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Objectives: This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned., Methods: Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members. Structured information was collected from organizations that confirmed having an HSS for medical devices., Results: Sixteen initiatives could be identified, of which 11 are currently ongoing. The purposes of the HSS range from raising awareness of trends and new developments to managing informed decisions on innovative health services in hospitals. The time-horizon is most often 3 years up to a few months before market entry. Three models of identification of new technologies crystallized: a reactive (stakeholders outside HSS inform), a pro-active (actively searching multifold sources), and a hybrid model. Prioritization is often conducted by separate committees via scoring or debate. The outputs focus either on in-depth information of single technologies or on a class of technologies or on technologies in specific disease areas., Conclusions: The identified HSS share the common experience that horizon scanning (HS) for medical devices is a resource-intensive exercise that requires a dedicated and skilled team. Insights into the identified HSS and their experiences will be used in the continued work of the IHSI MDWG on its proposal for an IHSI HSS for medical devices.

Background: Individuals of all ages and with all degrees of severity of the coronavirus disease (COVID) can suffer from persisting or reappearing symptoms called long COVID. Long COVID involves various symptoms, such as shortness of breath, fatigue, or organ damage. The growing number of long COVID cases places a burden on the patients and the broader economy and, hence, has gained more weight in political decisions. This scoping review aimed to give an overview of recommendations about possible long COVID healthcare pathways and requirements regarding decision-making and communication for healthcare professionals., Methods: A systematic search in four databases and biweekly update-hand searches were conducted. In addition to guidelines and reviews, expert opinions in consensus statements or clinical perspectives were also considered. Data were systematically extracted and subsequently narratively and graphically summarised., Results: Fourteen references, five guidelines, four reviews, one consensus paper, and four clinical perspectives were included. The evidence recommended that most long COVID-related healthcare should be in primary care. Patients with complex symptoms should be referred to specialized long COVID outpatient assessment clinics. In contrast, patients with one dominant symptom should be directed to the respective specialist for a second assessment. Depending on the patients' needs, further referral options include, e.g. rehabilitation or non-medical health services. Self-management and good communication between healthcare professionals and patients are crucial aspects of the long COVID management recommendations., Conclusions: The quality of the included guidelines and reviews is limited in the methods applied due to the novelty of this topic and the associated urgency for research. Hence, an update review with more rigorous data is recommended. Furthermore, the systematic collection of real-world data on long COVID surveillance needs to be set up soon to gather further information on the duration and severity of long COVID and thereby facilitate long COVID care planning., (© 2022. The Author(s).)

The European Network for Health Technology Assessment (EUnetHTA) was founded to support efficient production and use of health technology assessments (HTAs) across Europe by reducing redundancies through collaboration. To facilitate collaboration, a range of practical tools, methods and process definitions were developed. The article describes when and how these tools and methods are used along the HTA process with specific focus on "other technologies", that is medical devices and non-pharmaceutical procedures. EUnetHTA was able to deliver tangible achievements complying with its goals. The practical tools and the developed methods formed a basis for close collaboration among over 70 agencies at a European level. The activities of EUnetHTA laid a strong foundation for sustainable cooperation. In the long run, jointly produced assessments could realise economies of scale with improved quality, consistency and transparency for the health systems in Europe.

