bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP43 Decision-Making Tool In Case Of Beta-Lactam Allergy: How To Help Clinicians?
Authors: Bouchard Sylvie , Robitaille Geneviève , Karam Fatiha , Daigle Jean-Marc , Tardif Mélanie 
Published: December 2019

IntroductionBeta-lactams (BLs), especially penicillins, are the most commonly used antibiotics, particularly in primary care, and one of the most reported drug allergies. Fearing cross-reactivity, clinicians refrain from prescribing another BL (e.g., cephalosporin or carbapenem) to penicillin-allergic patients. This can have significant consequences for the patients and the health-care system (e.g., exposure to broad-spectrum antibiotics, increased risk adverse effects, and increased healthcare costs).MethodsTo assess the absolute cross-reactivity risk, two systematic reviews with meta-analysis were conducted. Then, an approach based on a knowledge mobilization framework considering scientific, contextual and experiential evidences was used. Focus groups with stakeholders, including primary care clinicians, pediatricians, infectious disease specialists and allergists/immunologists, were also held to meet the needs of all actors concerned.ResultsFollowing this work, it appears that true allergies to penicillin are very rare. Indeed, in patients with a history of penicillin allergy, very few are truly allergic and thus the risk of cross-reaction with another BL is even lower, varying according to structural and physicochemical similarities with alleged-penicillin. Moreover, the risk of having an anaphylactic reaction after penicillin exposure is very low, especially among children. As well, in patients with confirmed penicillin allergy, the observed reactions are usually delayed non-severe skin reactions. However, with a confirmed penicillin allergy, it is important to remain cautious when administering a new BL, especially if the initial reaction was serious or severe. Based on these key messages, a decision aid including an algorithm was developed. Likewise, individualized algorithms for common infections met in primary care were produced.ConclusionsFrom this work, health professionals non-specialized in allergology should be able to better manage the risks attributed to penicillin allergies. Therefore, patients should receive the most effective and safe antibiotics to treat their clinical conditions in primary care.
PP48 Risk Of Bias Of Systematic Reviews Connected To Journal Impact Factor?
Authors: Carrera Vanesa Huertas , Worthy Gill , Kleijnen Joseph 
Published: December 2019

IntroductionSystematic reviews (SRs) are today's cornerstone of evidence-based medicine. However, their risk of bias (ROB) may critically impact their findings. Hence, an impartial assessment of their ROB is paramount to their interpretation. The objective of this study is to evaluate the potential association between the results of the ROB assessment for a series of SRs and their corresponding journal's impact factor as determined by the citation reports.MethodsA sample of over 500 SRs and their corresponding ROB will be employed in this study. The source for these data will be the database KSR Evidence. The corresponding impact factor (IF) for the publishing journal as reported by the Science Citation Index will also be retrieved. The total of ROBIS signaling questions answered as ‘yes’ or ‘probably yes’ will be used to approximate the awarded quality (Quality) for each systematic review. An analysis of the potential correlation between Quality and the IF will be performed with a simple linear regression.ResultsResults will be presented in tables and figures. Preliminary results confirm that a statistically significant association between the suggested variables exists, though this is of low magnitude.ConclusionsFindings confirm that the ROB of an SR and the IF of the publishing journal are correlated.
PP65 Methods Applied For Systematic Reviews Of Economic Evaluations In Health Technology Assessment
Authors: Luhnen Miriam , Prediger Barbara , Neugebauer Edmund A.M. , Mathes Tim 
Published: December 2019

IntroductionWhen making decisions in health care, it is essential to consider economic evidence about an intervention. The objective of this study was to analyze the methods applied for systematic reviews of economic evaluations in Health Technology Assessment (HTA) and to identify common challenges.MethodsWe manually searched the webpages of HTA organizations and included HTA-reports published since 2015. Prerequisites for inclusion were the conduct of a systematic review of economic evaluations in at least one electronic database and the use of the English, German, French, or Spanish language. Methodological features were extracted in standardized tables. We prepared descriptive statistical (e.g., median, range) measures to describe the applied methods. Data were synthesized in a structured narrative way.ResultsEighty-three reports were included in the analysis. We identified inexplicable heterogeneity, particularly concerning literature search strategy, data extraction, assessment of quality, and applicability. Furthermore, process steps were often missing or reported in a nontransparent way. The use of a standardized data extraction form was indicated in one-third of reports (32 percent). Fifty-four percent of authors systematically appraised included studies. In 10 percent of reports, the applicability of included studies was assessed. Involvement of two reviewers was rarely reported for the study selection (43 percent), data extraction (28 percent), and quality assessment (39 percent).ConclusionsThe methods applied for systematic reviews of economic evaluations in HTA and their reporting quality are very heterogeneous. Efforts toward a detailed, standardized guidance for the preparation of systematic reviews of economic evaluations definitely seem necessary. A general harmonization and improvement of the applied methodology would increase their value for decision makers.
PP78 Analysis Of Resource Utilization In Psoriasis Care In The Brazilian Health System
Authors: Costa Andrade Larissa de Araujo , Moreira Ricardo , Vitale Vinicius 
Published: December 2019

