Technology Assessment Project Research Articles

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment.

Artificial intelligence (AI) has attracted much attention because of its enormous potential in healthcare, but uptake has been slow. There are substantial barriers that challenge health technology assessment (HTA) professionals to use AI-generated evidence for decision-making from large real-world databases (e.g., based on claims data). As part of the European Commission-funded HTx H2020 (Next Generation Health Technology Assessment) project, we aimed to put forward recommendations to support healthcare decision-makers in integrating AI into the HTA processes. The barriers, addressed by the paper, are particularly focusing on Central and Eastern European (CEE) countries, where the implementation of HTA and access to health databases lag behind Western European countries. We constructed a survey to rank the barriers to using AI for HTA purposes, completed by respondents from CEE jurisdictions with expertise in HTA. Using the results, two members of the HTx consortium from CEE developed recommendations on the most critical barriers. Then these recommendations were discussed in a workshop by a wider group of experts, including HTA and reimbursement decision-makers from both CEE countries and Western European countries, and summarized in a consensus report. Recommendations have been developed to address the top 15 barriers in areas of (1) human factor-related barriers, focusing on educating HTA doers and users, establishing collaborations and best practice sharing; (2) regulatory and policy-related barriers, proposing increasing awareness and political commitment and improving the management of sensitive information for AI use; (3) data-related barriers, suggesting enhancing standardization and collaboration with data networks, managing missing and unstructured data, using analytical and statistical approaches to address bias, using quality assessment tools and quality standards, improving reporting, and developing better conditions for the use of data; and (4) technological barriers, suggesting sustainable development of AI infrastructure. In the field of HTA, the great potential of AI to support evidence generation and evaluation has not yet been sufficiently explored and realized. Raising awareness of the intended and unintended consequences of AI-based methods and encouraging political commitment from policymakers is necessary to upgrade the regulatory and infrastructural environment and knowledge base required to integrate AI into HTA-based decision-making processes better.

EE450 Treatments and Diagnostics for COVID-19: A Living Systematic Review of Economic Evaluations

EE450 Treatments and Diagnostics for COVID-19: A Living Systematic Review of Economic Evaluations

Using real-world evidence in healthcare from Western to Central and Eastern Europe: a review of existing barriers

As part of the HTx (Next Generation Health Technology Assessment) project, this study was aimed at identifying the main barriers for application of real-world evidence (RWE)for the purposes of health technology assessment in the Central and Eastern Europeancountries. A mixed methods approach was employed to identify the main barriers: a scoping review of the literature and a series of discussions with stakeholders. Based on the applied approaches, we attempted to summarize the main barriers and challenges related to transferability of RWE in fivemain groups: technical, regulatory, clinical, scientificand perceptional barriers. Further research should pursue the development of detailed, consensus-based guidelines to improve the harmonization and standardization of RWE.

PP439 Data Driven Subgroups Of Patients With Type 1 Diabetes Based On Health Technology For Insulin Delivery

IntroductionPatients with type 1 diabetes (T1D) require the administration of insulin to maintain glycemic control. Currently, two modes of subcutaneous insulin delivery have gained wider acceptance: multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII). Randomized controlled trials have shown that CSII is associated with a slightly lower glycated hemoglobin (HbA1c) level when compared with MDI.The case study on diabetes by the H2020 Next Generation Health Technology Assessment project aims to link evidence from randomized controlled trials to real-world data to estimate the impact of health technology on specific subgroups of patients, as a first step in building prediction models to personalize treatment strategies. This work aims to assess whether patients with T1D can be stratified according to the use of health technology for insulin delivery and associated glycemic control from real-world data.MethodsWe used a longitudinal prospective data repository of T1D patients from 83 clinics in the United States (T1D exchange). A data-driven two-step clustering analysis was done on adult individuals (n = 8,034) with more than five years of disease duration. Clusters were based on body mass index (BMI), sex, age at diagnosis, diabetes duration, HbA1c level, and insulin delivery method. The optimal number of clusters was estimated based on silhouette width.ResultsWe identified the following four clusters of T1D patients characterized by differences in gender and insulin delivery method: men and women with insulin injections or pens and men and women with CSII. Individuals that used CSII had lower HbA1c levels, a higher BMI, and longer diabetes duration than those using Injections or pens.ConclusionsThis preliminary work identified subgroups of T1D patients linked to insulin delivery methods. Future research includes the study of complications associated with different clusters and additional data sources. While the data were sourced from the T1D Exchange, the analyses, content, and conclusions presented have not been reviewed or approved by the T1D Exchange.

