Systematic Review of Outcomes for Assessment of Medication Adherence Enhancing Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: The lack of universal guidance on outcome measures for evaluating medication adherence enhancing interventions (MAEIs) poses a challenge for assessing their effectiveness. This literature review aimed to provide a systematic overview of outcome measures currently used for the value assessment of MAEIs. METHODS: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and searched MEDLINE, PsycINFO, Scopus, CINAHL, and Academic Search Complete for randomized and nonrandomized clinical trials, prospective cohort studies, model-based economic evaluations, and value frameworks published in English between January 2010 and September 2020. Two independent reviewers screened all titles and abstracts, followed by a full-text review. Due to the large number of relevant studies, data extraction was limited to articles published between January 2018 and September 2020. We collected data on the general characteristics of the study, the type of intervention, and the outcomes measured. RESULTS: We screened 14 685 records and identified 308 articles for data extraction. Behavioral interventions were the most common (n = 143), followed by educational interventions (n = 110) and mixed-method interventions (n = 73). Outcomes were clustered into 7 categories with medication adherence (n = 286) being the most frequently measured, followed by clinical outcomes (n = 155), health-related quality of life (n = 57), resource use (n = 43), patient satisfaction (n = 31), economic outcomes (n = 18), and other outcomes (n = 76). CONCLUSIONS: Various outcomes measures have been used to evaluate MAEIs, with only a small number of studies exploring economic and patient-reported outcomes. Future research is warranted to develop a consensus-based set of criteria for assessing MAEIs to facilitate the comparison of interventions and enable informed decision making.

Methods for Measuring Multiple Medication Adherence: A Systematic Review-Report of the ISPOR Medication Adherence and Persistence Special Interest Group.

BACKGROUND: A broad literature base exists for measuring medication adherence to monotherapeutic regimens, but publications are less extensive for measuring adherence to multiple medications. OBJECTIVES: To identify and characterize the multiple medication adherence (MMA) methods used in the literature. METHODS: A literature search was conducted using PubMed, PsycINFO, the International Pharmaceutical Abstracts, the Cumulative Index to Nursing and Allied Health Literature and the Cochrane Library databases on methods used to measure MMA published between January 1973 and May 2015. A two-step screening process was used; all abstracts were screened by pairs of researchers independently, followed by a full-text review identifying the method for calculating MMA. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed to conduct this systematic review. For studies that met the eligibility criteria, general study and adherence-specific characteristics and the number and type of MMA measurement methods were summarized. RESULTS: The 147 studies that were included originated from 32 countries, in 13 disease states. Of these studies, 26 used proportion of days covered, 23 used medication possession ratio, and 72 used self-reported questionnaires (e.g., the Morisky Scale) to assess MMA. About 50% of the studies included more than one method for measuring MMA, and different variations of medication possession ratio and proportion of days covered were used for measuring MMA. CONCLUSIONS: There appears to be no standardized method to measure MMA. With an increasing prevalence of polypharmacy, more efforts should be directed toward constructing robust measures suitable to evaluate adherence to complex regimens. Future research to understand the validity and reliability of MMA measures and their effects on objective clinical outcomes is also needed.

A systematic review of the health-related quality of life and economic burdens of anorexia nervosa, bulimia nervosa, and binge eating disorder.

PURPOSE: To perform a systematic review of the health-related quality of life (HRQoL) and economic burdens of anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). METHODS: A systematic literature search of English-language studies was performed in Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL Plus, Business Source Premier, and Cochrane Library. Cost data were converted to 2014 Euro. RESULTS: Sixty-nine studies were included. Data on HRQoL were reported in 41 studies (18 for AN, 17 for BN, and 18 for BED), on healthcare utilization in 20 studies (14 for AN, 12 for BN, and 8 for BED), and on healthcare costs in 17 studies (9 for AN, 11 for BN, and only 2 for BED). Patients' HRQoL was significantly worse with AN, BN, and BED compared with healthy populations. AN, BN, and BED were associated with a high rate of hospitalization, outpatient care, and emergency department visits. However, patients rarely received specific treatment for their eating disorder. The annual healthcare costs for AN, BN, and BED were €2993 to €55,270, €888 to €18,823, and €1762 to €2902, respectively. CONCLUSIONS: AN, BN, and BED have a serious impact on patient's HRQoL and are also associated with increased healthcare utilization and healthcare costs. The burden of BED should be examined separately from that of BN. The limited evidence suggests that further research is warranted to better understand the differences in long-term HRQoL and economic burdens of AN, BN, and BED.