IntroductionPsoriasis is associated with metabolic disorders and has a significant negative impact on patients’ quality of life. There is little information about treatment patterns and the resources used to treat psoriasis and its associated comorbidities. This study aimed to evaluate the frequency of metabolic syndrome (MetS) and estimate the costs associated with psoriasis care in the Brazilian health system.MethodsA cross-sectional observational study was conducted of 293 Brazilian patients with psoriasis who attended selected dermatology outpatient centers in Brazil during a one-year period. Patients underwent detailed skin and rheumatologic assessments and a series of laboratory tests. The annual costs were estimated by multiplying the amount of each resource consumed by its unit cost.ResultsThe prevalence rate of MetS was high in this cohort (50%). Other metabolic disorders were more common in this group than in the general population, including hypertension (62%), diabetes (31%), dyslipidemia (75%), and obesity (53%). The disease duration was, on average, 17.2 years. There were 2,713 consultations reported by 288 patients (average of nine per patient per year). The most common specialists consulted were: dermatologists (93%); general practitioners (41%); cardiologists (27%); rheumatologists (18%); and endocrinologists (13%). There were 110 non-physician visits (average of 11 per patient per year), of which the most frequently consulted specialists were nutritionists (26%), psychologists (24%), and nurses (22%). A total of 279 patients (95%) had at least one medical test (average of 18 per patient per year). Among the treatments required for other conditions, 65% (n = 149) of prescribed medicines were for the cardiovascular system and 24% (n = 5/21) of hospitalizations were due to diseases of the circulatory system; myocardial revascularization was the costliest procedure (USD 2,298).ConclusionsMetS is frequently associated with psoriasis and directly affects health resource utilization in the Brazilian health system by increasing consultation costs. Further research is needed to evaluate the impact of a multidisciplinary treatment approach for psoriasis patients with MetS.
PP80 A Systematic Review Of The Gugging Swallowing Screen For Assessing Dysphagia
Authors: Lee Seon Heui 
Published: December 2019

IntroductionDysphagia is a clinical burden that can lead to serious complications like aspiration and pneumonia. Complications often result in longer hospital stays or an increased mortality rates. The Gugging Swallowing Screen (GUSS) assesses swallowing ability in patients by allowing separate evaluations for non-fluid and fluid textures, and is a potentially useful tool for determining the risk of aspiration and dysphagia. The purpose of this study is to analyze the validity and effectiveness of GUSS for dysphagia screening.MethodsWe conducted a systematic review by searching the following electronic databases: Medline, EMBASE, The Cochrane Library, KoreaMed, the Research Information Sharing Service, and the Korean Studies Information Service System. We included studies related to dysphagia screening with GUSS that were published in English or Korean up to November 2018.ResultsOf 297 unique studies identified, 219 were reviewed by two independent reviewers. Finally, eight articles were identified as being relevant for this study. With regard to validity, GUSS had a sensitivity ranging from 90 to 100 percent and a specificity of between 50 and 88 percent. In addition, GUSS results significantly correlated with the results of the videofluoroscopic swallow study and the fiberoptic endoscopic evaluation of swallowing. In terms of effectiveness, early systematic dysphagia screening with GUSS by nurses reduced the duration of screening and rate of pneumonia, compared with the control group (p = 0.004). The incidence of X-ray verified pneumonia in the GUSS group was also significantly lower than in the clinical screening group (p < 0.01), although there was no difference in the occurrence of pneumonia, compared with the 10 mL water swallowing test.ConclusionsResults showed that GUSS is a reliable and sensitive tool for screening patients for dysphagia. This early and systematic assessment can reduce the occurrence of aspiration and pneumonia, although further research is needed to establish the effectiveness of GUSS.
PP135 Setting The Scope For Assessing e-Health Technologies In Hungary
Authors: Takács Bence , Merész Gergő 
Published: December 2019