Model funkcjonalny HB-HTA z koordynującą rolą Agencji Oceny Technologii Medycznych i Taryfikacji

The functional model of the Hospital-Based Health Technology Assessment (HB-HTA) with the coordinating role of the Agency of the Health Technology Assessment and Tariff Systems The article presents the functional model of the HB-HTA (Hospital-Based Health Technology Assessment) project implementation with coordinating role of the Agency of the Health Technology Assessment and Tariff Systems.

Workshop: Real-world data: are we ready to take up the challenge?

Abstract Evidence provided by traditional clinical research often fails to answer patients’, physicians’ and healthcare decision-makers’ questions about real-world practice and outcomes; in fact, real-world effectiveness may considerably differ from efficacy assessed in clinical trial settings. The rise of interest in real-world data (RWD) - data routinely collected outside a controlled research environment - is driven by the increasing need for evidence in specific populations, such as comorbid or multi-treated people. RWD can also allow investigation of unanticipated, uncommon or long-term outcomes. In addition, RWD may represent the only source of information in some fields of special interest, e.g. rare diseases. Furthermore, current conditional reimbursement systems of drugs require dynamic evaluations of cost-effectiveness that have necessarily to take RWD into account. Indeed, RWD play a relevant role also in Health Technology Assessment (HTA) projects that should release the most up-to-date evidence and should be updated once new data are available. Nonetheless, common concerns about evidence derived from RWD include uncertainty about data quality, high possibility of bias, difficulties in managing a vast amount of data coming from different sources as well as legal and privacy requirements, in particular in the light of the new General Data Protection Regulation. However, HTA cannot exempt using RWD as it is entrusted to assess short- and long-term consequences of the application of health technologies, in terms of both health outcomes and costs. This workshop is an opportunity to discuss current and future challenges in the use of RWD in HTA and concerns preventing researchers from exploiting RWD full potential. Key messages Real-world evidence and randomized control trial data are considered mutually complementary in generating evidence and supporting decision-making. Real-world data have proved to be crucial as instrument to gather data in HTA and to support decision-making.

Safety of Bisphosphonates in Moderate-to-Severe (Stage 3b-5) Chronic Kidney Disease: A Bi-National Cohort Analysis of 291,096 Patients from Spain and the United Kingdom

