bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP40 Criminal Justice Costs And Benefits Of Mental Health Interventions
Authors: Janssen Luca , Pokhilenko Irina , Drost Ruben , Paulus Aggie , Evers Silvia 
Published: December 2019

IntroductionMental health disorders and their treatments produce costs and benefits in both healthcare and non-healthcare sectors. The latter one is often referred to as inter-sectoral costs and benefits (ICBs). Limited research is available on the inclusion of these inter-sectoral costs and benefits (ICBs) in economic evaluations. In this study, we focus on the identification and classification of ICBs of mental health-related interventions within the criminal justice sector in a broader European context. This study was conducted as part of the PECUNIA-project, which aims to develop new standardized, harmonized and validated methods and tools for the assessment of costs and outcomes in European healthcare systems. The aim of the study is to further conceptualize an internationally applicable list of ICBs of mental health-related interventions in the criminal justice sector. Additionally, we aim to facilitate the inclusion of ICBs in economic evaluations across EU by prioritizing important ICBs.MethodsData was collected via a systematic literature search on PubMed and PsychINFO. Additionally, a grey literature search was carried out in six European countries. In order to validate the international applicability of the list and prioritize the ICBs, a survey was conducted with an international group of experts from the criminal justice sector.ResultsThe literature search identified ICBs and resulted in a comprehensive list of items. A multi-dimensional list was constructed, distinguishing between costs as consequence of crime, and costs in response to crime. Based on the expert survey, the international applicability of the list was validated and the most important ICBs from the economic perspective were identified.ConclusionsThis study laid further foundations for the inclusion of important societal costs of mental health-related interventions within the criminal justice sector. More research is needed to facilitate the greater use of ICBs in economic evaluations.
OP71 Understanding Hospitals’ Performance Variability: Conceptual Framework
Authors: Cicchetti Americo , Marchetti Marco , Gabutti Irene , Boccia Stefania , Specchia Maria Lucia , Biondi Alessia , Ceccarelli Anna , de Waure Chiara , Grossi Adriano , Hoxhaj Ilda , Cacciatore Pasquale , Carini Elettra , Pezzullo Angelo Maria , Daugbjerg Signe 
Published: December 2019

IntroductionUnderstanding of the role of contextual factors in determining the real value of health technologies is one of the major challenges for the use of Health Technology Assessment (HTA) methodology within hospitals. Moreover, the responsibility of assessing hospital performance is problematic. Although a number of managerial tools are available to appraise outcomes, there is little evidence on the role of contextual variables and how they might contribute to hospital performance.MethodsBased on three extensive literature reviews, a pragmatic framework has been developed to understand interactions between organizational factors and health technologies on hospitals’ performance. Three main causal relationships emerge: (i) direct relationship between contextual factors and performance; (ii) an effect of contextual factors on the capability of technologies to “produce value”; (iii) an influence of organizational factors on clinical evidence-based decision-making. This pragmatic framework was designed within the IMPACT HTA EU Horizon 2020 Research Project.ResultsThe contextual dimensions are ascribable to five domains: organizational structure; managerial accounting tools; information, communication and technology (ICT) tools; human resource management (HRM) tools; hospital-based HTA procedures. The impact of contextual factors on technologies’ ability to produce value is highly overlooked in literature. Some effort in this sense exists only in the analysis of health information technologies. Moreover, among the contextual dimensions, only HRM tools have inspired a lively debate. The definition of hospital performance is amenable to multiple domains: accessibility, appropriateness, efficiency, safety and patient centeredness (continuity of care).ConclusionsAlthough hospital performance is a pivotal topic in the healthcare sector, a deep understanding of how contextual factors may affect it is missing. The theoretical framework developed provides a tool to understand the multiple dimensions able to affect hospital performance. On one hand contextual dimensions may provide a direct effect on hospital performance. On the other, they may affect the extent to which technologies are capable of producing value.
OP81 Building Technical Capacity To Promote Patient Involvement In Health Technology Assessment
Authors: Toledo-Chávarri Ana , Pego Yolanda Triñanes , Novella Blanca , Reviriego Eva , Cantero-Muñoz Paula , Gavin Patricia , Alvarez-Perez Yolanda , Perestelo-Perez Lilisbeth , Vicente-Edo Maria Jose 
Published: December 2019

