bluuebunny/crossref_metadata_2025 huggingface dataset:
Interoceptive deficits, non-suicidal self-injury, and suicide risk: a multi-sample study of indirect effects
Authors: Hagan Christopher R. , Rogers Megan L. , Brausch Amy M. , Muehlenkamp Jennifer J. , Joiner Thomas E.
Published: January 2019

Background

Interoceptive deficits (ID) have been associated with non-suicidal self-injury (NSSI) and suicidal behavior in multiple studies. Many of these studies are limited in scope, and have not fully examined possible mechanisms explaining how ID affect suicidal behavior.

Methods

This study assesses how self-reported ID relate to suicide ideation and attempts in six distinct and geographically diverse samples of adults (n= 2706) and one sample of adolescents (n= 436). Participants responded to a variety of self-report questionnaires and interviews.

Results

Contrary to our hypothesis, self-reported ID were only associated with suicidal ideation in two samples, one of which was the adolescent sample. Largely consistent with our predictions, self-reported ID exhibited an indirect effect on suicide attempts through versatility of NSSI in four of the five adult samples tested. Finally, the indirect effects of self-reported ID on suicide attempts through NSSI versatility did not act indirectly through behaviorally assessed pain tolerance.

Conclusions

We found that, in adults, self-reported ID are not associated with suicidal ideation, but are connected with a history of suicide attempts, through an indirect effect via NSSI. Our findings also indicate that the mechanism of action leading from self-reported ID to suicidal behavior may differ between adolescents and adults, and relate to suicidal behavior independent of pain tolerance. Clinical implications and future directions are discussed.
MÁS ALLÁ DE PAMPLONA (NUEVA GRANADA): CIRCUITOS CACAOTEROS DEL SUROCCIDENTE DURANTE LA TRANSICIÓN, 1790-1821
Authors: Granados Oscar , Pinto José Joaquín
Published: January 2019

This article seeks to analyze the cocoa circuits during the final years of the Viceroyalty of New Granada, the transition towards independence and the beginning of the world cocoa crisis in 1820. Added to the traditional circuits of Guayaquil and Maracaibo linked with Pamplona, the article identifies circuits that were speculated to exist in the southwest of New Granada, but because they did not move large volumes, they were not considered for production statistics. These small productions supplied the domestic market, also exported or integrated into circuits from other places that had better interactions in international markets. It is not a microhistory of cocoa in remote regions, it is the history of a cocoa overshadowed by the visibility of others.
OP02 Real-World Experience For Health Technology Assessment In Hospitals
Authors: Tal Orna , Tal Inbal
Published: January 2019

Introduction:

Health technology assessment (HTA) is scientifically incorporating the demand, effectiveness and expedience of adopting innovative technologies, supported by evidence-based medicine. The rapid development of innovations led to an accelerated need to comprehend their benefit and satisfaction through actual utilization. ‘Real World’ Experience (RWE) in action is a source for collecting information through practice that has not yet been formally published. The target is to identify challenges and barriers in adoption, considerations on significant investment and local adjustment. This study aimed to assess the benefit of RWE as a tool for gathering information understanding and evaluating new technologies as candidates for public funding.

Methods:

Twelve new technologies were assessed by 36 technology-assessors from the Ministry of Health (MOH) and the hospital, and were ranked using two scales: (i) the contribution of using RWE to benefit the assessment mechanism, and (ii) the perceptual “value” of the technology.

Results:

Analyzing the contribution of RWE to HTA, 67 percent of the technologies reviewed were recommended for adoption. Low RWE ranking correlated with a decision to reject technology adoption. The most important “value” among all assessors on RWE was “innovation”, and among hospital assessors, the parameter “local adjustment” was cardinal. MOH assessors highlighted RWE to increase knowledge of regulators to encourage adoption. The aspect relating to economic burden received only medium ranking.

Conclusions:

RWE provides an essential contribution to HTA throughout all stages in the life of the technology, especially at early phases. It is an important methodology to gather evidence from the ongoing experience of clinicians, increasing awareness towards promising innovations and amplifying the confidence of decision-making. In this new era of HTA, new concepts arise on the horizon: multi-dimensional evaluations. Expert opinion and RWE are paving the way towards better understanding of beneficial technologies, even in the absence of formal published evidence.
OP20 When Are Nationally Available Discounts Introduced In NICE Appraisals
Authors: Noon Kathleen , Painter Christopher , Montgomery Stephen
Published: January 2019

Introduction:

Offering a nationally available discount has become common to increase the chance of being recommended by the National Institute of Health and Care Excellence (NICE). This study reviewed all NICE technology appraisals (TAs) since October 2007 to determine whether a national available discount was submitted, and explore when these discounts were introduced.

