bluuebunny/crossref_metadata_2025 huggingface dataset:
OP115 Expanding Perspectives: The Role Of Environmental Scanning In Health Technology Assessment
Authors: Pollock Michelle , Guo Bing
Published: December 2019

Introduction

Environmental scan reports, usually consisting of literature reviews and/or key informant consultations (such as online surveys or personal interviews), broadly describe the current local, national, and international landscape surrounding health care practices, programs, or the use of technologies. Funding agencies and health organizations recognize environmental scans as a valuable way to inform decision-makers about the context, practice variations, and knowledge gaps surrounding a topic. Despite their increasing popularity in health technology assessment (HTA), there is limited guidance available for conducting environmental scans, variation in methods used across and within HTA agencies, and lack of consensus on an appropriate definition, purpose, and process.

Methods

We conducted an informal literature review and consulted experienced researchers from other HTA agencies to identify existing methods guidance for conducting environmental scans. We then adapted these methods to conduct an environmental scan of initiatives to accelerate cancer diagnosis.

Results

There was limited and vague guidance on the definition, purpose, and process of conducting environmental scans in the context of HTA. This introduced challenges but provided the flexibility to modify our approach to meet requestor needs. Our environmental scan included: (i) a literature review, to identify and describe relevant initiatives and to locate data on effectiveness (which is often out-of-scope for environmental scans but was of priority to the requestor); (ii) stakeholder surveys, which helped “fill in the gaps” of the literature review and helped locate additional initiatives; and (iii) targeted key informant interviews, which provided rich follow-up data on the initiatives most important to the requestor.

Conclusions

By describing our experiences adapting limited methods guidance to meet requestor needs, we hope to contribute to the evolving discussion about the definition, purpose, and process of environmental scans to inform health policy decision-making. We will reflect on challenges encountered, potential solutions, and lessons learned, and will discuss ongoing areas of methodological uncertainty.
PP02 Using Real World Data To Identify The Market For A New Technology
Authors: Macmillan Thomas , Chalkidou Anastasia
Published: December 2019

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.

Methods

Using 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.

Results

There 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.

Conclusions

The 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.
PP05 The First Choice Of Health Institutions Of Elderly In Zhejiang And Qinghai, China
Authors: Zhang Hao , Wei Jingming , Gao Qilong , Zhao Can , Dong Hengjin , Hu Xiaoqian
Published: December 2019

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.

Methods

The 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.

Results

The 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.

Conclusions

A 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.
PP10 Quality Of Reporting Economic Evaluations In Rehabilitation Research
Authors: Flemming Julie , Armijo-Olivo Susan , Chojecki Dagmara , Paulden Mike
Published: December 2019

Introduction

Economic evaluations are a growing field of interest in the rehabilitation area. Research has questioned the quality of reporting of health economic evaluations. Poor reporting hinders the ability to provide accurate information for health care decision making. Therefore, the objectives of this study are to document on overall reporting quality of the published literature for rehabilitation economic evaluations; to identify if reporting quality has improved in health economic evaluations within the field of rehabilitation therapy since the publication of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS); and to identify factors that could influence the reporting trends.

Methods

We searched databases for economical evaluations performed in the rehabilitation area published between 2013 and 2018. Study selection was performed by two independent reviewers using Covidence software. Data extraction was conducted by one reviewer using Microsoft Excel and independently verified by another reviewer. The quality of reporting was evaluated independently by two reviewers using the CHEERS checklist.

Results

The search of the literature resulted in a total of 2195 published articles. Of these, 117 were considered to be potentially relevant. Independent review of these 117 articles led to the inclusion of 88 articles. This study is ongoing and complete results will be presented at the conference. Fifty papers have been analyzed in full. In general, the quality of reporting of the economical evaluations in the rehabilitation field was poor. The total mean and median for the CHEERS checklist was 17 points (out of 25) (range 8-24). Most of the analyzed studies did not report important methodological features of the economical evaluation as evaluated by the CHEERS checklist.

Conclusions

The quality of reporting of economic evaluations in the rehabilitation field is poor and inconsistent. Commonly the methods of the analyzed studies are under reported, thereby creating challenges in determining whether the information presented is sound.
PP27 Additional Capabilities In Health Technology Assessment To Support Decision Making
Authors: Larocque Brigitte , Rhainds Marc , Coulombe Martin , Nourissat Alice
Published: December 2019

Introduction

Decision-making regarding an open or a closed fluid waste management system (FWMS) in the planning of thirty operating rooms (ORs) of a new hospital at the CHU de Québec-Université-Laval was an opportunity to explore additional capabilities in health technology assessment (HTA) to support evidence-based planning.

