Search

Objectives: The aim of this study was to determine the role of the patient’s point of view when assessing health technologies as well as the patients’ willingness to participate in this process in our country. Methods: A pilot study included 165 patients across Bulgaria recruited from December 2019 to March 2020. Appropriate descriptive and statistical methods were used. Results: The patient’s point of view was an essential element in HTA. Patients in Bulgaria have the desire and willingness to share their personal experience with institutions, but insufficient knowledge of the process hinders their full participation in HTA. Our results showed that the need for higher awareness in the field and familiarity with HTA methodology are critical factors for the inclusion of patients in the HTA procedures in Bulgaria. Conclusion: This study was one of the few ones focused on the impact of patient participation in HTA in Bulgaria. The patient’s role in the development of medical technology must be recognized and considered a critical factor in the future of HTA.

Background Health Technology Assessment (HTA), which can support public drug reimbursement decisions will play a core function in the planned national Pharmacare program in Canada. To address existing barriers to the use of HTA, these must be ranked in order of priority. The goal of this study was to access the relative importance of known facilitators and barriers to the use of HTA in the context of the Canadian health care system, with attention to differences between regions and stakeholder groups. Methods We used the best-worst scaling object case approach to elicit a quantitative ranking of a list of 20 facilitators and 22 barriers. A sample of 68 Canadian HTA stakeholders, including members of expert committees, decision/policymakers, researchers/academics, and others participated in the study. Their task was to identify the most important and the least important item in 12 sub-sets of five facilitators and 14 sub-sets of five barriers. Findings Relative Importance Scores derived via hierarchical Bayes analysis revealed relations, engagement, and contact between stakeholders as most important on both the barrier and facilitator sides. Other top-ranked facilitators included the availably of credible and relevant research. Other top-ranked barriers included inconsistencies in the evidence and limited generalizability. The availability of HTA guidelines did not rank highly on either side. The main limitation of the study was the challenge with reaching the relevant respondents; this was mitigated by involving the national HTA agency in the research. Conclusion Canadian stakeholders consider the relationships within the HTA network among the most important. Policies should focus on strengthening these relationships. Future research should focus on the connectivity and distribution of knowledge and power within the HTA network.

Orphan drugs have high acquisition costs and when standard health technology assessment (HTA) approaches are used to assess their cost-effectiveness, they often appear not cost-effective. The Canadian Patented Medicine Review Board (PMPRB), through new regulations, will apply HTA assessment results from the Canadian Agency for Drugs and Technologies in Health (CADTH) and Institut national d’excellence en santé et en services sociaux (INESSS) when setting the maximum price that can be charged for Category I patented medicines (treatments with an annual cost exceeding 150% of GDP per capita of Canada or with expected annual market size >$50M). Through these regulations, PMPRB has also established a willingness-to-pay threshold of CAD$200,000 or CAD$150,000 per quality adjusted life year (QALY) for medications with a prevalence of no more than 1 in 2000 across all approved indications. We reviewed the orphan drug submissions made to CADTH’s Common Drug Review (CDR) January 2015–May 2020 to understand how the methodology of assessing cost-effectiveness of orphan drugs has guided pricing in Canada. A total of 35 orphan drug submissions were assessed by CDR in this period, none of which met the willingness-to-pay threshold of CAD$50,000 per QALY. Only one drug met the CAD$200,000 per QALY for Therapeutic Criteria Level I, and two drugs met CAD$150,000 per QALY for other Therapeutic Criteria Levels proposed by PMPRB. Price reductions of 32–99% were recommended for treatments that were approved in order to be listed for reimbursement. This review showed that the new PMPRB regulations could be creating challenges for manufacturers of rare disease treatments to meet Canadian pricing regulations. These regulations may jeopardize the launch of new medicines and limit opportunities to add to the development of real-world evidence of orphan drugs, which can be used in reimbursement approaches such as pay-for-performance.