Methods:

All TAs between October 2007 and August 2017 were reviewed. The timing of the nationally available discount submission was allocated into one of four categories: initially submitted; initially submitted but changed; introduced after submission; or, other discount. An analysis was conducted to examine whether there was a temporal pattern in the introduction of nationally available discounts before or after January 2014, when the current Pharmaceutical Price Regulation Scheme (PPRS) came into effect.

Results:

Before 1 January 2014, a nationally available discount was only used in the minority of cases across recommended (22 percent of cases) and not recommended (19 percent) technologies. In the period since 1 January 2014, use of a nationally available discount increased overall, but to a greater degree in technologies ultimately receiving a positive recommendation from NICE (not recommended: 19 percent to 39 percent; recommended: 22 percent to 59 percent). In the period since 1 January 2014, the proportion of technologies with a positive recommendation where implicit price flexibility during the appraisal was revealed increased (from 20/186) to 40/182.

Conclusions:

With the current PPRS, the majority of technologies have offered a nationally available discount, most commonly at the time of submission; however, there is increasing evidence of implicit price flexibility during the appraisal process to achieve a positive recommendation.
OP29 The Impact Of Individual Patient Input; Strengthening The Evidence
Authors: Livingstone Heidi , Kastoryano Chloe , Thomas Lizzie , Verdiel Vassilia , Harris Kevin , Leng Gillian
Published: January 2019

Introduction:

The National Institute of Health and Care Excellence (NICE) assesses the efficacy and safety of interventional procedures for use in the National Health Service (NHS). Since 2006, NICE's Public Involvement Programme (PIP) has obtained ‘patient commentary’ to inform committee decisions, using a questionnaire asking patients about their experience of the procedure including benefits, disadvantages and side effects. Commentary is considered by the committee alongside other evidence. The PIP has piloted a project to: capture the impact of the patient commentary on the committee's decision-making; explore patterns of impact; and identify criteria that indicate when patient commentary may not be required.

Methods:

The pilot included all interventional procedures guidance started between February 2016 and February 2017. Committee members’ views were captured using a form completed whenever patient commentary was considered. Responses were anonymized, entered into an electronic system, analyzed, and correlated against ‘committee comments’ in the published guidance. After twelve months, there was an unrepresentatively narrow spread of conditions, and most topics were updating previously published guidance rather than novel topics. The pilot was therefore extended by six months.

Results:

Patient commentary commonly had an impact on decision-making; however, no discernible patterns have yet been identified, nor criteria for when it may not be required. Key findings were: (i) patient commentary is equally useful for guidance updates as novel guidance, and (ii) interpretation and assessment of ‘impact’ varied across committee members but the majority agreed it reinforced the other evidence.

Conclusions:

Patient commentary has a measurable impact on committee decision-making. Very occasionally it provides new evidence and routinely provides reassurance that the published evidence is substantiated by real-world patient opinion. Measuring the impact of commentary seems to have raised its profile, with more committee comments about patient issues included in guidance during the pilot than in preceding years. The project needs to be extended to identify which procedures are least likely to benefit from patient commentary and why.
OP30 From Framework To Action: Implementing Patient Engagement
Authors: Lang Amy , Wells David
Published: January 2019

Introduction:

This session will share lessons learned from implementing a comprehensive patient and public engagement framework (developed by winners of the 2017 Egon Jonsson Award) in one government agency's health technology assessment (HTA) process. The presentation will share strategic and operational considerations for successful implementation, and the early effects of patient involvement activities on the agency's HTA recommendations.

Methods:

This presentation used a case study approach to understand the application of the framework described above.

Results:

The comprehensive framework by Abelson and colleagues describes many different public and patient engagement activities that could be conducted at each stage of an HTA process. Health Quality Ontario has chosen to focus on engaging patients to: prioritize topics; develop an additional evidence stream on patient preferences and values; serve on a committee that reviews the HTA, deliberates, and makes recommendations; and provide feedback on draft recommendations. Strategic considerations for these decisions include: aligning engagement activities to an evidence-focused organizational culture, and investing in engagement activities earlier in the HTA process to allow for sufficient consideration of the patient voice in developing recommendations. These activities have impacted the agency's organizational culture, and evidence suggests they have also influenced recommendations for what should be publicly funded. Patient engagement activities have also led to increased feedback from the public and patients for some HTAs and the associated draft recommendations.

Conclusions:

Public agencies must make strategic decisions about how and when to invest scarce resources in patient and public engagement. Investing in direct patient engagement as an additional stream of evidence and supporting the involvement of health system users in decision-making has had a significant impact on HTA deliberations and recommendations. For some HTAs, these activities have facilitated greater public engagement as well.
OP33 Adopting Health Technologies: NICE Approach For Evidence Into Action
Authors: Chesworth Elaine , Wyart Katie , Chrisp Paul
Published: January 2019

Introduction:

Evidence and guidance alone do not change practice. A multitude of factors are influential upon whether a particular health technology is adopted in practice. The adoption team at the National Institute for Health and Care Excellence (NICE) engages with healthcare professionals to develop specifically tailored support for the adoption of NICE health technology assessments (NICE medical technologies, diagnostics and technology appraisal guidance).

