bluuebunny/crossref_metadata_2025 huggingface dataset:
OP72 Adherence Of Budget Impact Analyses To Principles Of Good Practice
Authors: Favato Giampiero , Oliva Cristina , Noikokyris Emmanouil
Published: January 2018

INTRODUCTION:

Budget Impact Analysis (BIA) is an integral element of a comprehensive Health Technology Assessment. Prior systematic reviews showed significant methodological dissimilarities in BIAs published from 2002 to 2015 (1,2). Aimed to improve the generalisability and transferability of outcomes, a guidance on methods was updated in 2014 (3). The objective of this study was to measure the adherence to Principles of Good Practice of BIAs published after the release of the updated guidelines.

METHODS:

Fifteen features representative of methodological appropriateness were identified from the Principles of Good Practice. A systematic review of the extant literature was conducted to identify BIAs published from January 2015 to December 2016. The adherence of each BIA to the Principles of Good Practice was defined by the number of representative characteristics taken into consideration as a percent of the total.

The full study protocol is available online: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016049287

RESULTS:

A sample of thirty-nine published BIAs were included in the analysis. The mean adherence of BIAs to the Principles of Good Practice was 69 percent (10.4 representative features out of 15). The highest adherence was 87 percent, while the lowest was 33 percent. The distribution of the scores was highly concentrated around the mean value, with thirty-four BIAs (87 percent of total sample) showing a level of adherence ≥ 60 percent. Only two BIAs reported an adherence < 50 percent (5 percent of total sample). Six representative features showed a level of adherence < 50 percent: off-label use (0 percent); uncertainty (26 percent); validation (33 percent); choice of computing framework (44 percent); eligible population (44 percent) and relevant features of healthcare system (49 percent).

CONCLUSIONS:

Compared to the Principles of Good Practice, the BIAs included in the systematic review were overcomplicated and deterministic, ignoring the impact of possible scenarios relevant to budget holders. The research advocates a wider use of scenario planning as a tool to link uncertainty to the economic assessment of new interventions.
OP73 Using Visualization In Scoping The Literature For A Prognostic Health Technology Assessment
Authors: Clowes Mark
Published: January 2018

INTRODUCTION:

One of the challenges of large scale Health Technology Assessment (HTA) projects is managing the large volume of studies retrieved by the requisite comprehensive literature searches. At the scoping stage of the project, a pragmatic judgement needs to be made as to how sensitive the search strategy should be in order to find all the relevant papers without returning an overwhelming volume of irrelevant studies.

METHODS:

For this HTA (evaluating prognostic and predictive markers in rheumatoid arthritis), the research team already had prior knowledge of several key markers of interest, but wanted to ensure that no others had been missed. Advice from practising clinicians was obtained, but for additional validation, a broad scoping search was conducted for ‘rheumatoid arthritis’ using the sensitive Haynes filters for prognostic (1) and clinical prediction (2) studies. Unsurprisingly, this initial search retrieved too many studies for them all to be admitted to the full review; but once those dealing with known markers had been removed, a sample of the remaining records was loaded into a software visualization tool (3) to display “heat maps” of frequently occurring terms and phrases.

RESULTS:

On this occasion, no additional markers were identified, however this provided reassurance that the advice obtained from clinicians was comprehensive, enabling the HTA team to proceed confidently with its evaluation of the selected markers.

CONCLUSIONS:

Visualization offers an alternative means of exploring and interrogating large text archives, and has the potential to complement the role of traditional search methods in identifying literature for systematic reviews and health technology assessments. As processing power increases and more and more full-text papers become available open access, it may provide a solution to some of the limitations associated with comprehensive searching.
OP79 Experimenting HTAi Patient Group Submission Template To Involve Patients
Authors: Lo Scalzo Alessandra , Amicosante Anna Maria Vincenza , Gillespie Francesca , Chiarolla Emilio , Jefferson Tom , Cerbo Marina , Paone Simona
Published: January 2018

INTRODUCTION:

The Health Technology Assessment International (HTAi) community recognises the importance of including patients’ views from published research and systematically obtaining input from patient organizations (POs). The HTAi's Patients and Public Involvement Subgroup has elaborated the Patient Group Submission Template for HTA (HTA Template) to facilitate the collection of evidence from patients via POs involvement. In 2015 AGENAS outlined a procedure to involve POs and tested the HTA Template within a Health Technology Assessment (HTA) report on dialysis.

METHODS:

The HTAi template was translated into Italian and adapted to the HTA report's specific information needs: to understand patients’ experiences with different dialysis modalities and any delivery problems at the regional level. Some questions were reformulated, others were cut and two different versions of the template were used. One was tailored to POs representatives and the other to individual patients selected with a purposive sampling procedure. We provided the HTA Template to POs appointed by an umbrella organization, Cittadinanzattiva, for their input and to identify other relevant POs to be involved. We identified a list of four associations, based on geographical location and typology of patients. Each POs representative completed the first template and administered the second one to, at least one patient for each five dialysis modalities. AGENAS staff provided support on a cascade basis POs collected and returned all templates.

