bluuebunny/crossref_metadata_2025 huggingface dataset:
OP151 Cost-Utility Of Gender-Neutral HPV Vaccination In Ireland
Authors: Teljeur Conor , Murchu Eamon O , Harrington Patricia , Ryan Mairin
Published: December 2019

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.

Methods

A 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.

Results

A 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.

Conclusions

The 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.
OP163 Health Technology Assessment Participation And Prioritization In Core Outcome Set Development
Authors: Clearfield Elizabeth , Naber Jennifer Al , Tunis Sean , Messner Donna
Published: December 2019

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.

Methods

For 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.

Results

HTA 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.

Conclusions

HTA participation in COS projects provides HTA representatives an opportunity to help shape COS in clinical research for better decision-making.
OP170 How Can Health Technology Assessment Participate In The Healthcare Quality Improvement?
Authors: Allouche Wafa , Gouddi Sami El , Allouche Emna , Mrabet Ali
Published: December 2019

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.

Methods

This 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.

Results

The 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.

Conclusions

HTA has many meeting points with healthcare quality dimensions. HTA is likely to become an increasingly important influence in health decisions.
PP20 Challenges In The Health Technology Assessment Of New/Emergent Non-Pharmacological Technologies
Authors: Garcia Emmanuel Gimenez , Garcia Xavier , Reig-Viader Rita , Romero-Tamarit Arantxa , Gutiérrez-Ibarluzea Iñaki , Espallargues Mireia
Published: December 2019

Introduction

The methodological guides for the assessment of new/emerging non-pharmacological technologies differ from the traditional health technology assessment (HTA) guidelines developed by the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). The aim of this study is to identify the special features and challenges of carrying out HTA on new/emergent non-pharmacological technologies.

Methods

The application of traditional and new/emergent HTA guidelines is compared along the consecutive evaluation phases in four practical cases carried out at the Agency for Health Quality and Assessment of Catalonia (AQuAS) in 2017-2018.

Results

Main learning and outstanding challenges: (i) Instead of following a defined protocol, the evaluations are carried out from a preliminary short report which generates a lack of justification and delimitation of its scope. (ii) References’ identification and data extraction are often limited due to lack of studies, and sometimes require the use of grey literature or other sources less informative, for example, trial registries. It can be challenging to exclude references related to other indications. (iii) The assessment of resource use and costs of running the technology is complicated due to the lack of public prices information and specific impacts of use. (iv) The evidence considered during the assessment usually does not meet high quality requirements (risk of bias) because of indirect evidence, lack of comparator or no having clearly defined outcomes, among others. (v) It's difficult to draw conclusions and, consequently, recommendations due to abovementioned aspects and especially for the usual evidence gap that faces this type of technology in early stages of diffusion and/or in a competition situation of manufacturer companies.

Conclusions

The most recent innovation in non-pharmacological technologies merits a differentiated assessment approach. However, there is need to reconsider the methodology applied in order to overcome the challenges and limitations identified.
PP30 Do Conditional Regulatory Pathways Affect Health Technology Assessment Recommendations?
Authors: Cai Jesmine , Wang Tina , McAuslane Neil , Liberti Lawrence
Published: December 2019

Introduction

In an effort to expedite the approval of drugs treating serious illnesses or addressing unmet medical need, conditional approvals have been used by the European Medicines Agency. In this study, the effects of conditional approvals were investigated in terms of health technology assessment (HTA) recommendations and timing in Europe.

Methods

First HTA recommendations of new active substances (NASs) issued between 2015 and 2017 were collected from the National Institute for Health and Care Excellence (England), Haute Autorité de Santé (France), Institute for Quality and Efficiency in Health Care (Germany), Scottish Medicine Consortium (Scotland) and Tandvårds-Läkemedelförmånsverket (Sweden). The HTA recommendations were then classified into the following categories: positive, positive with restrictions, negative and multiple and if the regulatory approval pathway had been standard or conditional.

Results

Of this cohort of NASs that received an HTA recommendation, eight of 56 in England, 12 of 83 in France, 11 of 77 in Germany, nine of 58 in Scotland and four of 49 in Sweden were approved via a conditional review. Generally, except in England, there were a higher proportion of positive first recommendations for conditional approvals when compared to standard approvals, with Germany showing the largest proportional difference (43 percent) between the two pathways and also a faster time to recommendation. This may relate to the proportion of conditional assessments that were orphan medicines. With the exception of Germany, the time taken from regulatory approval to first HTA recommendation for products with conditional approvals is higher than those for standard approvals, with the largest difference seen in Sweden (241 days longer).