Methods:

The NICE adoption team uses a structured process which involves engagement of healthcare professionals with experience or knowledge of the technology to identify the barriers to adoption. This information is used to populate the topic selection tool which presents the impact of adopting the technology under five headings: care pathway change; finance; difficulty to implement; education; and, patient acceptance. The result indicates which guidance would benefit from adoption support: plan and develop tailored solutions to address barriers to adoption which include a resource impact assessment and targeted communications; quality assure; and, publish tailored resources.

Results:

Examples of tailored outputs include: adoption resources sharing real world experiences of sites that have adopted the technology; and, NICE pilot projects, where the adoption team work closely with sites to support adoption of the technology at a local level. The team then share learning and results from the project to facilitate: engagement with national planning groups to coordinate wider scale adoption; resource impact assessments which help local cost impact of adoption to be estimated; engagement with general and specialist media; and, influencing national tariff.

Conclusions:

NICE's processes have evolved to facilitate the development of a wider variety of more tailored resources, to support adoption of NICE health technology assessments guidance into practice. We will continue to engage with healthcare professionals and be responsive in our processes to ensure the packages of adoption support are tailored to need.
OP60 Optimising Risk-Based Screening: The Case Of Diabetic Eye Disease
Authors: Sampson Christopher , James Marilyn , Whynes David , Eleuteri Antonio , Harding Simon
Published: January 2019

Introduction:

There is growing evidence that many people attending annual screening for diabetic retinopathy in the United Kingdom (UK) are at low risk of developing the disease. This has led to new policy statements. However, the basis on which to establish a risk-based individualized variable-recall screening program has not yet been determined. We present a methodology for using information on an individual's risk factors to improve the allocation of resources within a screening program.

Methods:

We developed a patient-level state-transition model to evaluate the cost-effectiveness of risk-based screening for diabetic retinopathy in the UK. The model incorporated a recently developed risk calculation engine that predicts an individual's risk of disease onset, and allocated individuals to alternative screening recall periods according to this level of risk. Using the findings, we demonstrate a means of estimating: (i) a threshold level of risk, above which individuals should be invited to screening, and (ii) the optimum screening recall period for an individual, based on the expected cost-effectiveness of screening and treatment.

Results:

The cost-effectiveness analysis demonstrated that standardized screening (current practice) is the least cost-effective program. Individualized screening can improve outcomes at a reduced cost. We found it feasible – though computationally expensive – to incorporate a risk calculation engine into a decision model in Microsoft Excel. In an optimized screening program, the majority or patients would be invited to attend screening at least two years after a negative screening result.

Conclusions:

Individualized risk-based screening is likely to be cost-effective in the context of diabetic eye disease in the UK. It is expected that risk calculation engines will be developed in other disease areas in the future, and used to allocate screening and treatment at the individual level. It is important that researchers develop robust methods for combining risk calculation engines into decision analytic models and health technology assessment more broadly.
OP68 Methods For The Economic Evaluation Of Precision Medicine
Authors: Pataky Reka , Regier Dean
Published: January 2019

Introduction:

Methods that accommodate heterogeneity in outcomes are not widely used in economic evaluation. With the growth of precision medicine (PM), where choice of treatment is informed by the molecular characteristics of the patient or disease, we expect to see greater heterogeneity in effectiveness and cost of interventions. Our objective was to compare analytical frameworks for valuing heterogeneity in economic evaluation, and consider their strengths and weaknesses for applications in PM.

Methods:

We conducted a literature review to identify papers that proposed an analytical framework for economic evaluation of a health intervention, and that placed a value on heterogeneous effects. We compared the frameworks considering the purpose of the analysis, including where in the product lifecycle the framework could be used, the types of PM interventions where the framework could be applied, and its ability to address methodological challenges of evaluating PM.

Results:

Five analytical frameworks were identified: covariate adjustment methods, value of stratification, value of heterogeneity (VoH), expected value of individualized care (EVIC), and loss with respect to efficient diffusion (LED) metrics. Each framework addresses a slightly different research question, and is suited to different settings and interventions. With the exception of covariate adjustment, all focus on maximizing net benefit within certain constraints and quantify the opportunity cost of ignoring heterogeneity. Only VoH considers the relationship between heterogeneity and uncertainty, and no framework explicitly includes the cost or uncertainty associated with identifying subgroups.

