bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP101 Do We Need To Extend Health Technology Assessment To Health Enhancement Assessment?
Authors: Hofmann Bjørn 
Published: January 2018

INTRODUCTION:Several health technologies used for therapy can also be used for health enhancement. Drugs stimulating cognitive abilities are but one example. Health Technology Assessment (HTA) has not been developed for assessing enhancements. This raises the question of how HTA should address the blurred distinction between therapy and enhancement. Should we (i) carve out a distinction between therapy and enhancement and limit HTA to therapy, (ii) use HTA for both therapy and enhancement (with some modifications), or (iii) should we develop a separate health enhancement assessment (HEA)?METHODS:A literature search of the medical, philosophical, and bioethical literature was conducted for debates, arguments, and suggested solutions to the issue of therapy versus enhancement.RESULTS:The same improvement in health may be therapeutic in one patient, but an enhancement in another. Moreover, both therapy and enhancement share the same goal: increased health and wellbeing. A wide range of arguments try to establish a difference between therapy and enhancement. They refer to naturalness, rehabilitation, normality, species-typical functioning/potential, disease, sustainability, and responsibility. On closer scrutiny few of these arguments do the job in bolstering the therapy-enhancement distinction. We already use a wide range of means to extend human abilities. Moreover, the therapy-enhancement distinction raises a wide range of ethical issues that are relevant for the assessment of a number of emerging health technologies.CONCLUSIONS:Existing HTA methodology can address a wide range of non-therapeutic health enhancements. However, a series of broader issues related to the goal of health care and responsibility for altering human evolution may not be addressed within traditional HTA frameworks. Specific HEAs may therefore be helpful.
PP053 A Case Study: Collective Individual Basis For The Judiciary Debate
Authors: Melo Daniela , Trindade Evelinda , Oliveira Daniel , Martins Patricia , Ribeiro Lúcia 
Published: January 2018

INTRODUCTION:The volume of lawsuits for drugs has increased in Brazil. The scientific evidence basis consideration by the Brazilian judiciary system is being debated. In the State of São Paulo, the drug with the highest number of lawsuits is insulin glargine. Between January and August 2016, the São Paulo State Department of Health lost 264 insulin glargine lawsuits requiring supply for adult patients (>18 years old). Insulin glargine has already been submitted and unfavorably assessed by the Health Ministry SUS Technology Incorporation National Commission (CONITEC), so is not available in the Brazilian public system.METHODS:Random analysis of 153 (58 percent) lawsuits were carried out on digital court records. Data collected from legal proceedings were: the type of diabetes (1, 2 or unspecified); age of the patient; origin of the order; specialty of the prescriber and the reason described for the request. Each record was structured with variables data within a matrix in Microsoft Excel© software. Analysis of frequencies, absolute and relative distribution of quantitative variables, as well as conceptual clusters in the qualitative textual analysis are presented.RESULTS:The mean age of the 153 patients was 49±17 years. The majority of patients requested insulin glargine to achieve glycemic control (n = 116; 76 percent): because -“diabetes is uncontrolled and the analogous insulin is essential to get it” (n = 106; 69 percent); or -“patient claims to have obtained glycemic control with insulin glargine but there are none of the mandatory laboratory tests results in lawsuits” (n = 7; 5 percent); or -“ask replacement of insulin detemir with glargine for glycemic control” (n = 3; 2 percent). Only 87 (57 percent) lawsuits reported the patients diabetes type: type 1 (n = 42; 28% percent or 2 (n = 45; 29 percent). Most of this judicialization came from private outpatient clinics (n = 116; 76 percent) and 99 (65 percent) were prescribed by endocrinologists.CONCLUSIONS:Judicial decisions are still insufficiently underpinned by scientific evidence (only the patients drug needs claim has been recorded to justify supply) and are incomplete regarding objective diagnostic variables. Also, the judges awareness of interdisciplinary measures to achieve diabetic patients glycemic control, besides complementary drugs, may improve the Brazilian judicialization burden.
PP059 National Survey Of Current United Kingdom Ambulance Service Transient Ischemic Attack Referral Pathways
Authors: Hampton Chelsey , Porter Alison , Bulger Jenna , Jones Charlene , Rees Nigel , Seagrove Anne , Snooks Helen 
Published: January 2018