Conclusions

Conditionally approved NASs showed a variable HTA outcome; although there was generally a higher proportion of positive recommendations thus enabling more likely access in conditional approvals, the timing from regulatory approval to HTA recommendation was longer compared with standard approvals. This warrants a better understanding of the factors and uncertainties underlying these recommendations, supporting timely access of NASs with conditional approval.
PP41 Cost-Effectiveness Modeling Of Chimeric Antigen Receptor T-Cell Therapies
Authors: Teitsson Siguroli , Macaulay Richard
Published: December 2019

Introduction

This study has two key aims. The first is to review cost-effectiveness (CE) models for chimeric antigen receptor T-cell (CAR-T) therapies that have been appraised by health technology assessment (HTA) authorities. The second is to identify the key challenges of CE modeling of CAR-T therapies based on the main points raised in the HTA appraisals.

Methods

A targeted HTA review of published CE models for CAR-T therapies in the United Kingdom (UK) and United States (US) was undertaken.

Results

Four relevant CE models were identified – three from the UK and one in the US. Of the three UK models, two were single technology submissions to the National Institute for Health and Care Excellence (NICE) and one was a ‘mock’ appraisal undertaken by NICE with a hypothetical evidence dataset. The one US model was published by the Institute for Clinical and Economic Review (ICER) committee. Two key model structures were adopted across the appraisals: a three-health state partitioned survival analysis model and a short-term decision tree followed by a three-health state partitioned survival model. The key modeling challenges identified can by summarized into five main categories: comparator evidence generation, estimation of long-term survival, curative benefit, health-related quality of life, and infrastructure/training requirements.

Conclusions

There are many challenges associated with the CE modeling of CAR-T therapies, with the most critical issues related to how uncertainty for long-term efficacy and safety can be addressed and mitigated. With more mature evidence sets in the future, stakeholders will get a clearer picture for the long-term benefit and risk of CAR-T therapies, but until then it is likely that HTA authorities will take a conservative stand when appraising the comparative value of CAR-T therapies.
PP54 A Cohort Case Study On Implantable Cardioverter Defibrillators
Authors: Soares dos Santos Augusto Cesar , Horta Maria da Glória Cruvinel , Fernandes Mariana , Rodrigues Luíza , Carvalho Lélia Maria de Almeida , Avelar Sandra de Oliveira Sapori , Pinto Elen Cristina , Scherrer Luciano Rios , Biscione Fernando Martin , Kelles Silvana Marcia
Published: December 2019

Introduction

Many patients presenting with arrhythmias are treated with antiarrhythmic drug therapy. However, for some patients, usually survivors of previous serious ventricular arrhythmias, treatment implies the use of implantable cardioverter defibrillators (ICDs) and/or Cardiac Resynchronization Therapy (CRT) devices.

Methods

This retrospective study evaluated a cohort of patients with arrhythmia requiring the use of ICDs, CRT or ICDs + CRT from January 2004 to March 2018. Data from a private healthcare organization in Belo Horizonte, Brazil were used to assess all-cause mortality and the need for replacement of the device. Continuous variables were expressed as mean and standard deviation. Cox proportional regression model and Log-Rank test were used to adjust the survival curve.

Results

Five hundred and ninety-three patients were included in the study (median age 67.6 years, range 23 to 89 years; male 62 percent). According to the type of device used to treat these patients, the distribution was 338 (57.0 percent), 169 (28.5 percent), 86 (14.5 percent), for ICDs, ICDs + CRT, CRT, respectively. After a mean follow-up time of 3.12 years (range 0 to 13.6 years), 283 devices were replaced (ICDs n = 140; ICDs + CRT n = 90; CRT n = 53) and 284 deaths occurred (median survival of 6.9 years). The median survival was 7.3, 5.8, 4.8, 5.5 years for ICDs single-chamber, ICDs dual-chamber, ICDs + CRT, CRT, respectively.