Background: Health technology assessments of medical devices (MD) present a well-recognized challenge to evaluators: the evidence on safety and clinical effectiveness is often of lower quality than for pharmaceuticals making a reliable assessment of the risk-benefit ratio difficult. Thus other factors might gain importance in decision making., Objective: To analyse which factors impact MD reimbursement decisions within the Austrian appraisal programme on "extra medical services" (procedures reimbursed in addition to case flat rates) for inpatient care over the past eight years., Methods: We collected variables on evidence base and device characteristics from all MD appraisals and assessed their impact on the reimbursement decision by means of odds ratios. Separate analyses were carried out for subgroups based on the risk class of the medical device subject of the assessment or the number of randomised controlled trials (RCTs) available for the assessment., Results: Of 59 devices, 23 (39%) were accepted for reimbursement (18 with restrictions) and 36 (61%) were rejected. Variables addressing the quality of the evidence base were positive predictors for risk class II devices only, whereas no significant association could be determined in devices of risk class III. Inversely, high risk device characteristics were positive predictors in the subgroup not supported by RCTs only., Conclusion: Our data indicate that the combination of high risk characteristics and a low evidence base are factors favouring a positive reimbursement decision of MD, albeit with restrictions. Further research should analyse if these restrictions are appropriate to generate evidence development and to contain risks associated with early access to these MD., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Introduction: The standardisation of European HTA and thus the reduction of redundancies require clearly defined processes and methods. The HTA Core Model®, a tool developed by the European Network EUnetHTA, is intended to ensure the transparent production of standardised and high-quality assessments in international collaboration., Methods: The present paper describes the experience with already published EUnetHTA assessments as well as possibilities for national/local adaptations of these assessments. The integration of jointly developed methods in routine processes of individual HTA agencies will be explained on the basis of a selected example. Further methodological initiatives in Europe will be presented., Results: So far, EUnetHTA has published four rapid assessments conducted through European cooperation between 6-9 HTA institutes during Joint Action 2 (2012-2015). Two assessments dealt with pharmaceuticals and two with non-pharmaceutical interventions. The overall duration of these assessments ranged from 7 to 9 months. There is initial information about the frequency and manner in which these assessments have been used for national/local HTA reports. According to a survey, a total of 28 HTA institutes have indicated that they want to make use of these assessments in their own context. In Austria, the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) has produced two reports based on EUnetHTA assessments. A further step towards cross-border collaboration and harmonisation is the implementation of these tools in a national and regional context. Beginning in 2015 the LBI-HTA will adjust two programme lines to the format of the HTA Core Model® in order to increase the transferability of HTAs and to reduce redundancies., Discussion: Barriers to European collaboration include the relevance of topics for individual HTA institutes and the timing of joint assessments. Implementing commonly developed methods as standard practice in local/national HTA institutes is mainly impeded by legislative requirements., Conclusion: Despite the initial positive experiences with international collaboration on specific topics and methods, the coming years will have to prove whether existing barriers can be overcome effectively., (Copyright © 2015. Published by Elsevier GmbH.)

Background: European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices., Methods: Since no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA., Results: 10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices., Conclusions: Market authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.

Objectives: The aim of this study was to present the development, structure and results of a database on planned and ongoing health technology assessment (HTA) projects (POP Database) in Europe., Methods: The POP Database (POP DB) was set up in an iterative process from a basic Excel sheet to a multifunctional electronic online database. The functionalities, such as the search terminology, the procedures to fill and update the database, the access rules to enter the database, as well as the maintenance roles, were defined in a multistep participatory feedback loop with EUnetHTA Partners., Results: The POP Database has become an online database that hosts not only the titles and MeSH categorizations, but also some basic information on status and contact details about the listed projects of EUnetHTA Partners. Currently, it stores more than 1,200 planned, ongoing or recently published projects of forty-three EUnetHTA Partners from twenty-four countries. Because the POP Database aims to facilitate collaboration, it also provides a matching system to assist in identifying similar projects. Overall, more than 10 percent of the projects in the database are identical both in terms of pathology (indication or disease) and technology (drug, medical device, intervention). In addition, approximately 30 percent of the projects are similar, meaning that they have at least some overlap in content., Conclusions: Although the POP DB is successful concerning regular updates of most national HTA agencies within EUnetHTA, little is known about its actual effects on collaborations in Europe. Moreover, many non-nationally nominated HTA producing agencies neither have access to the POP DB nor can share their projects.

