bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP121 Experiences With Using The GRADE-CERQual Approach In Systematic Review
Authors: Jensen Lotte Groth , Carstensen Kathrine 
Published: January 2019

Introduction:There are many approaches to synthesis of qualitative studies. The GRADE-CERQual approach (Confidence in the Evidence from Reviews of Qualitative research) provides a transparent method for assessing the confidence of evidence from reviews of qualitative research. This presentation aims at giving examples of applying CERQual, presenting and discussing its strengths and limitations.Methods:This presentation draws on practical experiences with the conduction of three qualitative systematic reviews using the CERQual approach. The reviews differ in aim and field of research.Results:The three CERQual reviews to be discussed in this presentation are: (i) Emergency departments and mental health patients - Purpose: Uncovering knowledge in a project on merging emergency departments to include both somatic and psychiatric patients. (ii) Parental responses to severe or lethal prenatal diagnosis – Purpose: Providing physicians with knowledge on a patient group from their daily clinical practice. (iii) Patients' experiences with home mechanical ventilation – Purpose: Disseminating important knowledge from a national project to an international audience.CERQual strengths:
•Presents complex and large amount of knowledge in a clear way•Pools knowledge from different studies into common outcome measures across studies•Presents an assessment of the quality and strength of outcome measures•The clear presentation makes it useful in decision making.CERQual weaknesses:
•Time consuming to conduct the reviews•Simplification of qualitative research, missing out on context and nuances.Conclusions:CERQual represents a useful tool to facilitate the use of qualitative evidence in clinical and political decision making. CERQual is time-consuming to learn, but a useful tool to apply when learned. CERQual may encourage more uniform reporting of qualitative research, including assessment of confidence in findings. This may increase the impact of systematic reviews of qualitative studies.
OP123 Translating Evidence To Action – The Role Of Health Research Funders
Authors: Reijmerink Wendy 
Published: January 2019

Introduction:National health research funders are accountable to the public with regard to the societal impact of the research, including health technology assessment (HTA), that they fund. Failing to do so can not only negatively affect public trust in the allocation of resources to funding agencies, but can also lead to public mistrust in science.Methods:We present the results of reducing research waste to ensure societal responsible research, both at an international and national level. In the Netherlands, the National Organization for Health Research and Development (ZonMw) developed an analytical framework to assess its research programs, including the national HTA program.Results:An evaluation of 12 national funding agencies in Australia, Europe and North America demonstrated that certain processes (e.g. how research questions are prioritized or decided) are not transparent. At the international level, health funders believe that they have a joint responsibility not just to seek to advance knowledge, but also to advance the practices of health-related research and research funding. In the Netherlands, ZonMw (HTA) research programs perform well regarding addressing societal relevance (e.g. stakeholder participation) and reasonably well on scientific quality (e.g. international cooperation and knowledge sharing). Efficiency (e.g. encouraging use of existing data and systematic reviews) appears to be less well developed, while integrity (e.g. preventing publication bias) is underexposed.Conclusions:Although ZonMw is doing reasonably well in terms of reducing research waste, it was concluded that more focus on societal impact assessment is needed. To do so funding agencies need to collaborate with all relevant stakeholders. This is especially relevant in the field of HTA where the ambition is to move from evidence to impact.
OP134 Pan-Canadian Oncology Drug Review Decisions And Access To Anticancer Treatments In Canada
Authors: Singh Ambrish , Hussain Salman 
Published: January 2019

Introduction:The Canadian Agency for Drugs and Technologies in Health (CADTH) pan-Canadian Oncology Drug Review (pCODR) plays an important role in public reimbursement decision-making for oncology drugs in Canada. This research studies the relation of positive pCODR decisions to new cancer treatment and their subsequent inclusion in Canada's public drug plans.Methods:We studied all oncology drugs that received an approval from Health Canada and were reviewed by the pCODR from inception till 26th Sep, 2017. The data was obtained from CADTH and Health Canada. Data such as indication, submission type and date, recommendation date, final recommendation, and subsequent provincial funding status was extracted and analyzed. Impact was evaluated by analyzing the percentage of drug submissions with assessment outcome (positive recommendation rate and conditional recommendation rate) and time taken for the final decision (recommendation gap). The percentage of drugs included in public formulary after positive recommendation by pCODR (coverage rate) and the gap in days from positive recommendation to subsequent coverage in provinces (coverage gap) was also assessed.Results:Among 119 drugs reviewed by pCODR, the positive recommendation rate was eight percent. Nine applications comprising seven drugs for six indications received positive recommendations, and genitourinary treatments received maximum positive recommendations. The conditional recommendation rate was 52 percent; 62 applications of 45 drugs for 46 indications received conditional recommendation. Lymphoma and myeloma treatments received maximum conditional recommendations. The average recommendation gap for positive and conditional recommendations was 180 and 172 days, respectively. The coverage rate for drugs with positive recommendation was 100 percent for all provinces except 89 percent for Newfoundland and Labrador, and 67 percent for Prince Edward Island. Among the provinces, British Columbia had a maximum of 433 days and Saskatchewan has the minimum of 165 days coverage gap.Conclusions:Despite Health Canada's approval, only a fraction of oncology drugs receive positive pCODR recommendation; furthermore, provincial drug plans take time to include these in the reimbursement formularies. While health technology assessment is crucial for appropriate allocation of limited resources, efforts should also be made to reduce access barriers, particularly to positively recommended oncology drugs inclusion in provincial formularies.
OP164 Hospital Budget Impact Of High-Cost Drugs: The Case Of Nusinersen
Authors: Demirdjian Graciela 
Published: January 2019