Conclusions

Randomized trials are often criticized for their enrollment of highly selected patients. Studies on real-word data can provide reliable information regarding the use of ICDs and/or CRT devices in the treatment of patients with serious ventricular arrhythmias.
PP72 Using INTEGRATE-HTA On The Example Of Rasterstereography For Scoliosis
Authors: Buchberger Barbara , Jastrzebski Kaya , Krabbe Laura
Published: December 2019

Introduction

Full health technology assessment (HTA) reports discuss not only the safety and efficacy of a technology, but also the economic, ethical, legal, socio-cultural, and organizational aspects. INTEGRATE-HTA is a completed European Union project that developed concepts and methods for a patient-centered, integrated assessment of complex technologies. Technologies can be considered complex if they are characterized by a large number of interacting components, a wide variability of outcomes, or a high degree of flexibility. In contrast to the usual linear approach of addressing individual HTA domains separately, the INTEGRATE-HTA methodology is based on the assumption that different aspects of the domains interact. From the very beginning, these interactions are captured systematically using various tools. Continuous reflection and compaction of these relations can lead to an extended perspective on a technology. As a result, complexity and mechanisms of action open up, helping to channel public discussion and implementation. We investigated whether using the INTEGRATE-HTA methodology improves the understanding of individual domains and their interactions.

Methods

According to the methodology, an initial logic model for rasterstereography in patients with scoliosis was developed and successively expanded. A synoptic table, showing multiple maps of individual aspects to domains, and a complexity checklist were used. In addition, harvest plots were created and the socio-cultural impact of the disease was highlighted as a semantic complex. A final logic model and an interaction figure were established to initiate discussion.

Results

Having been classified as slightly complex in the beginning, rasterstereography turned out to be highly complex after using a variety of tools and a final graphical representation; the multiple mapping of individual aspects to domains resulted in a high density of interactions.

Conclusions

The INTEGRATE-HTA methodology helped to identify interactions between domains and significantly expanded the perspective on a technology. It improved patient-centered understanding and facilitated the discussion of single aspects.
PP87 Inpatient Drug Reimbursement: Approaches For A Democratic Process
Authors: Wolf Sarah , Wild Claudia
Published: December 2019

Introduction

In the context of limited healthcare resources and high healthcare expenditures, the introduction of new, cost-intensive medicines forces decision-makers to prioritize drug funding, especially in the areas of orphan diseases and oncology. In democratic societies, health policy decisions need to be evidence-based, transparent, fair, and efficient. Therefore, in some countries standardized (transparent) processes exist. In Austria, decisions on the reimbursement of new medicines have not been made for a long time. The aim of the present study was to develop different scenarios for a standardized, centralized reimbursement process for expensive hospital drugs in Austria that favors democratic decisions.

Methods

A multi-stage approach was undertaken. Firstly, the reimbursement processes (only for original preparations) in Austria and other selected countries were investigated. Secondly, the strengths and weaknesses of these processes were analyzed based on predefined criteria, following the concepts of “accountability for reasonableness” (A4R) and “deliberative decision making”. Thirdly, scenarios for an Austria-wide uniform reimbursement process for hospital drugs were developed.

Results

Three scenarios were identified: (i) a reimbursement process for hospital drugs that follows the existing reimbursement process in the outpatient sector in Austria; (ii) a cooperative of decentralized Pharmaceutical and Therapeutics Committees for procurement, use, and reimbursement decisions for hospital drugs; and (iii) an adaptation of the existing reimbursement process of non-drug, highly specialized technologies to pharmaceutical interventions.

Conclusions

According to the concepts of A4R and deliberative decision making, a transparent, evidence-based, fair, and efficient allocation of limited healthcare resources is indispensable for justifying decisions on health funding priorities in democracies. However, these criteria can be diametrically opposed. For example, methods, processes, and decisions can be evidence based, transparent, and fair, but also significantly more time consuming. Thus, a balance between the individual options for action is necessary, and priorities must be set.
PP88 Economic Impact Of New Diagnostic Tools In Severe Sepsis
Authors: Neeser Kurt , Oelze Ilse-Barbara , Müller Elvira
Published: December 2019

Introduction

Constantly rising healthcare costs and the increasing incidence of antimicrobial resistance represent a growing burden on public health, affecting patients, physicians, payers, and health authorities. This analysis assessed the economic impact of improved diagnostic accuracy among septic patients.

Methods

A cost-consequence model was developed to evaluate two different scenarios for the treatment of severe sepsis: scenario one represents the current status of diagnostic performance used for an antimicrobial treatment; scenario two is based on the assumption that a more accelerated diagnostic process results in 15 percent more patients being treated with an efficient antimicrobial drug early in their therapy. Data for the average patient-related cost for diagnostics (EUR 1,182) and overall cost (EUR 12,090), length of hospital stay (average 18.7 days), and number of patients affected annually (n = 771) were derived from the German Diagnosis-Related Group Catalog for 2017. Further, the impact of optimal versus inadequate therapeutic approaches on length of hospital stay (38% decrease), hospitalization cost (40% decrease), and mortality rate (28% decrease) were derived from published sources.