INTRODUCTION:Patients presenting to emergency ambulance services with Transient Ischemic Attack (TIA) are usually conveyed to the Emergency Department (ED) with subsequent referral to specialist assessment at a TIA clinic within one week if at low risk of stroke. There is opportunity for paramedics to refer patients with TIA at low risk of recurrent stroke directly to a specialist TIA clinic, avoiding the transportation and care at the ED however evidence is lacking about current practice, safety and effectiveness of this intervention.We aimed to describe current service developments across the United Kingdom (UK) for the pre-hospital emergency care of patients with TIA, to inform the development of an intervention for testing.METHODS:We surveyed all UK Ambulance Trusts (n = 13) by email, asking them to identify initiatives related to the management of TIA, and followed up services reporting an alternative TIA pathway by telephone to gather further details.RESULTS:Twelve ambulance services responded to our survey. Eight reported that they had not developed or implemented TIA referral pathways. Three reported currently using a TIA referral pathway; one had discontinued their pathway due to service reconfiguration. All (4/4) pathways used the FAST test and ABCD2 tool to screen patients, in line with national guidelines, and classified patients as low risk if the ABCD2 score was ≤3. All indicated that eligible low-risk TIA patients should be referred by paramedics to specialist care, 2/4 by telephone, and 2/4 by fax.Although protocol compliance was audited in an initial pilot in one service, no formal evaluation of effectiveness was reported.CONCLUSIONS:Several UK ambulance services have introduced similar referral pathways for low risk TIA patients, avoiding transportation of patients to the ED. Existing initiatives can inform the development of an intervention for evaluation in a randomized trial.
PP089 Health Technology Assessment Of An Automated Compounding Of Parenteral Nutrition
Authors: Faggiano Francesco , Andellini Martina , Sabusco Francesca , De Vivo Liliana , Derrico Pietro , Ritrovato Matteo 
Published: January 2018

INTRODUCTION:Pediatric parenteral nutrition is mainly used in neonatal intensive care units (NICU) and requires close collaboration with the hospital pharmacy, especially for manufacturing time, application, preparation and delivery (1). In this context, a Health Technology Assessment (HTA) to evaluate an automatic system compared with a manual system was carried out.METHODS:The Decision-oriented HTA (DoHTA) method (2), coordinated by Bambino Gesù Children's Hospital (BGCH) HTA Unit, was applied to carefully assess the technology. It was developed starting from the European Network for HTA (EUnetHTA) Core Model® and integrated with the Analytic Hierarchy Process (AHP). Its purpose is to identify all the relevant assessment aspects of automatic system integrating the evidence from the scientific literature with experts’ judgments and the specific context analysis for BGCH: an evaluation scheme inherent safety, clinical effectiveness, technical and organizational aspects (represented by a decision tree at three levels: dimensions of evaluation, I and II level indicators) was subsequently created. A weight was finally associated to each identified element and the alternatives’ ranking was defined.RESULTS:The study results show a “performance value” associated with the automatic system greater than about thirty-two percentage points compared to the manual system.CONCLUSIONS:At the current state of the scientific evidence and the results of analysis carried out by the working group, it is believed that the choice should be made to introduce the automatic system is available in BGCH.More specifically, from the point of view of safety, automatic system is safer for both patient and operators; about clinical effectiveness, the system improves the nutritional intake, allows a reduction of post-infusional adverse events and the use of antibiotic therapy; concerning economic aspects, the analysis of available data shows a substantial equivalence between the alternatives considered; the technical-functional aspects show an improvement according to almost all indicators; organizational aspects show a slight improvement in the working and in process management and finally the legal aspects indicate a slight advantage for the automatic system.
PP095 Assessment Of Magmaris Resorbable Metal Stent In Patients With Angina
Authors: Sanchez-Gomex Luis Maria , Orrego Juan Pablo Chalco , Luengo-Matos Setefilla , Polo-Desantos Mar 
Published: January 2018