IntroductionIn December 2017, a patient involvement (PI) Interest Group was created in the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) Annual conference. It started as a voluntary group of health technology assessment (HTA) methodologists interested in PI. The objective of the Group is to promote and facilitate PI in HTA. With the support of the Spanish Ministry of Health and the RedETS Council the Interest Group grew to at least one member for each of the eight RedETS regional agencies and units. It currently has 22 members. The PI Interest Group works in periodic online meetings and an annual offline meeting to establish a space for experiences exchange and reach consensus on main issues regarding PI.MethodsRedETS published a strategy to facilitate effective and efficient PI in HTA processes in 2017. The long-term objective is to mainstream PI in all RedETS products. This strategy was built on a literature review and a qualitative study with semi-structured interviews. The interviews detected capacity building needs for technicians and methodologist in the network to be able to actively engage patients in HTA reports.ResultsSince the kick-off meeting the PI Interest Group has worked in a number of activities. The main lines of action since its creation were: (i) evaluation of PI process in RedETS HTA reports in 2017 and in current reports, (ii) discussion on main methodological and procedural aspects, and feasibility of different patient participation approaches, (iii) development of technical protocols and templates to facilitate PI, (iv) the creation/adaptation of educational materials for patients and (v) translation of the HTAi Glossary for patients to Spanish.ConclusionsPeer-to-peer learning processes can foster technical capacity of HTA methodologist in the Spanish HTA Network and may favor the implementation of the PI strategy.
OP130 Evidence-Informed Policy For Biologic Medicines In Brazil
Authors: Farinasso Cecilia , Silva Roberta Borges , Rego Daniela , Gomes Dalila , Leite Betânia , de Aguiar Aurelina Aguiar , Gonçalves Lenilson Pereira , Leão Luciana Simões Camara , Sachetti Camile Giaretta 
Published: December 2019

IntroductionThe Department of Sciences and Technology (Decit) of the Brazilian Government has played a vital role in drafting of the National Policy for Biologic Medicines. Decit has provided methodological support to the working group, conducting a rapid review and a rapid evidence synthesis to subsidize decisions and recommendations.MethodsWe used the Methodological Guidelines for the Elaboration of Evidence Synthesis for Health Policies, which is a product of our own team, based on the SUPporting POlicy relevant Reviews and Trials (SUPPORT) Tools for evidence-informed health Policymaking.ResultsThe Decit team participated in the key steps to develop an evidence-informed policy. Our product, “Barriers to Access to Biologic Products: a Rapid Review” was used for the prioritization of health problems and the description of the problem. We then proceeded to the evidence synthesis planning and definition of the research question from an acronym. Together with the coordination of the working group, we decided to tackle the problem of interchangeability of biologic products motivated solely by economic factors in a synthesis of policy evidence. Our evidence synthesis went so far as to describe policy options. The working group used this product to inform a Policy Dialog.ConclusionsThis was the first time that the Decit team provided hands-on methodological assistance the development of a health policy. Not all steps recommended in the SUPPORT Tools were feasible due to time restraints. We observed that rapid evidence synthesis products were helpful to inform decision-making.
OP144 mHealth App Evaluation Framework For Reimbursement Decision-making
Authors: Moshi Magdalena , Tooher Rebecca , Merlin Tracy 
Published: December 2019