Results

By using more efficient tests to enable earlier detection of sepsis in patients who otherwise would not receive appropriate treatment, 36 additional patients were appropriately treated. The overall annual length of hospital stay can be shortened by 319 days and the number of sepsis-related deaths reduced by three. The overall annual costs in scenarios 1 and 2 amounted to EUR 11.4 and EUR 11.2 million, respectively. The main savings resulted from reduced expenses for hospital stay, drugs, readmissions, and progression to septic shock.

Conclusions

Increasing cost pressure and the rise in multi-resistant germs are a burden, which will increase over the next decade. The present analysis showed that a willingness to intervene early and stop detrimental developments, and to invest in effective technologies, can promote affordable health care.
PP100 Unraveling Hospital-Based Health Technology Assessment In Brazil
Authors: Cardoso Ricardo Bertoglio , Cruz Luciane , Aziz Marina , Miguel Sandro , Cohen Mírian , Lima Ana Flávia
Published: December 2019

Introduction

In Brazil, hospital-based health technology assessment (HB-HTA) units have been implemented countrywide since early 2000 to improve decision-making processes. Multiple-criteria decision analysis (MCDA) can provide a deeper understanding of a given subject. The present study used MCDA to evaluate capacity building among HB-HTA units in Brazil.

Methods

This study analyzed preliminary data from a survey developed and sent to all HB-HTA units in Brazil in 2018. The survey comprised 116 questions covering a wide range of aspects. Initially, an expert panel was organized, and 46 objective questions (out of 116) were selected by four experts. Next, these experts classified the selected questions by weighting them according to their relative importance. A Likert scale was used to identify the levels of importance, which were converted to weights ranging from zero to one. The experts then defined a final importance score threshold of 60 percent to classify units as fully operational. Grades below this threshold indicated the need for a more detailed evaluation. Of the 80 survey questionnaires, 23 were evaluated by the proposed method.

Results

Importance weights for each classification were defined as follows: personnel (25%); level of expertise (31%); work production (31%); and infrastructure (13%). The mean final importance score for the HB-HTA units was 68 percent. The maximum and minimum scores achieved were 95 percent and 15 percent, respectively. The HB-HTA units had been established for an average of 6 years, and ten of the 23 units were classified as fully operational.

Conclusions

The multicriteria method presented by this study simplified HB-HTA unit evaluation, reducing the subjectivity of results. Final importance scores for each unit's categories indicated which areas need improvement. Results from the study indicated that infrastructure and personnel could be greatly enhanced, even though the production profile was satisfactory.
PP108 Assessing CHA2DS2-VASc Score For Predicting Ischemic Stroke In The Non-Atrial Fibrillation Population
Authors: Wen Qiuyue , Shen Jiantong , Shen Lijuan , Zhang Yi , Jiang Qi , Wu Qianqian , Ying Yiyi , Jiang Jianping , Qian Mingjing , Liu Tian heng
Published: December 2019

Introduction

Cerebrovascular disease is the most common cause of death in China, and the incidence of ischemic stroke (240 per 100,000 people) is higher than that of hemorrhagic stroke (82 per 100,000 people). More than 80 percent of strokes can be prevented by early control of risk factors. Therefore, identifying and managing high-risk groups is a top priority in preventing stroke. The CHA2DS2-VASc score is a key prediction tool for stratifying stroke risk in individuals with atrial fibrillation (AF) as follows: zero score is low risk; one is intermediate risk; and two is high risk. The present study was undertaken to evaluate the accuracy of the CHA2DS2-VASc scoring system for stratifying ischemic stroke risk in the non-AF population.

Methods

We searched PubMed, EMBASE, and the Cochrane Library in June 2018 for relevant diagnostic studies. Study selection, data extraction, and quality assessment (using the QUADAS-2 criteria) were performed independently by two authors. Methodological variation across the selected studies precluded meta-analysis, so the results were synthesized narratively.