In the drive towards faster patient access to treatments, health technology assessment (HTA) agencies are increasingly faced with reliance on evidence from surrogate endpoints, leading to increased decision uncertainty. This study undertook an updated survey of methodological guidance for using surrogate endpoints across international HTA agencies. We reviewed HTA and economic evaluation methods guidance from European, Australian and Canadian HTA agencies. We considered how guidelines addressed the methods for handling surrogate endpoints, including (1) level of evidence, (2) methods of validation, and (3) thresholds of acceptability. Across the 73 HTA agencies surveyed, 29 (40%) had methodological guidelines that made specific reference to consideration of surrogate outcomes. Of the 45 methods documents analysed, the majority [27 (60%)] were non-technology specific, 15 (33%) focused on pharmaceuticals and three (7%) on medical devices. The principles of the European network for Health Technology Assessment (EUnetHTA) guidelines published in 2015 on the handling of surrogate endpoints appear to have been adopted by many European HTA agencies, i.e. preference for final patient-relevant outcomes and reliance on surrogate endpoints with biological plausibility and epidemiological evidence of the association between the surrogate and final endpoint. Only a small number of HTA agencies (UK National Institute for Care and Excellence; the German Institute for Medical Documentation and Information and Institute for Quality and Efficiency in Health Care; the Australian Pharmaceutical Benefits Advisory Committee; and the Canadian Agency for Drugs and Technologies in Health) have developed more detailed prescriptive criteria for the acceptance of surrogate endpoints, e.g. meta-analyses of randomised controlled trials showing strong association between the treatment effect on the surrogate and final outcomes. As the decision uncertainty associated with reliance on surrogate endpoints carries a risk to patients and society, there is a need for HTA agencies to develop more detailed methodological guidance for consistent selection and evaluation of health technologies that lack definitive final patient-relevant outcome evidence at the time of the assessment.

Objectives Epiduroscopy is a minimally invasive procedure that is used in pain therapy to treat lumbar and root pain that is resistant to medical and infiltrative therapies. The indications for periduroscopy are partly shared with those of spinal cord stimulation (SCS): failed back surgery syndrome (FBSS) and stenosis of the vertebral canal in particular. The costs and risks of periduroscopy are considerably lower than those of SCS. The purpose of this study is to evaluate the clinical and economic advantages of integrating periduroscopy as a step prior to SCS for patients with severe lumbar or radicular pain that is unresponsive to pharmacological and infiltrative treatments. Materials and Methods Patients were enrolled if they had FBSS and spinal stenosis with indications for SCS and accepted periduroscopy treatment before the possible SCS trial. Patients were followed up for 24 months with evaluations of clinical data on the day after the procedure and at one and 24 months. The pain trend, satisfaction with the periduroscopy procedure, and the incidence of SCS implants in the study period were analyzed. Results A total of 106 patients were enrolled. Immediately after the procedure and in the first month, the reduction of pain and the level of patient satisfaction were high, but they were drastically reduced at 24 months with a progressive reappearance of symptoms that substantially overlapped with the pre-surgery levels. At 24 months, 48% of the patients underwent a neurostimulation trial, and a significant percentage of them were able to avoid the implantation of an SCS. Conclusions Periduroscopy appears to be rational as a step prior to SCS in terms of the improvement of pain symptoms in the short term, the definitive results in a significant percentage of patients, and the significant economic savings for the health system.

It is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of a new medical device prior to the widespread adoption of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. Even though dozens of organizations perform HTAs, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA. Thus, there are considerable discrepancies in the methodologies among HTAs such that the same device with the same underlying clinical evidence is often endorsed by one agency but not another, leading to inconsistencies in healthcare coverage policy decisions. Here, we propose a more simplified and unified approach for summarizing clinical effectiveness and safety outcomes for HTAs. We developed a short, semi-quantitative scoring tool that can be used to provide an overall evaluation of evidence strength in HTAs consisting of five categories: (a) the number of randomized controlled trials (RCTs) that have been performed using the technology, (b) the risk of bias among RCTs, (c) the effect size observed for the key effectiveness outcome, (d) the effect size observed for the key safety outcome, and (e) the generalizability of outcomes observed in RCTs to those observed in real-world clinical use. Utilization of this simplified semi-quantitative framework may simplify the HTA process and improve the consistency of the resulting recommendations.