Trauma-associated acute compartment syndrome (ACS) of the extremities is a well-known complication in adults. There are only a handful of articles that describe the symptoms, the diagnostic procedure and treatment of ACS in children. The aim of this study was to analyse the diagnostic procedures in children compared to adolescents with ACS to obtain evidence for the diagnosis, treatment and outcome of children with ACS. Twenty-four children and adolescents with ACS have been treated at the Department of Trauma Surgery of the Medical University of Vienna, Austria. Two age-related groups were investigated to compare the diagnostic and therapeutic algorithm: group A comprising children aged 2-14 years (n = 12) and group B comprising adolescents aged 15-18 years (n = 12). Patient characteristics, diagnosis and therapy-associated data, complications and clinical outcome were analysed. In both groups we found fractures in most of our patients (n = 19) followed by contusion of the soft tissues (n = 3). In group A most of our patients were injured as pedestrians in car accidents (n = 5) followed by low-energy blunt trauma (n = 3). The most common region of injury and traumatic ACS was the lower leg (n = 7) followed by the feet (n = 3). For fracture stabilisation most of the patients (n = 6) received an external fixator. The mean time from admission to the fasciotomy was 27.9 hours. In four patients a compartment pressure measurement was performed with pressure levels from 30 to 75 mmHg. A histological examination of soft tissue was performed in five patients. From fasciotomy to definitive wound closure 2.4 operations were necessary. The mean hospital stay was 18.9 days. In group B most of our patients had a motorcycle accident (n = 5). The most common region for traumatic ACS in this group was also the lower leg (n = 9). In most of the patients (n = 6) intramedullary nails could be implanted. The mean time from admission to the fasciotomy was 27.1 hours. In six patients a compartment pressure measurement was performed with pressures from 25 to 90 mmHg. In five patients a histological examination was performed. From fasciotomy to definitive wound closure 2.3 operations were necessary. The mean hospital stay was 18.4 days. Secondary fasciotomy closure was performed in all cases. A split-skin graft was only necessary in three patients (13%). We avoided primary closure in the same setting when the fasciotomy was performed. Thus, we found no difference between the two groups in the diagnostic procedures, the indication for fasciotomy, the number of operations needed from fasciotomy to definitive wound closure, time of hospitalisation and clinical outcome. The rate of permanent complications was 4.2% (one patient from group A), which means that nearly all patients experienced full recovery after fasciotomy. ACS represents a surgical emergency and the indication should be determined early even in doubtful cases to avoid complications.

Context: In addition to heart massage, the primary goal of cardiopulmonary resuscitation is efficient oxygenation and ventilation., Objective: To compare the ease of learning and handling of standard mouth-to-mouth resuscitation with the Combitube (Tyco Healthcare Nellcor, Pleasanton, CA) ventilation., Methods: After a 30 minute theoretical introduction and demonstration of mouth-to-mouth resuscitation and use of the Combitube in mannequins, following American Heart Association guidelines, 26 adolescent school children (15 of them 14 years old, 11 of them 10 years old) undertook two ventilation trials, each consisting of five single ventilations, with each technique. Only the second trial with each technique was evaluated. Qualitative implementation (grades: very good, good, failed) was evaluated, several procedure-related time points were recorded, and tidal volumes (ml) were measured., Results: With mouth-to-mouth resuscitation, the time interval until start of first ventilation was 36.5 seconds shorter than with the Combitube (P < 0.001). With the Combitube, the time needed for five single ventilations was 6.4 seconds less than with mouth-to-mouth resuscitation (P < 0.001) and mean tidal volumes were higher (mouth-to-mouth resuscitation, 450 +/- 384 ml, versus Combitube, 735 +/- 358 ml; P < 0.05)., Conclusion: Most of the school children performed both techniques to a high qualitative level. The study shows that mouth-to-mouth resuscitation and use of the Combitube have equal ease of learning, a precondition for proficient retention of skills. Tidal volumes were significantly higher with the Combitube and, not surprisingly, the time interval until the start of first ventilation was significantly shorter with mouth-to-mouth resuscitation. Regardless of the ventilation technique or device, we believe that subsequent retraining of ventilation skills is very important.

Bystanders are reluctant to perform basic life support (BLS) because of fear of failure and of infection, especially with mouth-to-mouth resuscitation (MTM). A possibility to enhance willingness could be the giving of MTM or BLS instructions at a very early age to the potential rescuers. The study aimed to investigate the effectiveness of MTM with respect to ventilation and the time needed for performing 5 ventilations. In this study, MTM was performed on a mannequin by 57 children and adolescents aged 10 and 14 years. This study showed that 14-year-olds effectively perform MTM, reaching the recommended tidal volumes. Ten-year-old children have already developed sufficient motor skills for MTM with no significant time differences compared with the 14-year-olds. However, physical demands may be rather high at this age. Further long-term studies are needed to investigate clinical benefits of early teaching of MTM or BLS that may lead to international guidelines with low age limits.