bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP007 Technology Adoption In Hospitals - Balancing Incentives - A Survey
Authors: Tal Orna , Tal Inbal 
Published: January 2018

INTRODUCTION:Health Technology Assessment (HTA) in the hospital framework involves evaluating safety and cost-effective benefits alongside additional perspectives. We must take into account: professional skills, patient mix, infrastructure costs, the competitive arena and promoting innovation as part of the hospital strategy. Within budgetary constraints, hospitals need to focus on clinical excellence, prioritizing selected technologies in key fields.METHODS:A survey was conducted among thirty-five mid-level managers; department directors and head nurses from eight medical centers. The data was collected from a structured questionnaire scoping five fields: clinical efficiency, risk, benefit, contribution of relevant “players” for decision making and impact of adoption.RESULTS:Personal characteristics of the responders correlated with certain trends: managers with longer seniority ranked life-saving higher than younger managers, as did men in comparison to women. Participants from the peripheral regions ranked improvement in quality of life higher than respondents from the center of the country. The importance of functional improvement of the patient was graded higher by nurses, compared to the physicians.In operative aspects, improving staff communication was considered significantly higher among experienced managers, women, staff members in the central region hospitals and among nurses in comparison to physicians. Women ranked improvement of medical standards and guidelines higher, irrespective of their professional sector. At initial stages of the technology lifespan, scientific evidence on effectiveness was found to have a stronger influence on adoption decisions than national guidelines.Budgetary repercussions of adopting a new technology were ranked significantly higher in the central region. Experienced managers attributed greater impact to economic issues than younger managers.Social dimensions, such as providing care for a large population, reaching the target population, improvement of service and patient preferences were graded significantly higher by women.CONCLUSIONS:The survey highlights the insights of managers for decision making on adopting technologies in hospitals. These decisions need to integrate clinical advantages, competitive markets and national strategies with personal and professional parameters assists in bridging the gaps between local hospital activities and governance.
PP019 Clostridium Difficile Infection Diagnosis: Hospital-based Health Technology Assessment
Authors: Senna Kátia , Santos Marisa , Tura Bernardo 
Published: January 2018

INTRODUCTION:Clostridium difficile infection is the leading cause of nosocomial diarrhea in developed countries and may progress to pseudomembranous colitis, sepsis and death. The risk factors are antibiotics use, advanced age and prolonged hospitalization. The diagnosis of Clostridium difficile infection is based on clinical history in combination with laboratory tests, which detect the Clostridium difficile presence or toxins. Clostridium difficile remains in spore form contaminating the environment and requiring measures to prevent hospital transmission. Tests with more accurate results to identify true carriers of Clostridium difficile allow the clinician to determine a safer treatment. This study evaluated accuracy and cost-effectiveness of the real-time polymerase chain reaction compared with the enzyme-linked immunosorbent assay from the perspective of a Brazilian public cardiology hospital.METHODS:A study diagram was constructed by type of test, linking the data of prevalence in hospital, accuracy and direct costs of tests. The costs were based on a hypothetical population comparing two strategies to identify the incremental expenditure between technologies. The analysis included comparisons for each test versus no test, and with each other. The prices were converted to the American currency taking into account the date of purchase of each product and respective price.RESULTS:For real-time polymerase chain reaction test versus no test, 214 patients would have tested to justify one empirical treatment suspension, at a cost of USD90,926.46. For enzyme-linked immunosorbent assay test, to prevent one unnecessary treatment, 375 patients would have to be tested at a cost of USD6,603.75. In the comparative analysis, only a single false-positive patient would have the treatment suspended after performing 375 real-time polymerase chain reaction tests at USD424.89 each one (USD159,333.75 in total). An incremental cost of USD152,730.00 may be necessary to benefit a single patient by discontinuing empirical treatment.CONCLUSIONS:The Real-time polymerase chain reaction test has restrictions as a test of choice for the diagnosis of Clostridium difficile infection, in services with low disease prevalence. It undergoes a significant change in its positive predictive value and does not offer a great impact in the clinical diagnosis.
PP020 Decision-Making Beyond Evidence Alone – Topic Prioritization For Health Technology Assessment
Authors: Ju Hong , Ng Kwong , Teo Elaine , Khoo Daphne 
Published: January 2018