Methods

Issues related to FWMSs in ORs were assessed from multiple data sources including: (i) systematic review in indexed databased and grey literature, (ii) waste management laws and regulations, (iii) local registry of reported incidents/accidents, (iv) occupational health and safety database, (v) electronic patient records (EPRs), (vi) field evaluation of two closed FWMSs, (vii) costs, and (viii) survey on FWMSs in ORs of other Quebec hospitals.

Results

Closed FWMSs in ORs could reduce health care professional exposure to blood and body fluids (BBF) according to two low-quality studies. Cases of occupational and patient exposure to BBF with closed FWMSs, some of which had severe issues, were reported to the U.S. Food and Drug Administration. Depending on the volume, discharge of BBF to the sanitary sewer may be authorized upon the approval of the competent municipal authorities. Compared to an open system, a closed FWMS has the potential to reduce manipulation of canisters during the cases because of large canister capacity (24 L). However, local data showed that BBF and irrigation fluid amounts in ORs are <2 L in 84 percent of cases and >2 L in a minority of surgeries, whereas a closed FWMS is associated with higher costs for BBF volumes <12 L. Other issues were observed during field evaluation (e.g., occupational noise). Closed FWMS implementation in other hospitals was very limited in the survey.

Conclusions

Available evidence does not support the widespread use of a closed FWMS. Use of mixed-methods in this particular HTA allowed to assist decision makers on the choice of an FWMS in the OR planning.
PP38 Productivity Loss In Patients With Chronic Diseases: A Pooled Analysis
Authors: Rashdan Omar , Brodszky Valentin
Published: December 2019

Introduction

Due to the unprecedented increase in medicine prices in recent years, the socio-economic perspective started gaining importance in health economic evaluations. Productivity loss evaluations provide a long-term economic impact visualization for a more informed reimbursed medicine decisions.

Methods

A pooled analysis of patient-level data from 11 cross-sectional, retrospective, cost-of-illness studies was performed. SPSS software was used for our statistical analysis. Analysis of variance (ANOVA) and correlation analysis were utilized to measure the effect of different variables on lost productivity hours. All costs were recalculated to account for the cumulative inflation till 2018.

Results

The sample size of included studies ranged between 68 (Multiple Sclerosis) and 480 (Diabetes), and the total number of patients enrolled in the analysis was 1,881 of which 956 were female. A total of 6,795 hours were reported as missed working hours per year. Overall, the female population reported a mean of 689.5 lost productive hours compared to 324.7 in males (p < 0.001). This translated into higher indirect costs at EUR 2,748 and EUR 1,530 for females and males, respectively. Patients with a college degree or higher reported lower yearly lost productive hours and indirect costs (358.4 hours and EUR 1,749) (p < 0.001) compared to patients with lower education level (845.6 hours and EUR 3,534) (p < 0.001). The average indirect cost as a percentage of gross domestic product per capita was highest in Schizophrenia patients at 97.5 percent and lowest in Benign Prostatic Hyperplasia at 1.9 percent. In patients below 65 years of age, a weak positive correlation was observed between age and lost productive hours with a Pearson value of 0.1 (p < 0.001).

Conclusions

Female gender and older age resulted in higher productivity loss, and Schizophrenia was the disease with the highest indirect costs per patient per year.
PP55 The Effectiveness Of Viabahn In Peripheral Artery Aneurysms
Authors: Soares dos Santos Augusto Cesar , Horta Maria da Glória Cruvinel , Carvalho Lélia Maria de Almeida , Fernandes Mariana , Rodrigues Luíza , Avelar Sandra de Oliveira Sapori , Scherrer Luciano Rios , Biscione Fernando Martin , Kelles Silvana Marcia
Published: December 2019

Introduction

Open repair was considered for several years the gold standard therapy for the treatment of peripheral artery aneurysms (PAAs). However, with advancements in endovascular technology increasing attention has been directed toward repairing PAAs using an endovascular stent graft.

Methods

This retrospective study evaluated a cohort of patients after the correction of PAAs with Viabahn. Patients treated from January 2011 to January 2018 were assessed for all-cause mortality, amputation and the need for re-intervention. Data were extracted from an administrative database from a healthcare organization in Belo Horizonte, Brazil.