A health technology assessment (HTA) is commonly defined as a multidisciplinary approach used to evaluate medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. To help inform HTA recommendations, the surveillance of social media platforms can provide important insights to the clinical community and to decision makers on the effectiveness and safety of the use of health technologies on a patient. A scoping review of the published literature was performed to gain some insight on the accuracy and automation of sentiment analysis (SA) used to assess public opinion on the use of health technologies. A literature search of major databases was conducted. The main search concepts were SA, social media, and patient perspective. Among the 1,776 unique citations identified, 12 studies that described the use of SA methods to evaluate public opinion on or experiences with the use of health technologies as posted on social media platforms were included. The SA methods used were either lexicon-or machine learning-based. Two studies focused on medical devices, three examined HPV vaccination, and the remaining studies targeted drug therapies. Due to the limitations and inherent differences among SA tools, the outcomes of these applications should be considered exploratory. The results of our study can initiate discussions on how the automation of algorithms to interpret public opinion of health technologies should be further developed to optimize the use of data available on social media.\ud

Standard outcome sets developed by the International Consortium for Health Outcomes Measurement (ICHOM) facilitate value‐based health care in healthcare practice and have gained traction from regulators and Health Technology Assessment (HTA) agencies that regularly assess the value of new medicines. We aimed to assess the extent to which the outcomes used by regulators and HTA agencies are patient‐relevant, by comparing these to ICHOM standard sets. We conducted a cross‐sectional comparative analysis of ICHOM standard sets, and publicly available regulatory and HTA assessment guidelines. We focused on oncology due to many new medicines being developed, which are accompanied by substantial uncertainty regarding the relevance of these treatments for patients. A comparison of regulatory and HTA assessment guidelines, and ICHOM standard sets showed that both ICHOM and regulators stress the importance of disease‐specific outcomes. On the other hand, HTA agencies have a stronger focus on generic outcomes in order to allow comparisons across disease areas. Overall, similar outcomes are relevant for market access, reimbursement, and in ICHOM standard sets. However, some differences are apparent, such as the acceptability of intermediate outcomes. These are recommended in ICHOM standard sets, but regulators are more likely to accept intermediate outcomes than HTA agencies. A greater level of alignment in outcomes accepted may enhance the efficiency of regulatory and HTA processes, and increase timely access to new medicines. ICHOM standard sets may help align these outcomes. However, some differences in outcomes used may remain due to the different purposes of regulatory and HTA decision‐making., The extent to which the outcomes used for market access and reimbursement decision making are patient relevant were assessed, by comparing these to standardized outcome sets developed by the International Consortium for Health Outcomes Measurement (ICHOM).

Der interdisziplinäre Workshop der AGs/AKs HTA, Methodik Systematischer Reviews, Gesundheitsökonomie und Medical Decision Making verfolgt zum einen die Entwicklungen im Bereich Health Technology Assessments (HTA) und der Entscheidungsfindung im Gesundheitsbereich auf europäischer[zum vollständigen Text gelangen Sie über die oben angegebene URL], 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS)

In June 2021, the US Food and Drug Administration granted accelerated approval to aducanumab for treating Alzheimer’s disease based on the drug’s amyloid reducing effects. This was despite evidence from several earlier studies that shrinkage of β-amyloid protein plaques does not predictably delay cognitive impairment.1 The controversial decision has drawn attention to the use of surrogate endpoints—laboratory values, radiographic images, or other physical measures that may serve as indicators of clinical outcomes such as symptom control or mortality—in clinical trials of new drugs.2 In fact, the approval of aducanumab is only the latest example of growing regulatory reliance on surrogate endpoints, even though their use can cause problems for patients, clinicians, drug regulators, and health technology assessment bodies. We argue for more selective use of surrogate endpoints when evaluating new drugs, restricting their use to chronic diseases, especially when collecting data on patient relevant clinical outcomes requires trials with unattainably long follow up.

This paper presents a framework which makes use of Sentiment Analysis techniques for retrieving Real World Data (RWD) starting from scheduled and corrective maintenance data. The scope of the analysis is to automatically extract features from maintenance work orders, in order to calculate Key Performance Indicators of maintenance operations on medical devices, for Health Technologies Assessment purposes. Data are extracted from Computerized Maintenance Management System reports of healthcare facilities.