Conclusions:

The ability to value heterogeneity is a critical component of economic evaluations of PM. The choice of an appropriate analytical framework will help strengthen the quality of economic evidence available to support health technology assessment of PM technologies, informing PM adoption decisions, and supporting efficient allocation of health care resources.
OP73 Problems And Promises Of Health Technologies: The Merits Of Early Health Technology Assessment
Authors: Grutters Janneke , Govers Tim , Nijboer Jorte , van der Wilt Gert Jan , Rongen Jan , Rovers Maroeska
Published: January 2019

Introduction:

Novel health technologies are being developed at a dizzying pace. The need to avoid unnecessary innovations and accelerate the adoption of valuable innovations is among the most important challenges facing healthcare systems today. To contribute to this challenge, we performed 30 so-called ‘early health technology assessments’ (HTA) over the last three years. We quantified the potential value, both in effects and cost. We will present our experience with performing these constructive assessments, as well as their feasibility and value in informing decisions.

Methods:

We performed secondary analyses on an existing database of 30 assessments. We analyzed the phase of development, stakeholders involved, type of decision informed, and the technology's next steps.

Results:

Out of the 30 technologies, four (13 percent) were in the idea screening phase, and had not yet started the development. Here, the room for improvement (headroom) was assessed. For 16 (53 percent) technologies that were under development but not yet studied, we performed headroom and threshold analyses. For the 10 (33 percent) developed technologies where some (pilot) data were already available, scenario and/or cost-effectiveness analyses were performed. The assessments, that were commissioned by developers, clinicians or hospital managers informed evidence-based decisions on (further) development, focus, research design or adoption in clinical practice. Preliminary results suggest that after the assessment, decisions were made to stop further development (n=2), continue outside healthcare (n=1), change the target population (n=3) or change the proposed positioning in the care pathway and/or value proposition (n=4).

Conclusions:

Stakeholders deemed an early, formative assessment useful in informing development, research and adoption decisions, in different stages of development. Even before developing a technology, headroom analyses appeared to be feasible and useful. Consequences of the assessments mostly related to a shift in focus, which may result in more efficient research and development, as well as more valuable innovations.
OP101 Hospital-Based Health Technology Assessment At UW Medicine
Authors: Landaas Erik , Devlin Allison , Walerius Erik , Buckingham Sandra , Flum David , Pellegrini Carlos , Yoshioka Francine , Thiebe Jackie , Sullivan Sean
Published: January 2019

Introduction:

New medical technologies are an important part of delivering innovative healthcare, however, expanding use of medical technology is a major contributor to rising costs. The increase in medical spending is related to new technologies being rapidly developed, marketed and adopted; and often being incorporated into health systems with little evidence. They also come with higher prices when compared to existing technologies.

Methods:

We describe how University of Washington (UW) Medicine has designed, and developed a new hospital-based health technology assessment (HB-HTA) program, Smart Innovation. Smart Innovation will replace a fragmented and complex set of purchasing and coverage-decision processes. The program will streamline the decision-making process for new medical technologies and balance quick turnaround with rigorous evidence standards. The program is also being developed in collaboration with UW Medicine's Value Analysis team, an evidence-based purchasing team and MedApproved, a new centralized software program for medical purchasing at UW Medicine.

Results:

Smart Innovation has been reviewing technologies during its first year and has received encouraging results. For example, by adopting a new liver ablation technology, UW Medicine has estimated improved patient outcomes by reducing the number of procedures and adverse events; as well as saving approximately USD 8,000 per patient. Additionally, The Smart Innovation program has achieved projected cost avoidance from deciding not to adopt uncertain or investigational technologies. For example, by not adopting a new bladder cancer screen, our models indicate UW Medicine will avoid spending USD 1.5 million per year.

Conclusions:

Smart Innovation is proving to be an effective program for reviewing and making critical healthcare policy decisions that is showing significant fiscal and patient improvements for UW Medicine. As the program continues to grow and become embedded into UW Medicine, its impacts will become even more valuable and system-wide.
OP124 Research Gaps In Health Technology Assessment In Brazil
Authors: Ell Erica , Leite Betânia , Gomes Dalila , Rego Daniela , Gonçalvez Lenilson , Leão Luciana Simões Camara , Couto Patrícia , Sachetti Camile Giaretta
Published: January 2019

Introduction:

In 2017 the Brazilian Ministry of Health (BMH), through the Department of Science and Technology (DECIT) and in partnership with the Hospital Alemão Oswaldo Cruz (HAOC), financially supported research activities focused on health technology assessment (HTA) on topics deemed important by the BMH. The aim was to help resolve the priority health problems of the Brazilian population and to strengthen the management of the Unified Health System, within the scope of HTA.

Methods:

A survey of HTA research needs was carried out in all BMH sectors through internal meetings conducted by representatives from each of the sectors. The problems and needs were then discussed, prioritized, and transformed into research lines in a workshop sponsored jointly by DECIT and the HAOC. Following this, a specific public call was made to the HTA community to comment on the prioritized research lines. The submitted research projects were then judged and selected by a committee of experts in the field. The approved projects were contracted, and when the projects were completed the results were presented and discussed by the researchers in a final seminar for representatives of the BMH technical areas.