Results

Fifty-two patients were included in the study (median age 69.1 years, range 15 to 90 years; male 63.5 percent), three of whom also received Viabahn for contralateral PAAs. In total, 84 devices were used (average 1.5 per PAA); distribution: popliteal and tibial arteries (n = 30; 57 percent), femoral and iliac arteries (n = 19; 37 percent), axillary artery (n = 1; 2 percent), splenic artery (n = 1; 2 percent), abdominal aorta (n = 1; 2 percent). After a mean follow up time of 1.98 ± 1.68 years, we observed death (n = 3; 5.8 percent), amputation (n = 3; 5.8 percent) and the need for re-intervention (n = 17; 32.6 percent) in 23 patients (44.2 percent). The combined overall survival for the first, second and third year of follow up was 70.2 percent (Confidence Interval [95% CI]: 58.9 - 83.6); 63 percent (95% CI: 51.0 - 78.0) and 57.3 percent (95% CI 44.6 - 73.6).

Conclusions

There are still several unanswered questions regarding the best approach for patients with PAAs. In the absence of well-designed clinical studies, the assessment of databanks on real-world patients may contribute to improve our understanding of treatment alternatives and provide guidance to improve current clinical results.
PP61 Advanced Therapy Medicinal Products Germany: Drugs Or Methods Review?
Authors: Müller Elvira , Neeser Kurt , Oelze Ilse-Barbara
Published: December 2019

Introduction

Advanced Therapy Medicinal Products (ATMPs) comprise medicines for human use based on gene therapy, somatic cell therapy or bioprocessed tissue products. ATMPs are pharmaceutically manufactured drugs and mostly subject to central authorization requirements. In terms of social law, it is an ambiguous situation and more heterogeneously dealt with. ATMPs are assigned to method evaluation as well as to the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) procedure designated for drugs.

Methods

Guidelines from Gemeinsame Bundesausschuss (G-BA), Institute for Quality and Efficiency in Health Care (IQWiG) and respective legislation, consultation results and methods/medical devices (MDs) evaluations according to §137h and for drugs according to AMNOG were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.

Results

ATMPs are subject to benefit assessment, with a decision at first on whether to be evaluated as a drug (e.g., Alofisel) or a method/device (e.g., Holoclar). By definition, an ATMP is classified as a treatment method, if the correct administration has at least the same significance for a successful therapy outcome as its mode of action. Depending on the respective decision, an evaluation as method follows or it must undergo the AMNOG process. According to G-BA's and IQWiG's point of view, randomized controlled trials (RCTs) are the “gold standard” for a benefit assessment of new therapies, including ATMPs. However, conduction of RCTs is not always possible for ATMPs which creates a disadvantage in the assessment right from the beginning. Otherwise no distinction is made between drugs and ATMPs in terms of reimbursement modalities. Outcomes based agreements could help overcoming inequalities and lead to quality-oriented reimbursement.

Conclusions

ATMPs represent a grey zone causing difficulties in classifying them either as method or drug. For individualized therapies evidence beyond RCTs and new reimbursement possibilities should be considered. Until new regulations are in place it is advisable to enter early into respective discussions with authorities.
PP107 Harpoon™: A Novel Device For Transapical Mitral Valve Repair
Authors: Hijas-Gómez Ana Isabel , Polo-DeSantos Mar , Luengo-Matos Setefilla , Sánchez-Gómez Luis María
Published: December 2019

Introduction

Mitral regurgitation (MR) is the most prevalent heart valve condition in Western countries. Open-heart mitral valve reconstruction is the conventional surgical treatment for MR, whereby the valve's cords are replaced with expanded polytetrafluoroethylene cords. Novel devices have introduced minimally invasive alternatives, such as transapical beating-heart valve repair. Among these alternatives, the Harpoon™ Mitral Valve Repair System (Edwards Lifesciences LLC) may have potential advantages (a smaller diameter valve introducer to minimize bleeding and a different anchoring mechanism). This study aimed to assess the efficacy and safety of Harpoon in minimally invasive mitral valve surgery.

Methods

An early assessment of the technology was conducted by reviewing relevant literature from the following databases: PubMed, EMBASE, Web of Science, the Trip Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, the Cochrane Library, and the Centre for Reviews and Dissemination. Relevant clinical studies published up to 30 January 2018 were included.

Results

Only two publications, by the same research group, were included: an observational study of 11 patients and the prospective, nonrandomized TRACER trial (n = 30). During the procedure, MR was reduced from severe to none in 73 to 86 percent of patients and severe to mild in 14 to 27 percent. At one month, MR was rated as mild or lower in 82 to 89 percent of patients. At six months, MR had worsened to moderate or severe in 16 percent of patients from the TRACER trial. Safety issues within 30 days (18% to 27% of patients) included intraoperative conversion to open surgery, reoperation, pleural effusion, hemopericardium, and atrial fibrillation. There were no intra- or postoperative deaths.