INTRODUCTION:Ischaemic heart disease is the leading cause of death worldwide. Magmaris™ is a new drug-eluting resorbable stent used for coronary reperfusion during a balloon angioplasty. Magmaris™ is composed of absorbable magnesium scaffold and its surface is coated with bioresorbable poly-L-lactide, which incorporates Sirolimus. Magmaris™ has theoretical advantages as the stent body disappears after vascular constrictive remodeling. It would provide the stability and elasticity of non-resorbable metal stents, but without long-term problems such as endothelial dysfunction, delay in endothelialization, risk of thrombosis and complications due to long-term antiplatelet medication. The objective of this work is to assess efficacy and safety of Magmaris ™ in patients with angina or silent ischaemia.METHODS:Early assessment of Magmaris™ identified through the Early-Awareness and Alert-System, “SINTESIS-new technologies”, of The Instituto De Salud Carlos III (AETS-ISCIII). The searched databases were: MEDLINE (PubMed), EMBASE, WOS, Clinical Trials and Cochrane Library. Clinical studies using Magmaris™ published in any language until December 2016 were reviewed.RESULTS:One prospective, non-randomized, non-controlled, multicenter, clinical trial with two publications was retrieved. The first publication (123 patients) showed mainly imaging outcomes of angiography, intravascular ultrasound and tomography at 6 months of follow up. The second publication (118 patients) with data from 12 months of follow up also reported: Target lesion failure in four patients (3.4 percent; 95 percent Confidence Interval, CI:0.9–8.4); one target-vessel myocardial infarction (0.8 percent; one myocardial infarction (0.8 percent); two clinically driven target lesion revascularisation (1.7 percent) and two clinically driven target-vessel revascularisation (1.7 percent). No definite scaffold thrombosis was observed. No procedural complications were reported. This trial is expected to continue up to 36 months of follow up.CONCLUSIONS:Clinical data show that Magmaris™ seems to be an effective and safe treatment in patients with angina or silent ischaemia undergoing balloon angioplasty. More research specially randomized controlled trials are necessary to confirm these results.
PP113 High-Sensitivity C-Reactive Protein (hsCRP) Measurements And Burden In Patients With History Of Myocardial Infarction
Authors: Deschaseaux Celine , Agrawal Rumjhum , Gabrielsen Anders , Jindal Ramandeep 
Published: January 2018

INTRODUCTION:The inflammatory marker C-reactive protein (CRP) can be measured by a high-sensitivity assay (hsCRP) specific to vascular inflammation. We aimed to identify published literature on prevalence of elevated hsCRP and associated clinical, economic, and humanistic burden in patients with a history of myocardial infarction (MI).METHODS:A comprehensive literature search was performed for publications in English between January 2000 and February 2016 in MEDLINE, EMBASE, and MEDLINE In-Process. Search terms were variations on ‘Post myocardial infarction’, ‘CRP’, ‘epidemiology’ and ‘burden’. Clinical and real-world studies reporting baseline CRP levels in patients with a history of MI were included in the analysis.RESULTS:Ten studies (prevalence: two; burden: two; both: six) were included. Cut-off points in hsCRP assays varied from >2 mg/L to ≥5.9 mg/L. Prevalence of hsCRP levels >2, >2.3, ≥2.37 and ≥2.9 mg/L were reported in 36 percent, 49 percent, 50 percent and 33 percent of patients, respectively (one publication each). Two publications reported >3 mg/L levels in 27.6 percent and 53.7 percent of patients. Levels of ≥3.3, ≥3.8, ≥4.2 and ≥5.9 mg/L were found in 38.8 percent, 25 percent, 25 percent and 24.7 percent respectively (one publication each). Of six studies reported CV events, four studies found elevated hsCRP levels to be predictive of future risk. Elevated hsCRP levels independently predicted all-cause mortality in four studies and CV mortality in three studies. Three publications included data on comorbidities: Diabetes was associated with elevated hsCRP in two of three analyses; hypertension in one out of two. No consistent associations between elevated hsCRP levels and hyperlipidaemia (one study), stroke or angina pectoris (one study) were found. No study reported economic, resource use or quality-of-life burden.CONCLUSIONS:Due to limited evidence on prevalence of elevated hsCRP and associated burden of illness in patients with a history of MI, further research is warranted. Variations in findings, cut-off points and methods between studies make generalisations difficult.
PP122 Strengthening Ethics Compliance In A Large Research Program: Uganda
Authors: Nabukenya Sylvia , Castelnuovo Barbara , Kambugu Andrew , Kayaga Maimouna , Opio Bruce , Orama Richard , Okoboi Stephen 
Published: January 2018

