Oral Presentations
OP136 Provision Of A Chimeric Antigen Receptor T-Cell Program: A Rapid Review
- Niamh Carey, Marie Harte, Claire Gorry, Laura McCullagh
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- Published online by Cambridge University Press:
- 31 December 2019, p. 31
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Introduction
The recent European Medicines Agency (EMA) approval of chimeric antigen receptor (CAR) T-cell therapies, axicabtagene ciloleucel and tisagenlecleucel, means the imminent arrival of health technology assessment (HTA) submissions to HTA agencies. HTA requires identification of all resources and organizational impacts pertaining to an intervention. Rapid review is a form of knowledge synthesis that abbreviates certain methodological aspects of systematic reviews to produce information in a timelier manner. Considering the time-sensitive nature of CAR T-cell HTAs, the aim of this research was to conduct a rapid review to identify the institutional requirements for the provision of a CAR T-cell program.
MethodsA Rapid Review protocol was developed and registered in PROSPERO. Electronic databases, EMBASE and MEDLINE, and grey literature were searched. All study designs published in English after the year 2000 were included. Studies pertained to the use of CAR T-cells in adult and pediatric patients with solid and hematological malignancies. No restrictions were placed on the comparators or study setting. Primary outcomes were organized into two categories: (i) resource use, (ii) processes relating to implementation of CAR T-cell programs. Secondary outcomes included associated costs of implementation and barriers to successful implementation. Screening, review, and extraction of relevant data was conducted by a single reviewer. Extracted data included publication details, population and setting, study characteristics, outcomes and outcome measures, and strengths and limitations of research. Data was synthesized by means of thematic analysis.
ResultsResults indicate that the provision of a CAR T-cell program in Ireland will require the establishment of bespoke infrastructural support. This includes additional outpatient facilities, ICU resources, and nursing capacity. Close relationships will need to be formed between hematology, ICU and neurology.
ConclusionsThe findings of this Rapid Review will inform the assessment of organizational impacts associated with the introduction of a CAR T-cell program, ensuring a robust HTA assessment.
OP137 Translating Results From Clinical Audit Studies To Local Context
- Carmen Moga, Dagmara Chojecki, Bing Guo
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- Published online by Cambridge University Press:
- 31 December 2019, p. 31
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Introduction
Despite widespread use of oxygen (O2) therapy, there is relatively little available information on routine O2 administration and monitoring; this is an issue particularly when considering the potential risks associated with inappropriate O2 utilization. A rapid health technology assessment (HTA) was conducted to inform the Respiratory Health Strategic Clinical Network Oxygen Summit in Alberta on aspects related to current practice in the use of O2 therapy in acute care, including administration, safety and quality, and inappropriate practice. Clinical audit is a tool used to determine deviations in practice and to identify opportunities for improvement. The objective of this presentation is to describe the experience and lessons learned from including clinical audit studies in the rapid HTA.
MethodsA standardized rapid review approach was used to identify, select, and synthesize evidence from studies published in English from 2005 to 2016. A supplementary literature search conducted in 2018 provided additional background information on the value, applicability, and limitation of using results from clinical audit studies to inform questions of good practice.
ResultsTwenty-four clinical audit studies on O2 therapy were identified; the majority were conducted in the United Kingdom. The studies varied in design, methodology, and data and outcomes reporting. Ten studies investigated the appropriateness of O2 therapy prescription pre- and post-implementation of local initiatives and interventions, which helped pinpoint major gaps in current practice, and identified general recommendations for improvement of practice. A list of reporting criteria is proposed for improving the reporting of clinical audit studies results.
ConclusionsConducting clinical audit studies is resource-intensive. In the absence of other research evidence and local practice data, translating results from clinical audit studies conducted in other jurisdictions, while challenging, can help address appropriateness questions. However, inferences from these studies may be suitable only for certain topics or an operating context.