Conclusions

Current evidence on the Harpoon device is scarce. Although published studies showed improvement in MR in most patients, there are still issues regarding safety, lack of long-term results, comparability with other procedures, and costs. While promising, further research is required before recommending routine use of this technology.
PP113 A Framework To Enhance Eurasian Economic Union Cooperation On Health Technology Assessment: Lessons From The European Network for Health Technology Assessment
Authors: Sultanov Marat , Kostyuk Alexandr , Almadiyeva Alima , Absattarova Karlygash
Published: December 2019

Introduction

The Eurasian Economic Union (EAEU), which currently includes Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia, was established in 2015. Pursuing economic integration, and modeled in part after the structure of European Union, the EAEU launched a common medicines market in 2017. There have been various developments regarding cooperation in health technology assessment (HTA) across the EAEU countries, exemplified by a conference held in Kazakhstan in 2017. Here we discuss some considerations for developing cooperation in HTA throughout EAEU based on the experiences of implementing the European Network for Health Technology Assessment (EUnetHTA).

Methods

Legal and review documents regarding the implementation of EUnetHTA were obtained from the European Commission website and research databases to inform this narrative review.

Results

Achieving recognition of the role of HTA at an inter-governmental level, akin to the actions of the European Commission prior to establishing EUnetHTA, appears pivotal at the current stage of HTA development among EAEU members. Similar to the EUnetHTA project stage of 2006-2008, the existing HTA structures and national standards will need to be accurately and systematically assessed by a working-group appointed specifically for that purpose. Besides the importance of accepting a unifying framework similar to the EUnetHTA core model, implementation features that are specific to the context of EAEU countries could include the development of common adaptation toolkits and glossaries. Capacity building efforts may also prove crucial to ensure the sustainability of HTA-related cooperation.

Conclusions

Optimization of resources by streamlining HTA processes, whether in research, policy, or results dissemination, and avoiding duplication of effort by HTA agencies, is relevant in the context of limited healthcare resources in developing countries. This overview is an attempt at facilitating discussion to inform policy and research efforts to streamline HTA processes.
PP130 Oral Supplements For Protein-Energy Wasting In Chronic Kidney Disease
Authors: Brito-Garcia Noe , Toledo-Chávarri Ana , Trujillo-Martin Maria , Leon-Salas Beatriz , Serrano Pedro , González-Hernández Nerea
Published: December 2019

Introduction

Malnutrition, specifically protein-energy wasting (PEW), is common in patients with chronic kidney disease (CKD), and its prevalence increases as CKD progresses. Oral nutritional supplementation (ONS) with complete formulas specific to this pathology, is a strategy aimed at meeting energy and protein requirements that are not possible with dietary recommendations and advice alone. This study systematically reviewed the available scientific literature on the safety and effectiveness of nutritional therapy with complete formulas specially designed for adults with CKD who have PEW that is not reversible through ordinary food consumption.

Methods

We systematically searched for articles published up to May 2018 in several electronic databases. We included comparative studies that evaluated the safety and effectiveness of complete nutritional formulas for malnourished adults with CKD. Relevant outcomes included rates of death, hospitalization, and adverse effects, and changes in nutritional status, anthropometrics, and health-related quality of life (HRQoL).

Results

Three systematic reviews and 22 primary studies were identified. The primary studies comprised nine randomized controlled trials, nine non-randomized comparative studies, and four before-after studies (the latter were only included in the safety review). The majority of studies were conducted in patients on hemodialysis. The studies exhibited methodological heterogeneity in terms of the methods used to measure nutritional status and the interventions and comparators evaluated. There was also inconsistency among the results. Adherence to ONS, especially in the long term, can be affected by taste fatigue produced by repeatedly taking the same formula. Some studies recommend supplementation during hemodialysis sessions.