Need for multicriteria evaluation of generic drug policies.

Policymakers tend to focus on improving patented drug policies because they are under pressure from patients, physicians, and manufacturers to increase access to novel therapies. The success of pharmaceutical innovation over the last few decades has led to the availability of many off-patent drugs to treat disease areas with the greatest public health need. Therefore, the success of public health programs in improving the health status of the total population is highly dependent on the efficiency of generic drug policies. The objective of this article was to explore factors influencing the true efficiency of generic prescription drug policies in supporting public health initiatives in the developed world. Health care decision makers often assess the efficiency of generic drug policies by the level of price erosion and market share of generics. Drug quality, bioequivalence, in some cases drug formulations, supply reliability, medical adherence and persistence, health outcomes, and nondrug costs, however, are also attributes of success for generic drug policies. Further methodological research is needed to measure and improve the efficiency of generic drug policies. This also requires extension of the evidence base of the impact of generic drugs, partly based on real-world evidence. Multicriteria decision analysis may assist policymakers and researchers to evaluate the true value of generic drugs.

Epidemiology, health-related quality of life and economic burden of binge eating disorder: a systematic literature review.

PURPOSE: To perform a systematic review on the epidemiology, the health-related quality of life (HRQoL) and economic burden of binge eating disorder (BED). METHODS: A systematic literature search of English-language articles was conducted using Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL Plus, Business Source Premier and Cochrane Library. Literature search on epidemiology was limited to studies published between 2009 and 2013. Cost data were inflated and converted to 2012 US$ purchasing power parities. All of the included studies were assessed for quality. RESULTS: Forty-nine articles were included. Data on epidemiology were reported in 31, HRQoL burden in 16, and economic burden in 7 studies. Diagnosis of BED was made using 4th Edition of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria in 46 studies. Lifetime prevalence of BED was 1.1-1.9% in the general population (DSM-IV). BED was associated with significant impairment in aspects of HRQoL relating to both physical and mental health; the Short Form 36 Physical and Mental Component Summary mean scores varied between 31.1 to 47.3 and 32.0 to 49.8, respectively. Compared to individuals without eating disorder, BED was related to increased healthcare utilization and costs. Annual direct healthcare costs per BED patient ranged between $2,372 and $3,731. CONCLUSIONS: BED is a serious eating disorder that impairs HRQoL and is related to increased healthcare utilization and healthcare costs. The limited literature warrants further research, especially to better understand the long-term HRQoL and economic burden of BED.

Adherence to the antirheumatic drugs: a systematic review and meta-analysis.