Background: Although contraindicated in patients with severe chronic kidney disease (CKD) due to a lack of safety data, bisphosphonates are commonly used to prevent or treat bone fragility in these patients. We studied the safety of bisphosphonates in patients with moderate-to-severe CKD. Methods: Patients with stage 3b+ CKD based on 2+ estimated glomerular filtration rate (eGFR) measures were identified in two primary-care records databases, the UK CPRD GOLD during 1997-2016 and the Catalan (Spain) SIDIAP during 2007-2015. New bisphosphonate users were propensity-scorematched with up to five non-users to minimise confounding, and followed until treatment discontinuation, switching, dropout, death, or 10 years. The primary outcome was CKD stage worsening (eGFR decline or renal replacement therapy). Secondary outcomes included hospitalised acute kidney injury (AKI), gastrointestinal bleeding/ulcers (GIE), and hypocalcaemia. Hazard ratios (HRs) were estimated using Cox regression for SIDIAP participants, and sub-HRs (sHRs) calculated using Fine-Gray models for CPRD. Findings: We matched 2,447 bisphosphonate users with 8,931 non-users from CPRD, and 1,399 users with 6,547 non-users from SIDIAP. Bisphosphonate use was associated with greater risk of CKD progression in both CPRD (HR [95% CI]: 1·14 [1·04, 1·26]) and SIDIAP (HR: 1·16 [1·04, 1·29]). No statistically significant risk differences were found for AKI, GIE, or hypocalcaemia. Interpretation: A modest (10%-15%) increased risk of CKD progression was identified in association with bisphosphonate use amongst patients with moderate-severe disease. No other safety concerns were identified. Our findings should be considered in combination with effectiveness data before prescribing bisphosphonates to patients with moderate-severe CKD. Funding Statement: Funding was provided by the National Institute of Health Research Health Technology Assessment project number 14/36/02. The project was partially funded by CIBERFES, Instituto Carlos III, Spain. JP and MJP-S are supported by PI16/00619 (Spanish Ministry of Health ISCIII FIS-FEDER) and RD16/0009/0013 (ISCIII FEDER RedinRen). Declaration of Interests: B Abrahamsen reports research grants from UCB and Novartis. NK Arden reports personal fees from Flexion, Freshfields, Janssen, Merck, and Regeneron. C Cooper reports lecture fees and honoraria from the Alliance for Better Bone Health Amgen, Eli Lilly, GSK, Medtronic, Merck, Novartis, Pfizer, Roche, Servier, Takeda, and UCB. A Judge is a subpanel member of the NIHR PGfAR, has received consultancy fees from Freshfields Bruckhaus Deringer, and has held advisory board positions (which involved receipt of fees) at Anthera Pharmaceuticals, INC. MK Javaid reports research support and speaker fees from Amgen. D Prieto-Alhambra reports research grants from UCB, Amgen, and Les Laboratoires Servier, and departmental (not personal) speaker and consultancy fees from UCB and Amgen. D Prieto-Alhambra is a member of the NIHR HTA CET panel since November 2017. DE Robinson, MS Ali, VY Strauss, L Elhussein, Y Ben-Shlomo, F Caskey, D Dedman, and A Delmestri have nothing to disclose. Ethics Approval Statement: This study was approved by the CPRD Independent Scientific Advisory Committee (protocol number 15_ 53R2A).

Wrinkles and Smiles — What is Good Aging? A Technology Assessment Perspective

(1) Background: In the light of recent changes in the discourse on positive ageing approaches, we take a closer look at the way “quality ageing” is understood, expressed and dealt with in technology assessment (TA) that investigates desirable frameworks and futures for an ageing society from a citizen, stakeholder and expert perspective. (2) Methods: A bottom up qualitative text analysis identifies quality ageing concepts in final reports of a sample of recent national and international (predominantly participatory) TA projects. Through clustering and meta-analysis we identify overarching patterns across the different reports. (3) Results: Seven main topical sectors that shape the TA perspective on quality ageing where identified: ethics, resources, activity, interaction, education, health, and policy. These are described by referring to a network of more than 40 topical sub clusters. (4) Conclusions: The TA perspective emphasizes the importance of a changed view on ageing in different contexts: for older adults themselves (e.g. as a precondition for an active and integrative lifestyle throughout one’s life), for their recognition in society (e.g. a different framing of discourses around ageing) and for those who work with and for older adults (e.g. a higher valuation of works connected to support and care).