RESULTS:

Researchers performed a thematic analysis of the answers received and this input was introduced in the HTA report within the chapter on Patients Aspects. Patients’ experiences closely corresponded to the ones in our qualitative literature's systematic review. However, PO representatives templates revealed an important problem of equity in access to different dialysis modalities across regions that we highlighted in the HTA report's recommendations.

CONCLUSIONS:

One of the template's limitations was related to self-administration. In some cases, a lack of familiarity with communicating one's views in writing may have affected the survey's informative power. This pilot also demonstrated the need for a more inclusive involvement procedure, as some important POs were not initially represented by the umbrella organization.
OP97 Program Budgeting Marginal Analysis For The Real World
Authors: Anderson Philippa
Published: January 2018

INTRODUCTION:

Program budgeting marginal analysis (PBMA) accommodates economic analysis, multi-stakeholder inputs, values, needs and perspectives within one framework in order to determine optimal use of available resources to deliver the highest ‘health value’. Two pilot PBMA projects in two different services were conceived and completed in a Welsh Health Board (HB) as ‘proof of concept’ methodology for robust prioritization decisons and for improving quality of patient care, outcomes and experience. The pilots were essential to enable development of a ‘bespoke’ PBMA process for the HB to implement.

METHODS:

The PBMA methods were based on methods and criteria for successful PBMAs reported in the literature. Project teams and stakeholder communities supported the PBMAs which were executed over a 12 -18 month period between 2013–15. Group decision support methods were used to facilitate meetings and decision making. Formal interviews with project team members and informal feedback informed development of the final PBMA framework.

RESULTS:

Identifying the costs and resources attributable to services and those that could be moved around services was challenging. Evidence of outcomes and ‘health value’ was more easily available. One PBMA pilot recommended that some modest service reorganization and quality improvement could be made within budget but no substantial improvement/decommissioning could be undertaken. The other pilot agreed a disinvestment decision on the basis of evidence and reallocated the resources to a higher value service. The HB commissioning team found the information from the PBMA ‘journey’ as useful as the recommendations. A PBMA framework for the HB was devised.

CONCLUSIONS:

A ‘Prudent PBMA’ framework trimmed back to the critical essentials enables success criteria to be met. PBMA is to be adopted as a ‘way of working’ to operationalize resource reallocation and disinvestment in the ‘real world’ of Welsh healthcare commissioning.
OP123 Health Technology Assessment In Digital Health: A Rapid Approach To Assess Health Apps
Authors: Dillon Bernice , Powell John , Campbell Mark , Salmon Mark , Marlow Mirella
Published: January 2018

INTRODUCTION:

The Health Technology Assessment (HTA) of mobile health applications involves significant challenges including rapid product development cycles, sparse evidence and uncertainty over the economic impact. However apps also provide unique opportunities, such as their potential reach and use of real-world data, which will facilitate their contribution to healthcare delivery. The National Institute for Health and Care Excellence (NICE), alongside other agencies, has been piloting the development of a health app assessment programme. This presentation reports the results of a study about the development of the Health App Briefing (HAB) which is designed as the output from a rapid assessment of the effectiveness and cost-saving potential of apps to inform decision makers in the United Kingdom National Health Service.

METHODS:

The HAB is built on the success of the NICE Medtech Innovation Briefings programme because many of the HTA challenges are similar to those found with medical devices. HAB development is grounded in four principles: rapid assessment; transparent process; independence from industry or the health service and input from commentators. The content includes an evidence summary for effectiveness including comments from specialist experts and users; a summary of information relating to the cost saving potential and a summary of other user benefits (including issues of access and usability). Novel features are the presentation of a rating of the potential value of the app to the health system and working with commissioners of the app to obtain real-world information for a case study about the economic impact.

RESULTS:

The development of four HABs along with a review of the learning from the piloting process will be presented. The review will include stakeholder feedback from a workshop.

CONCLUSIONS:

We believe the evaluation of this work presented here will be of interest to other HTA agencies around the world that are deciding how to approach the issues surrounding the assessment of health apps.
OP127 Analysis Of The Competencies To Be Acquired In Health Technology Assessment
Authors: Chiumente Marco , Gutiérrez-Ibarluzea Iñaki , Mueller Jani
Published: January 2018

INTRODUCTION:

Health Technology Assessment (HTA) is a multidisciplinary activity that systematically examines different dimensions related to the direct and indirect consequences of health technologies when implemented in healthcare systems. HTA is developed by multidisciplinary teams in order to cover all the mentioned dimensions. However, the quality of the processes produced by HTA teams will depend upon the competencies that those teams will acquire and incorporate including knowledge, skills and attitudes (1). The aim of this research was to determine how well these dimensions and competencies are covered in HTA academic Masters degree courses and manuals.