IntroductionMobile health (mHealth) applications (app) are being integrated into healthcare by patients and practitioners in Australia. However, there are currently no policies or frameworks available that can be used to conduct a health technology assessment (HTA) on mHealth apps for reimbursement purposes. The aim of the study was to determine what policy changes and assessment criteria are needed to facilitate the development of a system that evaluates mobile medical apps for regulatory and reimbursement purposes in Australia.MethodsTo obtain the information to determine what policy changes are needed and create an evidence-based framework that can evaluate mHealth apps for reimbursement decision-making, four studies were conducted. This research included (i) a policy analysis on international mHealth app regulation; (ii) a case study on American and Australian app regulation; (iii) a methodological systematic review on the suitability of current mHealth evaluation frameworks for reimbursement purposes; and (iv) the identification of HTA pathways and impediments to app reimbursement through stakeholder interviews. An evaluation framework for apps was created by combining and synthesizing the results.ResultsSoftware changes, connectivity, and cybersecurity need to be considered when evaluating mHealth apps for reimbursement purposes. Additionally, the potential dangers of apps providing misinformation, and poor software reliability in current regulation must be considered. Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement in Australia. They expressed caution around the lack of clarity regarding who is responsible for app quality as well as concerns about the digital literacy of medical practitioners and their patients.ConclusionsSince stakeholder trust in the current HTA process for medical devices in Australia is high, the process was adapted to create an evaluation framework for mHealth apps. The adaptations included making provisions for cybersecurity, software updates, and compatibility issues. Provisions to address concerns around practitioner responsibility and misinformation were incorporated into the framework.
OP162 Stakeholder Involvement In EUnetHTA Relative Effectiveness Assessments
Authors: González María Sánchez , Imaz-Iglesia Iñaki , Chalco-Orrego Juan Pablo 
Published: December 2019

IntroductionAppropriate involvement of stakeholders is one of the founding principles of the European Cooperation on Health Technology Assessment. The European Network for Health Technology Assessment (EUnetHTA) produces Rapid Relative Effectiveness Assessments (REAs) to assess pharmaceutical (PT) or other technologies (OT). Stakeholders essentially participate in the scoping, the draft assessment phase, or both.MethodsAll REAs published since 2013 were reviewed. Stakeholder participation in scoping (project plan) and draft assessment was evaluated. We aggregated categories of stakeholders in four groups (Health Care Providers and Academia, Patients and Consumers, Manufacturers, and Regulators and Payers). Means of collaboration (meetings, comments to project plan and draft assessment, questionnaires, focus groups) are also analyzed. Data is continuously updated with new REAs.ResultsMore than 20 REAs have been published at the moment, with a higher number of OT. Health Care Providers and Academia acted as experts in both phases, participating in all REA of OT, and less of PT. Manufacturers participated in all REA in the scoping phase. Regulators and Payers, less involved, participated mainly in the scoping phase. The main methods are providing comments in a standardized form and meetings. Patients' contribution, similar in OT and PT, has increased over the years. Questionnaires or interviews were the main method of involvement, followed by participation in meetings and focus groups. Visibility and transparency have also improved, with a clearer reporting of the stakeholder contribution in the last assessments.ConclusionsThe stakeholder involvement in EUnetHTA REAs is steadily growing, with the different nature of stakeholders’ categories reflected in their contribution to the assessments. EUnetHTA is standardizing stakeholder involvement procedures taking into account the particularities of each group when generating guidance for stakeholder involvement.
PP58 The Alliance Between Health Technology Assessment And Public Health In National Screening Policies
Authors: Varela-Lema Leonor , Puñal-Riobóo Janet , Cantero-Muñoz Paula , Faraldo-Vallés Maria José 
Published: December 2019