Introduction:Nusinersen is an orphan drug for spinal muscular atrophy (SMA) recently approved for marketing. Its high cost, striking but limited evidence of efficacy, and strong demand by media and patient organizations have generated a health policy conflict. We analyze the flaws of available evidence on nusinersen and its budget impact at a pediatric hospital, and report a collaborative strategy for drug procurement and financing.Methods:Nusinersen is the highest-cost drug assessed by our hospital-based health technology assessment (HB-HTA) program so far. At the time of our assessment, only interim-analysis data of the pivotal randomized trial submitted to Federal Drug Administration (FDA) for approval and the European Medicines Agency (EMA) report containing unpublished final results were available. These secondary sources and other published phase II results were appraised. As a referral hospital, we concentrate most of the 300 SMA patients in our country. Hospital budget impact estimation included drug and hospitalization costs for the first and following years. The HTA report was submitted to the Ministry of Health to address this financing issue.Results:The available evidence of efficacy raised serious methodological and clinical uncertainties. First-year treatment cost per patient was estimated in ARS 13,008,688 (USD 752,000, 10 percent of pharmacy annual drug budget). Hospital budget impact (70 eligible patients) was ARS 910,608,160 (USD 52,000,000; 18 percent of total annual hospital budget). Our recommendation was to contact central level authorities to resolve both drug financing and patient access by negotiating a shared-risk approach for an expanded access program, allowing further data collection for reassessment after 12 months. This, in turn, fostered mutual collaboration and consensus within the health system where several lawsuits were demanding drug coverage. Negotiation with the industry was initiated by the Ministry.Conclusions:This case is a clear example of forthcoming ultra-high-cost drugs unaffordable by hospital budgets. Their acquisition opportunity cost is a health policy matter requiring to display collaborative coping strategies with Ministries and other stakeholders including industry.
OP169 Usability Evaluation Of A Portable Dry-Electrode Electrocardiography Device In Vietnam
Authors: Kilimo Precious , Phan Ngoc , Le Tai , Hoang Thai , Han Dung , Dang Linh , Vu Nguyen , Pham Nga , Nguyen Tuan , Cao Hung , Nguyen Cuong 
Published: January 2019

Introduction:According to the Vietnamese Cardiovascular Association, one-fifth of Vietnam's population is suffering from cardiovascular disease (CVD) – now the leading cause of death in the country that accounts for about one-third of total deaths every year. Yet affordable and convenient solutions to monitor and detect CVDs remain limited and not available nation-wide. This study aimed to investigate the usability of a portable dry-electrode electrocardiography (ECG) device, paired with a mobile phone, in supporting ECG service delivery in Vietnam.Methods:An evaluation study was designed to combine a portable dry-electrode ECG device to measure and a mobile phone to receive and record ECG signals. Healthy young college students were invited to participate in the study. Three rounds of ECG measurement were administered for each of the participants. Usability of the device was assessed through the reliability of the measures and feasibility of use during intervention. Standard error of measurement (SEM) and intra-class correlation coefficient (ICC) estimations were used for reliability, while structured questionnaire administered before and after measures was used for feasibility assessments.Results:A total of 234 participants enrolled in the study. No major difference was found in SEMs between trials one and two (4.96 percent, 90% CI: 4.61 − 5.37) and two and three (4.14 percent, 90% CI: 3.85 − 4.48). A slight improvement was observed in ICC of trials two and three (0.95, 90% CI 0.94 − 0.96) in comparison to one of trials one and two (0.94, 90% CI: 0.92 − 0.95). The SEM and average ICC of all trials were 3.41 (90% CI: 3.17 − 3.69) and 0.96 (90% CI: 0.95 − 0.96) respectively. Forty-five percent of participants thought the device would be suitable for their parents while 69 percent thought the device would benefit their grandparents the most.Conclusions:High consistency of measures demonstrated that the device is reliable to provide ECG service delivery. The study also showed great potential of device usage in primary health care of Vietnam.
PP14 Development Of The European Network For Health Technology Assessment Standards Tool For Registries In Health Technology Assessment
Authors: Garcia Emmanuel Gimenez , Espallargues Mireia , Long Jae , Valentic Maja , Guzina Irena , Rodrigues Jorge , Varela-Lema Leonor , Dedeu Toni 
Published: January 2019

