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.

Do We Need Another CT Scanner?-The Pilot Study of the Adoption of an Evolutionary Algorithm to Investment Decision Making in Healthcare.

Objectives: The purpose of this study was to assess the feasibility of the adoption of a machine learning (ML) algorithm in support of the investment decisions regarding high cost medical devices based on available clinical and epidemiological evidence. Methods: Following a literature search, the set of epidemiological and clinical need predictors was established. Both the data from The Central Statistical Office and The National Health Fund were used. An evolutionary algorithm (EA) model was developed to obtain the prediction of the need for CT scanners across local counties in Poland (hypothetical scenario). The comparison between the historical allocation and the scenario developed by the EA model based on epidemiological and clinical need predictors was established. Only counties with available CT scanners were included in the study. Results: In total, over 4 million CT scan procedures performed across 130 counties in Poland between 2015 and 2019 were used to develop the EA model. There were 39 cases of agreement between historical data and hypothetical scenarios. In 58 cases, the EA model indicated the need for a lower number of CT scanners than the historical data. A greater number of CT procedures required compared with historical use was predicted for 22 counties. The remaining 11 cases were inconclusive. Conclusions: Machine learning techniques might be successfully applied to support the optimal allocation of limited healthcare resources. Firstly, they enable automatization of health policy making utilising historical, epidemiological, and clinical data. Secondly, they introduce flexibility and transparency thanks to the adoption of ML to investment decisions in the healthcare sector as well.

Patients' Expectations and Preferences for the Organizational Conditions of the Colorectal Cancer Screening Programme in Poland: A Qualitative Analysis.

(1) Background: Colorectal cancer (CRC) is a serious health problem in Poland as well as many European Union countries. The study aimed to describe factors that, from the patient's perspective, could increase the attendance rate and regularity of participation in the colorectal cancer screening programme (SP); (2) Methods: The qualitative approach was applied. The study involved six focus interviews conducted with 24 respondents (12 women and 12 men) aged 40-49, who had at least one first-degree family member diagnosed with CRC and persons aged 50-65, living in five selected voivodships (provinces) of Poland. The collected data were thematically coded. Further, a comparative analysis was conducted, and aggregated statements were formulated; (3) Results: The inclusion of primary care clinics within the CRC SP organization was reported as a key factor in improving the attendance rate and regularity of patient participation in the programme. Particularly important factors included an invitation in the form of a personal letter or a phone call made by staff from primary care clinics; (4) Conclusions: Patients were confirmed to have clear expectations and preferences for the organizational conditions of the CRC SP. Preferences nature allows them to be treated as one of the potential criteria for selecting critical parameters of CRC SPs.

Parental Knowledge about Allergies and Problems with an Elimination Diet in Children Aged 3 to 6 Years.

Allergic diseases are highly prevalent, and they can exert a significant influence on the patients' physical and mental well-being, thus affecting the quality of their lives and society as a whole. The aim of this study was to evaluate parental knowledge about allergens, allergy symptoms, and treatment of allergies, and to identify problems with adherence to an elimination diet and the underlying difficulties. Twelve kindergartens and the parents of 1350 preschoolers took part in the first stage of the study. In a screening trial, allergies were diagnosed in 197 children, and their parents participated in the second stage of the study. The child's age at the onset of the first symptoms was significantly correlated with allergy type. Age was significantly correlated with selected symptoms of an allergic reaction, and skin allergies were more prevalent in younger children. Erythema, skin reddening, and urticaria occurred more frequently in children aged 3−4 years (OR 1.45; 95%CI 1.24−1.77, p < 0.05) and were diagnosed in skin tests (OR 1.36; 95%CI 1.22−1.59, p < 0.05). Allergies to numerous food items were associated with a long-term elimination diet (OR 1.89; 95%CI 1.33−2.19, p < 0.01), as well as problems with preparing safe meals, shopping for food, or dietary adherence when eating out. According to the respondents, lack of support from other family members and compliance with dietary restrictions in kindergartens and when eating out posed the greatest barriers to dietary adherence. Parents do not have sufficient knowledge about environmental allergens and effective strategies for coping with acute allergic reactions, including anaphylactic shock. Children with diagnosed food allergies should enjoy a similar quality of life to their healthy peers, which is why the parents should be educated about diet therapy, duration of treatment, and safe food substitutes.