METHODS:

We analyzed what had been done in terms of competencies definition in HTA: how it has been reflected; theoretically and according to the authors, and how competencies can be structured; know-how and values. We explored HTA manuals and HTA academic Masters degree courses. We searched in Google with specific terms: building capacities, HTA, programs, Masters, diplomas. We used the HTAi vortal and the information related to courses (for example Masters degrees) and HTA agencies and network webpages for programs. The inclusion criteria were formal programs that describe HTA capacity building and not partial teaching of certain aspects of HTA and we excluded non-recognized institutions, or where there was no description of the programs or lack of detail regarding objectives and competencies to be achieved.

RESULTS:

We found 105 courses or programs and analyzed 8 reports and 3 manuals. The main challenges that we faced were: that information was difficult to retrieve, not similarly structured, difficulties to find key information in webpages, no program description at all in some cases and the need to contact institutions staff or register as a student to receive the information and finally, it was difficult to obtain contact details of key people. We structured the information on competencies in knowledge, skills and attitudes.

CONCLUSIONS:

The analyzed Masters degree courses and manuals did not cover all of the dimensions of HTA analysis in an equal and standardized way. The ethical, legal, social and organizational aspects were lacking in some of the programs, while, on the contrary, clinical and economic aspects were substantially included. On the basis of the information retrieved it would be good to define core competencies for HTA.
PP018 Clinical Risk Prediction Scores For Venous Thromboembolism In Hospitalized Patients
Authors: Mitchell Matthew , Mull Nikhil , Hecht Todd , Umscheid Craig
Published: January 2018

INTRODUCTION:

Risk prediction scores have been devised to identify patients at increased risk for Venous Thromboembolism (VTE) in different patient populations and settings. Guideline recommendations for VTE risk assessment vary greatly. We performed a systematic review to synthesize evidence on clinical risk prediction scores for VTE in hospitalized medical and surgical patients.

METHODS:

We systematically searched Medline, EMBASE, Cochrane, National Institute of Health and Care Excellence (NICE), National Guidelines Clearinghouse (NGC), and Guidelines International Network (GIN) databases up to March 2016. We included studies validating risk prediction scores for adult hospitalized patients. We excluded studies for any of the following reasons: non-English publication, conducted in non-OECD (Organisation for Economic Co-operation and Development) countries, validation cohorts focused solely on critical care patients, or scores developed for specific surgical or medical sub-specialty populations. We plotted receiver operating characteristic (ROC) curves of included studies and performed summary ROC meta-analyses for scores in which >1 external validation studies were combinable. Risk of bias was assessed qualitatively. We assessed the strength of the evidence base using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

RESULTS:

We screened 110 primary studies and included 18 of those for analysis. There were seven studies of the Caprini score, three studies of the Padua score, two studies of the IMPROVE score; and one study each of the Arcelus, Geneva, Khorana, RAP, and Kucher scores . Strength of evidence was downgraded for study risk of bias because most studies disproportionately included patients at high risk of VTE. Our summary estimates of the performance of the three combinable scores at clinically-relevant thresholds are: Caprini score at a threshold of three in surgical patients – 96 percent sensitivity, 44 percent specificity; IMPROVE at a threshold of one in medical patients – 96 percent sensitivity, 20 percent specificity; and Padua at a threshold of 4–87 percent sensitivity and 58 percent specificity.

CONCLUSIONS:

There is moderate strength evidence for use of the Caprini score to predict VTE in surgical patients and for the Padua and IMPROVE scores in medical patients. Lower thresholds may be warranted to achieve sufficient sensitivity to identify low risk populations who may not require routine VTE prophylaxis. Studies making direct comparisons of risk prediction scores in similar patient populations are lacking and are necessary to ascertain which score is most effective.
PP025 Thrombopoietin Receptor Agonist For Treatment Of Adults With Chronic Immune Thrombocytopenic Purpura
Authors: Ying Huang Grace Li , Churn-Shiouh Gau
Published: January 2018

INTRODUCTION:

This study aims to report the clinical effectiveness and cost-effectiveness of Thrombopoietin (TPO) receptor agonist for the treatment of adults with spontaneous Immune Thrombocytopenic Purpura (ITP) in Taiwan.

METHODS:

In the clinical effectiveness evaluation section, particularly for the TPO receptor agonist, we searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials to identify all randomized trials in chronic ITP. In the economic evaluation section, we performed a long-term cost-effectiveness analysis using a Markov model to evaluate the value of TPO receptor agonist to achieve durable platelet response for chronic ITP patients.