Introduction:Bridging gaps between registry-holders, Health Technology Assessment (HTA) producers and users is one of the aims of the European Network for HTA (EUnetHTA) Joint Action 3. In this context, a post-launch evidence generation tool is being developed, including a quality standards tool for registries in HTA. The standards tool for registries in HTA will enable, among others, registry owners to consistently collect high quality registry data, and HTA agencies to use proper registry data collected by others as evidence for their assessments. The objective is to present the first draft version of the tool structure, which is going to be piloted during the forthcoming months.Methods:A review and description of the currently available first version (November 2017) sections, items and criteria for HTA studies.Results:The tool is divided in three sections; “Methodological Information”, “Essential Standards” and “Additional Requirements”. The first section enables users to analyze not only the ability of the registry to answer to research questions but also to check the registry transparency. The second section encloses the essential elements of good practice and evidence quality (therefore all of them must be met before an HTA report can use the registry data). Finally, the third section includes elements of good practice and evidence quality useful to consider in planning and evaluating registries for specific purposes. Although suggestions are defined, the third section item requirements could depend on the individual HTA agency perspectives and needs.Conclusions:There is a clear growing availability and requirement for real world data for health technology assessment. A piloted and robust registry standards tool for HTA can provide a relevant basis to improve both the evidence generation but also to make more trustful and excellent evaluations.
PP17 Comprehensive Evaluation Of A Technology With Expanding Indications
Authors: Lambert Laurie , Désy François , Azzi Leila , Vutcovici Maria , Brière Anabèle , Boothroyd Lucy , Bogaty Peter , Racine Normand , de Guise Michèle 
Published: January 2019

Introduction:The use of transcatheter aortic valve implantation (TAVI) is evolving. Our Cardiovascular Evaluation Unit is implementing a comprehensive approach to inform decision-makers on optimal use of TAVI, including the development of quality standards. We are implementing a multifaceted evaluation framework in collaboration with clinical stakeholders.Methods:Our unit has carried out a continuous field evaluation in collaboration with the clinical teams at all six TAVI centers in Québec for the past four years (1 April 2013–31 March 2017), with regular feedback to the teams and sharing of results with each individual center. Hospital documentation was reviewed according to established national quality indicator definitions. Field evaluation data were combined with the results of systematic literature review to establish provincial standards for practice, through a deliberation process by an interdisciplinary committee of clinical experts from each center. Systematic surveillance of the literature is ongoing.Results:In the period 2013–2017, use of TAVI in Québec was limited to very elderly patients with significant comorbidities at high risk of operative mortality. We observed improvements in both processes of care (e.g. documentation of risk scores) and clinical outcomes (e.g. 30-day and 1-year mortality) over time. Our consensus standards recognize the potential value of TAVI for patients at moderate operative risk, identify uncertainties and recommend best practices for patient evaluation and clinical decision-making about choice of treatment.Conclusions:A comprehensive, long-term evaluation process of TAVI with feedback to centers is associated with improvements in processes of care and outcomes. In the present context of expanding clinical indications, we will continue to evaluate patient selection, processes and outcomes according to the newly-established provincial quality standards. This iterative approach facilitates continued evidence generation and decision-making for optimal use of an evolving intervention. We acknowledge the contribution of the members of the expert clinical committee.
PP25 Direct Costs Of Ischemic Heart Disease: Real World Data From Brazil
Authors: Schlatter Rosane , Hirakata Vania , Etges Ana , Polanczyk Carisi 
Published: January 2019