IntroductionDecision making regarding national population-based prenatal and newborn screening policies is recognized to be highly challenging. This paper aims to describe the formalized collaboration that has been established between the Spanish National Public Health Screening Advisory Committee (PHSAC) and the Spanish Network of Health Technology Assessment (HTA) agencies to support the development of evidence- and consensus-based recommendations to support this process.MethodsIn-depth description and analysis of the strategic and methodological processes that have been implemented within the Spanish National Health System prenatal and newborn screening frameworks, with special emphasis on the role, actions, and responsibilities of HTA agencies.ResultsThe role of HTA agencies is threefold: (i) support the PHSAC by providing evidence on safety, effectiveness and cost/effectiveness of the screening tests/strategies, as well as contextualized information regarding costs, organizational, social, legal and ethical issues; (ii) collaborate with the PHSAC in the development of formal evidence- and consensus-based recommendations for defining population screening programs, when required; (iii) analyze real-world data that is generated by piloted programs. This paper will provide real-life examples of how these processes were implemented in practice, with a special focus on the development of the non-invasive prenatal testing (NIPT) policy. Recommendations for NIPT were developed by a multidisciplinary group based on the European network for Health Technology Assessment (EUnetHTA) rapid assessment report and the predictive models that were built using national statistics and other contextualized data.ConclusionsThe current work represents an innovative approach for prenatal and newborn screening policymaking, which are commonly difficult to evaluate due to the low quality of evidence and the confounding public health issues. The paper raises awareness regarding the importance of joint collaborations in areas where evidence is commonly insufficient for decision making.
PP93 Efficacy Of Pharmacological Treatments For Type 2 Diabetes In China
Authors: Gu Shuyan , Yu Hai , Li Yuanyuan , Shen Yi , Zhen Xuemei , Gu Yuxuan , Wei Jingming , Shi Lizheng , Dong Hengjin 
Published: December 2019

IntroductionThere are multiple antidiabetic drugs available in China, which vary in their efficacy and safety. However, no study exists that compares all the classes of antidiabetic drugs simultaneously. This study aimed to estimate and compare the efficacy of alternative classes of antidiabetic drugs for Chinese patients with type 2 diabetes, either in a monotherapy regimen or combined with metformin.MethodsA systematic literature review was conducted by searching various literature databases to identify relevant randomized controlled trials published from 1990 to 2016. A meta-analysis was conducted to compare the efficacy of antidiabetic drug monotherapy and placebo or lifestyle interventions (i.e., diet and exercise), and antidiabetic drug plus metformin versus metformin alone, in Chinese patients with type 2 diabetes. An indirect comparison was used to estimate the efficacy of antidiabetic drug plus metformin versus placebo or lifestyle-intervention using metformin as the common comparator.ResultsThe database search identified 354 relevant studies. Compared with placebo or lifestyle interventions, combination therapies achieved greater reductions in hemoglobin A1c (HbA1c) level (1.9% versus 0.9%), body mass index (BMI) (2.66 versus 0.98 kg/m2), and total cholesterol level (1.07 versus 0.35 mmol/L) than monotherapies. For monotherapies, the top three treatments for reducing HbA1c level were insulin, sulfonylurea, and glucagon-like peptide-1 (GLP-1) receptor agonist. The top three monotherapies for reducing BMI level were metformin, GLP-1 receptor agonist, and α-glycosidase inhibitor. The top three monotherapies for reducing total cholesterol level were metformin, GLP-1 receptor agonist, and dipeptidyl peptidase-4 (DPP-4) inhibitor. For combination therapies, the top three treatments for reducing HbA1c level were GLP-1 receptor agonist plus metformin, insulin plus metformin, and glinide plus metformin. The top three combination therapies for reducing BMI level were glinide plus metformin, GLP-1 receptor agonist plus metformin, and DPP-4 inhibitor plus metformin. The top three combination therapies for reducing total cholesterol level were insulin plus metformin, GLP-1 receptor agonist plus metformin, and α-glycosidase inhibitor plus metformin.ConclusionsPharmacological treatments had better efficacy than placebo or lifestyle interventions, while combination drug therapies were superior to monotherapies.
PP128 Quantifying The Relative Importance Of Chronic Obstructive Pulmonary Disease Symptoms To Patients
Authors: Cook Nigel S. , Kostikas Konstantinos , Oezel Beyza , Tatlock Sophi , Mycock Katie , Gardner Tom , Criner Gerard J. , Burgel Pierre-Régis , Gutzwiller Florian S. 
Published: December 2019