INTRODUCTION:The infectious Diseases Institute (IDI) is a research institute at the College of Health Sciences, Makerere University. Over the years, the number of research studies has greatly increased with an average of fifty active studies per year. Because of the voluminous study activities, investigators were faced with inadvertences of ethical approval deadlines (1). In 2015, a centralized electronic Regulatory Affairs Information System (RAIS) was developed and piloted to track the regulatory process of the entire research projects. RAIS is a web-based system, developed using a Net framework and runs on any operating system using a web browser such as “Google Chrome” and “Mozilla Firefox”.METHODS:A signed approval letter from an accredited Research Ethics Committee, National Drug Authority and Uganda National Council of Science and Technology, the reviewed protocol, consent forms and data collection tools are uploaded electronically into the RAIS with study staff contact information, CVs and Good Clinical Practice (GCP) certificates. RAIS sends automatic “no reply” emails to the investigators and research administration notifying for the need of annual renewal 56, 28 and 14 days before the expiry date of the approvals. The investigator or designated person prepares the application package which is then forwarded to the Research Regulatory Officer for review and submission to the regulatory authority.RESULTS:From January 2015 to November 2016, fourty-three ongoing studies were uploaded to the RAIS of which eleven were clinical trials, twenty-one observational studies, seven diagnostic and four implementation studies. Studies that obtained their annual approvals before the expiry date was 90.7 percent, compared to 29 percent that had reported early submission for annual renewal between January 2013 and December 2014. RAIS has enabled continuity of study activities with timely annual renewed approvals, supported the tracking of staff GCP certificates and populated timely notifications to investigators, resulting in submission of annual application packages on time.CONCLUSIONS:RAIS has strengthened ethical regulatory compliance and provided an effective platform for tracking regulatory processes, thus enabled continuity of study activities with timely annual renewal approvals and greatly supported the tracking of staff GCP certificates.
PP171 Immuno-Oncology: A Patient Perspective
Authors: Rubinstein Judith , Ho S. Yin , Rubinstein Emily , Sliman Rachel 
Published: January 2018

INTRODUCTION:New immunotherapies have had great successes, but also incredibly debilitating side effects for patients. This discrepancy needs to be a focus of pharmaceutical companies because it will affect the way Health Technology Assessment (HTA) agencies review drugs. Two or three case studies of patient and caregiver experiences surrounding immuno-oncology clinical trials, both past and ongoing, will be used in order to gain a better understanding of how these trials have impacted individuals.METHODS:Conduct in-person or telephone interviews with patients and their caregivers to find out more about patient experiences and see how key takeaways can help pharmaceutical companies better prepare submissions for HTA agencies as they launch future immuno-oncology drugs.RESULTS:Preliminary results indicated that a patient completed a course of treatment and is very happy with the results. She had metastatic melanoma on her scalp. When she was being prepared for surgery, two new tumors on her scalp were discovered. As a result, she was included in a melanoma clinical trial.Another patient is still undergoing treatment and is responding, but is experiencing severe side effects that are impacting his life and that of his primary caregiver. He was hospitalized once for sepsis.CONCLUSIONS:Patient experiences can wildly vary. It is an area that needs more careful study, using both formal metrics and individual stories. Giving more attention to quality of life creates an opportunity for stronger submissions to HTA agencies and better assessments by those agencies.
VP24 The Development Of A Quality Management Tool For Health Technology Assessment Agencies In Spain
Authors: Márquez-Peláez Sergio , Gutiérrez-Ibarluzea Iñaki , Asua José , Molina-Lopez Teresa , Castro-Campos José Luis , Garcia-Armesto Sandra , Bono-Vega María , Bugarín-González Rosendo , Riobóo Janet Puñal , Luengo-Matos Setefilla , Brezmes-Delgado Ana , Suton Victoria Serra , Reynolds Jillian Margaret , Gonzalez-Enriquez Jesús , Serrano-Aguilar Pedro , Trujillo-Martin M. Mar 
Published: January 2018