How Useful Are Digital Health Terms for Outcomes Research? An ISPOR Special Interest Group Report.

OBJECTIVES: This study aimed to review definitions of digital health and understand their relevance for health outcomes research. Four umbrella terms (digital health, electronic health, mobile health, and telehealth/telemedicine) were summarized in this article. METHODS: PubMed/MEDLINE, Embase, Cochrane Library, and EconLit were searched from January 2015 to May 2020 for systematic reviews containing key Medical Subject Headings terms for digital health (n = 38) and synonyms of "definition." Independent pairs of reviewers performed each stage of the review, with reconciliation by a third reviewer if required. A single reviewer consolidated each definition for consistency. We performed text analysis via word clouds and computed document frequency-and inverse corpus frequency scores. RESULTS: The search retrieved 2610 records with 545 articles (20.9%) taken forward for full-text review. Of these, 39.3% (214 of 545) were eligible for data extraction, of which 134 full-text articles were retained for this analysis containing 142 unique definitions of umbrella terms (digital health [n = 4], electronic health [n = 36], mobile health [n = 50], and telehealth/telemedicine [n = 52]). Seminal definitions exist but have increasingly been adapted over time and new definitions were created. Nevertheless, the most characteristic words extracted from the definitions via the text analyses still showed considerable overlap between the 4 umbrella terms. CONCLUSIONS: To focus evidence summaries for outcomes research purposes, umbrella terms should be accompanied by Medical Subject Headings terms reflecting population, intervention, comparator, outcome, timing, and setting. Ultimately a functional classification system is needed to create standardized terminology for digital health interventions denoting the domains of patient-level effects and outcomes.

An evaluation of the knowledge on specific nutritional needs and factors affecting pregnancy outcome in women of reproductive age.

Background: Pregnancy is one of the few periods in a woman's life when extra weight is not perceived as a negative factor, but has positive connotations with healthy fetal development, which runs against the modern cult of a perfect, slim and healthy body. Most research studies focus on excessive rather than insufficient weight gain in successive trimesters of pregnancy. Objective: The aim of this study was to evaluate women's knowledge about the influence of diet on pregnancy outcome and to assess changes in body weight and eating behaviors during pregnancy. Materials and methods: The study consisted of an online survey. A total of 325 correctly and completely filled in questionnaires were considered. The respondents were divided into two groups: women without children (44.92%) and pregnant women and mothers (55.08%). The respondents' knowledge about eating behaviors during pregnancy was compared between the two groups. The responses given by mothers were used to evaluate weight gains during pregnancy and the nutritional status of pregnant women. Results: Changes in body weight during pregnancy were regarded as acceptable and pregnancy weight gain was considered a normal process by 92% of the respondents. Pregnant women had greater knowledge about the need for increased caloric intake in successive trimesters (p=0.0012). The respondents' knowledge about maternal health and healthy fetal development was assessed with the use of 10 true or false questions. The average score was 6.3±1.8 points, and no significant differences were found between mothers/pregnant women and women without children (6.6±1.3 vs 6.2±1.7, p>0.05). In the present study, 67% of the respondents were of the opinion that they followed a healthy diet, 14% claimed that they did not eat right, but were not motivated to make any changes. Conclusions: The respondents were aware that weight gain during pregnancy is a normal physiological process, but 1/3 of the respondents did not feel comfortable with the observed changes. The respondents did not have sufficient knowledge about the influence of maternal weight on fetal development. The use of diuretics and laxatives by pregnant women without medical consultation is a worrying phenomenon. These results indicate that women should have better access to knowledge about the impact of healthy nutrition on pregnancy outcome.

Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries.