Introduction: This systematic review and meta-analysis aimed to analyze the adherence rate for conventional and biological disease-modifying antirheumatic drugs (DMARDs) utilizing different assessment measures. Method: A systematic literature search was performed in four electronic databases, including PubMed, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL), covering the time frame from April 1970 to April 2023. Studies that present data on medication adherence among adult patients with rheumatoid arthritis (RA), specifically focusing on DMARDs (conventional or biological), were included in the analysis. The adherence rate for different assessment measures was documented and compared, as well as for conventional and biological DMARDs. A random-effects meta-analysis was performed to assess adherence rates across different adherence assessment measures and drug groups. Results: The search identified 8,480 studies, out of which 66 were finally included in the analysis. The studies included in this meta-analysis had adherence rates ranging from 12 to 98.6%. Adherence rates varied across several adherent measures and calculation methods. Using the subjective assessment measures yielded the outcomes in terms of adherence rate: 64.0% [0.524, 95% CI 0.374-0.675] for interviews and 60.0% [0.611, 95% CI 0.465-0.758] for self-reported measures (e.g., compliance questionnaires on rheumatology CQR-5), p > 0.05. In contrast, the objective measurements indicated a lower adherence rate of 54.4% when using the medication event monitoring system (p > 0.05). The recorded rate of adherence to biological DMARDs was 45.3% [0.573, 95% CI 0.516-0.631], whereas the adherence rate for conventional DMARDs was 51.5% [0.632, 95% CI 0.537-0.727], p > 0.05. In the meta-regression analysis, the covariate "Country of origin" shows a statistically significant (p = 0.003) negative effect with a point estimate of -0.36, SE (0.12), 95% CI, -0.61 to -0.12. Discussion: Despite its seemingly insignificant factors that affect the adherence rate, this meta-analysis reveals variation in adherence rate within the types of studies conducted, the methodology used to measure adherence, and for different antirheumatic drugs. Further research is needed to validate the findings of this meta-analysis before applying them to clinical practice and scientific research. In order to secure high reliability of adherence studies, compliance with available reporting guidelines for medication adherence research is more than advisable.

The hidden burden of atopic dermatitis in central and Eastern European countries.

BACKGROUND: Atopic dermatitis (AD) imposes a hidden burden through its negative effects on quality of life and productivity. We aim to estimate this hidden burden in adults and adolescents in Central and Eastern European (CEE) countries. METHODS: We created a burden of disease model to quantify AD's hidden burden. Humanistic burden was calculated by estimating the monetary value of quality-adjusted life years (QALYs) lost, using prevalence data from the Global Burden of Disease study and gross domestic product (GDP) per capita for each country. Indirect economic burden was estimated based on productivity loss from absenteeism and presenteeism, adjusted for labor force participation and unemployment rates. Total hidden burden was determined by combining productivity losses and QALYs lost. RESULTS: QALY loss due to AD ranged from 1,832 to 58,596 annually in CEE countries, equating to 38 million to approximately 1 billion Euros per country. Productivity losses ranged from 3.6 to 148.9 million Euros annually. The total hidden burden of AD represents 0.11% to 0.43% of the GDP. CONCLUSIONS: Our estimates reflect significant differences in population size, prevalence, and economic strength among CEE countries. Adjusting findings to country-specific GDP provided insights into AD's true hidden burden, offering valuable information for decision-making.

Atopic dermatitis (AD), commonly known as eczema, is a widespread skin condition causing itchiness and discomfort. While it is well known that treating eczema costs money and affects patients' health, there is more to its impact than meets the eye. Our study closely examined eczema's 'hidden' effects in Central and Eastern European (CEE) countries, such as its impact on work ability and life enjoyment.We found that eczema's impact is not just about the direct costs of treatment. It also includes how the condition leads to lost workdays and reduced productivity, and more importantly, how it lowers the quality of life for those who have it. This part of eczema's impact, which is not always easy to see or measure, can be just as significant.Our research is important because it shows that when health officials and policymakers think about how to deal with eczema, they need to consider these hidden effects too. Different countries in Central and Eastern Europe experience these effects in varying degrees. By understanding this, healthcare systems can make better decisions about where to put their healthcare resources. For example, they might decide to invest more in treatments or support that can improve the quality of life for people with eczema.In summary, our study highlights the need to look at the full picture of eczema's impact. This includes not only the costs of treatment but also how it affects people's lives in ways that are not always immediately obvious.

Breast cancer stage and molecular subtype distribution: real-world insights from a regional oncological center in Hungary.