INTRODUCTION:The Spanish National Network (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. The necessity of considering a Quality Management System has been detected and, consequently, a common tool for all the members needs to be developed. We describe in this study the process to achieve that goal.METHODS:Based on both a review of previous literature and the proposal for a self-evaluating tool, a group of experts from each agency through consensus have developed a tool for self-evaluation in Health Technology Assessment (HTA) agencies. Through the structure described in the handbook of the Andalusian Agency for Healthcare Quality (ACSA), each standard should have a statement or proposal that needs to also include evidence or good practices, and the corresponding evaluation questions. In separate workgroups, the definition of these proposals, evidence and evaluation questions were developed. One face-to-face meeting and two meetings via teleconference were necessary to achieve a final document with all the quality standards.RESULTS:From a proposed structure of sixty-six standards, the titles, definitions, statements and evidence as well as good practices and evaluation questions were established in workgroups with consensus among all of the members (1 - 3). The final version of the self-assessment tool was composed of sixty-eight standards, grouped in twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process, and IV Resources.CONCLUSIONS:Quality management requires an evaluation tool and this version, based on a systematic review and consensus, is a useful and practical instrument for developing a handbook by each member of REDETS. An online version of the tool is in process of development.
VP46 Cost Analysis Of Popliteal Aneurysm Management
Authors: Pinget Christophe , Allain Elisabeth , Saucy François 
Published: January 2018

INTRODUCTION:Popliteal artery aneurysm (PAA) is the most common peripheral arterial aneurysm and the second most common aneurysm after abdominal aortic aneurysm (AAA). It presents a risk of occlusion, which may lead to acute ischemia and leg amputation. To prevent these risks, asymptomatic PAA >2cm and symptomatic PAA must be treated. Although open PPA repair (OPAR) is still the gold standard, endovascular PAA repair (EPAR) is increasingly used to manage PAA. The objective of this study is to compare the cost of these two medical procedures from the hospital perspective.METHODS:Data were retrieved from the administrative database of Lausanne University Hospital (CHUV – Switzerland). Based on diagnostic codes and medical procedure codes, we selected all patients who underwent OPAR or EPAR between 2011 and 2015. Patient's age, length of stay and cost were compared between both groups using Student t-test.RESULTS:We included seventy-three patient stays (OPAR forty and EPAR thirty-three). Gender balance was identical between groups (97 percent of male), but age was statistically significantly different (OPAR 67.5, EPAR 73, p = .04). EPAR induced shorter mean length of stay (5.1 days versus 11.7 days, p = .0000) and lower mean global cost (CHF 16,555 versus CHF23,514, p = .0085). Cost of procedure amounted to CHF 9,536 for OPAR versus CHF 3,848 for EPAR, medical supply and implants amounted to CHF 1,284 for OPAR versus CHF 7,041 for EPAR and other costs of hospital stay amounted to CHF 12,694 for OPAR versus CHF 5,666 for EPAR. (CHF 1.00 = USD1.00 = EURO 0.93)CONCLUSIONS:With higher patency rate, OPAR is still associated with better medical outcomes than EPAR. But EPAR is significantly less costly than OPAR. Implant cost of EPAR is more than offset by longer length of stay and operating time of OPAR.