INTRODUCTION:The number of health technologies needing evaluation far outweighs available resources, and most Health Technology Assessment (HTA) agencies use criteria-based frameworks for topic prioritization (1,2). Despite variability, most frameworks include clinical, economic and budget impact. Some limitations of current frameworks lack mentioning of any explicit political/ethical deliberation and an evaluation on the potential impact of the HTAs (1).METHODS:During a topic prioritization for HTA, Left Ventricular Assist Device (LVAD) as destination therapy for adults with end-stage heart failure was submitted. The prioritization criteria used were largely in line with those described above. We also included criteria on ethical/equity consideration and the potential impact of an HTA on decision making. A literature search was conducted to gather clinical and economic evidence on LVAD for the target population, supplemented by local data on potential need for and budget impact of providing a LVAD service.RESULTS:LVAD was scored high on clinical, economic and budget impact with a moderately high need, which would generally subject it to an HTA in order to inform a policy decision. However LVAD was also considered as a technology with a high impact on ethical and political grounds, given that it is a technology offering survival and quality-of-life benefits for a small group of patients for whom effective treatment is otherwise lacking. Through deliberation, the prioritization panel concluded that the impact of an HTA would be low, as a policy decision on whether a LVAD program should be funded would go beyond evidence. Therefore an HTA was not recommended for LVAD.CONCLUSIONS:To inform decision making, an evaluation on the potential impact of the HTA itself taking into account of the ethical/political consideration of funding a technology is of equal importance as the evidence alone. Subsequently, limited HTA resources can be reserved for technologies where an HTA can truly make a difference.
PP038 EQ-5D-3L Electronic Version Development For The Brazilian Population
Authors: Miguel Sandro , Bagattini Ângela , Camey Suzi , Polanczyk Carisi , Cruz Luciane 
Published: January 2018

INTRODUCTION:Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.METHODS:A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.RESULTS:Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.CONCLUSIONS:Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.
PP061 Direct Cost Of Physiotherapeutic Devices Judicialization In Brazil
Authors: Moraes Dominique , Tarbes Luciana , de Veras Bruna , Santos Marisa 
Published: January 2018

INTRODUCTION:The “Judicialization of health” is a judicial option, provided by the Brazilian constitution, which aims to guarantee the access of the population to healthcare products or services to which they were denied or that were otherwise unavailable on the Unified Health System (SUS) (1). This highlights deficiencies in public policies (2). Considering the progressive impact of the judicialization on the budget and the lack of real-world evidence on the subject, the objective was to describe the judicialization profile of physiotherapeutic devices in the city of Rio de Janeiro and to estimate the spending on them within the system.METHODS:The profile was traced based on the analysis of the processes (n = 243) submitted to the Technical Advice Unit of the Rio de Janeiro Justice Court between May 2013 and September 2015, which litigated the provision of physiotherapeutic devices. Direct cost information was obtained from both public and private sources. The analysis was carried out using the SUS perspective.RESULTS:About 63 percent of the patients were over 60 years old. The majority of the requests were due to chronic respiratory diseases, the most common being obstructive sleep apnea-syndrome (31 percent), chronic obstructive pulmonary disease (14 percent) and pulmonary fibrosis (11 percent). The most judicialized devices were continuous positive airway pressure (21 percent), oxygen concentrator (17 percent) and portable oxygen cylinder (13 percent). None of these devices are currently covered by SUS. The expenses related to the purchase of the devices pleaded was approximately USD812,500 over 29 months.CONCLUSIONS:The total spend on these devices were considered very high when compared to Rio de Janeiro's health budgetary capacity. This scenario could be worse if this type of demand were not planned, and needed to be accomplished quickly with urgent purchases. The results obtained shows that judicialization phenomenon has a meaningful impact on the economic viability of the Brazilian healthcare system.
PP092 Real World Data: Biologic Treatment For Naive Patients In Lazio Region
Authors: Mecozzi Alessandra , Marcellusi Andrea , Sciattella Paolo , Mennini Francesco 
Published: January 2018