IntroductionE-health and m-health are emerging health technology fields that could possibly give a new scope to health technology assessment (HTA). The Division for Health Technology Assessment (DfHTA) is currently assessing medicines and non-drug technologies (medical devices intended for patient use or for use in hospitals). The experience assessing medical devices for use in hospitals yielded difficulties which could also arise from the critical appraisal of e-health or m-health technologies. The objective of this study was to explore the foundations for HTA guidance on e-health or m-health technologies.MethodsA targeted literature review was conducted to map the current status of technology assessment practices for e-health and m-health technologies and to assess its concordance with current reimbursement processes in countries belonging to the Organisation for Economic Co-operation and Development. Experiences from past evaluations of other medical devices that could not be evaluated under the current guidance guided the literature search. The findings of this research were used to create a recommendation to amend the current Hungarian Guideline for Health Economic Analyses.ResultsThe resulting articles of the targeted literature review provided an insight into current practices on of assessing e-health and m-health products, particularly with respect to the domains of safety, quality, and impact. Recommendations suggested including a list of requirements for companies to submit for critical evaluations of e-health and m-health technologies, in support of a self-assessment approach.ConclusionsAs for other HTA bodies, there is an urgent need for the DfHTA to increase its capacity to assess digital health technologies for entry into the healthcare system, with a focus on the relevant clinical domains. The reimbursement process for these technologies remains a challenge for public funding bodies.
PP136 How To Apply Health Technology Assessment To Large Scale e-Health Processes
Authors: Severinsen Gro-Hilde , Silsand Line , Ekeland Anne 
Published: December 2019

IntroductionThere are enormous expectations for e-health solutions to support high quality healthcare services, with accessibility, and effectiveness as key goals. E-health encompasses a wide range of information and communication technologies applied to health care, and focuses on combining clinical activity, technical development, and political requirements. Hence, e-health solutions must be evaluated in relation to the desired goals, to justify the high costs of such solutions.MethodsHealth technology assessment (HTA) aims to produce rational decisions for purchasing new technologies and evaluating healthcare investments, like drugs and medical equipment, by measuring added value in relation to clinical effectiveness, safety, and cost effectiveness. It is desired to also apply HTA assessment on large scale e-health solutions, but traditional quantitative HTA methodology may not be applicable to complex e-health systems developed and implemented as ongoing processes over years. Systematic reviews and meta-analyses of these processes risk being outdated when published, therefore action research designed to work with complex, large scale programs may be a more suitable approach.ResultsIn the project, we followed the development of a new process-oriented electronic patient record system (EPR) in northern Norway. Part of the process was structuring clinical data to be used in electronic forms within the system. This was the first time a health region structured the clinical data and designed the forms; receiving feedback alongside the process was very important. The goal was to use structured forms as a basis for reusing EPR data within and between systems, and to enable clinical decision support.DiscussionAfter designing a prototype of a structured form, we wrote an assessment report focusing on designing a methodology for such development, which stakeholders to include, and how to divide the work between the health region and the system vendor. The answers to such questions will have both practical and economic consequences for designing the next phase of the process.
PP173 Is Early Modelling Too Late? Preventing Pitfalls And Optimizing Value
Authors: Berardi Andrea , Macaulay Richard , Johal Sukhvinder 
Published: December 2019

IntroductionDrug development is a risky business. Manufacturers are faced with the dilemma of whether or not to invest at any stage in the development process. Even once marketing authorization has been attained, payers are becoming increasingly demanding of evidence to justify price premiums in the face of increasing budgetary pressures. Cost-effectiveness is a critical decision-making criterion for many payers, and restrictions to sub-populations is common. Early economic modelling at very early phases of the development pathway can inform optimal investment decision-making, including go/no-go decisions and clinical trial design, particularly in population selection. To test the hypothesis of changing payer requirements, we carried out a study on the trends in reimbursement submissions where payers approved but ultimately restricted the population compared to the marketing license or the company's target population.MethodsA systematic literature review of all single technology appraisals (STAs) by the National Institute for Health and Clinical Excellence (NICE) was carried (01/01/2006- to 16/11/2018). We used a linear regression model to examine the relationship between frequency of optimizations and time.ResultsIn total, 357 STAs outcomes were identified, 55 percent were recommended and 26 percent were optimized. The proportion of optimized recommendations increased over time vs all other outcomes (p = 0.01), with more technologies being optimized over time (p < 0.01).ConclusionsThe results indicate an increasing trend by NICE towards maximization of value through approval of drugs in select groups of patients. From a manufacturer's perspective, prediction of such outcomes at an early stage is fundamental for investment purposes and to maximize financial returns. An early stage model provides a framework to examine these issues as well as identifying data gaps, where real world evidence can be planned to support the value argument for products, and to inform clinical trial design through value of information analysis.
PP178 Health Technology Assessment Of Laboratory Medicine
Authors: Di Mauro Roxana , Faggiano Francesco , Andellini Martina , Derrico Pietro , Ritrovato Matteo 
Published: December 2019