Results:

A total of 135 research gaps were identified, of which forty-two lines of research were included in the research call after the prioritization workshop and the search for evidence in the literature. The call involved an amount of BRL one million (USD 280,442), and seventeen research projects were financed, including two systematic reviews, seven rapid reviews, and eight economic evaluations.

Conclusions:

The promotion of research by the BMH has enabled the search for scientific evidence to support public policies and decision making in health services.
OP144 Health Economics In Clinical Practice Guidelines: The Know-Do Gap
Authors: Scott Ann , Moga Carmen , Harstall Christa
Published: January 2019

Introduction:

Clinical practice guidelines (CPGs) are an ideal implementation mechanism for promoting effective clinical practice, but without due consideration of costs they may do more harm than good and become a source of inefficiency. The Alberta Guideline Adaptation Program sought current best practice for incorporating economic information into CPGs to better leverage health technology assessment (HTA) and health economic expertise in its guideline development program.

Methods:

A comprehensive, systematic review of published and grey literature was undertaken to: (i) catalogue theoretical frameworks and practical methods for incorporating economic information into CPGs and forecasting the post-implementation economic impact of CPGs; (ii) summarize current methods for evaluating the economic impact of CPGs; and, (iii) identify barriers and facilitators to incorporating economic information into CPGs.

Results:

Rigorous economic analyses were infrequently incorporated in CPG development. While a selection of guidance documents and CPG manuals published between 2001 and 2017 by leading CPG developers emphasized the health economist's role and the importance of incorporating economic evidence into CPGs, few provided adequate guidance on the best way to do this. There is no agreement on how best to monitor the economic impact of CPGs. Analysis of a sample of over 100 studies published between 2005 and 2013 identified the three main methods currently used to assess the post-implementation economic impact of CPGs: pre-test/post-test cost analyses, mapping studies, and modelled cost-effectiveness studies. The key elements of each study type were summarized and compared.

Conclusions:

The review highlighted the under-recognized know-do gap among developers with respect to using health economics information and expertise in CPG development. It identified the advantages and potential limitations of applying health economics to CPG development, as well as areas where developers can better utilize HTA researchers and health economists to improve the quality of guidelines and better document the resource implications and feasibility of the interventions they recommend.
OP157 Quo Vadis Romanian Health Technology Assessment?
Authors: Pana Adrian , Cosa Ioana Cristina
Published: January 2019

Introduction:

The Romanian healthcare system has been struggling to use a more transparent approach in evaluating health care technologies for more than 10 years. No systemic and satisfactory approach to evaluate health technologies was implemented until the present. The objective of the presentation is to describe the characteristics of the HTA system used by the Romanian healthcare authority as well as the consequences of the drug assessments by using the actual Romanian health technology assessment (HTA) evaluation framework, from the initiation in May 2014 to the end of year 2017.

Methods:

The drug reimbursement context and the healthcare legislation regarding HTA evaluation were studied. A critical appraisal of the scorecard was conducted, taking into consideration general principles of the health technology assessment. A descriptive analysis covering the assessment drug reports issued by the National Agency for Drug and Medical Devices (NADMD) issued between May 2014 and December 2017 was presented, together with the decision made by the Ministry of Health and the Romanian government.

Results:

During the analyzed period of time, more than 10 updates of the reimbursement list were implemented by the Ministry of Health. By November 2017, more than 180 drugs (new INN, new indications or fix dose combinations) were included in the reimbursement system with conditional or unconditional reimbursement; more than 230 reports were assessed by the NADMD. While the new drugs reimbursed between May 2014 and November 2017, in the most part demonstrated cost savings, a lot of new innovative drugs proposed to be evaluated were rejected since the drugs had no comparators on the Romanian market and their costs were considered to have a negative impact on the healthcare budget.

Conclusions:

The rapid HTA assessment has many strengths, by using a proper scorecard. Limitations and weakness of the actual scorecard were identified, mainly regarding the lack of a basic budget impact analysis which must include at least the direct healthcare cost, as well as the imported results of different healthcare environments that are not matching the Romanian context. Opportunities to implement a more rapid and accurate HTA evaluation are identified since the scorecard could be updated in order to address the HTA general principles.
OP166 How Responsive Is Industry To Value Based Procurement?
Authors: Restovic Gabriela , Cuenca Nuria , Rodriguez Ferran , Verboven Yves , Sampietro-Colom Laura
Published: January 2019

Introduction:

The European Union (EU) directive (2014/24) on public procurement strives to stimulate innovation and seeks for methodologies to implement a quality/cost based approach to search for the most economically advantageous tendering (MEAT). MedTech Europe launched the MEAT value-based-procurement (VBP) framework and tool which considers product's value from different perspectives/dimensions. Results from the first EU pilot, testing the feasibility to use the MEAT framework at a university hospital, are presented.