OP138 Stakeholders’ Involvement When Developing A mHealth Assessment Tool
- Elisa Puigdomenech Puig, Elisa Poses Ferrer, Lina Masana, Mireia Espallargues
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 31-32
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Introduction
Due to the specific characteristics and challenges of mobile health (mHealth) technologies there is a need to have assessment tools based on their particularities to be used by health technology assessment (HTA) agencies and evaluation experts. In the development of a comprehensive and practical evaluation tool for the evaluation of mHealth solutions we aimed to include the views and opinions of key stakeholders: health professionals, developers, hospital managers, HTA agencies, patients and general public.
MethodsFocus groups and an online modification of the Delphi technique are being used to discuss and agree on domains and criteria to be included in the mHealth assessment tool. Domains and criteria used for health apps evaluation were drawn from a literature review on the topic. The initial list includes 95 criteria grouped into the following domains: purpose of the app, privacy and security, clinical effectiveness, content of the intervention, user experience and usability, interoperability, expenses, impact on the organization, and legal and ethical aspects. Data coming from focus groups is currently being analyzed from a thematic and content analysis perspective.
ResultsFocus groups with professionals have showed that the most important domains to be considered when evaluating health apps are those related with security, user experience, and clinical effectiveness. Some criteria were considered to be mandatory (mainly regarding safety issues), on which a first step assessment should indicate whether the app ‘pass or fails’ for the subsequent throughout assessment. Focus groups with patients will provide insight on critical aspects related to the choice, use and adherence to a health app.
ConclusionsInsights from main stakeholders on the design of the tool for mHealth assessment are relevant and complementary between them. Next steps include (i) the agreement of criteria by using an online modification of the Delphi Technique and (ii) piloting of the tool.
OP140 Adult Patient Access To Electronic Health Records
- Petra Schnell-Inderst, Stefanie Neyer, Alexander Hörbst, Gerhard Müller, Uwe Siebert, Elske Ammenwerth
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- 31 December 2019, p. 32
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Introduction
In order to facilitate patient information, patient involvement, and to support patient-centered care, healthcare organizations are increasingly offering access to patient data that are stored in the institution-specific electronic health record (EHR). Patients can access these data, read, and print them, or download and integrate them into any type of patient-held record. This EHR access is typically web-based and called “patient portal” allowing the independent access via the Internet from everywhere. A patient portal may also offer additional features such as prescription requests, appointment booking, messaging, personal health-related reminders, individual therapeutic recommendations, personal diaries, and social networking with other patients. In a Cochrane review, we assessed the effects of providing access to EHR for adult patients on patient empowerment and health-related outcomes compared to usual care.
MethodsAccording to the methods of evidence-based medicine, we developed a protocol for a Cochrane review, which is published in the Cochrane database.
ResultsWe identified ten randomized controlled trials (RCTs) including 6,668 randomized participants. Seven RCTs took place in the USA, two in Canada, and one in Japan. Additional functionalities of interventions and disease conditions were heterogeneous. Three studies (n = 601) reported on patient empowerment. The risk differences reported were neither statistically significant nor clinically relevant. Eight studies (n = 2,070) reported on nine different risk factors (blood pressure, blood glucose, poor asthma control, 10-year Framingham risk score, cholesterol, body mass index, composite score of eight variables, intraocular pressure, composite score of three variables). The results were heterogeneous. Mostly there were no statistically significant risk differences between study groups.
ConclusionsOverall, there is no evidence for a clear positive effect of patient portals on patient empowerment and health related outcomes (mainly risk factors). However, we identified only a small number of studies. The usage of portals was often low and several studies were older.
OP142 Reviewing Methods For Early Assessment
- Linn Nathalie Stome, Tron Moger, Kristian Kidholm, Kari Kvaerner
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- 31 December 2019, pp. 32-33
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Introduction
The project DigiHelse aims to support the municipality health in Norway by offering a digital communication platform to users of the home care service nationally. In a concept stage of innovation, an early assessment of the potential socioeconomic value of the project was carried out by means of stakeholder insight and scenario drafting. As the assessment showed favorable potential in providing decision support and reducing risk, the project received funding to move into the pilot phase. The objective of this study is to reassess the effect of stakeholder insight and scenario drafting by validating the results using empirical data from the first pilot of DigiHelse.