Governing nanosafety in Austria – Striving for neutrality in the NanoTrust project

New and emerging technologies such as nanotechnology and advanced materials are characterized by manifold areas of application and high uncertainty, making the anticipation of effects difficult. Since 2007, the Austrian technology assessment project “NanoTrust” is dedicated to assisting policy-makers in issues surrounding the safety of nanotechnology applications. The choice was made early on to build and maintain a governance network and to take a more active role in contributing to pre-emptive risk management and the initiation of new processes. Characterized by a dominant risk frame and a broad scope, the Austrian nanotechnology discourse places a distinct focus on scientific expertise and strong interdisciplinary efforts. Ten years into the project, the Austrian nano governance network has shown signs of undergoing an institutionalisation process and we reflect on how we have sought to maintain our neutrality and independence as TA practitioners. This exercise in reflection seeks to gain insights on the strategies employed in practice when shaping technologies at stages of high uncertainty and engaging closely with actors in governance networks over longer periods of time.

The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

The HTA Core Model® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. The HTA Core Model is now available for everyone around the world as a framework for assessing value.

VP47 Health Technology Assessment Of Intensive Care Ventilators For Pediatric Patients

INTRODUCTION:The purpose of the study was to evaluate different type and manufacturers of intensive care ventilators in order to support the healthcare decision-making process about the choice to adopt the best available technology for ventilation of pediatric patient in intensive care units at Bambino Gesù Children's Hospital.METHODS:The technology assessment process was developed by using a new methodology, the Decision-oriented Health Technology Assessment (HTA) (DoHTA), a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel, integrating the Analytic Hierarchy Process (1). A literature review was carried out to gather evidence on safety and overall effectiveness of different kind of intensive care ventilators, with several ventilation modalities and strategies. The synthesis of scientific evidence, and results of the specific context analysis resulted in the definition of components of the decisional hierarchy structure, consisting in detailed characteristics of the technology's performances covering the aspects on feasibility, safety, efficacy, costs, and organizational and technical characteristics of the technology. A subgroup of these indicators has been included in a checklist form for the evaluation of different type and manufacturers of intensive care ventilators, each of which was tested in three independent runs performed in three different departments. In addition, an economic evaluation was also carried out.RESULTS:Preliminary DoHTA results showed that the domains with the highest impacts within the evaluation are safety and clinical effectiveness (34.8 percent and 25.7 percent, respectively) followed by organizational aspects, technical characteristics of technology and costs and economic evaluation. The final objective is to define the alternatives’ ranking through a comparison between alternative technologies’ performances.CONCLUSIONS:The technology assessment project allowed to identify strengths and limits of the most recent intensive care ventilator’ models in the specific contexts of use by involving all health professionals interested, and eventually identify the best option for the hospital.

OP49 Restrictive Versus Non-Restrictive Drug Reimbursement Systems

INTRODUCTION:Existing literature shows evidence on the differences in drug reimbursement decisions across countries. These differences are the reason for this study. The main aim of this research is to model the impact of drug reimbursement decisions on health outcomes (that is, life expectancy, healthy life years and mortality rates). In particular, this study is looking at countries that have different acceptance, restriction and rejection rates for drug reimbursement decisions.METHODS:The current study is based on a longitudinal dataset with data from nine European countries from 2002 to 2014. This dataset is formed of primary data on drug reimbursement decisions (that is, cancer drugs) collected in the Advancing and strengthening the methodological tools and practices relating to the application and implementation of Health Technology Assessment (ADVANCE-HTA) project and secondary data on life tables and indicators of health and socioeconomic status (from Eurostat and World Bank). Following the longevity model defined by Lichtenberg (1), a panel data model with country and year fixed-effects is run on this dataset in order to model the impact of the level of access to drugs on health outcomes.RESULTS:The results show that the rate of adoption of new drugs into a national health system does not have any significant effect on life expectancy. However, more restrictive systems are positively and significantly related with healthy life years. Finally, for mortality rates, higher rejection rates are associated with lower deaths.CONCLUSIONS:To conclude, contrary to the public opinion, results show that a more restrictive drug reimbursement system is not related with a worse health outcome, it is either associated with a positive outcome or it is not related.