OBJECTIVE: Examining the distribution of breast cancer (BC) stage and molecular subtype among women aged below (< 45 years), within (45-65 years), and above (> 65 years) the recommended screening age range helps to understand the screening program's characteristics and contributes to enhancing the effectiveness of BC screening programs. METHODS: In this retrospective study, female patients with newly diagnosed BC from 2010 to 2020 were identified. The distribution of cases in terms of TNM stages, severity classes, and subtypes was analysed according to age groups. RESULTS: A total of 3282 women diagnosed with BC were included in the analysis. Among these cases 51.4% were detected outside the screening age group, and these were characterized by a higher TNM stage compared to those diagnosed within the screening age band. We observed significantly higher relative frequency of advanced BC in the older age group compared to both the screening age population and women younger than 45 years (14.9% vs. 8.7% and 7.7%, P < 0.001). HR-/HER2- and HER+ tumours were relatively more frequent among women under age 45 years (HR-/HER2-: 23.6%, HER2+: 20.5%) compared to those within the screening age range (HR-/HER2-: 13.4%, HER2+: 13.9%) and the older age group (HR-/HER2-: 10.4%, HER2+: 11.5%). CONCLUSIONS: The findings of our study shed light on potential areas for the improvement of BC screening programs (e.g., extending screening age group, adjusting screening frequency based on molecular subtype risk status) in Hungary and internationally, as well.

Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases.

Despite the availability of affordable pharmaceuticals treating cardiovascular diseases (CVDs), many of the risk factors remain poorly controlled. Fixed-dose combinations (FDCs), a form of incremental innovation, have already demonstrated improvements over combinations of single medicines in adherence and hard clinical endpoints. Nevertheless, there are many barriers related to the wider use of FDCs in CVDs. Our aim was to identify these barriers and explore system-level facilitators from a multi-stakeholder perspective. Identified barriers include (i) hurdles in evidence generation for manufacturers, (ii) limited acceptance of adherence as an endpoint by clinical guideline developers and policymakers, (iii) limited options for a price premium for incremental innovation for healthcare payers, (iv) limited availability of real-world evidence, and (v) methodological issues to measure improved adherence. Initiatives to standardize and link healthcare databases in European countries, movements towards improved patient centricity in healthcare, and extended value assessment provide opportunities to capture the benefits of FDCs. Still, there is an emerging need to facilitate the generalizability of sporadic clinical evidence across different FDCs and to improve adherence measures. Finally, healthcare payers need to be convinced to pay a fair premium price for the added value of FDCs to incentivize incremental innovation in CVD treatment.

Cost-Effectiveness and Impact on Health Care Utilization of Interventions to Improve Medication Adherence and Outcomes in Asthma and Chronic Obstructive Pulmonary Disease: A Systematic Literature Review.

BACKGROUND: Poor adherence to asthma and chronic obstructive pulmonary disease maintenance therapies impairs health outcomes. Proven and cost-effective programs to promote adherence and persistence are not yet in regular widespread use. Implementation costs are a potential barrier to uptake of such programs. OBJECTIVE: We undertook a systematic literature review and narrative synthesis of studies investigating the cost-effectiveness of treatment adherence-promoting programs or that determined their impact on health care budget directly or via health care resource use (HCRU). METHODS: We identified relevant publications using Medline and PreMEDLINE (PubMed), Embase (Embase.com, Elsevier), and EconLit for publications between January 2000 and July 2021. We also searched clinical trial databases and selected conference proceedings. RESULTS: Of 1,910 potentially relevant articles, 26 met prespecified inclusion criteria and underwent data extraction. Eleven reported a direct assessment of adherence, 15 included economic evaluations, and 17 described HCRU. None included an analysis of biologic medication use. When they were studied, interventions were often found to be highly cost-effective, with dominant incremental cost-effectiveness ratios in some cases. Reductions in direct costs and HCRU (health care visits, hospital admissions, and/or the use of medications, including add-on/reliever treatment and antibiotics) were frequently reported. Reported use of maintenance treatments improved in some studies. Counseling and/or digitally informed programs were used in all cases in which favorable outcomes were observed. CONCLUSIONS: Adherence-promoting interventions are mostly cost-effective and often result in reduced HCRU and associated costs. Multidisciplinary care involving one-to-one advice and digitally enhanced communications appear to offer the greatest benefit.