MethodsThrough collecting empirical data on resource consumption and inquiries to the service from four intervention districts and one control district in Oslo, the socioeconomic value of DigiHelse was reassessed. In addition to survey and register data collected before and after the pilot, behavioral data was introduced as a new data source.
ResultsThe effect of early assessment by means of stakeholder insight and scenario drafting was successfully studied adding empirical data from the projects first pilot. The real-time data on user behavior registered in the DigiHelse server contributed to verify the assumptions from the first assessment of the project. Although the results from the analysis were less optimistic than the first assessment, the study revealed important improvement measures necessary to improve the innovation process.
ConclusionsThe usefulness of early assessment is questioned, due to lack of precision of estimates caused by scarce available data. The present study presents a first step in evaluating the precision of employing stakeholder insight and scenario drafting as additional information in early assessment of innovation. The studied approach to early assessment showed potential in enhancing decision support and reducing risk from a concept stage of innovation.
OP143 Assessment Of mHealth Apps: Is Current Regulation Policy Adequate?
- Magdalena Moshi, Jacqueline Parsons, Rebecca Tooher, Tracy Merlin
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- Published online by Cambridge University Press:
- 31 December 2019, p. 33
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Introduction
Australians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.
MethodsA policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.
ResultsAll included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.
ConclusionsNone of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.
OP144 mHealth App Evaluation Framework For Reimbursement Decision-making
- Magdalena Moshi, Rebecca Tooher, Tracy Merlin
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- Published online by Cambridge University Press:
- 31 December 2019, p. 33
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Introduction
Mobile 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.
OP147 Educational Costs And Benefits Of Mental Health Interventions
- Irina Pokhilenko, Luca Janssen, Aggie Paulus, Ruben Drost, Silvia Evers
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 33-34
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Introduction
The burden of mental health disorders has a wide societal impact affecting primarily individuals and their significant others. Mental health interventions produce costs and benefits in the health care sector but can also lead to costs and benefits in non-healthcare sectors, also known as inter-sectoral costs and benefits (ICBs). The aim of this study was to develop an internationally applicable list of ICBs in the educational sector resulting from mental health interventions and to facilitate the inclusion of ICBs in economic evaluations across the European Union (EU) by prioritizing important ICBs.
MethodsSome ICBs of mental health interventions were identified in earlier research, which were used as a basis for this study. Additional data was collected via a systematic literature search of PubMed and a grey literature search carried out in six EU countries. In order to validate the international applicability of the list and prioritize the ICBs, a survey was conducted with the international group of experts from the educational sector. The outcomes of the expert survey were used to create the condensed list containing the most important ICBs.
ResultsThe literature search allowed identifying additional ICBs and creating a comprehensive list of items. In order to improve its usability, a multi-dimensional list was constructed distinguishing between tangible (i.e. special education) and intangible items (i.e. cognitive deficits). Based on the expert survey, the international applicability of the list was validated and the most important ICBs from the economic perspective were determined.
ConclusionsMental health interventions can affect a large number of educational facilities. The list of ICBs developed in this study could be used to select relevant educational facilities for economic evaluations of specific mental health disorders. Further research is needed to define, measure, and valuate the identified ICBs in order to facilitate the practical application of the list in economic evaluations.
OP151 Cost-Utility Of Gender-Neutral HPV Vaccination In Ireland
- Conor Teljeur, Eamon O Murchu, Patricia Harrington, Mairin Ryan
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- Published online by Cambridge University Press:
- 31 December 2019, p. 34
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Introduction
A number of economic evaluations of gender-neutral human papillomavirus (HPV) vaccination have been published, generally finding that the cost-effectiveness is sensitive to the uptake rate in girls. In Ireland there is a girls-only program in place, but the initial high uptake rate (>85 percent) was substantially impacted by high profile negative publicity concerning perceived vaccine safety issues. Efforts to address perceived safety concerns have recently yielded a partial recovery in uptake rates. The aim of this study was to estimate the cost-utility of extending the program to include boys and explore the impact of fluctuating uptake rates.