Experiences with coverage with evidence development (CED) schemes are fairly limited in Central and Eastern European (CEE) countries, which are usually late adopters of new health technologies. Our aim was to put forward recommendations on how CEE health technology assessment bodies and payer organizations can apply CED to reduce decision uncertainty on reimbursement of medical devices, with a particular focus on transferring the structure and data from CED schemes in early technology adopter countries in Western Europe. Structured interviews on the practices and feasibility of transferring CED schemes were conducted and subsequently, a draft tool for the systematic classification of decision alternatives and recommendations was developed. The decision tool was reviewed in a focus group discussion and validated within a wider group of CEE experts in a virtual workshop. Transferability assessment is needed in case of (1) joint implementation of a CED scheme; (2) transferring the structure of an existing CED scheme to a CEE country; (3) reimbursement decisions that are linked to outcomes of an ongoing CED scheme in another country and (4) real-world evidence transferred from completed CED schemes. Efficient use of available resources may be improved by adequately transferring evidence and policy tools from early technology adopter countries.

State of the Art in Adoption of Contact Tracing Apps and Recommendations Regarding Privacy Protection and Public Health: Systematic Review.

BACKGROUND: During the COVID-19 pandemic, contact tracing apps have received a lot of public attention. The ongoing debate highlights the challenges of the adoption of data-driven innovation. We reflect on how to ensure an appropriate level of protection of individual data and how to maximize public health benefits that can be derived from the collected data. OBJECTIVE: The aim of the study was to analyze available COVID-19 contact tracing apps and verify to what extent public health interests and data privacy standards can be fulfilled simultaneously in the process of the adoption of digital health technologies. METHODS: A systematic review of PubMed and MEDLINE databases, as well as grey literature, was performed to identify available contact tracing apps. Two checklists were developed to evaluate (1) the apps' compliance with data privacy standards and (2) their fulfillment of public health interests. Based on both checklists, a scorecard with a selected set of minimum requirements was created with the goal of estimating whether the balance between the objective of data privacy and public health interests can be achieved in order to ensure the broad adoption of digital technologies. RESULTS: Overall, 21 contact tracing apps were reviewed. In total, 11 criteria were defined to assess the usefulness of each digital technology for public health interests. The most frequently installed features related to contact alerting and governmental accountability. The least frequently installed feature was the availability of a system of medical or organizational support. Only 1 app out of 21 (5%) provided a threshold for the population coverage needed for the digital solution to be effective. In total, 12 criteria were used to assess the compliance of contact tracing apps with data privacy regulations. Explicit user consent, voluntary use, and anonymization techniques were among the most frequently fulfilled criteria. The least often implemented criteria were provisions of information about personal data breaches and data gathered from children. The balance between standards of data protection and public health benefits was achieved best by the COVIDSafe app and worst by the Alipay Health Code app. CONCLUSIONS: Contact tracing apps with high levels of compliance with standards of data privacy tend to fulfill public health interests to a limited extent. Simultaneously, digital technologies with a lower level of data privacy protection allow for the collection of more data. Overall, this review shows that a consistent number of apps appear to comply with standards of data privacy, while their usefulness from a public health perspective can still be maximized.

Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis - a systematic review and meta-analysis.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I2 = 68.4 %], PMT 96 %, [I2 = 0 %]; Qbet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I2 = 15.6 %] versus 94 %; Qbet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Qbet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Qbet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

Future of Data Analytics in the Era of the General Data Protection Regulation in Europe.

The development of evidence to demonstrate 'value for money' is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the other side, especially when it comes to "personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveals information about his or her health status". At the forefront of these discussions are data protection issues as well as the population's trust in digital services. It seems that the new era has begun, where citizens and patients will have the ability to manage their personal or self-generated data. The European Commission has laid the groundwork for this paradigm shift that will steadily emerge in the coming years. To prepare for this change, we believe attention should be given to data security and other rules of data privacy. It has become increasingly important to ensure that individuals are properly introduced into complex environments with multiple sources of Big Data for clinical and behavioral purposes to provide an optimal balance between societal and individual benefits. In this article, a number of issues are considered and discussed, based upon the authors' experience, with the aim of helping the reader better understand the implications of the use of Big Data and the importance of data protection in the coming years.

Treatment of bypass failure in patients with chronic limb threatening ischemia - open surgery vs. percutaneous mechanical thrombectomy.

