bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP71 Evidence Grading Systems Used In Health Technology Assessment Practice
Authors: Corabian Paula , Tjosvold Lisa , Harstall Christa 
Published: January 2019

Introduction:To facilitate moving from research findings to conclusions when conducting systematic reviews (SRs) and health technology assessments (HTAs), evidence grading systems (EGSs) have been developed to assess the quality of bodies of evidence and communicate (un)certainty about the effects of evaluated technologies. Use of EGSs has become an essential step in conducting SRs and HTAs and those relying on review conclusions should be aware of EGSs’ potential limitations.Methods:This study aims to identify EGSs used in SR and HTA practice, and summarize findings on their inter-rater reliability (IRR). Relevant sources were searched to identify EGSs used in recently published SRs and IRR studies of available EGSs. Members of the International Network of Agencies for Health Technology Assessment were surveyed regarding their current approaches.Results:Preliminary results indicate that only two conceptually similar EGSs are currently used by several organizations in SR and HTA practice: (i) the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and (ii) the Agency for Healthcare Research and Quality Evidence-based Practice Center Program (AHRQ-EPC). Both approaches emphasize a structured and transparent method. However, results from published IRR studies suggest there is a risk for variability in their application due to researchers’ diverse levels of training and experience in using them, and the complexity and heterogeneity of evidence in SRs.Conclusions:Validated EGSs can play a critical role in whether and how research findings are eventually translated into practice. However, our results indicate a low level of uptake of EGSs in HTA practice. Both currently used EGSs are susceptible to misuse that allows different researchers to grade the same body of evidence differently, and their performance has not been robustly explored in terms of IRR. If these results stand up to replication, one cannot rely on conclusions of published SRs, which has implications for the decisions they inform.
OP80 Reconciling Ethical And Economic Notions Of ‘Value’ For HTA
Authors: Kibel Mia , Vanstone Meredith 
Published: January 2019

Introduction:Different disciplinary frameworks in the field of Health Technology Assessment (HTA) may hold different, and potentially contradictory, assumptions about a technology's value or optimal use. For example, economic analyses may be based on outcome measures that are socially controversial or ethically problematic. This can result in economic and ethical evaluations that are difficult to reconcile, leaving HTA short of its goal to provide policy decision-makers with a holistic assessment of technology. We use the case of non-invasive prenatal testing (NIPT) to explore whether the capabilities approach can be used to align economic and ethical concepts of value in assessments of morally challenging health technologies. The capabilities approach is an economic framework which bases wellbeing assessments on a person's abilities, rather than their expressed preferences.Methods:To develop concepts for capabilities relevant to NIPT, we started with Nussbaum's capabilities framework, and conducted a directed qualitative content analysis of interview data from twenty-seven Canadian women with personal experience of this technology.Results:We found that eight of Nussbaum's ten capabilities related to options or choices that women valued in the context of NIPT, and identified one new capability, Care Taking. NIPT has a meaningful impact on women's capabilities, and capabilities concepts can capture the value of NIPT without relying on health outcomes of ambiguous social and ethical value. A capabilities approach may help reconcile ethical and economic value frameworks for NIPT.Conclusions:The capabilities approach can contribute to economic evaluations of morally challenging health technologies that better reflect patient preferences and ethical concerns, and may contribute to more holistic HTAs. It provides a framework within which policy analysts from diverse disciplines can communicate about the social and ethical value of morally challenging health technologies. Future research should focus on operationalizing the capabilities approach for use in evaluations of NIPT and other morally challenging health technologies.
OP82 Ethical Challenges Related To Engaging Patients And The Public In HTA
Authors: Vanstone Meredith , Bidonde Julia , Bond Ken , Abelson Julia , Schwartz Lisa , Tripp Laura , Canfield Carolyn 
Published: January 2019