RESULTS:

Our findings revealed that the National Health Insurance (NHI) in Taiwan covers TPO receptor agonists romiplostim and eltrombopag, which have also been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) of Australia and the National Institute for Health and Care Excellence (NICE) in the United Kingdom. In addition, a systematic review and meta-analysis combining six trials were included to assess the current evidence on the role of TPO receptor agonist in chronic ITP. The primary outcome of randomized controlled trials (RCTs) showed an improving trend in significant bleeding events; however there was not any significant difference between the TPO receptor agonists group and the control group (placebo). The gain in life years and quality-adjusted life-years (QALYs) from introducing long-term use of TPO receptor agonists over current clinical practice were 1.52 years and 1.44 QALYs, respectively. Most of the sensitivity analysis results show that the ICER values were greater than 3GDP per capita in Taiwan.

CONCLUSIONS:

Compared to placebo, and despite a significantly increased platelet response, there was no evidence to demonstrate that TPO receptor agonists did improve significant bleeding events in chronic ITP. The effect on overall survival awaits further analysis. Although long-term studies are lacking, current data demonstrated that adverse effects of TPO receptor agonists were similar to that of placebo.
PP049 Exploring The Utility Of A Validated Quality Appraisal Tool
Authors: Moga Carmen , Guo Bing , Harstall Christa
Published: January 2018

INTRODUCTION:

The Health Technology Assessment (HTA) researchers at the Institute of Health Economics, in collaboration with researchers from two HTA agencies in Australia and Spain, developed, piloted, and validated a 20-criteria quality appraisal checklist specific for case series studies (before-after single arm studies with no control group) (1,2). Since its publication in 2012, the use of the checklist has spread globally through the HTA community and to researchers in other areas. This presentation will briefly introduce the tool, summarize user experiences, outline potential challenges, and provide practical solutions for using or adapting the checklist to various HTA topics.

METHODS:

Feedback from fifteen researchers was collected informally by email and/or formally by questionnaire. The questions included focused on the relevance, clarity, and usefulness of the checklist and its instructions, as well as potential revisions and/or addition of other criteria.

RESULTS:

While some of the checklist's criteria apply to all studies of a particular type, others are specific to the research question and/or the technology under investigation; discussion on the modification and/or adaptation of the checklist and its instructions is therefore required before commencing appraisal. Some criteria are difficult to score owing to study reporting limitations. Quality assessment can be challenging when multiple types of studies are included; however, currently there is no single universally validated tool available for diverse study designs. There are frequent demands for a cut-off point in order to separate high- from low-quality studies. However, no scale or numeric scoring was developed for the checklist, due to the well-recognized risks associated with such a scoring system.

CONCLUSIONS:

The increased use of the checklist and general positive feedback indicates the need for such a tool. User feedback helped improve our understanding of the checklist's applicability with various topics, as well as the potential refinements needed to increase its utility and robustness.
PP052 Hospital-based Health Technology Assessment Of Prasugrel In Patients With Stent: Outpatient Use
Authors: Costa Márcia Gisele , Santos Marisa , Peixoto Rafaela
Published: January 2018

INTRODUCTION:

A reference hospital, specialized in cardiology, has standardized clopidogrel, ticagrelor and recently the incorporation of prasugrel was approved with an estimate of fifteen patients with stent implantation monthly. Stent thrombosis is a rare but serious complication and it is recommended that patients be treated with antiplatelet therapy. Considering the existing therapeutic options and the low adherence to treatment, a cost study was requested to discuss a disinvestment proposal.

METHODS:

Perspective of the hospital; Population: patients with myocardial infarction and stent implantation; Intervention: prasugrel; Comparators: clopidogrel and ticagrelor; Outcomes of interest: stent thrombosis and major bleeding; and types of study: meta-analyses and randomized clinical trials. Literature review was performed in the Medline database, via Pubmed and performed meta-analysis. Cost estimates: data collection made in the institution's database.

RESULTS:

Thirteen articles were selected; there are no differences in the outcomes for prasugrel and ticagrelor; discontinuation of treatment is the most important risk factor for stent thrombosis and major bleeding is an important predictor of nonadherence to treatment. Quantitative analysis: three clinical trials. All showed a superiority of prasugrel and ticagrelor over clopidogrel for outcome of stent thrombosis (Odds Ratio, OR .60 Confidence Interval, CI 95 percent [.40; .90]), which was committed by the heterogeneity of studies (I2 = 64 percent); and favorable outcome for clopidogrel compared to ticagrelor and prasugrel for the outcome of major bleeding (OR 1.28 CI 95 percent [1.10; 1.50]). Annual cost with treatment of the fifteen patients: clopidogrel = USD5,765.86; prasugrel = USD41,047.48; and ticagrelor = USD44,081.30.

CONCLUSIONS:

The evidences found support the opening of a disinvestment process and suggest to the managers of the institution a reflection on: strategy to optimize adherence to treatment; and especially in the cost of opportunity with new technologies about 10 times more expensive.
PP066 Disseminate Results Through Social Video And Social Networks
Authors: Eksell Susanne , Egenvall Debora
Published: January 2018

INTRODUCTION:

We are experiencing a fundamental change in the way our target groups interact with information online, moving from passive consumption to more active creation of content, for example social video and social networks. This means a great potential in reaching more people in a cost-effective way which in the end will result in greater impact.