IntroductionRecent studies have investigated the re-organization and automation of laboratory medicine as a challenge for the hospital in terms of reduction of costs, turnaround time, workload, optimization of human and technological resources and improvement of safety. The purpose of this study was to conduct a health technology assessment (HTA) evaluation process about the possibility to re-organize and automate laboratory medicine at Bambino Gesù Children's Hospital.MethodsThe decision-oriented HTA (Do-HTA) method, involving the integration of the European Network for HTA (EUnetHTA) CoreModel and the Analytic Hierarchy Process, was applied to assess the best technology solution. Twenty-one professionals were involved to define tender specifications related to the adaptation works of the new dedicated rooms, and the automatic technologies and organizational solutions for the new laboratory department. Finally, two manufacturer companies were consulted.ResultsUsing Do-HTA, the study was focused on laboratory technologies while the infrastructure evaluation was conducted by the Engineering and Logistic Units of the hospital. Results showed that the total performance score of the first proposal was slightly higher (2.5 percent) than the second one, proving the comparable high qualitative level of both manufactures technologies. After an accurate analysis, evaluating all aspects (safety, clinical efficacy, cost, organization & technical criteria) and integrating the infrastructure evaluation, the decision has fallen upon the first company offer.ConclusionsThis HTA project provided an in-depth examination of two proposed technological and organizational solutions. Thanks to the Do-HTA method, which produced and developed data and all needed information, it was possible to guide and assist the decision makers on the choice between the two technical solutions.
VP22 Applying The IDEAL Framework To NICE Interventional Procedure Guidance
Authors: Anjum Sharika , Powell John , Harris Kevin 
Published: December 2019

IntroductionThe IDEAL (Idea, Development, Exploration, Assessment, Learning) Framework measures the maturity of evidence base behind surgical innovation. The NICE Interventional Procedures (IP) programme issues guidance for the United Kingdom National Health Service (NHS) on use of surgical innovation. One of four recommendations can be made: (a) standard arrangements, (b) special arrangements, (c) research only, and (d) do not use. This study aimed to investigate whether the recommendation of NICE IP guidance corresponded with the stage of innovation as determined by IDEAL, thus IDEAL's role in informing future guidance production.MethodsA retrospective sample of 103 pieces of guidance issued between 2015 and 2018 was analysed. One researcher examined the evidence base and determined the corresponding stage of the IDEAL framework, numbered 1, 2, 2a, 3 and 4. The primary outcome measure was the association between stage of evidence on IDEAL framework and the recommendation of published NICE IP guidance.ResultsThere were twenty-one (20 percent), thirty-three (32 percent), three (3 percent), forty (39 percent) and six (6 percent) procedures at IDEAL stages 1, 2, 2a, 3 and 4, respectively. Of those at stage 1 (idea), 48 percent were given research only arrangements, 43 percent special arrangements, and 10 percent standard. Many of the procedures at stages 2 (development) and 2a (exploration) were given standard arrangements (39 percent and 67 percent respectively). Forty-three percent of stage 3 (assessment) and 67 percent of stage 4 (learning) guidance were identified standard. At stage 4 none were given a ‘research only’ recommendation.ConclusionsProcedures given ‘standard’ arrangements guidance are more likely have a mature and robust evidence base as determined by IDEAL. Those with limited evidence are more likely to be given a more cautious ‘research only’ guidance. Routine use of this framework could help inform future guidance production however cannot replace the decision-making function of the NICE committee which also involves patient experiences, population characteristics, risk of serious safety events, and equity issues.
VP37 Patient Involvement In EUnetHTA Assessments (Non-Pharma Technologies)
Authors: Ettinger Sabine , Erdos Judit , De Villiers Cecilia 
Published: December 2019

IntroductionPatients can provide valuable experience on living with diseases, health-related quality of life, various therapies and relevant outcomes. Their input and perspectives can be helpful in complementing health technology assessment (HTA) processes. The European Network for HTA (EUnetHTA), funded by the European Commission, aims to further advance and standardise patient involvement processes in order to add to the quality and applicability of HTAs and to allow capability building.MethodsDifferent methods for patient involvement in HTAs on non-pharmaceutical technologies were tested: Patient input templates (open questions sent to relevant patient organizations, or published on EUnetHTA website); scoping meeting with patients/patient representatives; one-on-one conversation and group conversation. Applied methods depended on the scope of the HTA and other factors like timelines of HTAs and burden of disease for patients.ResultsPatients were included in eight of sixteen HTAs on non-pharmaceutical technologies. Applied methods were: group conversation (n = 2), scoping meeting (n = 1), patient input templates (n = 4), one-on-one conversation (n = 2,) and other approach (i.e. written feedback on scope n= 2). In some HTAs more than one method was used. Main reasons for not including patients were inability to identify suitable patients or tight timelines. Patients' feedback on health-related quality of life and outcome measures proved most useful in the scoping phase.ConclusionsThe different approaches were useful for complementing HTA processes. Those need to be further tested and evaluated in order to formulate deeper understanding about the impact of patient involvement on HTA. Additionally, feedback from patients that were actively involved in the HTAs should be collected to further improve the involvement methods that should serve as basis for future recommendations post 2020.