Conclusions

The studies with less risk of bias indicated a trend toward improvements in rates of death and hospitalization, HRQoL and, to a lesser extent, some anthropometric variables and serum markers, such as albumin, when ONS was given to patients with CKD. High quality comparative studies are needed to make conclusive statements about the effectiveness of this intervention.
PP137 Toric Intraocular Lenses and Spectacle Independence: A Systematic Review
Authors: O'Boyle Derek , Vives Caridad Perez , de Haan Jan , Ender Frank , Busutil Rafael
Published: December 2019

Introduction

Astigmatism is a common ocular condition that causes reduced visual acuity. The condition is highly prevalent in cataract patients, with preoperative astigmatism of at least 0.5 diopters being present in 78 percent of cataractous eyes. Residual uncorrected astigmatism after cataract surgery is associated with significant costs, primarily driven by the lifetime cost of spectacles (estimated at EUR 1,608 to EUR 3,608 in Europe). Toric intraocular lenses (IOLs) are a safe and effective way of correcting astigmatism, while also reducing the need for spectacles after cataract surgery. The objective of this review was to assess the published evidence relating to spectacle independence in patients implanted with toric IOLs, compared with those receiving non-toric IOLs with or without astigmatism reducing surgical interventions (SI).

Methods

A systematic literature search was conducted of the EMBASE, MEDLINE, and Cochrane Library databases. Articles were selected if they included adult patients undergoing phacoemulsification who had age-related cataracts and preoperative regular corneal astigmatism of at least 0.5 diopters, and assessed spectacle independence as an outcome.

Results

Seven studies met the inclusion criteria: four randomized controlled trials and one non-randomized comparative study comparing toric IOLs with non-toric IOLs, and two randomized controlled trials comparing toric IOLs with non-toric IOLs plus SI. Spectacle independence was evaluated as the number of patients who reported not requiring spectacles for distance viewing at 3 or 6 months. Figures for spectacle independence ranged from 60 to 100 percent for toric IOLs, 31 to 50 percent for non-toric IOLs, and 36 to 65 percent for non-toric IOLs plus SI. In each study, toric IOLs demonstrated superior spectacle independence compared with the control group.

Conclusions

The benefits of toric IOL implantation for astigmatic cataract patients included a higher rate of spectacle independence, compared with non-toric IOLs with or without SI. For this group of patients, the lifetime economic burden of spectacle acquisition costs can be reduced with the implantation of toric IOLs during cataract surgery.
PP150 Bevan Health Technology Exemplars: Early Dialogue To Systematize HTA
Authors: Myles Susan , Charles Sion , Davies Claire , Elston Lauren , Howson Helen , Poole Ruth Louise
Published: December 2019

Introduction

Wales has ambitious health, wealth, and innovation policies and a clear goal to use the economic muscle of the Welsh National Health Service (NHS) to support its strong life sciences sector. Health Technology Wales (HTW) has a clear remit to appraise technologies over the span of their lifecycle from innovation to obsolescence. HTW is collaborating with the Bevan Commission through their national Health Technology Exemplars (HTEs), which partners NHS and industry stakeholders to strengthen innovation within the Welsh health system.

Methods

Health technology assessment (HTA) methods were used to produce topic exploration reports for assessing the evidence underpinning applicant innovations. A “Dragons’ Den” expert panel was convened to select the successful HTEs.

Results

Fourteen Bevan HTEs were awarded funds, which were matched by industry partners. Application of HTA methods resulted in more critical consideration of technology value propositions, including: developing pull models of innovation focused on delivering health technology solutions for current problems facing NHS Wales; supporting early dialogue between the NHS and industry partners around demonstrating evidence of improved patient outcomes; and focusing on transformative rather than incremental innovation. The most promising innovations will progress to rapid HTA, where the evidence generated will be used to develop guidance for NHS Wales.

Conclusions

HTA methods were productively deployed at the innovation phase of the technology lifecycle to support evidence-informed allocation of scarce innovation resources. In this way, HTW is working with key stakeholders to identify and offer early support to the most promising innovations, with the aim of expediting their adoption and realizing health benefits for patients as quickly as possible. The Bevan Commission has partnered with HTW to routinely build in HTA and evidence considerations in its future innovation calls and competitions. Thus, HTW has established a “feeder” pipeline for assessing bottom-up service-led innovations and encouraging evidence consideration throughout the lifecycle of innovative technologies.
PP156 Reimbursement Of New Treatment Methods In Hospitals: Status In Germany
Authors: Oelze Ilse-Barbara , Müller Elvira , Neeser Kurt
Published: December 2019

Introduction

Since 2005, new treatment and diagnostic methods (NUBs) were reimbursed by individual supplementary fees. The assessment procedure for NUBs is induced by hospitals submitting a request for additional compensation of healthcare treatment to the Institute for the Fee System in the Hospital (InEK). In 2016, the legal norm §137h SGB V was introduced to evaluate medical devices (MD) of high risk classes by the Federal Joint Committee (G-BA). InEK grants a status that is valid for twelve months and impacts additional compensation as well as assessment required by G-BA. The effects of this rating seem to differ between hospitals and Statutory Health Insurance (SHI).