METHODS:

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), have developed an easy way to produce and disseminate our results through social video and social networks.

SBU has a special social media editorial committee for communication via social media, which includes participants from different departments. The editorial committee discusses on a weekly basis the issues to be raised on the agency's Twitter and LinkedIn accounts.

SBU works actively with social video as a message channel. During the past year several videos have been published with various themes (1 - 3). All of the members of the social media committee have attendend a short training course in order to be able to produce and publish social videos. For shorter production, we make ourselves with iPhones and editing with iMovie or Adobe Premiere Pro. For more extensive videos we produce together with a production agency.

RESULTS:

The number of followers on Twitter have increased from 500 in December 2015, to 1,400 in December 2016. Our followers are for example professors, doctors, nurses, physiotherapists, journalists, politicians, and opinion makers from patient organizations.

In our latest recruitment processes we have been experiencing significant number of qualified candidates, who found the link to our website through social media networks like Facebook and LinkedIn.

CONCLUSIONS:

Social media should be at the heart of digital transformation as it crosses boundaries: you will have a broader impact and it has a great potential in reaching your target groups in a cost-effective way.
PP069 Health Technology Assessment Of Radium-223 Dichloride In Resistant Metastatic Prostate Cancer
Authors: Kheiraoui Flavia , Ferriero Anna Maria , Sacchini Dario , Tucci Marcello , Procopio Giuseppe , Ricardi Umberto , Fanti Stefano , De Vincentis Giuseppe , Danesi Romano , Restelli Umberto , Croce Davide , Vecchio Fabio , Bianchi Cosetta , Favaretti Carlo
Published: January 2018

INTRODUCTION:

Metastatic castration-resistant prostate cancer (mCRPC) is an incurable disease and represents a significant clinical, economic, and social burden. The therapeutic scenario of mCRPC has completely changed over the last years with the approval of several treatments (1). Radium-223 is a new target-alpha therapy showing a significant survival benefit in mCRPC patients (2,3). The study aimed to evaluate the introduction of radium-223 in Italy using Health Technology Assessment methodology.

METHODS:

To assess epidemiological, clinical, economic, organizational, social, and ethical aspects, a literature review was carried out. A cost-effectiveness and a budget impact analysis were performed from the National Health Service (NHS) perspective to compare radium-223 with other treatments and determine the budgetary impact of the utilization of radium-223 for the treatment of mCRPC.

RESULTS:

In Italy, prostate cancer represents the most diagnosed cancer in men and the third in the whole population. When the disease becomes metastatic, approximately 80 percent of patients develop bone metastases, commonly associated to skeletal-related events (SREs) with a significant impact on survival, quality of life, and costs (1). Radium-223 is a novel alpha particle emitting therapeutic agent which targets new bone growth surrounding bone metastases. Different from other radiopharmaceuticals, radium-223 prolongs overall survival with a favorable safety profile (2,3). In order to optimize patient outcome, the management of radium-223 should be viewed in a multidisciplinary context. The administration is quite simple and requires only basal shielding. Currently it can be administered in hospital inpatient settings and in some regions the outpatient usage is allowed. Finally, radium-223 showed a favorable budget impact profile and cost-effectiveness when compared with best supportive care and new therapeutic agents (abiraterone, enzalutamide, cabazitaxel) (1).

CONCLUSIONS:

The introduction of radium-223 allows provision of a new therapy, offering a valid alternative to patient with mCRPC without any increase of costs for the NHS.
PP097 Challenges Of Rapid Reviews In Health Technology Assessment: Case Study From An Italian Region
Authors: Negro Antonella , Camerlingo Maria Domenica , Maltoni Susanna , Trimaglio Fabio
Published: January 2018

INTRODUCTION:

Rapid reviews are an attractive tool for Health Technology Assessment (HTA) as they may be a support in decision making when time and resources are limited. Rapid reviews are carried out in few weeks (from 3 weeks to 6 months) and require adjustments from standard systematic review methods. Methodology on how to carry out rapid reviews is still debated and guidance regarding the most suitable method to apply is lacking. Kaltenthaler (1) has recently proposed a checklist of items to be considered when undertaking a rapid review. We appraised our rapid assessment on the use of frequency domain (FD)-optical coherence tomography in percutaneous coronary interventions, based on a rapid review of the literature, using the items proposed (1).

METHODS:

The checklist reports four key points to consider when planning a rapid review: (i) scoping search - needed to quantify the available evidence and to inform rapid review protocol, (ii) results reporting – considering heterogeneity of intervention, comparators, and outcomes, (iii) clear communication with policy makers - ensuring that review responds to the policy question and (iv) reporting on methods - methodology used, strengths and limitations.