Identifying and presenting key country-specific indicators related to medication adherence: a comprehensive study across European countries.

This study tackles the critical challenge of medication non-adherence in healthcare by pinpointing indicators related to medication adherence (IRMAs) across 39 European countries and Israel. Utilizing a structured expert survey methodology within the European Network to Advance Best Practices and Technology on Medication Adherence (ENABLE; COST Action CA19132), our research identified key country-specific IRMAs and collected data on these indicators to understand the multifaceted nature of medication adherence. The research was conducted in two phases: firstly, defining key IRMAs through a two-round expert survey, and secondly, gathering country-specific data on these IRMAs through literature reviews and additional expert surveys. The study revealed a diverse range of 26 top-ranked IRMAs, including six related to country characteristics, four to social/economic factors, three each to therapy-related and patient-related factors, one to condition-related factors, and nine to healthcare system-related factors. The availability of country-specific data on these IRMAs varied among the countries, highlighting the need for more comprehensive data collection and research. The findings from this study not only underscore the complexity of predicting medication adherence but also lay the groundwork for developing targeted, country-specific interventions to improve adherence. Moreover, this research offers valuable insights for policymakers, highlighting the importance of understanding the multifaceted nature of medication adherence and offering a valuable resource in formulating targeted health policies to enhance health outcomes and reduce the economic burden associated with medication non-adherence.

Engagement of medication users in the development and implementation of digital medication adherence technologies: a multi-stakeholder study.

BACKGROUND: This study aims to create a comprehensive framework for the development and implementation of digital medication adherence technologies (DMATech), focusing on critical stages where engagement of medication users (MU) is considered meaningful, i.e. adds significant value, as agreed upon by participating stakeholders. METHODS: Through a literature review and expert consensus, a framework was outlined covering key DMATech development and implementation phases and steps. An in-person workshop with MU representatives and adherence experts, using the Nominal Group Technique, further refined these stages for MU engagement. RESULTS: The DMATech framework included three phases: 'Innovation,' 'Research and Development,' and 'Launch and Implementation,' each encompassing multiple steps. The workshop, attended by five MU representatives and nine adherence experts, identified critical stages for MU input including context analysis, ideation, proof of concept, prototype creation, DMATech's iteration, critical evaluation, healthcare implementation, real-world assessment, and improvement. Nevertheless, there was a divergence of consensus regarding the importance of MUs engagement in regulatory, financial, and marketing aspects. CONCLUSIONS: This study provides a holistic framework for DMATech development and implementation and underscores the necessity of MU engagement at various stages. Modes of MU engagement cannot be generalized; a case-by-case evaluation of engagement strategies is essential.

Half a Century of Fragmented Research on Deviations from Advised Therapies: Is This a Good Time to Call for Multidisciplinary Medication Adherence Research Centres of Excellence?

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

New terminology of medication adherence enabling and supporting activities: ENABLE terminology.

Introduction: Medication non-adherence negatively affects the effectiveness of evidence-based therapies and sustainability of healthcare systems. Lack of agreed terminology of medication adherence enabling and supporting activities leads to underuse of the available tools. The ENABLE COST Action was aimed at proposing a new terminology for these activities in order to help both scientific research and its clinical application. Methods: Initial discussions within the ENABLE Working Groups allowed for the conceptualization of four interlinked terms related to adherence, i.e., "medication adherence technology", "medication adherence enhancing intervention", "best practice" and "reimbursement". The iterative process of internal discussion was structured around two dedicated international workshops. Moreover, extensive stakeholder consultations have been organised, including an interactive online survey used to assess the level of agreement with, and the clarity of relevant terms and definitions proposed. Results: Detailed analysis of the results of this process allowed for fine-tuning of the items, and finally, for proposing the final set of definitions. Across all the three phases of this process, the definitions were substantially modified to better reflect the concepts, simplify the language, and assure completeness and cohesiveness of terminology. Feedback obtained from the stakeholders helped this process and confirmed that the final terms and definitions were well received by the experts active in the field of medication adherence. Discussion: Covering the gap in the existing terminology, this work proposes a cohesive set of terms and definitions applicable to medication adherence enabling and supporting activities. Promoting evidence-based approach to this field, this terminology may help research, clinical practice and policy.