Introduction:It is widely recognized that the incorporation of patient and public perspectives can enrich health policy decision-making. Methodological and practical advice on engaging patients and the public has proliferated in recent years, with many health technology assessment (HTA) agencies working to formalize their processes in this area. However, despite growing enthusiasm for patient and public engagement, many ethical issues remain unaddressed including: balancing risks and benefits to participants; recruitment methods; reimbursement for time spent participating; representation; and, information disclosure.Methods:In this critical analysis, we draw on our collective experiences engaging with patients and public in the context of HTA. We use principles from two theories, i) research ethics, and ii) participatory governance, to analyze these challenges. The purpose of this analysis is to explore the ways in which risks and benefits to patient and public participants might be balanced in HTA activities.Results:We begin by describing some ethically challenging experiences we have faced when soliciting views and values from patients and members of the public, some anticipated and some unexpected. These challenges include unexpected disclosures of information, navigating power differentials when working with vulnerable populations, eliciting information about potentially traumatizing experiences, and fairly representing controversial and conflicting opinions. We offer examples about what types of patient engagement activities may subject participants to unreasonable risk, and suggest some guiding principles to help plan ethical patient and public engagement activities.Conclusions:Patient and public engagement requires more than just procedural methodological expertise- it also requires the ability to identify and analyze relevant ethical issues. We posit that health technology assessors have a moral obligation to ensure that the risks of patient and public engagement activities do not outweigh the benefits. We call upon the HTA community to engage in thoughtful deliberation about what can be learned from experiences within HTA and in other contexts.
OP86 Outpatient Initial Management Of New-Onset Diabetes In Children
Authors: Larocque Brigitte , Nourrisat Alice , Rhainds Marc , Coulombe Martin , Bouchard Isabelle 
Published: January 2019

Introduction:Management of new-onset diabetes is important to achieve metabolic stabilization, minimize acute complications, and to provide insulin therapy, diabetes education and psychological support. A health technology assessment (HTA) was conducted to determine if an outpatient setting could be effective and safe for new-onset diabetes in children, and how it can be implemented in our pediatric center.Methods:A systematic search on initial management (outpatient versus in-hospital) of diabetes in children was performed in multiple databases and grey literature. Practice guidelines (CPGs), systematic reviews (SRs), randomized controlled trials (RCTs) and non-randomized comparative studies (NRCSs) published up to August 2017 were identified. Telephone interviews with key informants from two children's university teaching hospitals were performed to collect information on outpatient initial management models and issues related to their implementation. An interdisciplinary group of experts from our pediatric center collaborated in this project.Results:According to 5 CPGs, hospitalization would not be required for children without acute complications at time of diagnosis or after initial treatment of ketoacidosis if outpatient care facilities, resources, and education are available. Results from one SR and 7 NRCSs suggested that outpatient initial management is associated with good metabolic control (glycated hemoglobin) and is as safe as the inpatient care model, based on rate of hospital admissions, severe hypoglycemia, and ketoacidosis episode. However, few data regarding treatment adherence, knowledge acquisition, and emotional adaptation were identified. Outpatient education programs can be successfully provided on several consecutive or non-consecutive days after diagnosis as reported by two children's university teaching hospitals.Conclusions:Although data on effectiveness and safety are scarce and of low-quality, outpatient management of newly diagnosed diabetes, uncomplicated or stabilized, is recommended in children. However, data on children and their families should be collected as part of the implementation evaluation in order to enhance its efficacy and the quality of the patients’ and families’ experiences.
OP90 Do Patients With Open Fractures Need Urgent Surgery?
Authors: Mitchell Matthew D. , Williams Kendal , Mehta Samir , Fowler-Gagliardi Loriann , Thomas Julie 
Published: January 2019