RESULTS:

When we applied the checklist proposed by Kaltenthaler (1) to our rapid review on the use of FD-optical coherences tomography it resulted that: the scoping search revealed no useful systematic reviews to answer policy-makers questions and a high number of relevant studies. For results presentation, we used a narrative synthesis reporting outcome data grouped in domains previously defined by an evidence profile. Domains consisted of technical performance, safety, efficacy, and change in management. No meta-analysis was performed due to paucity of randomized controlled trials (RCTs) for the efficacy domain and high heterogeneity in outcomes measures for technical performance. Analysis of some of the outcomes was extremely time-consuming (technical performance) and did not provide particularly useful information for the commissioning body. A clearer and more intensive dialog with policy makers to adjust extent of research question and/or outcomes to be investigated would have probably improved usability for final users. Description of methods was partial.

CONCLUSIONS:

The checklist by Kaltenthaler (1) helped us to reflect on the method we used to carry out rapid reviews and to pinpoint possible solutions to improve it.
PP107 Amiodarone For Arrhythmia In Chagas Patients: A Systematic Review
Authors: Cruz Luciane , Stein Cinara , Migliavaca Celina Borges , Colpani Verônica , Miguel Sandro , Falavigna Maicon
Published: January 2018

INTRODUCTION:

Chagas disease, caused by the protozoan parasite Trypanosoma cruzi, is a neglected chronic condition with a high burden of morbidity and mortality. It affects about 6 million people in twenty-one countries of Latin America, and has recently become a global health concern (1), especially due to immigration from endemic areas into the developed world. Cardiac arrhythmias are common in patients with Chagas cardiomyopathy and amiodarone has been widely used as an antiarrhythmic drug. Amiodarone has been recommended as the treatment of choice for all patients with sustained ventricular tachycardia (2). The objective of this systematic review is to evaluate the effect of amiodarone in arrhythmia patients with the cardiac form of chronic Chagas disease.

METHODS:

Searches was conducted in MEDLINE (PubMed), EMBASE and LILACS from the inception to December 2016. Studies regarding the use of amiodarone to treat arrhythmia in patients affected by Chagas disease were included, and the outcomes were arrhythmia, adverse effects and sudden death. Selection of articles and data extraction were made by two independent reviewers.

RESULTS:

The database search found 378 articles but only 9 studies with 373 subjects fulfilled the eligibility criteria. The nine studies selected were composed of case series (two), crossover clinical trials (two), and clinical trials (five). Results showed that amiodarone reduced ventricular extrasystoles in all studies and ventricular tachycardia in eight studies. During treatment with amiodarone, patients in eight studies had side effects. Corneal microdeposits and gastric discomfort were the most common adverse effects present in studies. Three studies reported sudden death during follow-up.

CONCLUSIONS:

Amiodarone seems to be an effective antiarrhythmic drug for Chagasic patients, reducing uncomfortable symptoms such as tachycardia. This information can be useful in the primary care context, supporting general practitioners to manage Chagas cardiopathy, mainly when specialized cardiologic consultants are not available.
PP116 Data Linkage Across Ambulance Services And Emergency Departments
Authors: Porter Alison , Halter Mary , Clark Sophie , Dorning Holly
Published: January 2018

INTRODUCTION:

Most callers to emergency ambulance services are transported to hospital emergency departments (EDs), but ambulance services receive no information on patient outcomes. Pre-Hospital and Emergency Department (PHED) Data is a two-year mixed-methods observational study of the process and potential benefits of linking ambulance and ED data to allow analysis of patient outcomes. We report on our first aim, to examine the potential opportunities and challenges of this data linkage initiative.

METHODS:

We approached six hospital trusts in an English metropolitan area. We used a structured learning log to collect data on the process, time input and reflections. We analyzed these data with descriptive statistics, and qualitatively for themes.

RESULTS:

All six trusts agreed to participate. We used an algorithm based on date, time and patient demographics to link data. We achieved a dataset of 775,018 records covering 2012 – 2016, and a linkage rate of 81 percent.

Initial set up tasks within the ambulance service took 30 hours 20 minutes. We then identified five stages of tasks with each hospital trust: negotiating senior approval; exploring data availability; information governance agreement; data transfer; and linking. Mean time spent by the research team on these processes was 30 hours 30 minutes per trust (range: 17 hours 20 minutes to 43 hours 10 minutes), plus additional time from staff of hospital trusts. The most intensive phases were: negotiating senior approval (mean: 8 hours 5 minutes), and data linking (mean: 12 hours 40 minutes). The stage which took the longest was information governance (mean: 19 weeks).

Key themes included the positive attitudes of trusts to participating, the range of decision makers involved, and the need for sustained input from the research team.