Methods:

The framework and tool were tested using two types of technologies: high volume (underpads, diapers) and highly specialized (transcatheter aortic valve implantation). Companies were invited to participate following standard procurement rules. For each dimension, criteria, metrics and weights were defined, using multidisciplinary hospital teams. In parallel, companies were asked to do the same. Product performance scores were obtained from companies’ information. Challenges to implement MEAT in real life were identified through face-to-face meetings.

Results:

The process was well perceived by companies and hospital. Nevertheless, the level of information provided by companies was heterogeneous (quantity and quality). A match in the cost and outcome criteria was observed between hospital and companies; but relative weights assigned differed. Value propositions and robustness of information provided by companies varied across technologies and size of companies. Implementing the MEAT VBP framework and tool need extra time and knowledge.

Conclusions:

MEAT VBP value technologies ahead of price, leading to the most economic advantageous purchasing. Nevertheless its implementation in real life is limited.
PP03 Evidence Synthesis In Spasticity In Children
Authors: Weijers Laure , Guyot Patricia , Kalyvas Chrysostomos , Danchenko Natalya , Freemantle Nicholas , Dinet Jerome , Senturk Oyku
Published: January 2019

Introduction:

Botulinum toxin type A (BoNT-A) is used in the management of lower limb spasticity in children, which affects more than 2.5 million children worldwide. BoNT-A aims to improve active function and to prevent or delay future musculoskeletal complications. The objective was to evaluate the relative efficacy and safety of different BoNT-A to manage spasticity in children, in the absence of head-to-head evidence.

Methods:

A systematic literature review was conducted in March 2016 to identify all relevant randomized controlled trials. The evidence base was synthesized by means of Bayesian network meta-analyses. Scenario analyses included standardized mean differences (SMD). The endpoints were Modified Ashworth Scale (MAS), Tardieu scale-spasticity grade and Goal Attainment Scale (GAS) (SMD only) at twelve weeks post-injection, and any adverse events.

Results:

Thirty-eight studies were identified, ten of which met the inclusion criteria for quantitative synthesis. For MAS, abobotulinumtoxinA 15 U/kg/leg was significantly better compared to onabotulinumtoxinA 4 U/kg/leg (−0.99 [−1.49; –0.50]), onabotulinumtoxinA 4 U/kg/leg + casting (−0.81 [−1.30; –0.32]) and numerically (although not statistically significantly) better than onabotulinumtoxinA 8 U/kg (−0.70 [−1.64; 0.22], Pbetter=93%). For GAS, abobotulinumtoxinA 15 U/kg/leg was numerically better than onabotulinumtoxinA 12 U/kg/leg. On Tardieu scale-spasticity grade, abobotulinumtoxinA was comparable to other treatments. AbobotulinumtoxinA 15 U/kg/leg showed the highest SUCRA value on MAS and GAS. On tolerability, abobotulinumtoxinA was found to have comparable or fewer adverse events than onabotulinumtoxinA 4 U/kg/leg.

Conclusions:

Our analyses suggest that abobotulinumtoxinA offers a comparable or favourable efficacy on tone (measured by MAS), spasticity (Tardieu scale-spasticity grade), functional outcomes (GAS) and tolerability versus onabotulinumtoxinA, in the management of children with lower limb spasticity. The results must be interpreted in the context of the heterogeneity of the evidence base and sparse evidence base.
PP18 An Access Evidence IT Solution Within A Pharmaceutical Company
Authors: Gyldmark Marlene , Rosenthal Rachel , Granser Martin , Escher-Kirch Jasmin
Published: January 2019

Introduction:

During 2014, Roche tested whether the EUnetHTA HTA Core Model© was a useful, exhaustive and relevant value framework to promote efficiencies in scoping, storing and sharing health technology assessment (HTA) evidence within a pharmaceutical company. The conclusion was positive and Roche decided to build a cloud based information technology (IT) platform to store all relevant HTA evidence to support global and regional market access activities, tagged with metadata according to the HTA Core Model©., The platform should be user-friendly and promote efficiencies and knowledge sharing across the organization. Eventually this platform may also be used by external stakeholders to access relevant HTA evidence.

Methods:

In order to better equip global functions, regions and affiliates in a major pharmaceutical company with user-friendly and fast access to product-relevant HTA and payer evidence as well as access evidence plans, an easy-to-use IT-based platform was needed. The platform, internally called #TAg, is a central repository of information to support market access activities and promote collaboration between Affiliate, Region and Global teams. The platform uses metadata to label all types of evidence and uses the HTA Core Model© domains to categorize the evidence.

Results:

The platform #TAg was developed throughout 2016/2017 and officially launched on 1 October 2017. Within the first 30 days, the platform has been readily accepted by affiliates, regions and global functions through significant use uptake as measured by user registration and download activities. In addition, #TAg was used successfully in a pilot project for a submission to an external HTA body.