MethodsA previously published cost-utility model used in the United States of America and Norway was adapted to the Irish setting and populated with Irish epidemiological and cost data. Comparators included no vaccination, and girls-only and gender-neutral vaccination, both with either a 4-valent or 9-valent vaccine. Vaccination is at age 12 years and oropharyngeal and penile cancers were excluded in the base case analysis. Additional analyses were used to incorporate fluctuating uptake rates into the model.
ResultsA 9-valent girls-only program dominated the existing girls-only 4-valent program. The incremental cost-effectiveness ratio (ICER) for a gender-neutral 9-valent program was EUR 50,823/quality-adjusted life year (QALY). Gender-neutral vaccination would be cost-effective at a willingness-to-pay threshold of EUR 45,000/QALY when the uptake rate is below 78 percent. The ICER decreased to between EUR 41,000 and EUR 42,000/QALY when the uptake rate was allowed to fluctuate across six to 12 yearly cycles.
ConclusionsThe cost-effectiveness of gender-neutral HPV vaccination is highly sensitive to the assumed uptake rate in girls. Large fluctuations in HPV vaccine uptake rates have been observed in a number of countries in the last decade. Incorporating fluctuating uptake rates in the model shows that a gender-neutral program may be more cost-effective than when a stable uptake is assumed.
OP152 Pharmacoeconomic Assessment And Drug Expenditure Reduction In Ireland
- Cormac Kennedy
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- Published online by Cambridge University Press:
- 31 December 2019, p. 34
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Introduction
All new products to be reimbursed from the Irish health budget are subject to a rigorous assessment by the National Centre for Pharmacoeconomics (NCPE). Following assessment, a recommendation is made regarding its cost-effectiveness at the submitted price. This may lead a reduction in the drug price. This study aimed to determine the reduction in expenditure due to the pharmacoeconomic assessment process in Ireland.
MethodsProduct details, submitted price and gross budget impact were recorded for each NCPE submission from 2012 to 2015. The latter was chosen as reimbursement data are currently available until 2016. A product was included if its assessment suggested price reduction was required and the product was reimbursed under the High-Tech Drug Scheme (HTDS), a scheme for high cost drugs in a primary care setting. The utilization and actual expenditure of each product was extracted from national reimbursement data for the year after approval. The expected expenditure, calculated using the submitted price, was then compared to the actual expenditure.
ResultsA total of 162 products were assessed during the study period. There was a potential price reduction for 65 products based on the assessment outcome. Of these, 15 were reimbursed under the HTDS. A reduction in expenditure was evident for eight of the 15 products (53 percent). The average reduction was eight percent of the expected expenditure. All products showed an actual expenditure greater the predicted budget impact submitted by the applicant.
ConclusionsTo the authors’ knowledge, this is the first report of expenditure reduction due to a pharmaco-economic assessment process. With the ever-increasing utilization of high cost drugs, the study demonstrates the importance of a process to assess and negotiate cost-effective drug prices. However, the study underestimates reductions, as it is yet to include commercial rebates returned to a central budget. Future research will aim to capture these reductions.
OP157 Carbon Ion Radiotherapy: A Systematic Review
- Gregor Goetz, Marija Mitić, Tarquin Mittermayr, Claudia Wild
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 34-35
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Introduction
Due to the promising physical dose distribution of carbon ion radiation therapy (CIRT), CIRT can be regarded as a novel tumor irradiation technique and is sometimes considered as a breakthrough therapy for various tumor types. However, it is unclear whether superiority or inferiority can be claimed when compared to standard irradiation. This study aimed to assess the scientific evidence regarding the effectiveness and safety of CIRT.