CONCLUSIONS:

We found the process of data linkage was feasible, but requires dedicated time from research and trust staff, over a prolonged period, to achieve set up. Linked data are now being analyzed.
PP141 Legal Governance: How Does Law Circumscribe The Social Role Of Health Technology Assessment?
Authors: Bernier Louise , Legault Georges-Auguste , Daniel Charles-Etienne , Bédard Suzanne Kocsis , Béland Jean-Pierre , Bellemare Christian , Dagenais Pierre , Gagnon Hubert , Parent Monelle , Patenaude Johane
Published: January 2018

INTRODUCTION:

One of the barriers of integrating ethics in Health Technology Assessment (HTA) relates to the social role of HTA (1). The aim of this study is to provide a better understanding of the way by which law circumscribes the social role of HTA. Our hypothesis: HTA's social role is embedded within a mixed governance based on hard law and soft law.

METHODS:

Three HTA agencies were conveniently selected for our study: Haute Autorité de santé (HAS) (France), National Institute for Health and Care Excellence (NICE) (United Kingdom) and Institut national d'excellence en santé et en services sociaux (INESSS) (Québec, Canada). Our analysis of the legal, administrative and procedural documents relating to the existence and assessment processes of these three agencies is guided by the following criteria:

1.

The normative strength of the documents (categories of hard law or soft law) (2)

2.

The definition of the agencies’ social role (1)

3.

The integration of ethics in the agencies’ mandate.

RESULTS:

Hard law contributes to establish a general mandate and some legal legitimacy for these agencies. Soft law, grounded in the HTA producers' practices, plays a major role in the legal governance of HTA. Our results demonstrate that these agencies existing practices seem to circumscribe their social role further than their constitutive laws. In this context, social actors become responsible to define, structure and operationalize the implementation of HTA.

In addition, the legal framework (hard law) through which HTA unfolds does not clearly support its structural and social role. Despite existing legal frameworks, the normative legitimacy of HTA is not entirely established, as it depends on soft law. Taken altogether, this maintains a persisting conceptual vagueness in HTA governance.

CONCLUSIONS:

The social role of HTA should be defined either through modifying existing legislations (hard law) or through harmonization of the agencies internal policies and regulations (soft law). Such legal initiatives would help clarify the aims of HTA evaluations: assessments (scientific) or appraisal (value-laden), and therefore give a clearer indication on how best to integrate ethics in HTA.
PP147 Physician And Patient Reported Anxiety And Depression In Hemophilia
Authors: Jacob Ian , Camp Charlotte , O'Hara Jamie , Skinner Mark , Walsh Shaun
Published: January 2018

INTRODUCTION:

Anxiety and depression are major drivers of health-related quality of life, adherence to therapy, and motivation to self-manage chronic conditions. A number of studies have shown rates of anxiety and depression to be higher among individuals with hemophilia compared to that of the general population (1). As the primary point of care for persons with hemophilia, hematologists are well-placed to assess the mental health state of their patients (2). The aim of this study is to explore physician- and patient-reported rates of anxiety and depression among a cohort with severe hemophilia.

METHODS:

Data were drawn from the Cost of Haemophilia across Europe – a Socioeconomic Survey (CHESS), a cost-of-illness study in severe hemophilia A and B across five European countries (France, Germany, Italy, Spain, and the UK) (3). Physicians provided clinical and sociodemographic information for 1,285 adult patients, 551 of whom completed corresponding questionnaires, including EuroQol EQ-5D-3L. We compared the self-reported EQ-5D with physician reports of anxiety and depression.

RESULTS:

Across the five countries, physicians recorded a diagnosis of anxiety disorder in 189 patients (15 percent; range 4 percent-28 percent) and depression in 178 patients (14 percent; range 10 percent-28 percent). Seventy-three patients (6 percent) recorded comorbid anxiety and depression. Forty-six percent of patients with anxiety and 58 percent of patients with depression were receiving some form of treatment for their condition.

Within the EQ-5D measure, 42 percent of individuals recorded problems with anxiety or depression, with 6 percent of patients reporting “extreme” anxiety or depression. Twenty-two percent of individuals with a self-reported problem were not recorded with a corresponding diagnosis by their hematologist; 39 percent of patients reporting “extreme” anxiety or depression were absent of any physician-reported diagnosis.

CONCLUSIONS:

Anxiety and depression are notable conditions within the hemophilia community, particularly so among those with severe condition. The mental health of individuals with hemophilia is an important aspect in ensuring therapy adherence and overall wellbeing and should be considered as part of a multidisciplinary approach to management of the condition.
PP148 Development And Evaluation Of A Tool Supporting Prescription Behavior
Authors: Lorenzoni Valentina , Ferrari Vincenzo , Freschi Cinzia , Turchetti Giuseppe
Published: January 2018

INTRODUCTION:

The increasing complexity of decision-making in clinical practice and the financial pressure requires clinicians to develop some background about the economic consequences of their decisions and to become more and more managers of pre-defined budgets. The present work aims at describing a simple technology solution that could support prescription decisions and illustrates the results of a preliminary assessment of the tool in a sample of professionals. The solution has been developed to allow informed decision-making in the prescription of oral anti-diabetic drugs (OADs) in type II diabetes mellitus (T2DM) patients by supporting prescriptive appropriateness.