Conclusions:

A complete knowledge management system for HTA evidence is important for driving efficiency in scoping, storing and disseminating access evidence information within a pharmaceutical company. #TAg has so far proved a good start on such a system with further development expected in the coming years.
PP19 Opioid Poisoning Deaths: A National Picture
Authors: Jones Matthew , Snooks Helen , Evans Bridie , Watkins Alan , Fuller Gordon
Published: January 2019

Introduction:

The factors associated with opioid poisoning death are poorly understood. We performed a retrospective autopsy study of decedents (a term used for people who are deceased) of opioid poisoning in Wales in 2015. Using anonymized linked data, we describe demographic characteristics, patterns of emergency service utilization, and clinical presentation prior to death.

Methods:

Decedents of opioid poisoning in Wales in 2015 were identified from the Office of National Statistics (ONS) mortality dataset. Records were linked with the Emergency Department Dataset (EDDS) by the National Welsh Informatics Service (NWIS); and held in the Secure Anonymized Information Linkage (SAIL) databank. The data were accessed and analyzed in the SAIL gateway.

Results:

Age at death ranged from eighteen to seventy-eight years, with a mean age of forty-two years. Average male age was forty-one years and average female age was forty-four and a half years. Seventy-three percent of decedents were men (n = 228/312). Eight-seven percent of decedents (n = 281/312) attended the emergency department in the three years prior to death. In total 2081 attendances were made, forty-one percent of which involved conveyance by ambulance. Attendances per individual ranged from one to 114, with over half of decedents attending more than three times. Diagnostic codes were mostly missing or non-specific, with only seven and a half percent of attendances representing eighty-two decedents, coded as drug related. Treatment codes were also mostly missing or non-specific, with sixteen percent of attendances representing 148 attendees attributed a treatment code. Thirty-nine percent of attendances (n = 822) ended in treatment and discharge, whilst twenty-seven percent (n = 562) led to hospital admission.

Conclusions:

Matching previously published data, we found that fatal opioid poisoning is preceded by a period of high emergency health service utilization. On average decedents were in their fifth decade and more likely to be male than female. Attendances varied widely, with men less likely to attend than women.
PP26 Facial Palsy Therapy: Can Novel ‘Smart Spectacles’ Help People Smile?
Authors: Szczepura Ala , Khan Amir , Holliday Nikki , Nduka Charles , Neville Catriona , Johnson Karen , Mistry Hema , Oxford Samuel
Published: January 2019

Introduction:

In the United Kingdom (UK), 23,000 people annually are diagnosed with facial palsy (acute onset facial paralysis). For nearly one third this will result in a permanent disability, including in some the inability to smile. In addition to initial pharmacological therapy, guidelines recommend tailored facial exercise (TFE) therapy repeated every day. However, not all patients are currently able to access such specialist physical therapy. ‘Smart specs’ (using miniaturized sensors in the frames to measure facial movement) are currently being developed. Linked to a smartphone, these could allow people to practice TFEs discreetly, provide immediate feedback, and supply data on outcomes to the patient and their clinician.

Methods:

Modelling of introduction of Facial Remote Activity Monitoring Eyewear (FRAME) into treatment pathways for patients with facial palsy. This included: (i) review on effectiveness of TFE therapy; (ii) national surveys (medical staff, facial therapy specialists and patients) to gather data on access to TFE therapy; (iii) Delphi Exercise to identify consensus on key outcome measures; and, (iv) economic modelling to estimate cost-effectiveness and determine a range of acceptable costs for the technology. In parallel, research to examine target markets to inform product development, and production of integral commercialization plan.

Results:

Searches short-listed ten studies to add to the three included in the 2011 Cochrane review. Surveys indicate approximately thirteen percent of eligible UK patients access personalized TFE therapy. Estimated annual expenditure on hospital treatments for facial palsy patients is currently >GBP 80 million (>USD 106 million) compared with <GBP 0.5 million (<USD 0.66 million) on TFE therapy. Patients with permanent defects can suffer a loss of up to two quality-adjusted life years (QALYs).

Conclusions:

Findings from this study, particularly in relation to costs and benefits, will inform the design of a subsequent randomized controlled trial. A novel wearable technology could make a major difference to people's lives, as well as generating potential efficiencies for healthcare.
PP29 Evaluating Supplementary Search Methods: Outcomes To Measure And Why
Authors: Talens-Bou Juan , Cooper Chris , Varley-Campbell Jo
Published: January 2019

Introduction:

In a recently published review of supplementary search methods, we proposed that researchers could usefully record time taken to search and present outcome values in similar way to existing studies, to facilitate generalisability of outcomes, where appropriate. We also discuss the idea of linking literature search effectiveness to study value. In this vignette, we discuss which outcomes we believe are important to measure and why. We discuss this in the context of the review of supplementary search methods and using a recently submitted evaluation of contacting study authors for context.