Methods

The published InEK decisions on NUBs were analyzed according the decision criteria and possible impact on price negotiations with SHI.

Results

In 2018, 705 NUB requests were assessed by InEK. NUB Status 1, granting negotiation of additional coverage, was assigned to 171 procedures. Status 2 – no additional reimbursement possible - was given in 472 cases, the remaining had not sufficient information. Most NUBs (n = 368) requests did not fall under §137h; however, those with sub-Status “B” (allocated to 12) led to controversies; no participant had requested an evaluation according to §137h for the NUB. Two consultation requests receiving Status 1 B were regarded as not eligible according to § 137h by the G-BA. To avoid price negotiation delays, early consultations according to § 137h are recommended by G-BA during the NUB application.

Conclusions

The NUB process enables hospitals to receive a supplemental payment when using innovative technologies not listed in the existing German healthcare system. The question of which requirements must be fulfilled to guarantee the reimbursement should be asked at an early stage. Consultation requests to the G-BA in due time are strongly recommended. Contact between manufacturers and hospitals are advisable to support the NUB application.
PP192 An Institutional Ethical Framework For HTA: Stakeholder Participation
Authors: Goetghebeur Mireille , Demers-Payette Olivier , Pomey Marie-Pascale , Ganache Isabelle , Roy Denis
Published: December 2019

Introduction

In a context of rapidly evolving technologies and growing evaluative challenges, the National Institute of Excellence in Health and Social Services (INESSS) is developing an institutional ethical framework making explicit and transparent the guiding principles and new modalities of process for health technology assessment for public coverage.

Methods

This framework is co-built by the INESSS experts - drugs, social services, technology and health services and cross-cutting methodologies - through literature and practice reviews as well as a consultative process on key topics with external collaborators.

Results

The development process aims to: (i) identify the principles applicable to all the objects evaluated, (ii) define the evaluation strategies used to appropriately address evaluation challenges in the clinical, organizational, economic and societal dimensions, (iii) equip the scientific teams to successfully integrate diversified knowledge from the literature, stakeholders participation and medico-administrative data banks, and (iv) facilitate deliberation leading to evidence-informed recommendations. It is envisioned as a fully integrated process rooted in a reflexive multi-criteria approach supporting fair and reasonable decision. The presentation will focus on one of the key aspects of this framework, i.e., the development of principles for stakeholder participation based on a recent INESSS methodological forum on the topic, and the agile deployment of innovative processes and tools in various projects, including the patient partnership developed with a pioneering academic centre.

Conclusions

This framework provides explicit, transparent and cross-cutting processes and a framework for continuous improvement. The goal is to promote stakeholder engagement and enable increasingly complex arbitration aimed at equity and social justice, in a context of rising costs and uncertainty, and focused on the creation of value for our fellow citizens.
VP01 Methods Of Patient Involvement Now And Beyond 2020: A Case Study
Authors: Livingstone Heidi , Leng Gillian , Thomas Victoria
Published: December 2019

Introduction

Involving patients and the public in the health technology assessment (HTA) has always been fundamental to NICE. To ensure the appropriate method of patient involvement remains relevant to the evolving types of HTA, NICE uses varying methods of involvement. These methods have been reviewed to ensure they remain current and relevant for HTA now and beyond 2020, and also to give guidance on the approaches that should form a standard baseline and those that could be optional.

Methods

We identified and mapped the different methods of patient involvement used at NICE across five types of HTAs: diagnostics; medical technologies; medicines; ultra-orphan conditions; and surgical procedures. We looked at the varying methods of early engagement identifying similarities and differences, and considered the benefits and challenges of each.

Results

The different methods of patient and public involvement include: lay members (generalist and topic expert) involved in decision making, individual patient input (written and oral), and patient group (organisation) input (written). The types of involvement fell into the following categories: written group submissions, written individual statements, surveys of individuals, pre-meeting events/workshops, oral testimonies at committees, and written consultation responses. The common methods across all HTA types were generalist lay members and consultations.

Conclusions

This review highlighted the varying methods of involvement at NICE and highlighted additional methods that could be standardised across the different types of HTAs as a baseline. These included patient organisation submissions and a method for additionally including individual patients in each type of HTA. We identified that where patient involvement started early and continued at each stage of the process including a pre-meeting event, it was particularly helpful to the stakeholders’ ability to contribute.
VP02 Involving Patients In HTA Beyond 2020: A Thematic Review
Authors: Livingstone Heidi , Li Xia , Leng Gillian , Thomas Victoria
Published: December 2019

Introduction

Involving patients and the public in the health technology assessment (HTA) is crucial and a key part of the NICE patient and public involvement (PPI) policy. To advance the development of our PPI policy in HTA and build capacity for 2020 and beyond, we took stock of knowledge on stakeholders’ views of involving this cohort in HTA.