METHODS:

The tool developed is compatible with many kinds of hardware architectures and the most diffused web browsers. The system allows real-time reproduction of economic evaluation of the different therapeutic options for the management of T2DM patients. Assessment of “ease to use” and “usefulness” of the tool was performed in a convenience sample of clinicians and pharmacists through a specific questionnaire.

RESULTS:

The tool was developed to compare dipeptidyl-peptidase inhibitors (DPP4i) with sulfonylureas, as second line therapy, for T2DM patients. The tool has a user-friendly Graphical User Interface allowing users to quickly and easily select the therapeutic options to compare, choosing geographical context, perspective of analysis, and changing some model parameters. Feedbacks obtained from thirty-three different professionals were generally positive for the “ease to understand information offered”, “ease of introduction of the tool to support usual working activity”, “usefulness within the usual working activity”.

CONCLUSIONS:

The study showed that the introduction of the tool as a support for clinicians in optimizing their practice could satisfy unmet needs of professionals by supporting informed prescriptive appropriateness in the choice of OADs as it allows to consider diabetes drug related costs in a comprehensive way. The routinely use of the tool developed could become a solution helping clinicians in the management of several diseases.
PP156 New Information And Communication Technologies And Hospitals' Design
Authors: Alves Eduardo , Bezerra Benefran
Published: January 2018

INTRODUCTION:

The hospital's design today must be prepared for changes resulting from the incorporation of new information and communication technologies (ICT) (1). These will affect non-finalistic (warehouse, archive), diagnostic support (laboratory and image) and finalistic activities (emergency, surgical center, clinics) (2). The Health Technology Assessment (HTA) is fundamental in the dimension of the impact of each technology on the structure of healthcare facilities (HCF). In this way, this work intends to evaluate the trends of impact of the new ICT on hospitals’ structure.

METHODS:

The main technologies under discussion in Management of HCF in Brazillian Health Regulatory Agency were raised. From this survey an impact matrix was built with hospital environmental design and the trends of adequacy of its space.

RESULTS:

ICT that tend to decrease the physical space are: electronic health record for the archive, use of digital imaging for radiology, Radio-Frequency Identification (RFID) for the warehouse, point of care and automated laboratory equipment for clinical laboratories.

ICT that tend to increase physical space are: Telemedicine for the surgical center, Internet of Things - IoT for Intensive Care Units, beds for emergency and hospitalization.

The technologies that present an undefined tendency in relation to physical space are: automatic dispensers of drugs for nursing posts.

The use of database servers and the need for network points are still undefined due to the use of Wi-Fi technology and cloud storage. However, it's possible to increase use of electricity and the internet.

CONCLUSIONS:

It is concluded that the new ICT will have an impact on the planning and building of the future HCF (3). The designs of today's buildings should consider this trend so that the future reality is adequate and the regulatory requirements about HCF should be able to consider it.
PP166 From An Institutional Strategic Plan To A Knowledge Transfer Tool For Health Technology Assessment: Case Of Drug-eluting Stents
Authors: Poder Thomas , Erraji Jihane , Coulibaly Lucien , Koffi Kouamé , Fisette Jean-Francois , Dagenais Pierre , Déry Véronique
Published: January 2018

INTRODUCTION:

Knowledge transfer (KT) of Health Technolgy Assessment (HTA) results presents numerous challenges, one being the lack of time of busy decision makers. Our hospital-based HTA unit is now part of a large network comprising 100 installations. To bridge the gap between complex HTAs and even more limited time by executive officers and managers, we needed to develop a new approach to deliver effectively key HTA messages. We initiated a new strategy with a report on drug-eluting stent (DES). DES may have the potential to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention (PCI). However, the technology is expensive and some concerns about safety remain. The second generation of DES stents show promising results in terms of efficacy and safety.

METHODS:

We conducted a systematic review of meta-analyses comparing bare-metal stents (BMS) with second generation DES. Data extracted were used to perform a cost-benefit analysis for our organization. Main findings were illustrated in relation to the strategic plan of our institution.

RESULTS:

As compared to BMS, the second generation of DES is very effective and potentially leads to huge savings. Safety is improved as regard to myocardial infarction, but not to mortality. For our institution, the use of second-generation DES has the potential to reduce waiting lists for a PCI. In an effort to improve clarity of the results and increase knowledge transfer among managers, we developed a new communication strategy involving the six axes considered as strategic by our Chief Executive Officer, namely: university mission, judicious use of resources, accessibility and quality of care and services, to build for and with the staff, and to act for and with the patient and his family. This led to a smart visual scheme directly showing the results in terms of what is important for our hospital. This initiative was very appreciated by managers.

CONCLUSIONS:

Using our institutional strategic plan to communicate our results allowed a greater visibility of HTA activities and was greatly appreciated by managers. This will help in disseminating our results locally and in promoting the utility of HTA.