Results

Seven prospective studies involving 50,652 patients (6,760 with ischemic stroke) were included. The treatment threshold ranged from two to four across the studies. Three studies reported diagnostic accuracy at a threshold of two, with a sensitivity above 0.8 and a specificity ranging from 0.32 to 0.68. The diagnostic odds ratio was greater than two (seven studies). The two studies using a treatment threshold of four reported a sensitivity of 0.59 to 0.76 and a specificity of 0.43 to 0.69. One study used a threshold of three, with a sensitivity of 0.79 and a specificity of 0.39.

Conclusions

The CHA2DS2-VASc score may be used to predict ischemic stroke in the non-atrial fibrillation population. Treatment thresholds greater than two provide more optimal diagnostic accuracy, although the predictive performance of the CHA2DS2-VASc score may be better in patients with chronic obstructive pulmonary disease but not AF.
PP125 PhotoVoice: Promoting Knowledge Exchange About Patients’ Experiences
Authors: Pego Yolanda Triñanes , Varela Lucía , Mazaira-Castro José , Vallés Maria José Faraldo
Published: December 2019

Introduction

In the past decades the community-based participatory research method known as PhotoVoice has gained relevance, but there are few published studies on its application in the field of health technology assessment (HTA) and clinical practice guidelines (CPGs). The aim of this presentation was to describe a PhotoVoice project linked to a CPG on major depression in children and adolescents.

Methods

The design of the study was adapted to the main objective, which was to enhance the understanding of major depression and improve clinical practice with the contributions of clinicians, methodologists, and patients. Seven adolescents and ten of their family members participated in the study through PhotoVoice sessions and focus groups. The audio recordings of all sessions were transcribed verbatim and coded, and a thematic analysis was undertaken.

Results

Six themes emerged: (i) a lack of understanding and information about depression in childhood and adolescence; (ii) the importance of support groups; (iii) the need to favor early care and access to services; (iv) the adaptation of therapeutic strategies tailored to individual needs; (v) the sensitivity of professionals; and (vi) fostering interaction between the health and education systems. Photographic exhibitions were planned to share the main results. These exhibitions were promoted to increase public awareness and reduce stigmatization, and to reach clinicians and policy makers. From a methodological point of view, the use of PhotoVoice in this study helped to effectively incorporate the lived experiences, concerns, and preferences of patients and their relatives into the CPG. The study also confirmed the value of photographs and participatory methods. The main limitations and strengths of the study, as well as suggestions for future research, are also outlined.

Conclusions

PhotoVoice is a flexible, effective, and innovative method of obtaining information about patients’ perspectives and experiences, and it offers the added value of being able to reach the main stakeholders, including policymakers and the public.
PP126 Analyses Of User Requirements In The Evaluation Of Medical Equipment
Authors: Cardoso Ricardo Bertoglio , Brust-Renck Priscila G. , Fogliatto Flavio Sanson , Dos Santos Helena Barreto
Published: December 2019

Introduction

Human-centered approaches to eliciting requirements for medical equipment selection are recognized as improving healthcare outcomes, safety, and end-user satisfaction. Nevertheless, there are many challenges to conducting rigorous investigations to identify requirements that satisfy different hospital services and types of end users (e.g., patients, healthcare professionals, and clinical engineers). By establishing a systematic method for selecting medical recliners, this study provides detailed technical characteristics and user requirements associated with several hospital areas, as well as a comparison between two end users (health professionals and patients) and their different perceptions of usability.

Methods

First, clinical engineers and senior nurses from seven hospital services identified and rated the technical characteristics of medical recliners. Ratings were then used to stratify all services in well-defined similar groups using hierarchical and non-hierarchical clustering algorithms. Next, users of hospital recliners (60 patients and 56 healthcare providers) from each group were interviewed to identify their requirements for an ideal medical recliner. Finally, analyses of variance were performed to identify consensus decisions from users across the different hospital contexts as to which technical characteristics were the most relevant.

Results

The contribution of senior nurses and clinical engineers led to the identification of 41 technical characteristics. The analysis of 116 participant interviews identified 95 different requirements, extracted from 1,052 user suggestions. Correspondence analysis of the most important requirements, combined for each of the three stratified service groups, indicated that two-thirds of all user requirements (14 out of 20) were fulfilled by five out of 32 quantitative technical characteristics, regardless of context.