OP73 Using Visualization In Scoping The Literature For A Prognostic Health Technology Assessment

INTRODUCTION:One of the challenges of large scale Health Technology Assessment (HTA) projects is managing the large volume of studies retrieved by the requisite comprehensive literature searches. At the scoping stage of the project, a pragmatic judgement needs to be made as to how sensitive the search strategy should be in order to find all the relevant papers without returning an overwhelming volume of irrelevant studies.METHODS:For this HTA (evaluating prognostic and predictive markers in rheumatoid arthritis), the research team already had prior knowledge of several key markers of interest, but wanted to ensure that no others had been missed. Advice from practising clinicians was obtained, but for additional validation, a broad scoping search was conducted for ‘rheumatoid arthritis’ using the sensitive Haynes filters for prognostic (1) and clinical prediction (2) studies. Unsurprisingly, this initial search retrieved too many studies for them all to be admitted to the full review; but once those dealing with known markers had been removed, a sample of the remaining records was loaded into a software visualization tool (3) to display “heat maps” of frequently occurring terms and phrases.RESULTS:On this occasion, no additional markers were identified, however this provided reassurance that the advice obtained from clinicians was comprehensive, enabling the HTA team to proceed confidently with its evaluation of the selected markers.CONCLUSIONS:Visualization offers an alternative means of exploring and interrogating large text archives, and has the potential to complement the role of traditional search methods in identifying literature for systematic reviews and health technology assessments. As processing power increases and more and more full-text papers become available open access, it may provide a solution to some of the limitations associated with comprehensive searching.

VP101 Medical Devices For Treatment-resistant Hypertension: Health Technology Assessment Report

INTRODUCTION:While optimal medical therapy (OMT) represents the current standard of care for treatment-resistant hypertension, non-pharmaceutical therapeutic approaches, such as renal denervation and carotid baroreceptor stimulation therapy, have been proposed. The present Health Technology Assessment (HTA) project was aimed at assessing benefits and risk of those approaches versus OMT.METHODS:A systematic review of evidence on effectiveness and safety was performed together with a review of economic studies. A contextual analysis of market availability and use of the technology in Italy was also performed.RESULTS:In Italy, ninety-nine renal denervation procedures were performed in 2014. Ten studies from six trials were included in the review and meta-analysis. No evidence of dominance or increased harms of renal denervation compared to OMT were found. Four economic evaluations were included and reported dominance of renal denervation. These were based on short-term clinical data and three evaluations used the same Markov model assuming dominance of renal denervation. Estimated average prospective cost of the procedure was EUR6,129.90 (range EUR3,821.15 – EUR9,714.23). We updated the results of an earlier assessment published by an Italian Regional agency on carotid baroreceptor stimulation therapy (1). None of the three studies identified as ongoing in 2015 were completed or had published preliminary results and the technology was not assessed further within the present HTA project.CONCLUSIONS:Even if follow-up was limited to 6 months, randomised evidence showed no benefits of the procedure. Economic evaluations were unreliable, based on unrealistic assumptions of effectiveness and contrived therapy regimes. Further investment in renal denervation should await the results of well-designed and adequately followed-up trials assessing the impact of renal denervation on major cardiovascular events compared to OMT. Future economic evaluations should be based on realistic assumptions of cost and effectiveness.

EXPERIENCES IN ADAPTING EUROPEAN NETWORK FOR HEALTH TECHNOLOGY ASSESSMENT RAPID REVIEWS TO INFORM LOCAL DECISION MAKING.

