement of OMPs. Results: Screening programs are broadly implemented but the number of screened diseases differs significantly (2-35 diseases), either between EU and non-EU countries, between EU member states and sometimes even within a single country. In most countries rare disease registries are operating with regional, national, European or worldwide coverage. The number of rare disease registries is growing, as a result of the National Plans (EU) and increased international scientific cooperation. France, Russia, and Poland have a centrally acting registry. National plans are present in all EU countries but implementation varies and is ongoing. The number of reimbursed OMPs in the selected countries ranges from nearly all available OMPs in the Netherlands, Germany, and France to zero in Armenia. Reimbursement rules differ considerably regionally and a trend is observed of reimbursement conditions getting stricter for expensive (orphan) drugs. Discussion: Inequality in patient access to new OMPs still exists due to variations in national policies, healthcare budgets, health insurance, and reimbursement systems. The observed differences are challenging for rare disease patients, health authorities and manufacturers alike. Progress can be seen, however, and international cooperation and harmonization is slowly but steadily expanding in the rare disease arena.

Drug Policy in the Russian Federation.

OBJECTIVES: To describe characteristics of the drug policy in Russia in terms of health technology assessment (HTA), registries of patients, pricing of drugs, cost-containment methods, and reimbursement of drugs. METHODS: The legal and regulatory frameworks and the literature were reviewed to analyze several aspects of Russian healthcare: the scheme of cooperation between its structures, its levels, drug provision, issues related to HTA, the reimbursement system, pricing of medicines, and cost-containment methods. RESULTS: The Russian drug policy has improved over the last few years: HTA has been developed, rules for the pricing of drugs and cost-containment methods have been established, and registries of patients have been created. The reimbursement system in Russia is different from the ones in Western Europe and consists of a few programs: reimbursement for specific categories of citizens, vital and essential drug list, list of 24 orphan diseases, list of 7 nosologies, and other programs, depending on region. Financing for drug provision in Russia is divided into 2 levels: federal and regional. There is still a lack of transparency and equality in healthcare as well as huge differences in access to healthcare, depending on region. CONCLUSIONS: The healthcare system in Russia is complicated and needs improvement. Nowadays, changes are being made; for example, there are attempts to implement HTA at federal and regional levels.