Health-related quality of life and utility in patients receiving biological and non-biological treatments in rheumatoid arthritis.

Biological treatments earn increasing significance in the treatment of rheumatoid arthritis (RA) but are associated with high incremental cost-effectiveness ratio compared to conventional antirheumatic treatments such as disease-modifying antirheumatic drugs. As the most important objective of medical technologies should be to increase life years and/or patients' health-related quality of life (HRQoL), measuring QoL and utility in RA patients treated with biological therapies is crucial. The objective of this study is to compare the utility and QoL of patients treated with biological (n = 85) and non-biological (n = 168) antirheumatic drugs in Hungary in a cross-sectional non-interventional study. A measure of impairment (Disease Activity Score (DAS)-28), QoL measure (EuroQol five Dimension (EQ-5D) Visual Analogue Scale (VAS), Rheumatoid Arthritis Quality of Life (RAQoL)) and utility measures (indirect: EQ-5D index, direct: time trade-off (TTO)) were applied using an interview method. The Pearson correlation was used to assess the strength of the relationship of different measures in the total study group (n = 253). The EQ-5D index (biological treatment: 0.608, non-biological treatment: 0.483; P = 0.012) and DAS-28 (biological treatment: 3.8, non-biological treatment: 4.5; P = 0.003) showed statistically significant difference between the two subcohorts after adjusting data by age, gender and disease duration. Our results indicate that patients on biological treatment have lower disease activity and higher utility; however, it was not statistically significant in all cases. According to our knowledge, TTO was not used previously in Hungarian RA patients. Utility data concerning biological treatments are essential for cost-utility models in health technology assessment reports for public reimbursement.

Secondary primary malignancies after treatment with chemo-immunotherapy in treatment-naïve patients with CLL: a systematic literature review.

OBJECTIVES: In chronic lymphocytic leukemia (CLL), therapy-related cytotoxicity and the resulting immunodeficiency are thought to contribute to the development of secondary primary malignancies (SPM). Here, we analyzed clinical trial data on the occurrence of SPM following chemo-immunotherapy (CIT) regimens in treatment-naïve CLL patients. METHODS: A systematic literature search was conducted covering multiple databases between 2003 and 2019. Data from relevant clinical trials on the proportion of patients with SPMs were extracted. Then, the number of SPM patients/person-years was calculated by taking into account the trials' follow-up time. Finally, a random-effects meta-analysis to pool the rates from individual studies was performed. RESULTS: We identified 22 studies reporting SPM data available for analysis. Random-effects meta-analysis estimated that the number of SPM patients/1000 person-years was 24 (95%CI: 19-29). Results from trials with cancer-specific data indicated 19 (95%CI: 14-26) solid and 9 (95%CI: 6-12) hematological SPM patients/1000 person-years. These estimations did not change significantly when sub-groups were analyzed by CIT regimens. CONCLUSION: Although pooling data with the intention to analyze adverse event rates is challenging, our study concluded that for CIT regimens, SPM should be considered an important adverse outcome. Different regimens showed similar trends; however, other clinical and demographic factors also have profound impact.