The Scottish Health Technologies Group (SHTG) produces rapid reviews on nonmedicine technologies to inform advice for decision making in the National Health Service in Scotland (NHSScotland). This study describes our experiences and lessons learned in adapting for NHSScotland two rapid Relative Effectiveness Assessments (REAs) produced as part of the European Network for Health Technology Assessment (EUnetHTA) project to test collaborative preparation and then local adaptation. The REAs were examined for their relevance to NHSScotland and the feasibility of their adaptation evaluated using a screening toolkit. Some supplementary literature searches were conducted and additional background information on epidemiology and the specific technologies was sought. To inform decision making within Scotland, it was also necessary to identify and review cost-effective analyses. Robust evidence reviews were delivered for NHSScotland. Time saved was less than anticipated, partly due to the need to add in health economic information, and partly because of attempts to supplement and update the EUnetHTA material. The preparation of an accompanying advice statement for NHSScotland enabled the inclusion of local contextual information. Collaborative production and adaptation of HTAs is feasible and would be aided by the inclusion of cost-effectiveness analyses in the original work. Agencies should develop clear processes for adapting such reviews for their context with the focus on selecting appropriate topics for adaptation, avoiding unnecessary supplementation of the original work, and ensuring local ownership of final advice.

Hospital-based health technology assessment (HTA) in Finland: a case study on collaboration between hospitals and the national HTA unit.

BackgroundThis study examines, as a part of the European Union funded Adopting Hospital Based Health Technology Assessment (AdHopHTA) project, the results and barriers of collaboration between Finnish hospitals and the national health technology assessment (HTA) agency, Finohta. A joint collaborative HTA program has existed since 2006 between the Finnish hospitals and the national agency.MethodsA case study method was used. Information about the collaboration between Finnish hospitals and Finohta was retrieved from interviews and publications, and categorised per theme. Hypotheses and indicators of successful collaboration were determined beforehand and reflected on the observations from the interviews and literature.ResultsOverall, 48 collaborative HTA reports have been performed during 7 years of collaboration. However, there were no clear indications that the use of HTA information or the transparency of decision-making regarding new technologies would have increased in hospitals. The managerial commitment to incorporate HTAs into the decision-making processes in hospitals was still low. The quality of the collaborative HTA reports was considered good, but their applicability in the hospital setting limited. There were differing expectations about the timing and relevance of the content. Signs of role conflict and mistrust were observed.ConclusionsDespite collaborative efforts to produce HTAs for hospitals, the impact of HTA information on hospital decision-making appears to remain low. The difficulties identified in this case study, such as lack of managerial commitment in hospitals, can hopefully be better addressed in the future with the guidance and tools having been developed in the AdHopHTA project. Collaboration between hospitals and national HTA agencies remains important for the efficient sharing of skills and resources.

How Much do Needlestick Injuries Cost? A Systematic Review of the Economic Evaluations of Needlestick and Sharps Injuries Among Healthcare Personnel.

OBJECTIVE To provide an overview of the economic aspects of needlestick and sharps injury (NSI) management among healthcare personnel (HCP) within a Health Technology Assessment project to evaluate the impact of safety-engineered devices on health care METHODS A systematic review of economic analyses related to NSIs was performed in accordance with the PRISMA statement and by searching PubMed and Scopus databases (January 1997-February 2015). Mean costs were stratified by study approach (modeling or data driven) and type of cost (direct or indirect). Costs were evaluated using the CDC operative definition and converted to 2015 International US dollars (Int$). RESULTS A total of 14 studies were retrieved: 8 data-driven studies and 6 modeling studies. Among them, 11 studies provided direct and indirect costs and 3 studies provided only direct costs. The median of the means for aggregate (direct + indirect) costs was Int$747 (range, Int$199-Int$1,691). The medians of the means for disaggregated costs were Int$425 (range, Int$48-Int$1,516) for direct costs (9 studies) and Int$322 (range, Int$152-Int$413) for indirect costs (6 studies). When compared with data-driven studies, modeling studies had higher disaggregated and aggregated costs, but data-driven studies showed greater variability. Indirect costs were consistent between studies, mostly referring to lost productivity, while direct costs varied widely within and between studies according to source infectivity, HCP susceptibility, and post-exposure diagnostic and prophylactic protocols. Costs of treating infections were not included, and intangible costs could equal those associated with NSI medical evaluations. CONCLUSIONS NSIs generate significant direct, indirect, potential, and intangible costs, possibly increasing over time. Economic efforts directed at preventing occupational exposures and infections, including provision of safety-engineered devices, may be offset by the savings from a lower incidence of NSIs. Infect Control Hosp Epidemiol 2016;37:635-646.