Methods:

In a recently completed systematic review, we contacted eighty-two study authors to ask three questions. We aimed to measure the following outcomes when contacting study authors: Effectiveness - determined as number of contacts compared to number of replies; Efficiency - i) time to make contact and ii) time between contact and reply. We determined this in hours, minutes and seconds, in line with other studies; Cost - determined by comparing the efficiency of contacting authors with the effectiveness; and Value - determined by reading and comparing the published studies with the replies received to see if any unique data were identified.

Results:

Effectiveness: thirty-eight answers were received from eighty-two possible contacts. Efficiency: In total, author contact took six hours, fifty-four minutes and twenty-five seconds across thirty-nine weeks. Replies were received across zero to thirty-nine days (median fourteen days). Cost: Cost for staff time was GBP 80.33 (EUR 91.20) or GBP 2.11 (EUR 2.40) per e-mail reply received. Value: We were able to identify value in author replies for each of the questions asked.

Conclusions:

In a recently published review of supplementary search methods, and a linked evaluation of the effectiveness of contacting study authors, we suggest outcomes that should be measured to determine effectiveness of literature search methods. We conclude that measuring these outcomes demonstrate both effectiveness and value.
PP50 Microcosting With Time-Driven Activity-Based Costing Applied On Brazilian HTA System: ECMO Case Study
Authors: Etges Ana Paula B S , da Rosa Priscila , Notti Regina K , Cruz Luciane N , Doebber Madeni , Cardoso Liane , Polanczyk Carisi A , Rohde Luis Eduardo
Published: January 2019

Introduction:

Extracorporeal circulatory membrane oxygenation (ECMO) is a technology that allows recovery of adults in cardiorespiratory failure with encouraging results, but is not available in the Brazilian universal public health system (SUS) due to high implementation costs. Time-driven activity based costing (TDABC) is applied to measure processes in an economic perspective by identifying opportunities to make processes more efficient through the reduction of resources used in each activity. The literature has explored the use of TDABC to measure costs related with clinical procedures and technologies in microcosting studies, identifying opportunities to improve the process by making it more efficient. This research measures the real costs to implement ECMO in Brazil to compare with the current public reimbursement system.

Methods:

This study applied TDABC using data from 6 patients to measure costs of ECMO intervention considering the public perspective in Brazil. In sequence, standard price payed by SUS was used to estimate the current reimbursement amount received by the hospital for ECMO procedure. Cost variable analysis was conducted to understand when and how patients receiving ECMO are using hospital resources. Cost data were collected from an academic public hospital using an average of 18 months (2016–2017) for the department costs.

Results:

The real average cost was USD 128,923. Most significant resource costs was medical staff, particularly for the three survivor patients, and the ECMO equipment presented the second highest cost. ECMO activities were separated into: before implantation of ECMO, period using ECMO, intensive care post-ECMO and rehabilitation, being the period where ECMO is the most expensive, particularly in nurse and physician costs. The SUS average was USD 31,437, which shows a difference of USD 97,485 between the real ECMO cost and the public reimbursement in Brazil.

Conclusions:

A critical element of the propagation of ECMO in Brazil and its reimbursement by public health system is the high cost and out-of-date standard payments by the Ministry of Health. Effort to implement a trustworthy method to guide decisions of SUS for the adoption and financing new technologies is essential to contribute to the optimization of public health policies in a country with a universal health system and limited resources dedicated to health sectors.
PP58 Hasty HTA: Delivering Health Technology Assessments Under Severe Time Constraints
Authors: Teljeur Conor , Harrington Patricia , Ryan Máirín
Published: January 2019

Introduction:

Health technology assessment (HTA) is a resource-intensive decision support tool that is typically structured around a set of defined domains. Sometimes urgent requests for HTAs arise that may be subject to very short timeframes, creating unique challenges. This study aimed to describe some of the options for carrying out a “hasty HTA”, and the impact of those options.

Methods:

We recently completed a HTA for the Department of Health in Ireland with a strict 2-month deadline. We considered the impact of the short timeline using the project management triple constraint framework whereby the quality of a project is constrained by cost, scope, and schedule.

Results:

When delivering HTAs within short timeframes the schedule is an inflexible constraint. Providing interim advice pending a full assessment may set a precedent, or may not be possible if capital expenditure is already entailed. Additional staff should enable research to be completed faster, although economies of scale may not fully apply. Frequently such resources are not readily available. The reduction of scope through the omission of domains offers the best prospect of facilitating a short timeframe for a HTA. Scope may also be reduced through a less comprehensive analytical approach, but this creates a risk of reduced accuracy. Curtailing data collection and analysis is likely to increase uncertainty in the findings. Risk management is important when comprehensive quality assurance may not be possible.

Conclusions:

Carrying out HTAs in short timeframes has implications for content, approach, and, potentially, quality. Agencies must consider how they can meet the needs of the decision maker without overly compromising accuracy or relevance. Due to resource constraints, the best approach is likely to be judicious changes to the scope to remove assessment elements that are unlikely to have a substantive impact on the decision.