Review of the scientific literature on the use of automated breast ultrasound for screening / Az automatizált emloultrahang-daganatszurés szakirodalmi áttekintése

Several technological developments have been carried out recently to improve the effectiveness of breast cancer screening. Most of them have emerged as a complementary method to mammography. Automated breast ultrasound is one of these technologies. The objective of this study is to provide an overview on guidelines and recommenda-tions related to the application of automated breast ultrasound as a screening modality and to summarize the scien-tific literature. Targeted literature review was performed to collect information. We searched in publicly available databases for guidelines and recommendations as well as scientific publications on screening and early detection. We found substantial amount of information about automated breast ultrasound mainly for patients with dense breast; however, breast cancer screening guidelines have not yet incorporated this technology. 9 clinical studies were in-cluded in the review, most of them were single-arm studies with relatively short follow-up time. Most of them were performed in the USA. Results were presented mainly for short-term outcomes of breast cancer screening: sensitiv-ity, specificity, tumor detection rate and recall rate. The opportunity for retrospective evaluation of the images and the reproducibility are considered the most important advantages. Evidence suggest that the cancer detection rate can be improved compared to mammography alone in women with dense breast. The main disadvantages of this technology are the high recall and false positive rates. Further scientific evidence is required to reduce uncertainty related to the use of automated breast ultrasound for breast cancer screening.

The role of low-dose computed tomography in lung cancer screening / A kis sugárdózisú komputertomográfia szerepe a tüdorákszurésben

Introduction: Lung cancer is a serious public health problem in Hungary, but currently there is no nationwide screening program for the early detection of the disease. Several technological developments have been carried out recently to improve the effectiveness of lung cancer screening. Low-dose computed tomography (LDCT) is one of these technologies. Objective: The objective of this study is to provide an overview on guidelines and recommendations related to the application of LDCT as a novel lung cancer screening modality and to summarize the scientific literature and screening practices of other countries. Method: We performed a targeted literature review to collect information about LDCT in lung cancer screening. We searched in publicly available databases for guidelines and recommendations as well as scientific publications on screening and early detection of lung cancer. Results: In our literature search, we identified 16 guidelines and recommendations for lung cancer screening and LDCT. Regarding the efficacy of LDCT lung cancer screening, 10 foreign randomized controlled trials and 2 Hungarian trials were reviewed. Information on screening practices of 10 European countries were identified. Discussion: Evidences suggest that LDCT screening improves the detection of lung cancer, especially at early stages, and reduces cancer-specific mortality. Conclusion: In summary, in the high-risk population, LDCT can be considered an effective screening modality for the early-stage detection of lung cancer and for reducing lung cancer mortality. The ongoing Hungarian and foreign pilot programs may provide futher evidence for the implementation of a nationwide LDCT lung cancer screening program.

Development of a breast cancer screening protocol to use automated breast ultrasound in a local setting.

Introduction: The sensitivity of mammography screening is lower in women with dense breast. Increasing the efficacy of breast cancer screening have received special attention recently. The automated breast ultrasound (ABUS) shows promising results to complement mammography. Our aim was to expand the existing breast cancer screening protocol with ABUS within a Hungarian pilot project. Methods: First, we developed a protocol for the screening process focusing on integrating ABUS to the current practice. Consensus among clinical experts was achieved considering information from the literature and the actual opportunities of the hospital. Then we developed a protocol for evaluation that ensures systematic data collection and monitoring of screening with mammography and ABUS. We identified indicators based on international standards and adapted them to local setting. We considered their feasibility from the data source and timeframe perspective. The protocol was developed in a partnership of researchers, clinicians and hospital managers. Results: The process of screening activity was described in a detailed flowchart. Human and technological resource requirements and communication activities were defined. We listed 23 monitoring indicators to evaluate the screening program and checked the feasibility to calculate these indicators based on local data collection and other sources. Partnership between researchers experienced in planning and evaluating screening programs, interested clinicians, and hospital managers resulted in a locally implementable, evidence-based screening protocol. Discussion: The experience and knowledge gained on the implementation of the ABUS technology could generate real-world data to support the decision on using the technology at national level.