Burden of Disease Study and Priority Setting in Korea: an Ethical Perspective.

When thinking about priority setting in access to healthcare resources, decision-making requires that cost-effectiveness is balanced against medical ethics. The burden of disease has emerged as an important approach to the assessment of health needs for political decision-making. However, the disability adjusted life years approach hides conceptual and methodological issues regarding the claims and value of disabled people. In this article, we discuss ethical issues that are raised as a consequence of the introduction of evidence-based health policy, such as economic evidence, in establishing resource allocation priorities. In terms of ethical values in health priority setting in Korea, there is no reliable rationale for the judgment used in decision-making as well as for setting separate and distinct priorities for different government bodies. An important question, therefore, is which ethical values guiding the practice of decision-making should be reconciled with the economic evidence found in Korean healthcare. The health technology assessment core model from the European network for Health Technology Assessment (EUnetHTA) project is a good example of incorporating ethical values into decision-making. We suggest that a fair distribution of scarce healthcare resources in South Korea can be achieved by considering the ethical aspects of healthcare.

An embedded realist review of what works, for whom, how, and in what circumstances to reduce repeat pregnancies in adolescence: a systematic mixed-methods review

BackgroundThe UK has one of the highest rates of pregnancies in adolescence in western Europe; a large number of them are repeat pregnancies. Previous research has demonstrated substantial emotional, psychological, and educational harm to young mothers after unintended conceptions. We aimed to synthesise evidence about how to reduce repeat pregnancies in adolescence. MethodsA multistreamed, mixed-methods systematic review was conducted. Between May 8 and May 27, 2013, we searched the major electronic databases for articles published from 1995 onwards, and updated the search between June 11 and June 16, 2014 (see appendix for list of databases and search terms used). No language restrictions were imposed during the searches; however, grey literature searches were restricted to English and a UK context, to enhance applicability of results to UK public health agencies. Data extraction was conducted independently by two reviewers, and disagreements resolved by a third reviewer if necessary. The principles of realist synthesis were applied to all included literature to uncover theories about what works, for whom, how, and in what context. Included literature was quality appraised with realist principles of relevance and rigor. Initial theory areas were developed through scoping the evidence, group discussion by the authors, and stakeholder engagement. Stakeholders included representatives from public health, primary care, sexual health, obstetrics, midwifery, and adolescent mothers. Theory areas were further refined and populated with evidence that either confirmed or contradicted the theory. A deliberative synthesis process resulted in the surfacing of an emerging story that included several key contexts and mechanisms, which resulted in a number of outcomes (context+mechanism=outcome configurations). FindingsThe searches identified 8664 documents initially, and 816 in repeat searches, filtering to 12 randomised controlled trials (RCTs), four quasi RCTs, ten qualitative studies, and 53 other quantitative studies published from 1995 to 2013. Four documents found in searches of the grey literature were also included in the realist synthesis. Contexts included experiences of young mothers, their knowledge and understanding, and their community or psychological perspective. Mechanisms included tailoring, motivations, and taking control. Potential outcomes resulting from the context+mechanism=outcome configurations included managing expectations, accessing services, and engagement with the issue of pregnancy in adolescence. InterpretationPregnancy in adolescence is a complex issue, with many factors to consider. The key contexts and mechanisms highlighted can help guide policy makers and professionals towards areas that need to be attended to concerning the issue of repeat pregnancy in adolescence. These findings provide a conceptual platform on which proposed interventions might be built to enhance their potential to work. FundingThis work was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) project number 11/141/05.

Planned and ongoing projects (pop) database: development and results.

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. 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. 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. 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.