IntroductionIn healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs.Method and analysisThis protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O’Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted.Ethics and DisseminationThis scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we conducted a systematic review to examine processes, progress, outcomes, and challenges of harmonization/interaction initiatives between HTA bodies and regulatory agencies. MEDLINE, EMBASE, and the International Pharmaceutical Abstracts database were searched up to 21 October 2019. Searches for gray literature (working papers, commissioned reports, policy documents, etc.) were performed via Google scholar and several institutional websites. An online cross-sectional survey was also conducted among HTA (n = 22) and regulatory agencies (n = 6) across Europe to supplement the systematic review. Overall, we found that while there are areas of divergence, there has been progress over time in narrowing the gap in evidentiary requirements for HTA bodies and regulatory agencies. Most regulatory agencies (4/6; 67%) and half (11/22, 50%) of the HTA bodies reported having a formal link for "collaborating" with the other. Several mechanisms such as early tripartite dialogues, parallel submissions (reviews), adaptive licensing pathways, and postauthorization data generation have been explored as avenues for improving collaboration. A number of pilot initiatives have shown positive effects of these models to reduce the time between regulatory and HTA decisions, which may translate into faster access for patients to life-saving therapies. Thus, future approaches aimed at improving harmonization/interaction between HTA bodies and regulatory agencies should build on these existing models/mechanisms while examining their long-term impacts. Several barriers including legal, organizational, and resource-related factors were also identified, and these need to be addressed to achieve greater alignment in the current regulatory and reimbursement landscape.

Background: Robotic surgery is a mini-invasive technique that involves the execution of interventions with collaborative robots. Among them, the MAKO system is a high-tech robotic platform for prosthetic surgery in orthopaedics. Liguria faces the problem of the balance between demand and offer of arthroplasty due to the high presence of the elderly concerning its demographic configuration. The high passive mobility due to the interventions of orthopaedic prostheses and the presence on Ligurian soil (Local Health Unit 5, LHU5) of a robotic system for the prosthetic implant, suggest to perform an assessment of the assistant consequences, economic, social and ethical caused by the adoption of MAKO technology with an HTA approach.Methods: We conducted a comprehensive review of the scientific literature to find evidence on the benefit of MAKO robotic-arm assisted surgery for partial (UKA) or total (TKA) knee arthroplasty. Data on the number of admissions for UKA and TKA interventions and the hospital stay average in Liguria was extracted from the regional database.Results: The literature search identified 14 papers. Most of them were not considered with proper evidence because not being peer-reviews published in an indexed journal, studies conducted on cadavers, limited to the operative phase and lacking clinical outcomes, non-experimental studies, studies without comparators or with inadequate comparators. Thus, we selected 3 studies. Focusing on the LHU5 data from the regional database, we observed an annual increase of about 90% in hospitalizations and an average decrease of 3-day hospitalization days.Conclusions: The type of studies and the evidence available are rather thin and not consolidated either from clinical effectiveness or safety or cost-effectiveness. It is not possible today to estimate adequately how and how much these costs will be translated into practical clinical benefits and possible economic savings. Therefore, it is believed that the adoption of this technology should exclusively take place in the context of a research activity aimed at defining all the possible dimensions of the technology (safety-efficacy-cost/effectiveness).

Introduction: Public health (PH) interventions are crucial for ensuring sustainable healthcare services. Nevertheless, they represent a neglected area in the field of health technology assessment (HTA) due to various methodological issues and their complex design that goes beyond clinical setting. The present study provides an environmental scan of HTA initiatives related to the assessment of PH technologies on a global level. Methods: We conducted a cross-sectional survey among 85 HTA-related European and international societies, health bodies, and networks from September 2018 to January 2019. The questionnaire contained four sections and 18 questions regarding activities related to the evaluation of PH technologies, information on existing PH technologies, and methodologies of assessment as well as barriers and facilitators to reaching a decision and implementing a PH technology. Results: Among 52 survey responses, the majority of the respondents came from European countries (35%), followed by North American (27%), and South American (19%) countries. The main type of organizations covered by our survey included HTA agencies, public administrations, and research institutes. Seventy-one % of the institutions reported engagement in any aspect of HTA in the area of PH (N = 37). Among those, 81% evaluated less than 5 PH technologies from 2013 to 2018. The most common barriers for reaching a decision on PH technologies were lack of data, conflicting stakeholder priorities, and methodological issues. A total of 76 PH interventions were reported, and most cited initiatives were related to chronic disease screening, prevention of infectious diseases, and maternal, prenatal, and neonatal screening. Conclusion: Our survey reported a rather limited involvement of HTA in the evaluation of PH technologies. In particular, an evaluation of behavioral and lifestyle interventions remains extremely rare. The implementation of collaborative HTA approaches in the setting of PH practice and policy needs to be prioritized and further strengthened. Moreover, ensuring reliable data structures and consolidation of HTA methods for the evaluation of PH technologies will be crucial for tackling the enormous burden of non-communicable diseases in societies.