Conclusions

Human-centered methods can identify similarities between health technology characteristics and decrease the complexity associated with selecting technologies, while simultaneously fulfilling the requirements of multiple users and hospital departments.
PP159 Is Community Paramedicine A Safe/Effective Alternative To Usual Care?
Authors: Guo Bing , Corabian Paula , Yan Charles
Published: December 2019

Introduction

Due to an aging population, shortage of healthcare staff, and escalating healthcare costs, there has been a recent shift in the professional roles and responsibilities in acute care settings to help bridge the care gap. Paramedics, whose primary responsibilities have been in emergency/transportation services, are increasingly involved in the management of chronic diseases in the community setting. However, even with additional training, there are concerns about the safety and effectiveness of this expanded role. The objective of this presentation is to highlight some of the key findings from a health technology assessment report on the safety and effectiveness of community paramedicine in assessing and managing conditions/diseases with low acuity.

Methods

A systematic review was conducted to identify studies that evaluated the safety and effectiveness of different community paramedicine programs.

Results

Four systematic reviews and 20 primary studies (one randomized controlled trial (RCT) and 19 observational studies) were identified. Of these, two systematic reviews and 14 primary studies focused on the safety and effectiveness of Emergency Care Practitioner (ECP) programs ̶ widely implemented programs whereby a paramedic or nurse undertakes activities traditionally performed by physicians, such as the initial assessment of patients, provision of simple treatment, or referral of patients to other clinical care. Limited evidence showed that ECP programs are promising in reducing repeated emergency calls, emergency department visits, hospital admissions/readmissions, and emergency transport charges. While the majority of included studies did not report any safety outcomes, no significant safety issues were identified from the cluster RCT. Evidence for other types of community paramedicine is limited.

Conclusions

Evaluation of the impact of community paramedicine programs remains methodologically challenging. Additional cluster RCTs may help determine the effectiveness of community paramedicine programs; safety outcomes should be a key element of future observational studies.
VP04 The Influence Of Sponsorship On The Treatment Effects Of Trials
Authors: Arienti Chiara , Stefano Negrini , Da costa Bruno , Armijo-Olivo Susan
Published: December 2019

Introduction

Limited public money is available for funding research and the majority of clinical research undertaken is funded by industry. Mechanisms to regulate conflicts of interest within the research process have been implemented. However, these policies by themselves do not protect against potential sponsorship bias that would affect research results to inform decision makers when using the results of these trials. Therefore, the main aim of this study was to evaluate the influence of sponsorship bias on the treatment effects of RCTs.

Methods

This was a meta-epidemiological study. A random sample of RCTs included in meta-analyses of physical therapy (PT) area were identified. Data extraction including assessments of appropriate influence of funders was conducted independently by two reviewers. To determine the association between biases related to sponsorship biases and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach.

Results

We analysed 393 trials included in forty-three meta-analyses. The most common sources of sponsorship for this sample of PT trials were government (n = 205, 52.16 percent) followed by academic (n = 44, 11.2 percent), and industry (n = 39, 10 percent). The funding was not declared in a high percentage of the trials (n = 85, 22 percent). The influence of the trial sponsor was assessed as being appropriate in 246 trials (63 percent) and considered inappropriate/unclear in 147 (37 percent) of them. There was a significant difference in effects estimates between trials with appropriate and inappropriate influence of funders (ES= 0.15; 95% CI -0.03, 0.33;). Trials with inappropriate/unclear influence of funders tended to have on average a larger effect size than those with appropriate influence of funding

Conclusions

Treatment effect size estimates were 0.15 larger in trials with lack of appropriate influence of funders. Systematic reviewers should perform sensitivity analyses based on appropriateness of influence of sponsorship in included trials.
VP15 Consumer Willingness To Pay For A Hypothetical Zika Vaccine In Brazil
Authors: Muniz Roberto , Godói Isabella , Reis Edna , Garcia Marina , Guerra Augusto Afonso , Godman Brian , Ruas Cristina
Published: December 2019

Introduction

The Zika virus is a newly emerging infection associated with increasingly large outbreaks especially in countries such as Brazil where an estimated 326,224 cases were confirmed between 2015 and 2018. Common symptoms associated with Zika include headache, conjunctivitis, fever, erythema, myalgia, vomiting, diarrhea, and abdominal pain. However, the symptoms are usually self-limiting and last on average for 4 to 7 days, with patients typically not accessing the public healthcare system (SUS). In severe cases, symptoms include neurological disorders and neonatal malformations. A future Zika vaccine can contribute to decreasing the number of cases and associated complications. However, this has to be balanced against continuing costs to control this and other vector borne diseases. Consequently, information about consumers’ willingness to pay (WTP) for a hypothetical Zika vaccine can help with price setting discussions in Brazil starting with the private market before being considered within SUS.