MethodsA systematic literature review was conducted using the European Network for Health Technology Assessment (EUnetHTA) Core Model® for rapid relative effectiveness assessment. The literature search for clinical outcome studies on CIRT was performed in four databases [Cochrane (Central), Centre for Research and Dissemination (CRD), Embase and OVID MEDLINE]. The risk of bias was assessed using the Cochrane Risk of Bias Tool (for randomized controlled trials) and the Institute of Health Economics (IHE) Checklist (for observational studies). The evidence synthesis was restricted to 12 tumor regions (and 54 indications) and studies with a low or moderate risk of bias, published between 2005 and 2017.
ResultsIn total 27 studies were eligible for the qualitative synthesis of the evidence regarding the effectiveness and safety of CIRT; one randomized controlled trial that primarily focused on the feasibility of CIRT, three case-control studies, three before-after studies focusing on quality of life, and 20 further case series studies. Overall, insufficient scientific evidence was found for 13 (out of 54) indications in seven tumor regions and no scientific evidence was found for 41 (out of 54) indications.
ConclusionsTheoretically, CIRT is undoubtedly a promising cancer treatment. To date, however, 54 oncologic indications in 12 tumor regions under investigation lack randomized controlled trials assessing the long-term effectiveness and harms associated with its use. CIRT must be considered as an experimental treatment due to the lack of high-quality clinical research.
OP162 Stakeholder Involvement In EUnetHTA Relative Effectiveness Assessments
- María Sánchez González, Iñaki Imaz-Iglesia, Juan Pablo Chalco-Orrego
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- Published online by Cambridge University Press:
- 31 December 2019, p. 35
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Introduction
Appropriate 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.
OP163 Health Technology Assessment Participation And Prioritization In Core Outcome Set Development
- Elizabeth Clearfield, Jennifer Al Naber, Sean Tunis, Donna Messner
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- Published online by Cambridge University Press:
- 31 December 2019, p. 35
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Introduction
A core outcome set (COS) is a minimum standardized set of agreed-upon outcomes for clinical trials of a specific condition. COS development can improve research by aligning stakeholder priorities for the outcomes most important in decision-making across the life-cycle of a product. It is important to include health technology assessment (HTA) representatives in COS development to ensure that outcomes useful to HTA are consistently included in clinical trials. Here we describe the role of HTA representatives in two COS projects: coreHEM, for gene therapy for hemophilia, a genetic blood clotting disease; and coreNASH, for nonalcoholic steatohepatitis (NASH), a progressive form of fatty liver disease that can lead to cirrhosis. We will describe the voting patterns of HTA representatives and consider aspects of their role in shaping the final COS.
MethodsFor each multi-stakeholder COS, a modified Delphi process was utilized (three online surveys plus an in-person consensus meeting). Candidate outcome lists were compiled via a literature review complemented by participant interviews. Voters condensed and prioritized the lists by rating each outcome on a scale of 1-9 (not important-essential). Votes on each outcome were stratified by stakeholder group; HTA votes were compared with those of other stakeholders.
ResultsHTA representatives made up 12.2 percent and 13.5 percent of the voters in coreHEM and coreNASH, respectively. They tended to give the highest votes to mortality outcomes, outcomes measuring the severity of disease, and outcomes related to a patient's quality of life, general well-being and general health perspective. HTA votes helped certain outcomes meet the inclusion criteria in the final voting rounds; without HTA voters, the “mental health status” outcome in coreHEM and the “hepatic-related mortality” and “liver transplantation” outcomes in coreNASH would have been eliminated.
ConclusionsHTA participation in COS projects provides HTA representatives an opportunity to help shape COS in clinical research for better decision-making.