Introduction:Calling in staff and preparing the operating room for an urgent surgical procedure is a significant draw on hospital resources and disrupts care of other patients. It has been common practice to treat open fractures on an urgent basis. HTA methods can be applied to examine this prioritization of care, just like they can be applied to the acquisition of drugs and devices.Methods:Our center completed a rapid systematic review of guidelines, systematic reviews, and primary clinical evidence, on urgent surgical debridement and stabilization of open fractures of long bones (“urgent” being defined as within six hours of the injury) compared to surgical debridement and reduction performed at a later time point. Meta-analyses were performed for infection and non-union outcomes and the GRADE system was used to assess the strength of evidence for each conclusion.Results:We found no published clinical guidelines for the urgency of treating open fractures. A good systematic review on the topic was published in 2012. We found six cohort studies published since completion of the earlier review. The summary odds ratio for any infection in patients with later treatment was 0.97 (95% confidence interval (CI) 0.78–1.22, sixteen studies, 3,615 patients) and for deep or “major” infections was 1.00 (95% CI 0.74–1.34, nine studies, 2,013 patients). The summary odds ratio of non-union with later treatment was 0.95 (95% CI 0.65–1.41, six studies, 1,308 patients). There was no significant heterogeneity in any of the results (I-squared = 0 percent) and no apparent trends in the results as a function of study size or publication date. We graded the strength of each of the conclusions as very low because they were based on cohort studies where the treating physician could elect immediate treatment for patients with severe soft-tissue injuries or patients at risk of complications. This raises the risk of spectrum bias.Conclusions:Default urgent scheduling of patients with open fractures for surgical debridement and stabilization does not appear to reduce the risk of infection or fracture non-union. Based on this information, our surgery department managers no longer schedule patients with open fractures for immediate surgery unless there are specific circumstances necessitating it.
OP91 Individual Participant Data Meta-Analysis Of Exercise Rehabilitation In Heart Failure
Authors: Ciani Oriana , Walker Sarah , Warren Fiona , Smart Neil , Piepoli Massimo , Davos Costantinos , Eames Tim , Taylor Rod 
Published: January 2019

Introduction:Traditional meta-analyses synthesize aggregate data obtained from study publications or study authors, such as a treatment effect estimate and its associated uncertainty. An increasingly important approach is the meta-analysis of individual participant data (IPD) where the raw individual-level data are obtained for each study and used for synthesis. This study compares and discusses results from an IPD meta-analysis vs standard meta-analysis of randomized controlled trials of exercise cardiac rehabilitation in chronic heart failure (CHF).Methods:Based on a previous systematic review, the Exercise Training Meta-Analysis of Trials for Chronic Heart Failure (ExTraMATCH II) identified and collected IPD from randomized controlled trials (RCTs) that compared exercise rehabilitation with a non-exercise control with a minimum follow-up of six months. For this abstract, the outcome of interest was all-cause mortality. Original IPD were checked for consistency and compiled in a master dataset. Standard meta-analytic models were used for aggregate data whilst two-stage and one-stage approaches, accounting for the clustering of participants within studies, were planned for statistical analyses of IPD.Results:Overall thirty-three RCTs were included in the original systematic review, whereas within the ExTraMatch II project, IPD on all-cause mortality were obtained from seventeen RCTs of approximately 3,700 patients. From aggregate data there was no significant difference in pooled mortality (relative risk 0.92, 95% confidence interval 0.67 to 1.26). IPD analysis revealed 701 events across exercise and control groups. Our ongoing IPD analyses will allow us to examine how patients’ characteristics (e.g. age, New York Heart Association functional class, ejection fraction) modify treatment benefit.Conclusions:Given the limitations of current trial level meta-analysis evidence in CHF, access to individual data from several RCTs offers a timely and important opportunity to revisit the question of which CHF patient subgroups benefit most from exercise-based rehabilitation.
OP100 Implementing Electronic Health Record In A Children's Hospital
Authors: Andellini Martina , di Mauro Roxana , Faggiano Francesco , Derrico Pietro , Scorteccia Lorella , Ritrovato Matteo 
Published: January 2019