Methods

A cross-sectional study was conducted among residents in one of the main provinces of Brazil (Minas Gerais) regarding their WTP for a hypothetical Zika vaccine with agreed characteristics. This included a mean effective protection of 80 percent, with the possibility of some local and systemic side-effects. The discussed price was USD 56.41 (BRL 180.00) per vaccination as this figure was utilized in a previous WTP study for a dengue vaccine.

Results

Five hundred and seventeen people were interviewed. However, thirty would not be vaccinated even if the vaccine was free. Most of the resultant interviewees (489) were female (58.2 percent), were employed (71.2 percent), had private health insurance (52.7 percent), had household incomes above twice the minimum wage (69.8 percent) and did not have Zika (96.9 percent). The median individual maximum WTP for this hypothetical Zika vaccine was USD 31.34 (BRL 100.00).

Conclusions

WTP research can contribute to decision-making about possible prices alongside other economic criteria once a Zika vaccine becomes available in Brazil alongside other programmes to control the virus.
VP21 Economic Burden Of Pertussis Treatment In Brazil, 2014
Authors: Bagattini Ângela , Policena Gabriela , Russell Louise , Toscano Cristiana
Published: December 2019

Introduction

Despite availability of a cheap, widely accessible vaccine, pertussis remains an important cause of morbidity and mortality in children worldwide. A resurgence of pertussis in Brazil peaked at 8,815 cases in 2014. We estimate the economic burden of pertussis hospitalizations and outpatient cases in Brazil in 2014.

Methods

Taking the Brazilian public health system (SUS) perspective we obtained numbers of hospitalizations from the National Hospitalization Information System (SIH) for discharge diagnosis ICD10:A37 and numbers of confirmed outpatient cases from the surveillance information system (SINAN). We estimated costs per case for seven age groups (<1, 1-4, 5-9, 10-19, 20-39, 40-64, and 65+ years). Hospitalization costs were obtained from SIH, which reimburses direct medical (hospital stay, healthcare professional services, and physical therapy) and non-medical costs (parent/caregiver stay accompanying a hospitalized child). Cost of outpatient management was estimated from national guidelines (diagnostic exams, medical visits, and medications) and national pricing lists. Total economic burden was derived by multiplying costs/case by numbers of hospitalized and outpatient cases, respectively, and converted to US Dollars (USD) (December 2014: 1 BRL = USD 0.39).

Results

A total of 8,815 pertussis cases occurred in Brazil in 2014; 55.9 percent were hospitalized. Total cost to the public health care system was USD 2.6 million, 95 percent for hospitalizations. Cost/case was highest at the extremes of age for both hospitalized <1y, BRL 1,378.54 (USD 537); 65y+, BRL 1,875.00 (USD 731) and outpatient cases BRL 41 (USD 16) for <4y and 20y + . Children <4 years accounted for 95.4 percent of hospitalizations, 51.2 percent of outpatient cases, and 95.4 percent of total costs. Children <1 year accounted for 88.1 percent of hospitalizations, 29.1 percent of outpatient cases, and 89.3 percent of total costs.

Conclusions

Pertussis economic burden in an outbreak year was largely due to hospitalizations in children <1y. Additional prevention strategies are required targeting this population.
VP49 Real-world Evidence For Economic Evaluation Of Medical Devices
Authors: Pongiglione Benedetta , Torbica Aleksandra
Published: December 2019

Introduction

Randomized controlled trials (RCTs) are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. The low external validity of RCTs and the general shortage of clinical evidence available to support the use of many medical devices have emphasized the necessity for exploring the use of real-world data (RWD) as a complementary source to RCTs data for establishing a more robust evidence base on the effectiveness of medical devices. The aim of the present project is to assess in a comprehensive way the existing sources of real world data on medical devices in Europe.

Methods

The guidelines to the mapping exercise have been outlined in a research protocol. First, all national relevant sources (e.g. website of Ministry of Health, national institutions, research bodies) are screened, both in local language and English. Second, we perform a systematic search on PubMed using a set of key words for each case study, adapted to each country setting. Finally, we seek advice from key actors in the field of the device and clinical conditions, such as manufacturers or clinicians.