Background: Lower limb bypass occlusion in patients with chronic limb threating ischemia remains a challenge. We can choose between different treatment options: open surgery, local thrombolysis, thrombectomy/atherectomy devices. In this pilot study, we compare clinical outcomes and treatment costs between open surgery (OS) and percutaneous mechanical thrombectomy (pMTH). Patients and methods: This pilot study represents a retrospective analysis of hospital data of 48 occluded bypasses admitted from 2013 to 2018. Only patients presenting with severe ischemia and recrudescence of symptoms (Rutherford 4-6) were included in the current analysis. Two cohorts of patients were analysed: patients who underwent OS and patients that underwent pMTH. Primary clinical outcomes were one-year cumulative patency and limb salvage rates. Total cost was calculated as a sum of intra- and post-operative costs. To weigh clinical benefits against the economic consequences of OS versus pMTH a cost-effectiveness framework was adopted. Results: We analysed a series of 48 occluded bypasses 17 treated with open surgery and 31 with pMTH. Procedural success was 100% in both groups. When comparing one-year death rates (p-value = .22) and re-occlusion rates (p-value = .43), no statistically significant differences were observed between the two cohorts. Mean patency duration in the surgery cohort was significantly shorter (p-value < .05). Primary patency (OS 41.2% vs. pMTH 48.4%) and limb salvage rate (OS 88.2% vs. pMTH 90.3%) at one year are similar in both groups. The total cost of surgery was substantially higher (OS 10,159€ vs. pMTH 8,401€) Conclusions: This pilot study, although limited to 48 occluded bypasses, demonstrates that endovascular treatment with pMTH is less invasive, less time consuming and less expensive, and produces greater health benefits than traditional OS.

'Without data, you're just another person with an opinion'.

Introduction: Given the recent impressive digital transformation worldwide, the importance of data has reached a new dimension. It is, therefore, provocative to ask whether data can save healthcare systems from bankruptcy.Areas covered: We reviewed published examples in the search for the evidence on how the growing amount of data could change the way we used to assess the value of healthcare technologies, ensuring a more holistic approach in the decision-making process while reducing the waste in the healthcare.Expert opinion: The growing amount of data will continue to provide a multitude of valuable insights that can save healthcare systems from bankruptcy. Electronic medical records, IoT, wearables, and mobile applications generate constant data streams that can be utilized endlessly thanks to methodological advancements such as SNA, unsupervised and supervised machine learning, and natural language programming. However, interoperability across these multiple data sources still pose a challenge for the future development of data-driven healthcare. Already today however, decision makers can utilize Big Data to develop conditional coverage schemes for very expensive and complicated health technologies suitable for personalized healthcare. More advanced payers may utilize even data analytics even further and develop AI-based pricing schemes.

How to Value Digital Health Interventions? A Systematic Literature Review.

In Europe, there were almost twice as many patents granted for medical technology (13,795) compared to pharmaceuticals (7441) in 2018. It is important to ask how to integrate such an amount of innovations into routine clinical practice and how to measure the value it brings to the healthcare system. Given the novelty of digital health interventions (DHI), one can even question whether the quality-adjusted life years (QALY) approach developed for pharmaceuticals can be used or whether we need to develop a new DHI's value assessment framework. We conducted a systematic literature review of published DHIs' assessment guidelines. Each publication was analyzed with a 12-items checklist based on a EUnetHTA core model enriched with additional criteria such as usability, interoperability, and data security. In total, 11 value assessment guidelines were identified. The review revealed that safety, clinical effectiveness, usability, economic aspects, and interoperability were most often discussed (seven out of 11). More than half of the guidelines addressed organizational impact, data security, choice of comparator, and technical considerations (six out of 11). The unmet medical needs (three out of 11), along with the ethical (two out of 11) and legal aspects (one out of 11), were given the least attention. No author provided an analytical framework for the calculation of clinical and economic outcomes. We elicited five recommendations for the choice of DHI's value criteria and a methodological suggestion for the pricing and reimbursement framework. Our conclusions lead to the need for a new DHI's value assessment framework instead of a QALY approach.

The effects of payments for pharmaceuticals: a systematic literature review.