Introduction:The adoption of electronic health records (EHR), which contain large volumes of aggregated longitudinal clinical data, guarantees substantial benefits, including better care, improved safety and decreased clinical risks; however, it is also associated with significant costs and large technical and organizational impacts. For these reasons, it is important to conduct a comprehensive evaluation of health care delivery outcomes. The purpose of the study is to gather evidence on the safety and overall effectiveness of EHR implementation at Bambino Gesù Children's Hospital.Methods:A decision-oriented health technology assessment (HTA) method was applied to assess the technology on clinical, technical, organizational, economic, legal, ethical and safety domains. It is a new implementation of the EUnetHTA CoreModel integrated with the Analytic Hierarchy Process. The evaluation structure was a hierarchical decision tree filled with indicators of a technology's performance, where each indicator was weighted based on its relative impact on decision making. Finally, the alternatives’ ranking was defined. A subgroup of these indicators has been included in a checklist for the evaluation of six EHR implementation projects. This checklist was used as a tool by each involved professional during demo sessions.Results:The assessment took into consideration all the recommendations about the benefits and disadvantages of EHR. In particular, EHR seems to offer many benefits in terms of safety and clinical effectiveness, such as improved continuity, quality of care and accessibility of the data. Its implementation resulted in important organizational outcomes such as EHR configuration, learning curve and training; usability was the main technical characteristics of the technology taken into account. Finally, legal aspects on privacy and data security assumed a key role.Conclusions:A detailed technology evaluation of EHR has permitted the hospital's decision-makers to knowingly assess its introduction in the hospital.
OP109 Comparison Of The Health System Establishment Periods In Eighty-Eight Countries
Authors: Cheng Xuan , Lei Hai-Chao , Yang Yu-Jie , Fan Na-Na , Pan Yi-Ming , Huang Jia-Wen , Zhang Xu , Du En-Huan 
Published: January 2019

Introduction:Health system reform is considered a tough issue worldwide. Great efforts have been made toward health system building and strengthening. However, it is still unclear which health system is appropriate for different countries. This study aimed to systematically compare the characteristics of the establishment periods between eighty-eight counties of National Health Service (NHS) and Social Health Insurance (SHI).Methods:Forty-eight NHS countries and forty SHI countries with data availability were selected. The establishment years of current health systems and other eighteen indicators in economics, society, population and health during establishment periods were collected. Comparison between NHS and SHI was conducted by descriptive analysis of every indicator.Results:Most NHS countries were established during the cold war, while SHI had been set up since the cold war ended. The median of gross domestic product (GDP) per capita, urbanization rate and aging rate of SHI were USD 1535 in current dollars, 58.2 percent and 9.8 percent, respectively; compared with USD 1387, 41.2 percent and 4.7 percent, respectively of NHS. NHS countries had a smaller total population, lower mortality rate and elderly dependency ratio, while the birth rate and children's dependency ratio were higher. SHI countries showed a higher life expectancy and lower mortality rate in infants and children. NHS countries spent less in total health expenditure and a lower proportion of GDP. The median health expenditure per capita of SHI and NHS were USD 188 and USD 131 in current dollars, respectively. There was little difference among maternal mortality rates, and public and private health expenditure proportions.Conclusions:NHS and SHI countries had different characteristics during the health system establishment periods. NHS was established earlier than SHI overall, so that SHI revealed higher levels in economic and social development. Health outcomes of NHS countries were slightly lower than SHI ones, while health expenditure was more in SHI countries. Specific social, economic, demographic and health conditions should be considered when countries are building their own health systems.
OP113 Iramuteq Analysis Of Trastuzumab's Public Consultation In Brazil
Authors: Carvalho Viviane , Silva Everton , Sousa Maria-Sharmila , Sampaio Ricardo , Barreto Jorge 
Published: January 2019