Results

Information on existing sources of RWD for each case studies are provided in a template including details on the key features of the source (e.g. data producer, data collection period, sample size, study design, geographical coverage) and the main content of the dataset, distinguishing socio-demographic information, clinical and epidemiological data, data on resource use and health outcomes. The data mapping includes all countries of the project participants, i.e. Italy, UK, Netherlands, Switzerland, Germany, Hungary, and we enlarge the scope of our mapping including other countries: Spain, France, Denmark, Finland, Sweden, Poland and Hungary as well as international databases at pan-EU level. The number of available sources of RWD and their quality vary depending on case study and across countries. For example, in the case of orthopaedics, many countries have a national registry and administrative data, such as hospital discharge, contain useful information, although not as detailed. When a registry is not available, it is often the case that more observational studies are available; this occurs for example in France.

Conclusions

In this work we shows the importance of RWE and map in an accurate and comprehensive way which source of RWD are currently available and to what extent they are known and used in medical, epidemiological and economic research.
VP65 HTA Beyond 2020: Need For “Professionalization”?
Authors: Nyamadzawo Evidence
Published: December 2019

Introduction

Health Technology Assessment (HTA) should continue evolving in order to effectively meet stakeholder expectations in the next decade. There is need for strengthening current expertise while developing new capabilities to keep up with rapid innovations in health care. Institutionalizing knowledge and skill through professionalization of HTA is a critical factor for successful “smart capability building” and the practice of HTA beyond 2020.

Methods

Professionalism is understood to mean different things by different people. This paper does not primarily focus on whether HTA is or should be a “profession” but on the development of institutions, structures, and attitudes that are characteristic of a profession and the impact they could have on the practice of knowledge and skill in HTA. “Professionalization” is used in this case to refer to the status of institutions, structures and attitudes and the process of establishing them. Professional standards include both ethical standards and standards of (technical) competence. Ethics applies to standards of competence, because stakeholders expect professionals to adhere to standards of competence and ethical standards. I will argue for the institutionalization of the practice of HTA knowledge and skill for mutual benefit and the prevention of exploitative and unjust use of HTA capabilities and processes. Is expertise necessary in HTA? Yes, conducting HTA requires specialized skills and knowledge. Effective decision-support requires multidisciplinary and efficient HTA teams. Core competencies and smart capabilities must be clearly defined and institutionalized for the production of effective HTA in the coming decade. Credentialism also becomes necessary for protecting the public from the consequences of bad evidence and bad choices. It will also protect the integrity of HTA practitioners and bolster professional autonomy.

Results

Professionalization is instrumental in the development of ethical standards and standards of technical competence necessary for successful HTA practice.

Conclusions

HTAi should professionalize HTA to facilitate and guide “smart capability building”.
VP67 Caring For Children With Neurodevelopmental Disorders
Authors: Andrade Aurélio , Girardi Juliana , de Mello Nicole , Köptcke Luciana , Elias Flávia
Published: December 2019

Introduction

Professionals dealing with children with Neurodevelopmental Disorders (NDDs) need to be constantly trained because of the numerous challenges posed by the particularities arising from the multiple conditions that pervade child development. The aim of this study is to describe the training processes of education, health and social care professionals who care for children aged 0 to 12 years with neurodevelopmental disorders.

Methods

The revision overview was registered in the PROSPERO platform CRD42018100715 that followed the parameters of the PRISMA protocol and aimed to identify the existing multi-professional training processes, aimed at health professionals, education and social assistance aimed at promoting skills for care with children and families with TND. The research question was structured according to the acronym PICO. The search was performed in PubMed, Embase, Cochrane Library, CRD, Web of Science, Campbell Library, Health System Evidence, Epistemonikos and Joanna Briggs databases in May 2018.

Results

We selected 23 articles. Of these, 21 (91 percent) were health professionals, 22 (96 percent) referred to intellectual disability, 16 (71 percent) were in the American continent and 15 (65 percent) used in-service training as educational resource. The outcomes showed that the structuring of teaching-learning in the practice of health, education and social care professionals determines a more inclusive proposal in the treatment of children with NDD.

Conclusions

The health professional is the most trained to attend children with NDD, however, training and development policies are lacking for professionals from other areas who act as a gateway to diagnostic services. Establishing in-service training initiatives strengthens the support and structuring of intersectoral programs that would facilitate multi-professional participation in the prognosis and treatment directed at children with NDD. Therefore, associating the use of assistive technologies allows new opportunities to access tools and electronic devices that allow the formation of professionals.