Introduction:In Brazil, cardiovascular disease accounted for twenty-eight percent of deaths in 2013 with an estimated prevalence of five to eight in adults over forty years of age. Health care costs have quadrupled in the last decade, reaching USD 125 billion in 2013, of which forty-four percent were paid by the public system. The objective of this study was to estimate the direct costs associated with inpatient stay for myocardial infarction in a public teaching hospital from the perspective of the service provider.Methods:We used a bottom up microcosting methodology for collecting data from computerized hospital records and patients' hospital bills. The costs included salaries of health professionals, medications, consumables, laboratory and diagnostic tests performed during hospitalization and maintenance expenses. Mean, standard-deviation, median and total costs were calculated. The costs were presented as mean and median values in Brazilian currency and converted to US dollars by the exchange rate.Results:A total of eighty-one patients were included in this study. The mean population age was 60 ± 10.6 years, the follow-up period were 107 ± 2.6 months; fifty-four percent were male, eighty-four percent had hypertension, thirty-six percent had diabetes, and twelve percent had previous cerebrovascular accident. During follow-up, there were 101 hospitalizations for myocardial infarction, of which fifty-seven with intensive care unit (ICU) days. The total cost with hospitalizations was USD 177,288, of which fifty-two percent were the health professionals’ costs. The average cost for hospitalization was USD 1,755 (median USD 1,221). However, the average reimbursement paid by the public system was USD 1,188 (median USD 1,044) per hospitalization, generating a deficit of thirty-two percent for the hospital.Conclusions:These results may indicate the necessity of reviewing the public reimbursement policies for the service providers in Brazil. Besides that, these data may also serve as input for the economic evaluation in coronary artery disease.
PP34 A Cost-Utility Analysis Of The Syncope: Pacing Or Recording Trial
Authors: Hofmeister Mark , Sheldon Robert , Spackman Eldon , Raj Satish , Talajic Mario , Becker Giuliano , Essebag Vidal , Sarah Rose M. , Ritchie Deborah , Morillo Carlos , Krahn Andrew , Safdar Shahana , Maxey Connor , Clement Fiona 
Published: January 2019

Introduction:For patients with bifascicular block and syncope of unknown origin, different American Heart Association guidelines give Class 2A recommendations for two treatments: the implantable loop recorder (ILR) and empiric pacemaker insertion (PM). Equipoise reflected in guidelines may contribute to uncertainty in management and inefficient resource use. The objective of this analysis is to determine the cost-effectiveness of ILR compared to PM in the management of older adults (age>50 years) with bifascicular block and syncope over two years, from the perspective of a Canadian publicly funded health care system, in the Syncope: Pacing or Recording In ThE Later Years (SPRITELY) trial.Methods:Resource utilization data was collected throughout the trial, and unit costs were assigned (2017 Canadian dollars). Utility was measured at baseline and annually with the EQ-5D-3L. Quality adjusted life years (QALYs) were calculated as area-under-the-curve, and adjusted for baseline imbalances in utility. Confidence intervals for the incremental cost effectiveness ratio were generated with non-parametric bootstrapping.Results:Mean cost in participants randomized to PM was CAD 9,759 (USD 7,400), compared to CAD 13,453 (USD 10,200) in participants randomized to ILR. The ILR strategy resulted in 0.020 QALYs more than the PM strategy. The incremental cost effectiveness ratio was CAD 186,553 (95% CI: −831,950–1,191,816) (USD 141,900, 95% CI: −632,740–906,440) per additional QALY. In 1,000 bootstrapped replicates, the cost of the ILR strategy was always greater than that of the PM strategy. At the threshold of CAD 50,000 (USD 38,000) per additional QALY, the probability that the ILR strategy is the cost effective option is 0.504.Conclusions:ILR costs were greater than PM costs, with little difference in QALY outcomes over two-years. Findings are generalizable to patients similar to SPRITELY participants, from the perspective of the Canadian health care system. However, practice pattern variation and payment systems inhibit generalizability to other countries. Future analysis will explore cost and QALY outcomes in countries that participated in the SPRITELY trial.
PP57 Grading The Quality Of Evidences In HTA Process
Authors: Andellini Martina , di Mauro Roxana , Faggiano Francesco , Derrico Pietro , Ritrovato Matteo 
Published: January 2019

Introduction:In decision-making processes, health technology assessment (HTA) plays an important role ensuring the adoption of effective technologies and translating scientific evidence into decisions. Bambino Gesù Children's Hospital developed a new method which integrates EUnetHTA Core Model with multi-criteria decision analysis (MCDA) enabling decision makers to make a more informed decision between different alternatives. This approach quantifies assessment parameters, which are defined by literature evidence, or by expert opinion when lacking such evidence. MCDA results (i.e. decision tree of assessment elements, weighting systems and numerical values of technology’ performance) are derived from expert judgement. This means that indicators are weighed by the same weight system; either they are supported by strong literature evidence or otherwise based on expert opinion. The objective of this work is to use the GRADE approach to weight the relevance of each indicator starting from its source of information because different level of evidence should result in different weights.Methods:A GRADE level was associated with each judgement value of performance indicators and a normal probability function was built with the standard deviation inversely proportional to GRADE level to describe the possible dispersion of the judgement due to the different levels of evidence that support each indicator. The higher the GRADE value, the lower the associated standard deviation. A Monte Carlo simulation was carried out to evaluate the expected value of technology’ performance modulated by GRADE level.Results:Four Gaussian distributions were built and associated to four GRADE levels. When an indicator has a low GRADE level, its performance value will vary in a broader way according to the linked Gaussian distribution.Conclusions:This study showed the importance of applying the GRADE system to indicators’ sources of information because this can modify the overall computation of parameter weights and performance, proportionally to their robustness.