OP165 Health Technology Assessment And Public Health Priority Setting In China
- Yue Xiao, Yingpeng Qiu, Liwei Shi, Kun Zhao
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- Published online by Cambridge University Press:
- 31 December 2019, p. 36
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Introduction
Since 2009, China has initiated a national program on free provision of essential public health services. The national program has expanded both in terms of service categories and funding, showing China's great commitment to universal health coverage. However, with slowdown of public input in the health sector, the government decided to prioritize interventions and optimize reimbursement packages. Researchers in the China National Health Development Research Center (CNHDRC)—the Chinese national health technology assessment (HTA) agency were asked to design the tools to facilitate the decision process.
MethodsWith multi-criteria decision analysis (MCDA) method, the researchers analyzed value dimensions in public health issues, and built an evidence matrix for the priority-setting decisions. Supported by HTA tools, they appraised interventions and services through literature review and field studies, and projected budget impact of potential adjustment decisions based on cost analysis results. A deliberative process of key stakeholder groups was taken, and their views were counted in making the final recommendations.
ResultsBased on evidence review and scores of stakeholders’ judgment, two public health service interventions were recommended for removal, and another two for adjustment (one for merger, one for optimizing care pathway). Cost estimation and potential budgetary impact were also analyzed to support financial decisions.
ConclusionsHTA and MCDA are key tools for defining the value criteria, evidence framework, and deliberative process for the essential public health program. However, lack of cost-effectiveness evidence hinders fine-tuned decisions on resource allocation. Continual health economic evaluation needs to be conducted in the near future.
OP168 The EUnetHTA Quality Management System: Development And Evaluation
- Reza Fathollah-Nejad, Miriam Luhnen, Maike Rehrmann, Maya Nocon, Heike Hutner
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- 31 December 2019, p. 36
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Introduction
One objective of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3 (JA3) is to set up a quality management system (QMS) for joint work that serves as a standalone infrastructure for a sustainable European HTA-collaboration. Structures of the QMS (quality policy, processes and procedures, and organizational structures) combined with the measures of QM (quality planning, assurance, control and improvement) both ensure achieving the objective of producing high-quality HTAs.
MethodsBased on a thorough concept with involvement of a spectrum of EUnetHTA partners, re-evaluation, internal workshops and national expertise, the existing inventory consisting of procedures, templates, methodological guidelines and tools is being refined, complemented and revised. Procedures are gradually being transferred into Standard Operating Procedures (SOPs), seamlessly and chronologically covering all assessment phases. Supplemented by quality-control-checklists and templates these SOPs are linked to relevant guidelines and tools. The so-established QMS is subject to continuous improvement by recurrently applying the Plan-Do-Check-Act (PDCA)-cycle. Members of the assessment teams are surveyed after the publication of each EUnetHTA-report (check-phase). Processed results lead to modification, maintenance and improvement of the inventory (act-phase).
ResultsThe majority of content has already been developed or revised and was already made available to the assessment teams to put to practical test. The survey results are systematically collected, processed and compiled. Derived from these results, a comprehensive report and a thorough list of improvement measures have been developed and will serve as a basis for further adaptions.
ConclusionsThe establishment of structures of QMS and measures of QM both are supposed to assure high-quality HTA-reports for EUnetHTA and a possible permanent European collaboration on HTA after JA3 as proposed by the EU-commission's regulation proposal 2018/0018 (COD). The installed systematic data collection, processing and compilation mechanisms are a solid basis for the identification of future needs for developments.
OP169 Implementation Of A Quality Management System In The Spanish Network Of Health Technology Assessment
- Sergio Márquez-Peláez, Isabel Viguera-Guerra, Teresa Molina-Lopez, Juan-Antonio Blasco Amaro, Workgroup REDETS
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 36-37
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Introduction
The Spanish network of health technology assessment (HTA) agencies (REDETS) is a collaboration of eight agencies, units and services, commissioned by the national and regional governments. The network coordinates work within a common methodological and work framework, guided by the principles of mutual recognition and cooperation. In 2016, a common self-assessment quality tool was developed for the implementation of an overall Quality Management System. Currently we are working on the second step that deals with actions about management, joint activities as a network, and organizational aspects of the network.