Methods

We carried out a thematic review of the existing evidence on the involvement of patients and the public in HTA, including: technology appraisals consultation 2017 (110 comments): technology appraisals consultation 2018 (205 comments); and PIP review consultation 2017 with a CHTE focus (162 comments). We used Thomas and Harden's (2008) thematic synthesis to code the data ‘line-by-line’, to develop ‘descriptive themes’, and then to generate ‘analytical themes’. This was followed by using Patton's (1999) triangulation of qualitative data sources to further challenge and refine the emergent themes.

Results

We identified three themes, namely (i) earlier and full engagement, (ii) simpler and easier engagement, and (iii) patient evidence. Respondents emphasised the significance of involving patients earlier and throughout the process of developing every appraisal to enable them to gain a greater sense of participation and ownership. Respondents also expressed a strong view of making it simpler and easier for patients to engage in the process through various methods, e.g., standardising the approaches, and support and training. Finally, respondents expressed their positive attitudes toward using patient evidence in HTA, clarifying how patient evidence is captured and used, and offering a clear feedback mechanism to the impact of patient evidence on decision-making.

Conclusions

This review highlighted the significance of earlier and full engagement with people, making it simpler and easier for people to work with us, and being clearer about how we use patient evidence with a clearer feedback mechanism as to the impact of their input on the final decisions.
VP18 Potential Of Real World Evidence For ‘IDEAL’ Procedures Research
Authors: Poole Ruth Louise , Myles Susan , Carolan-Rees Grace
Published: December 2019

Introduction

Randomized trials and similarly robust research methods generate evidence in carefully controlled settings, often with strict inclusion criteria. But patients in the ‘real world’ often have multiple comorbidities, and treatments are delivered within diverse environments. Trials are also difficult to fund, and rarely collect longitudinal data. Because of these, and other limitations, researchers are increasingly recognizing the inherent value of real world evidence (RWE). This is not only true for pharmaceutical products, and may have even more relevance in the evaluation of complex interventional procedures and non-medicines healthcare technologies. The Idea, Development, Exploration, Assessment, Learning (IDEAL) Framework guides the developmental ‘pipeline’ of surgical (and other) procedures, as well as medical device research (IDEAL-D). IDEAL informs the production of high-quality evidence of safety and effectiveness, but there is potential to further expand its applications.

Methods

Our aim is to investigate the feasibility of using of RWE alongside the IDEAL Framework in the assessment of procedures and devices. Methodological experts from the IDEAL Collaboration, HTA agencies and other healthcare research organisations are contributing their unique perspectives and experiences to explore these methods. As part of this work, Cedar Healthcare Technology Research Centre (Cedar) has attempted to retrospectively apply the IDEAL criteria to a series of RWE projects conducted on behalf of the National Institute for Health and Care Excellence (NICE) Interventional Procedures and Medical Technologies Evaluation Programmes.

Results

Cedar's experience indicates that there may be options for using retrospective routinely-collected linked data and other existing sources to address some of the requirements of IDEAL. Likewise, the IDEAL Framework is expected to be a helpful reference when designing new databases and clinical registries for prospective collection of relevant and informative evidence. Examples from several projects will be shared at the Health Technology Assessment International (HTAi) conference.

Conclusions

Initial signs are that there are likely to be a number of ways in which IDEAL and RWE could complement one another.
VP25 HTA Enables Nurses To Discontinue Continuous ECG Monitoring
Authors: Mitchell Matthew , Lavenberg Julia , Holland Sara , Mull Nikhil , Williams Kendal
Published: December 2019

Introduction

Providers frequently issue orders for telemetry (continuous ECG monitoring) of hospital inpatients, but they rarely issue orders to discontinue telemetry. This can cause telemetry beds to be unavailable for patients who need them.

Methods

Our hospital health technology assessment (HTA) center conducted a rapid systematic review of evidence on algorithms, guidelines, and other tools for nurses to identify patients who no longer need telemetry. Databases searched included Medline, CINAHL, the Cochrane Library, National Guideline Clearinghouse, and Joanna Briggs Institute.