Introduction:In Brazil, the “Sistema Unico de Saúde” (SUS) is a public health system that has universal coverage, comprehensive care, and principles like community participation. The incorporation, update or exclusion of new health technologies is done by the National Committee for Technology Incorporation (CONITEC), which issues reports on the incorporation of technologies and submits them to public consultations, which is the main mechanism of public involvement and an opportunity to influence the decision to access and coverage to new health technologies. Our study aimed to investigate a typology of social representations on the contributions from 2012 to the CONITEC's public consultations to the incorporation of Trastuzumab for the treatment of initial breast cancer in Brazil.Methods:Our study deployed a mixed-methods approach to semi-quantitatively analyze the social representativeness and corpus composition of all the public consultation contributions for the recommendation of the Trastuzumab's incorporation for treatment of initial breast cancer within SUS, as well as the authors' qualitative analysis of the IRAMUTEQ software as a potential effective and efficient tool to semi-qualitatively analyze such public consultations. All contributions were included (127 contributions, from several Brazilian states) and organized into a single corpus, which was submitted to 5 types of analyzes (classical lexical analysis, analysis of group specificities, descending hierarchical classification; similitude analysis and word cloud).Results:The general corpus consisted of 114 texts, separated into 685 text segments (TS), with use of 79.12 percent of total TS (684). The analyzed content was categorized into four classes: Class 1 – Patient Representations/ Advocacy (186 ST-34.3 percent); Class 2: Pharmaceutical Industry/ Advocacy (181 ST-33.4 percent); Class 3: Health Professionals (81 ST-14.9 percent); and Class 4: Individual Contributions (94 -17.3 percent). Class 1 corpus consisted mostly of contributions made from a breast cancer patient association/ advocacy report, which focused mainly on lay expertise terminology. We observed a proximity in corpus between Classes 2 and 3, showing a potential approximation between the pharmaceutical industry and health professionals' contributions, to whom the main word occurrences related to health technologies. Class 4 corpus focused on improvement and individual need, as well as in corpus referring to SUS.Conclusions:From our findings, we observed: (i) a potential similarity in contributions of health professionals and pharmaceutical industry; (ii) how lay expertise might affect the contributions of patients individually and within advocacy and patient organizations; and (iii) the uses and limitations of IRAMUTEQ as potentially effective and efficient tool to semi-qualitatively analyze health technology assessment public consultation contributions.
OP119 Appraising Qualitative Research For Qualitative Evidence Syntheses
Authors: Majid Umair , Vanstone Meredith 
Published: January 2019

Introduction:The growth of the evidence-based policy movement sought to determine how to better assess and incorporate qualitative evidence in clinical practice and policy development. The question engendered was not whether qualitative research is valuable but how researchers can enhance its rigor. From this discussion arose over one hundred appraisal tools for the quality appraisal process of qualitative studies. For those without a deep familiarity with the qualitative research paradigm, navigating through the breadth of tools to find the most suitable tool for the task is a cumbersome process. This presentation will review the descriptive characteristics of available quality appraisal tools for assessing the quality of primary qualitative studies in qualitative evidence syntheses (QES). This presentation will also offer a critical discussion on the use of reflexivity as a de facto quality criterion, and how methodological reporting may influence the application of quality criteria in QES.Methods:We conducted a systematic search to identify quality appraisal tools of qualitative research designed for use in QES. This search built upon the work of Santiago-Delefosse and colleagues by extending their search to 2016.Results:We identified eight appraisal tools intended for use in the quality appraisal process of a QES. We provide a description of the structure, content, objectives, and philosophies of tools followed by considerations concerning their historical antecedents, common patterns regarding structure, content, and purpose, and the implications of these patterns on the QES process.Conclusions:Quality appraisal of qualitative research is an important step in QES, and there have been a proliferation of tools for this purpose. By providing an overview of available tools detailing their intent and strengths, this presentation will assist those engaging in QES to choose an appropriate tool for their work.