MethodsA structured search strategy in the main electronic databases and a manual search in websites of networks national and international agencies were carried out in June 2017, in order to gather previous knowledge and developed standards. Through the information included in this review, and with the collaboration of all members, a group of standards for REDETS was developed. Finally, standards proposed were discussed in a face-to face meeting until an agreement was reached.
ResultsA proposal of 31 standards was put forward taking all the collected information. The aim of each standard was defined, and its level of compliance was specified. Those standards were grouped under nine quality criteria structured in four dimensions: (i) Responsibility and Resources, (ii) Performance and Membership, (iii) Procedures, and (iv) Relations.
ConclusionsBased on the gathered information and the agreement of the all members, we developed a toolkit embracing a group of standards for the joint activities within the Spanish Network, network administration and management. It is a complementary instrument of the previous self-evaluating tool, following the establishment of an overall quality management system and under the philosophy of continuous improvement processes.
OP170 How Can Health Technology Assessment Participate In The Healthcare Quality Improvement?
- Wafa Allouche, Sami El Gouddi, Emna Allouche, Ali Mrabet
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- Published online by Cambridge University Press:
- 31 December 2019, p. 37
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Introduction
Providing high-quality and affordable care is a big challenge facing policy makers, especially in low and middle income countries (LMIC). The purpose of this presentation is to illustrate how health technology assessment (HTA) benefits the improvement of the healthcare quality, and to highlight the fact that HTA domains match to the dimensions of health quality: safety, effectiveness, efficiency and patient-centeredness.
MethodsThis presentation will be based on explaining the ability of HTA to improve the quality of healthcare. Some countries, mainly LMIC where resources are limited, do not have formal HTA whose goal is to inform the development of safe, effective and patient centered health policies. The theoretical concepts of HTA demonstrate a strong connection between HTA and healthcare quality improvement. By way of illustration an example of successful experiences will be given.
ResultsThe presentation items are: - The definition of health technology - Introduction to health technology assessment as a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology. - Why is health technology assessment used, the identification of the HTA report domains including Safety, Clinical Effectiveness, Ethical analysis, Social aspects, Legal aspects and the importance of patient experience in HTA. - The identification of the six dimensions of healthcare quality and the determination of the connection between HTA and healthcare quality improvement. - A presentation of the international Decision Support Initiative (iDSI) experience in some LMIC.
ConclusionsHTA has many meeting points with healthcare quality dimensions. HTA is likely to become an increasingly important influence in health decisions.
Poster Presentations
PP02 Using Real World Data To Identify The Market For A New Technology
- Thomas Macmillan, Anastasia Chalkidou
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- Published online by Cambridge University Press:
- 31 December 2019, p. 37
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Introduction
King's Technology Evaluation Centre (KiTEC), a United Kingdom- based health technology assessment consultancy, was tasked with identifying a specific group of heart failure patients who had repeat readmissions in order to accurately identify the potential market for an innovative device designed to diagnose heart failure as a way to avoid costly and avoidable hospital readmissions. The device enables clinicians to remotely diagnose heart failure and appropriate medication can be administered instead of a hospital visit. Our methodology describes an accurate way to quantify the at risk population without the need for a costly trial.
MethodsUsing big data from national registries – the heart failure specific National Institute for Cardiovascular Outcomes Research (NICOR) database and the national Hospital Episodes Statistics for the National Health Service (HES) – KiTEC has devised a methodology of linking the two datasets in order to (i) accurately identify patients with repeat readmissions over a 5-year period and (ii) calculate the risk factors for readmissions. Data is linked using a common field, meaning information from both databases can be analyzed at patient level (it is pseudo-anonymized before KiTEC receives it). This allows for unprecedented granularity, as we are able to exploit the heart failure specific detail of NICOR alongside the wealth of admissions data available in HES.
ResultsThere are significant challenges surrounding the use of registry data, especially in the enormous size of the datasets and in privacy legislation aimed at protecting personally identifying data. The usual regulatory approvals for health research are also more complex when linked datasets are proposed. These are important considerations, especially when linking two complementary databases.