Results

We found no guidelines or existing systematic reviews of nurse-driven protocols for discontinuing telemetry. There were three published articles describing projects where protocols for discontinuing telemetry were tested. All three of these studies were of low methodologic quality. They all found that use of the protocol reduced the number of hours of telemetry monitoring that were used in the hospital. Two studies published in letter form reported adaptations of computerized order entry systems where nurses assess the patient's readiness for discontinuing telemetry and either discontinue telemetry or report to the ordering physician when the stated discontinuation criteria are met.

Conclusions

Our hospitals are now implementing the HTA findings in our electronic ordering system.
VP26 HTA In Nursing: Scoping Trends With An ICF Component Analysis
Authors: Wübbeler Markus , Geis Sebastian
Published: December 2019

Introduction

Nursing is a worldwide growing but still underdeveloped health technology assessment (HTA) field. A systematic overview about the current trends in HTA and nursing would shed some light on the issues of (i) the HTA base in this sector, and (ii) outcomes addressed with the interventions and technologies.

Methods

We conducted a scoping review using the National Health Service (NHS) Centre for Reviews and Dissemination HTA database, including all abstracts of HTA reports related to nursing. To systemize the interventions and technologies assessed in the HTA reports, we designed an International Classification of Functioning, Disability and Health (ICF) Map connecting the targeted healthcare outcomes with the components of the ICF Classification.

Results

We identified seventy-eight HTA reports related to nursing care, published between the years 1992 and 2018. Overall, forty-four reports did not outline any particular outcome and had to be categorized as unclear. The remaining thirty-four reports addressed three ICF components (body functions, activities/ participation, environmental factors) with sixty-eight ICF content categories. Frequent ICF contents were services, systems and policies (code e5, n = 15), cardiovascular/ respiratory functions (code b4, n = 10), mental functions (code b1, n = 7), digestive functions (code b5, n = 7), domestic life (code d6, n = 7), and sensory functions/ pain (b2, n = 6). Six HTA reports evaluated interventions/ technologies with presumed effects on at least four ICF content categories from two ICF components.

Conclusions

HTA in the field of nursing is often complex, including multicomponent approaches and a wide range of potential outcomes relevant for the HTA assessment. The ICF model might be useful to support a more streamlined understanding of complex interventions in this sector. Furthermore, reports might benefit from linking the ICF Classification with HTA, especially for the assessment of complex interventions.
VP39 The Alphabet Lottery? How NICE Outcomes Vary By Appraisal Committee
Authors: Macaulay Richard , Liu Lok Wan , Roibu Cornelia , Berardi Andrea
Published: December 2019

Introduction

NICE (National Institute for Health and Care Excellence) makes recommendations on the public reimbursement of medicines based on their clinical- and cost-effectiveness. The recommendation is made by an Appraisal Committee (comprising a multi-disciplinary group of independent experts) as part of a technology appraisal. There are four Appraisal Committees (A,B,C,D); this research investigates whether appraisal outcomes vary by committee.

Methods

All publicly-available Final Appraisal Determinations from NICE Single Technology Appraisals (STA) were screened (01/10/2009-14/11/2018) and key data were extracted. Homogeneity in rates of acceptance or rejection across the committees was assessed using Chi-squared tests.

Results

The Appraisal Committee was identified for 298 technologies, 56% (168/298) of which were ‘recommended’. The number of technologies assessed by each committee was similar (A:79, B:62, C:91, D:66). However, STAs conducted by Committee D were significantly less likely to receive ‘recommended’ outcomes (A:68% [54/79], B:65% [40/62], C:53% [48/91], D:39% [26/66]; p < 0.01). STAs for oncology indications had higher ’not recommended’ outcomes than those for non-oncology indications (25% vs. 9%). The lower ‘recommendation’ rates for committee D persisted across oncology (A:60%, B:83%, C:50%, D:38%; p = 0.01) and non-oncology indications (A:73%, B:53%, C:55%, D:40%; p < 0.01). However, STAs conducted by Committee D were significantly more likely to receive ‘optimized’ recommendations (A:16%, B:21%, C:33%, D: 36%; p < 0.01) and when considering the rates of ‘recommended’ and ‘optimized’ outcomes compared to ‘only in research’ and ‘not recommended’ outcomes, no significant differences were found (A:85%, B: 85%, C:86%, D:76%; p = 0.27).

Conclusions

STAs undertaken by NICE Appraisal Committee D was associated with a significantly lower rate of ‘recommended’ outcomes but tended to an ‘optimized’ recommendation significantly more than the other committees. Further research is needed to determine if this reflects any deviation in uniform implementation of NICE methodology between Committees.