The existence of different forms of out-of-pocket payments (OOPs) for pharmaceuticals across the globe provokes the question whether they can achieve more negative or positive consequences. A systematic literature review was conducted to assess the association between drug cost sharing and health care services utilization, health care costs as well as health outcomes. Studies published in The Cochrane Library, PubMed, Embase were searched with such keywords as: drug, pharmaceutical, cost sharing, out of pocket, co-payments paired with the following: impact, health outcomes, health care costs and utilization. The final review included 18 articles. A total of 11 publications reported the association between drug cost sharing and health care utilization patterns, of which nine found a statistically significant direct relationship. In all 10 publications concerned the association between drug copayments and health care costs. Majority were limited to the impact on the drug budget. Seven studies looked into the link between drug cost sharing and health outcomes, of which five reported statistically significant inverse relationship. There is some evidence for the association between drug copayments, health outcomes and health care services consumption. The optimal system of OOPs' payments for pharmaceuticals needs to prevent drugs' overconsumption and mitigate the risks of excessive cost sharing's burden.

How can multi criteria decision analysis support value assessment of pharmaceuticals? - Findings from a systematic literature review.

INTRODUCTION: As budget constraints become more and more visible, there is growing recognition for greater transparency and greater stakeholders' engagement in the pharmaceuticals' pric-ing&reimbursement (P&R) decision making. New frameworks of drugs' value assessments are searched for. Among them, the multi-criteria decision analysis (MCDA) receives more and more attention. In 2014, ISPOR established Task Force to provide methodological recommendations for MCDA utilization in the health care decision making. Still, there is not so much knowledge about the real life experience with MCDA's adaptation to the P&R processes. AREAS COVERED: A systematic literature review was performed to understand the rationale for MCDA adaptation, methodology used as well as its impact on P&R outcomes. EXPERT COMMENTARY: In total 102 hits were found through the search of databases, out of which 18 publications were selected. Although limited in scope, the review highlighted how MCDA can im-prove the decision making processes not only regarding pricing & reimbursement but also contribute to the the risk benefit assessment as well as optimization of treatment outcomes. Still none of re-viewed studies did report how MCDA results actually impacted the real life settings.

Revealed preferences towards the appraisal of orphan drugs in Poland - multi criteria decision analysis.

BACKGROUND: A Multi Criteria Decision Analysis (MCDA) technique was adopted to reveal the preferences of the Appraisal Body of the Polish HTA agency towards orphan drugs (OMPs). RESULTS: There were 34 positive and 23 negative HTA recommendations out of 54 distinctive drug-indication pairs. The MCDA matrix consisted of 13 criteria, seven of which made the most impact on the HTA process. Appraisal of clinical evidence, cost of therapy, and safety considerations were the main contributors to the HTA guidance, whilst advancement of technology and manufacturing costs made the least impact. CONCLUSIONS: MCDA can be regarded as a valuable tool for revealing decision makers' preferences in the healthcare sector. Given that only roughly half of all criteria included in the MCDA matrix were deemed to make an impact on the HTA process, there is certainly some room for improvement with respect to the adaptation of a new approach towards the value assessment of OMPs in Poland.

Cost-utility analysis of vortioxetine versus agomelatine, bupropion SR, sertraline and venlafaxine XR after treatment switch in major depressive disorder in Finland.

BACKGROUND: To assess the cost-utility of vortioxetine versus relevant comparators (agomelatine, bupropion SR, sertraline, and venlafaxine XR) in the finnish setting in major depressive disorder (MDD) patients with inadequate response to selective serotonin- /serotonin-norepinephrine reuptake inhibitors. METHODS: A one-year analysis was conducted using a decision tree with a Markov state transition component. The health states were remission, relapse and recovery. A Finnish healthcare payer perspective was adopted. RESULTS: Vortioxetine was less costly and more effective versus all comparators in both direct and societal perspectives. Vortioxetine reduced the average annual direct costs by 4% versus venlafaxine XR and 8% versus sertraline. The greater efficacy associated with vortioxetine was translated into a higher percentage of patients in remission and recovery. The model was most sensitive to changes in remission rates at 8 weeks. CONCLUSION: This cost-utility analysis showed vortioxetine to be a good alternative for MDD patients switching therapy in Finland.