All health economics reviews on chronic and episodic migraine published to date underline the heterogeneity of results. Currently, the need for the generalizability of economic evaluations across different jurisdictions is considered a key issue to avoid unnecessary overlaps and to minimize the time to reimbursement decisions. The aim of this study was to review the economic evaluations on the prophylaxis and treatments for migraine published in the previous 10 years (since 2009) and to perform a critical assessment of their generalizability. We searched PubMed, EMBASE, and EconLit databases. Articles underwent a three-stage selection process. To assess the level of generalizability, we used the checklist implemented by Augustovski et al. Studies were classified as: (1) generalizable; (2) transferable; and (3) context specific. In total, 227 articles were identified after running the search string and 11 studies were included in our review. Overall, none of the studies was judged as generalizable and three were judged transferable according to the established criteria. Our review suggests that no evidence on the economic value of either acute or prophylactic treatments against migraine is generalizable to different jurisdictions. However, the majority of studies reporting results about prophylactic treatments were found to be transferable.

Introduction Allergic rhino-conjunctivitis (ARC) is an IgE-mediated disease that occurs after exposure to indoor or outdoor allergens, or to non-specific triggers. Effective treatment options for seasonal ARC are available, but the economic aspects and burden of these therapies are not of secondary importance, also considered that the prevalence of ARC has been estimated at 23% in Europe. For these reasons, we propose a novel flexible cost-effectiveness analysis (CEA) model, intended to provide healthcare professionals and policymakers with useful information aimed at cost-effective interventions for grass-pollen induced allergic rhino-conjunctivitis (ARC). Methods Treatments compared are: 1. no AIT, first-line symptomatic drug-therapy with no allergoid immunotherapy (AIT). 2. SCIT, subcutaneous immunotherapy. 3. SLIT, sublingual immunotherapy. The proposed model is a non-stationary Markovian model, that is flexible enough to reflect those treatment-related problems often encountered in real-life and clinical practice, but that cannot be adequately represented in randomized clinical trials (RCTs). At the same time, we described in detail all the structural elements of the model as well as its input parameters, in order to minimize any issue of transparency and facilitate the reproducibility and circulation of the results among researchers. Results Using the no AIT strategy as a comparator, and the Incremental Cost Effectiveness Ratio (ICER) as a statistic to summarize the cost-effectiveness of a health care intervention, we could conclude that: SCIT systematically outperforms SLIT, except when a full societal perspective is considered. For example, for T = 9 and a pollen season of 60 days, we have ICER = €16,729 for SCIT vs. ICER = €15,116 for SLIT (in the full societal perspective).For longer pollen seasons or longer follow-up duration the ICER decreases, because each patient experiences a greater clinical benefit over a larger time span, and Quality-adjusted Life Year (QALYs) gained per cycle increase accordingly.Assuming that no clinical benefit is achieved after premature discontinuation, and that at least three years of immunotherapy are required to improve clinical manifestations and perceiving a better quality of life, ICERs become far greater than €30,000.If the immunotherapy is effective only at the peak of the pollen season, the relative ICERs rise sharply. For example, in the scenario where no clinical benefit is present after premature discontinuation of immunotherapy, we have ICER = €74,770 for SCIT vs. ICER = €152,110 for SLIT.The distance between SCIT and SLIT strongly depends on under which model the interventions are meta-analyzed. Conclusions Even though there is a considerable evidence that SCIT outperforms SLIT, we could not state that both SCIT and SLIT (or only one of these two) can be considered cost-effective for ARC, as a reliable threshold value for cost-effectiveness set by national regulatory agencies for pharmaceutical products is missing. Moreover, the impact of model input parameters uncertainty on the reliability of our conclusions needs to be investigated further.