INTRODUCTION:The introduction of new biologic treatments has radically changed the management of Immune-mediated inflammatory diseases (IMID). Due to the high costs of the treatments a strong control and monitoring of claims databases could help decision makers to understand the consequences of their decisions.The objective of the study was to identify the cohort of biologics treatment-naïve patients in the years 2011–2013 in the Lazio region (6 millions of inhabitants), in order to investigate the parameters influencing the biologic treatment expense at the regional level.METHODS:Patients were enrolled based on administrative databases of the Lazio region. Treatment-naïve patients were defined as subjects who did not have a prescription in the two years before the index prescription. Switcher patients were defined as those who had an Anatomical Therapeutic Chemical classification (ATC) prescription different than the one at enrolment, within one year of the index date. Treatment adherence was estimated as the number of doses actually prescribed as compared to the number indicated in the Summary of Product Characteristics (SPC).RESULTS:From a total number of 10,120 patients treated with biologic drugs between 2011–2013 in the Lazio region, 2,929 were estimated as treatment-naïve patients (42 percent male). The most frequently used drugs were etanercept (31 percent), adalimumab (30 percent) and infliximab (17 percent). Considering the disease treatment distribution, 28.6 percent of patients were treated for rheumatoid arthritis, 25.5 percent for psoriatic arthritis, 16.4 percent for psoriasis and the remaining patients for other diseases. Some patients switched biologic therapy (367), of which 22.6 percent were within the first 120 days. Total mean adherence was estimated in 87.7 percent: 21.5 percent of patients showed a low adherence (SPC< 60 percent) while 18.1 percent were estimated as dose increase patients (SPC>110 percent), 11.4 percent for rheumatic diseases, 32.3 percent for dermatological diseases and 26.9 percent for inflammatory bowel disease.CONCLUSIONS:The study provides a map of the current treatment settinga with biologics in the Lazio region considering the disease, adherence and prescribed treatments. A considerable number of treatment-naïve patients were identified (2,929), 12.5 percent of whom switched ATC within 1 year. Total mean adherence was estimated in 87.7 percent, low adherence occurred in 21.5 percent of patients, while dose-increase was in 18.1 percent.
PP125 Evidence-based Policy Making – Bottom-Up Heuristic Engagement Process
Authors: Trindade Evelinda , Buehler Anna Maria , Petramale Clarice , D'Albuquerque Luiz Augusto Carneiro , Uip David , Pozzo Lorena 
Published: January 2018

INTRODUCTION:Solid organ and hematopoietic cell transplantation are some of the more expensive procedures universally paid by the public Brazilian Unified Healthcare System (SUS). Transplanted patients depend on maintenance immunosuppression to prevent death or graft loss. A bottom-up heuristic process proposed new immunosuppression drugs for incorporation into the SUS.METHODS:Systematic evidence synthesis and Brazilian transplantation registries base-cases, Kaplan-Myer survival and economic assessments were presented in specialized national congresses with open public Delphi sessions to build professional Clinical and Therapeutic Protocols (PCDT) by consensus. Five consensus transplantation PCDTs with a SUS perspective budget impact and sensitivity analysis were submitted to the Health Ministry SUS Technology Incorporation National Commission (CONITEC) plenary for a decision. PCDTs were publicized in CONITEC Internet and Diário Oficial da União, an, official periodic publication, as well as undergoing widespread dissemination through mailings for Public Consultation. Public contributions were added to PCDTs to support Health Ministry policy making.RESULTS:The São Paulo State Health Secretariat coordinated the synthesis and economic assessments made by 115 experienced transplantation specialists and health technology evaluators over ten years. Heart, lung, liver, pancreas and hematopoietic cells transplantation PCDTs (with tacrolimus, sirolimus and everolimus alternative immunosuppression) can significantly prevent 27.8 percent, 28.1 percent, 7.2 percent, 11.1 percent and 4.3 percent graft loss or graft versus host disease and death, respectively, for refractory transplantees rescue during the first year post-transplantation, saving healthcare resources. Ten-year follow-up data demonstrated partial benefits were sustained. Analysis demonstrated +USD689,655.17, +USD501,567.40, -USD377,802.51, +USD221.289,42 and +USD50.734,08 budget impact, respectively, resulting in an overall USD1,085,443.55 for 2,146 transplantees. The 5 PCDTs were favorably voted by CONITEC plenary members, 155 public contributions were added by patients and stakeholders, and the Brazilian Health Ministry decided to adopt the SUS reimbursement listing.CONCLUSIONS:Democratic participation gave PCDTs real-world basis adjustments, SUS innovation and improved compliance.
PP130 Nudging In Public Health: Accountability For Practical Wisdom
Authors: Stanak Michal 
Published: January 2018

INTRODUCTION:Nudging is the application of behavioural sciences aimed at influencing behaviour in a non-prescriptive way. It is a tool of public health decision makers to produce health gain. Just like decisions in the field of Health Technology Assessment (HTA), nudging decisions are inevitably value laden. The current European Network for HTA (EUnetHTA) approach to evaluate ethical aspects encompasses mainly utilitarian and principlistic approaches. The aim of this project is to incorporate the virtue ethics approach in public health decision-making processes based on the example of nudging.METHODS:The narrative analysis of nudging is based on a systematic literature search conducted from 28 October to 13 November 2015 in the following databases: Medline via Ovid, Embase, and TRIP Database. A total of sixty-two articles were listed as relevant as a result of searches and, in addition, twenty-five more articles were found through hand searching.RESULTS:Regardless of the potential issues related to nudging (manipulation or coercion), nudging is considered cost-effective and inevitable because of the malleability of human psychology for example, alcoholic drinks served in smaller glasses nudge people to drink less alcohol.No policy intervention, nudging or HTA, is value neutral and hence it requires an ethical evaluation. It takes traits of character, virtues, to discern which principle to apply in what circumstances and phronesis, practical wisdom, is the key virtue of a decision maker. Phronesis is not a moral judgement deduced from principles, but it is context specific, bottom-up, action orientated, and framed through dialogues. It focuses on the agent, the decision maker, who, via the use public scrutiny, should be held accountable for phronetic decisions made.CONCLUSIONS:Nudging is a cost-effective tool that can improve the populations health in a non-prescriptive way. Transparent reporting open to public scrutiny is necessary for the sake of evaluating whether the decisions made were phronetic for it takes traits of character, virtues, to decide between competing moral principles.
PP135 Stakeholder Involvement In A Health Technology Assessment Of Hyperhidrosis
Authors: Wade Ros , Rice Stephen , Moloney Eoin , Stoniute Julija , Layton Alison , Levell Nick , Stansby Gerard , Jones-Diette Julie , Llewellyn Alexis , Wright Kath , Craig Dawn , Woolacott Nerys 
Published: January 2018