Does cost sharing do more harm or more good? - a systematic literature review.

BACKGROUND: There are positive and negative consequences of the implementation of out of pocket (OOP) payments as a source of the healthcare financing. On the one hand, OOP burden increases awareness of treatment costs and limits unnecessary use of healthcare services. On the other hand, it may prevent the sick from accessing needed care. Consequently there are several aspects that ought to be taken into consideration while defining the optimal structure of OOP payments. The objective of this study was twofold. Firstly, it was to understand what actions are taken to decrease the OOP burden. Secondly, it was to address the question whether the implementation of any form of formal OOP payments may impact negatively upon fairness in financial contribution. METHODS: The literature search was conducted using the Pubmed, Embase, Cochrane Library and Center of Review and Dissemination databases. Only studies which measured the Kakwani index of progressivity in at least two time points were included. Articles written in English published between January 2004 and September 2015 were searched. No geographical restriction was imposed. An increment of more than 0.10 in the Kakwani index was considered as a significant health policy impact. RESULTS: In total 16 publications were included, of which nine studied attempts to decrease the OOP burden, four described the consequences of the introduction of formal fees, and three covered both topics. Overall, a significant health policy impact was noted in four cases. All of them related to a reduction in the OOP burden, with three and one noting a change towards the progressivity and regressivity of direct healthcare payments respectively. Among jurisdictions which introduced formal fees, none study noted a significant impact on the regressivity of OOP spendings. CONCLUSIONS: In the majority of cases, a health policy impact on the distribution of OOP health payments was insignificant. The reduction of OOP burden cannot be achieved successfully without adequate extension of healthcare coverage or engagement of other sources of healthcare financing. When formal fees are being introduced, protection against catastrophic healthcare payments is needed for the most vulnerable groups.

The use of non-economic criteria in pricing and reimbursement decisions in Central and Eastern Europe: issues, trends and recommendations.

INTRODUCTION: According to some experts, there is still room for improvement with regard to the inclusion of ethical considerations in Health Technology Assessment (HTA). AREAS COVERED: The pros and cons of the introduction of non-economic criteria in the HTA process in Central and Eastern Europe (CEE) are discussed. In comparison to Western Europe, financial considerations are even more important in CEE settings; however, it could also be said that attachment to equity and justice is part of CEE's heritage. Therefore, the trade-off between conflicting principles is evaluated. Expert commentary: To ensure the right balance between equity and efficiency in decision making, the current HTA framework has to be further augmented to allow all conflicting criteria to be addressed to a satisfactory degree. Following other examples, the applicability of multi criteria decision analysis technique to CEE settings should be further investigated.

Health technology assessment of public health programmes in Poland, years 2010 and 2013.

BACKGROUND: In Poland, among other responsibilities, local governments are obliged to organize public health activities for local communities. To fulfill their obligations in this respect, authorities can organize preventive care in the form of health programs. Prior to their implementation, local governments must seek however opinion of the Polish HTA (Health Technology Assessment) agency. HTA recommendations do inform final decision making process but are not obligatory to be followed. OBJECTIVE: Firstly, It was to provide an insight into what extend local governments utilize health programs in their endeavors and the scope of health topics included. Secondly, it was to elicit recommendations for future authors of health programs in order to increase the chances of positive HTA recommendation. METHODS: The retrospective analysis of HTA recommendations issued by the Polish HTA agency (AHTAPol) in 2010 and 2013 was conducted. RESULTS: There were 67 and 294 HTA recommendations issued in 2010 and 2013 respectively of which 47.8% and 34.4% were negative. Among authors, city councils and communes dominated. Vaccinations were the most commonly chosen target health intervention. In total, six key recommendations for local governments interested in the implementation of health programs were elicited. CONCLUSIONS: To increase the chances for positive HTA recommendations, the health program has to be designed for health problems supported by sound clinical evidence which is not covered by the scope of reimbursement offered by National Health Fund. The targeted health intervention has to be supported by the evidence of proven clinical efficacy and safety and utilize available epidemiological data.