Health technology assessment (HTA) is a recognized paradigm used worldwide to support funding, coverage, reimbursement, and, recently, procurement decisions globally. In its bare essence, the HTA paradigm supports systematic generation and collection of the evidence to understand the value of new and existing technologies in order to inform decision-making, at different levels, in health care. HTA appraisals are commonly structured around several dimensions ranging from the health problem addressed, the technology’s safety and effectiveness profiles, and its value for money to other aspects related to the expected organizational, ethical, social, and legal issues associated with the use of the technology within the health system. Several countries have adopted a formal and structured process for the HTA of innovative health technologies including initial identification and priority setting, the methods and processes for the assessment and appraisal phases, and final dissemination of results and translation into policy.

The Clinical Engineering Division of the International Federation for Medical and Biological Engineering (IFMBE/CED), chaired by Ernesto Iadanza in the period 2015–18, has done its part in advancing clinical engineering in Italy by having many contacts and participations in Italian events and conferences in the last years. To further confirm this, the third edition of the International Conference of Clinical Engineering and Health Technology Management (ICEHTMC, 2019, http://www.icehtmc.com ) will be held in Rome in October 2019, in combination with the Global Clinical Engineering Day (October 21). There is no doubt that today Italy is having a big impact on the worldwide clinical engineering, for example, also exporting at European Union level its coding system for medical devices. Very good signals arrive from academia, with more and more students choosing this path and with excellent figures in their placement after graduation. Nevertheless, there is still a lot to do—both on the legislative level and on the organizational level—before seeing a clinical engineer sitting at all the tables of healthcare top managers.

Writing the second edition of the Handbook of Clinical Engineering is also a great opportunity to reflect on the several achievements made by biomedical engineering (BME) in the past 20 years. In fact, the first edition of this book was designed at the end of the 1990s and published in 2004. After 20 years, the scenario in which this book is conceived is significantly different. One of the main differences is in the extent to which BME is recognized from international policy-makers. This opens novel opportunities for BME and requires BMEs to take more responsibility in the way they contribute to face socioeconomic challenges. Understanding this change is a fundamental step toward the designing of BME education in the next decades.

Introduction: Incidental Events in the maintenance activities in the Dehydration Unit of Gas Refineries due to human error, indicate the inadequate effectiveness of the techniques available to identify human errors. The purpose of this research is to identify and analyze human error in this repair activity using the PHEA predictive human error analysis technique and provide appropriate control strategies to prevent or reduce the consequences of identified errors. Methods: In this technique, all activities and tasks performed to achieve the main goal were identified using the HTA technique, and then possible types of human error in each phases of the above process were predicted and identified by using the PHEA method and using a series of guidance words.After determining the consequences of each of the errors, appropriate control methods were also provided. Results: Out of 11 operations and 111 sub task occupations analyzed in the PHEA worksheets, a total of 337 errors were identified, of which there were 246 action errors, 13 checking errors, 28 retrieval errors, 33 information communication errors and 17 planning errors. The most significant identified errors are Operation omitted, Misalign, Operation incomplete, Operation mistimed, Right operation on wrong object and Operation too little/too much. Conclusion: According to the results, functional errors are the most common abundance that emphasizes the necessity of using control strategies in the form of adequate and effective training for personnel, preparation and modification of instructions, monitoring of implementation of work and hardware changes.

Der interdisziplinäre Workshop der AGs/AKs HTA, Methodik Systematischer Reviews, Gesundheitsökonomie und Medical Decision Making verfolgt zum einen die Entwicklungen im Bereich Health Technology Assessments (HTA) und der Entscheidungsfindung im Gesundheitsbereich auf europäischer[zum vollständigen Text gelangen Sie über die oben angegebene URL], 64. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)

Resumen: La monitorización ambulatoria de la presión arterial (MAPA) es una herramienta clínica útil para el diagnóstico y confirmación de hipertensión arterial en pediatría y permite igualmente el diagnóstico de condiciones especiales como la hipertensión de delantal blanco e hipertensión enmascarada. Exis ten recomendaciones internacionales para su realización e interpretación, sin embargo, aún quedan interrogantes por resolver. En esta guía se resume la bibliografía disponible y se intenta estandarizar, a través de consenso de especialistas nacionales, la aplicación de esta técnica. Se necesitan más estudios de investigación en niños que aporten nuevos valores de referencia y que determinen la relación de alteraciones en MAPA con resultados clínicos a largo plazo.