IntroductionPrevious qualitative research analyzing social media and online community discussions highlighted the symptomatic burden of cough and mucus (sputum), alongside shortness of breath, in patients with chronic obstructive pulmonary disease (COPD). The objective of this study was to determine the relative importance of these symptoms and their consequences (for example, disturbed sleep) to COPD patients, compared with conventional COPD endpoints (lung function and exacerbations).MethodsA total of 1,050 patients (at least 40 years of age) with moderate to severe COPD or chronic bronchitis, and regular symptoms of cough and excess mucus production, are to be recruited through patient advocacy groups (PAGs) from five countries (Australia, France, Japan, the United Kingdom, and the United States; 150 to 400 patients per country). A discrete choice experiment was designed with input from clinical experts and the PAGs, plus scientific advice from the National Institute for Health and Care Excellence (NICE) in the United Kingdom. Patients’ preferences for the conditional relative importance of symptoms and impact of COPD will be quantified based on trade-offs they are willing to make among hypothetical COPD disease state profiles, described by differing attributes and levels. Hierarchical Bayesian analysis with effect-coding parameterization will be undertaken on the choice data to estimate (using Gibbs sampling) the relative value each respondent places on an attribute level.ResultsThe feedback from NICE informed the selection of screening criteria and the statistical analysis plan, as well as the inclusion of a health status measure, the EQ-5D-3L. Qualitative patient interviews and pilot testing of the attributes and levels grid have been completed, informing finalization of the online survey design.ConclusionsPatient preference studies evaluating the relative importance of symptom burden through assessment of disease state preference values are an important new form of patient-based evidence for informing value-based decision making in HTA. The present study should facilitate a more patient-centered approach to developing new treatments for and improving the care of patients with COPD.
PP141 Functional Connectivity Magnetic Resonance Imaging To Detect Autism
Authors: Polo-DeSantos Mar , Pablo Juan , Orrego Chalco , Hijas-Gómez Ana Isabel , Luengo-Matos Setefilla , Sánchez-Gómez Luis María 
Published: December 2019

IntroductionAutism is a neurodevelopmental disorder characterized by alterations in the intellectual, social, communication, and behavioral capabilities of an individual, and is rarely detected in children before 24 months of age. Early diagnosis and intervention may be more effective at a younger age. Functional connectivity magnetic resonance imaging (fcMRI) of 6-month old infants may be able to identify brain connection patterns related to at least one of the characteristics of autism, which normally appear at 24 months of age, by using a mathematical model to analyze the neuroimaging data.MethodsClinical studies published up to December 2018 that used fcMRI to detect autism in infants were reviewed. The literature databases searched included PubMed, Web of Science, the Trip Database, DynaMed, the Cochrane Library, the International Clinical Trials Registry Platform, and ClinicalTrials.gov. Early assessments of fcMRI analysis were identified through the Early Awareness and Alert System of the Agencia de Evaluación de Tecnologías Sanitarias.ResultsOnly one prospective study of 59 infants at 6-months of age was retrieved. A fcMRI analysis was performed to identify 2,635 pairs of functional connections from 230 brain regions. The infants were subsequently assessed for autism at 24 months of age using gold standard tests. The functional connections correlated with at least one of the behaviors related to autism evaluated at 24 months of age. Eleven infants (19%) were diagnosed with autism at 24 months. Compared with the gold standard test results, the predictive model achieved the following: sensitivity 0.82 (95% confidence interval [CI]: 0.52 - 0.95); specificity 1.00 (95% CI: 0.93–1.00); positive predictive value 1.00 (95% CI: 0.70–1.00); negative predictive value 0.96 (95% CI: 0.87–0.99); and negative likelihood ratio 0.18 (95% CI: 0.05–0.64). Adverse effects were not reported in the study.ConclusionsThe fcMRI analysis could help in early detection of autism and the development of preventive interventions. However, the evidence is sparse and more well-designed studies are needed.