INTRODUCTION:Hyperhidrosis is characterized by uncontrollable excessive sweating, which occurs at rest, regardless of temperature. Symptoms can significantly affect quality of life. There is substantial variation in the secondary care treatment of hyperhidrosis and uncertainty regarding optimal patient management. The objective of the Health Technology Assessment (HTA) was to review the evidence and establish the expected value of undertaking additional research into effective interventions for the management of primary hyperhidrosis in secondary care. Capturing the perspectives of patients and clinicians treating hyperhidrosis was an important part of the research.METHODS:The assessment included a systematic review and economic model, including value of information analysis. Patients, dermatologists, a vascular surgeon and a specialist nurse (who set up the UK Hyperhidrosis Support Group) provided advice at various stages, including at an end-of-project workshop, to help interpret results and prioritize research recommendations.RESULTS:Patient and clinician advisors were unsurprised by the finding that there is evidence of a large effect of botulinum toxin injections on axillary hyperhidrosis symptoms in the short to medium term; there was consensus amongst patients and clinicians that botulinum toxin injections were very effective. The advisors agreed that a trial of botulinum toxin injections (plus anesthetic) versus iontophoresis for palmar hyperhidrosis would be useful. Patients and clinicians were happy with the sequence of treatments identified as being cost effective for axillary hyperhidrosis: iontophoresis, botulinum toxin injections, anticholinergic medication, curettage, endoscopic thoracic sympathectomy. All patients agreed that the Hyperhidrosis Quality of Life index (HidroQoL©) tool was superior to other commonly used tools for assessing quality of life in hyperhidrosis.CONCLUSIONS:Patients and clinicians considered the key findings of the systematic review and economic analyses to be appropriate. Advisors advocated a trial of botulinum toxin injections (plus anaesthetic) versus iontophoresis for palmar hyperhidrosis. Patients preferred the HydroQoL® tool over other commonly used quality of life tools in hyperhidrosis research.
PP149 Assessment Of New Medical Devices With Administrative Databases
Authors: Callea Giuditta , Cavallo Maria Caterina , Tarricone Rosanna 
Published: January 2018

INTRODUCTION:Administrative data (for example, hospital discharge databases, HDDs) can be used as a real world source of clinical and economic evidence for assessing new medical devices (MDs), provided that their use can be identified in the data. In absence of updated classification systems for procedures and diagnoses, which allow to identify the use of new technologies in the data, traceability can still be achieved thanks to authorities coding guidelines (that is, indication on how to combine the existing codes for procedures and/or diagnoses when new technologies are used).In 2009 Italy adopted version 2007 of the International Classification System of Diseases (ICD-9-CM) and version 24 of Diagnosis Related Groups (DRGs), which are still in use. The aim of this work was to investigate the capacity of the classification system currently used in Italy, which is at high risk of obsolescence, to identify innovative MDs.METHODS:To achieve our goal, we performed a systematic search of all the national and regional coding guidelines published from 2009 (that is, the year of introduction of the new classification systems) to 2015. We extracted from each document the list of technologies for which the Ministry of Health and/or the Regional Authorities provided with coding indications.RESULTS:Our results show that only a few recent technological innovations can be identified in the Italian HDDs. This reduces the possibility for decision makers to measure new technologies outcomes and costs in the real world clinical practice.CONCLUSIONS:The traceability of new MDs' can support Heath Technology Assessment (HTA). Indeed, HTA programs should use real world evidence to re-assess MDs 2–3 years after their introduction in clinical practice. The use of routinely collected data, such as HDD, would allow to measure new technologies' “real” effectiveness in “real” world, on “real” patients in “real” hospitals to complement the evidence from Randomized Controlled Trials.