This article provides a practical overview of cost-effectiveness analyses and their application in respiratory medicine. It serves as a guide to explain non-health economists the key concepts and methods of cost-effectiveness analyses. The case for health economics is made, some key methodological issues are explained, using non-expert terminology and easy to understand examples from the fields of asthma, COPD, tuberculosis, lung cancer and other respiratory diseases. The current state-of-the-art as well as a future perspective is provided.

Reimbursement decisions on new oncology drugs are now often made while uncertainty remains about a drug's risk–benefit profile. One consequence of this is a delay in patient access to valuable new medicines. We share our perspectives on strategies to mitigate sources of uncertainty in the health technology assessment process. These include flexible approaches for evaluating the additional benefit, such as better use of surrogate endpoints and health-related quality of life data, and renewed research efforts to define the optimal target population and generate real-world evidence post-authorisation.

Background The relevance of studies focusing on patient satisfaction becomes imperative for patients with cancer, who often face major changes in their lifestyles. Their perceived uncertainty in illness and their personal experiences with the services received are crucial factors for a qualitatively adequate assistance. Objectives To assess the determinants of patient satisfaction, using a sample of 306 Bulgarian oncology outpatients. Methods The hypotheses tested concern the extent to which patient satisfaction depends on the uncertainty in illness; the patients' assessment of technical and interpersonal skills of nurses and medical staff; the information provision; and some organizational aspects. Patients were asked to answer a questionnaire composed of internationally validated scales assessing the determinants of patient satisfaction (measured through the European Organization for Research and Treatment of Cancer), uncertainty in illness (assessed through the Mishel Uncertainty in Illness Scale), and patients' health status (assessed through the EuroQol 5-dimensional questionnaire and the visual analogue scale). An ordered logit model was run, using the level of overall patient satisfaction as a dependent variable. Results This is one of the first studies carried out in Bulgaria for oncology patient satisfaction of subjective factors related to the frailty of the oncology patient status such as age, self-assessed health-related quality of life, and uncertainty in illness. Nevertheless, other determinants, reflecting the quality of the care provided, also have an impact on patient satisfaction, namely, the assessment of the nonmedical personnel, the perception of medical technical skills, and the access to a medical center. Conclusions Results stress the relevance of reducing uncertainty in illness in patients with cancer by implementing a satisfactory patient-physician relationship in the management of the disease.

Background Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas. Methods Medicines for oncological, metabolic and infectious diseases with EBAs finalised before 25 January 2016 were evaluated. Respective manufacturer’s dossiers, regulatory assessments, G-BA appraisals and oral hearing minutes were reviewed, and PEPs were examined to determine whether they were considered relevant to patients by the G-BA. Furthermore, the acceptance of symptomatic vs asymptomatic PEPs was also analysed. Results A total of 65 EBAs were evaluated. Mortality PEPs were widely accepted as patient-relevant but were only used in a minority of EBAs and exclusively in oncological diseases. Morbidity PEPs constituted around 72 % of assessed PEPs, but were excluded from the EBA in over half of the corresponding assessments as they were not considered patient-relevant. Symptomatic endpoints were largely deemed patient-relevant, whereas acceptance of asymptomatic endpoints varied between therapeutic areas. Conclusions This evaluation identified inconsistencies in patient relevance of morbidity-related PEPs as well as in acceptance of asymptomatic endpoints by the G-BA in all three disease areas examined. Better harmonisation between the regulatory authorities and the G-BA is still required after 5 years of AMNOG health technology assessment in Germany. Electronic supplementary material The online version of this article (doi:10.1186/s12913-016-1902-8) contains supplementary material, which is available to authorized users.