ConclusionsThe use of real world data has the potential to paint a true and accurate picture of a patient population, while avoiding many of the biases inherent in typically research studies. However, there are other important challenges to overcome, namely difficulties analyzing huge datasets and navigating complex legislation to access patient data.
PP03 Development Of A Medical Device Maintenance Management System
- Ronald Alexis Rivas, Benicio Grossling, Pedro Galvan
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- Published online by Cambridge University Press:
- 31 December 2019, pp. 37-38
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Introduction
Health technologies are fundamental in an operational health system. Medical devices, in particular, are crucial for disease prevention, diagnosis, treatment and rehabilitation. Recognizing this important role of health technologies, the World Health Assembly adopted, in May 2007, resolution WHA60.29, which addresses issues arising from inadequate installation and use of health technologies, as well as the need to formulate national strategies for the implementation of evaluation, planning, procurement and management systems for health technologies, in collaboration with personnel dedicated to the evaluation of health technologies and biomedical engineering. Maintenance management computer systems and software have evolved to help maintain medical equipment and control associated costs. A Computerized Maintenance Management System contains a database about an organization's maintenance operations.
MethodsThe pilot study of observational and descriptive design will include all the medical/laboratory equipment that the Research Institute of Health Sciences (IICS) has that meets the inclusion criteria. The work will be carried out at the IICS, which aims to develop a computerized system for the maintenance of equipment that allows the linking of Quick Response (QR) codes to an application (WebApp) by means of cameras in smartphones, able to relate each QR code (attached to a medical/laboratory equipment) to its corresponding URL, and thus able to access all the technical information of each IICS team and therefore monitor their maintenance (preventive, corrective, predictive), history, spare parts, budgets, and technical specifications.
ResultsWe have a database of all medical devices installed in the research center; we look forward to developing the program to include the data. The project focuses on the effective tool for decision making regarding the evaluation of the installed sanitary technology and those that will be installed.
ConclusionsThe study proposes an effective solution for maintenance management, using data that supports administrative decisions regarding the acquisition of equipment in the future; that is, the system can contribute when it comes to evaluating installed and acquired sanitary technology.
PP05 The First Choice Of Health Institutions Of Elderly In Zhejiang And Qinghai, China
- Hao Zhang, Jingming Wei, Qilong Gao, Can Zhao, Hengjin Dong, Xiaoqian Hu
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- Published online by Cambridge University Press:
- 31 December 2019, p. 38
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Introduction
The utilization of medical resources in China is unbalanced and insufficient. In order to find a way to maximize their utilization to face challenges in the upcoming decade, this study aims to investigate the elderly's first choice of health institutions when they were ill in the Zhejiang and Qinghai provinces, and to explore the potential pathways related to their choices, respectively.
MethodsThe data used in this study was from cross-sectional surveys in Zhejiang and Qinghai. According to the Anderson Health Service Utilization Model, we applied structural equation modeling to explore the complex pathways from socioeconomic status (SES), accessibility, and health status to the elderly's first choice of health institutions.
ResultsThe proportion of the elderly who selected community health institutions (CHI) as their first choice of medical institutions in Qinghai was higher than in Zhejiang. The Zhejiang model revealed a significantly negative direct effect of SES and significantly positive direct effects of accessibility to CHI and health status on the choice of institutions, and a significantly positive indirect effect of SES on choice of institutions, through the mediating factor of health status. SES played an important role in the Zhejiang model in direct and indirect ways. In the Qinghai model, only SES and accessibility to CHI had significantly direct effects on the choice of institutions, with accessibility to CHI having the biggest effects. SES had a significant and positive indirect impact on choice of institutions, through the factor of accessibility to CHI.
ConclusionsA better understanding of the complex pathways from factors to elderly's choices of health institutions was essential, which may inform priorities for maximizing the utilization of CHI further and prepare to face challenges in the new decade. Through this research method, policymakers could explore the specific pathways based on their own economic and societal status.