bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP55 HTA And High Cost Innovative Therapies - Focus On Cancer Drugs
Authors: Raycheva Ralitsa , Stefanov Rumen 
Published: January 2019

Introduction:High-cost innovative therapies are considered as high-risk investments in the reality of limited health care budgets. Health technology assessment (HTA) facilitates evidence-based decision making that relies on robust assessment of the clinical cost-effectiveness of the technology that is often not available for expensive cancer therapies (CT).Methods:The objective of the study is to undertake a systematic comparison between HTA agencies worldwide in order to identify similarities and differences in the methods and processes in HTA of CT. A cross-sectional web-based survey was conducted between September 2013 and May 2015. We received responses from 161 HTA organizations based in thirty-nine countries.Results:HTA of CT is mainly performed by agencies in South America (38.46 percent), Australia (37.05 percent) and Europe (36.07 percent), followed by agencies in North America (20.00 percent) and Asia (16.67 percent). Logically, the agencies in high income countries produce more assessments of CT (40.23 percent), which in 34.43 percent they determine as innovative technologies compared with 10.00 percent of the units based in middle income countries and active in CT assessment (11.11 percent). We prove association (p < 0.05) between (i) the type of HTA and income per capita; the level at which the organization operates; its main activity; and the level of recommendation dissemination; (ii) the main target group and consumers of the final HTA product; the stage of evolution of the technology, on which it is likely to be assessed; and approaches to identify innovative technologies. The most active in the preparation of HTA reports are biomedical companies (50.00 percent), government agencies (42.11 percent) and professional organizations (40.00 percent). HTA bodies that assess CT distribute recommendations (37.50 percent) nationally and they are mainly addressed to private health care providers (66.67 percent).Conclusions:Making coverage decisions based on HTA recommendations control the technologies introduction into the healthcare system that is why it's very important this tool to be properly adjusted to the specific needs of CT assessment.
PP66 Hospital Cleaning: Detergent Or Disinfectant-Detergent? A Rapid Review
Authors: Harkin Kathleen , Dee Anne 
Published: January 2019

Introduction:Healthcare-associated infections (HAIs) are an important, potentially preventable reason to maintain a clean healthcare environment. However, guidelines from Europe and North America do not concur—European guidelines recommend using neutral detergent (followed by chlorine-based disinfection (CBD) if required), whilst North American guidelines recommend using detergent or hospital-grade disinfectant-detergents for routine cleaning or decontamination of noncritical healthcare environmental surfaces. The objective of this study was to compare the effectiveness on rates of HAIs of: (i) disinfectant-detergents versus detergents; and (ii) the active ingredient of many disinfectant-detergents—quaternary ammonium compounds (QAC)—versus CBD.Methods:A rapid review of systematic reviews was conducted using the following search terms: keywords and controlled vocabulary terms for the concepts of “healthcare environmental surfaces” AND (“QAC-based disinfectants” OR “disinfectant-detergents” OR “decontamination”) AND (“environmental contamination” OR “colonization” OR “HAIs”). The search filters included systematic reviews, guidelines, and technology reports. The following databases were searched: The Cochrane Library; PubMed; and health technology assessment and guideline websites for gray literature. Systematic reviews of studies comparing the effects of disinfectant-detergents with detergent, or comparing QAC with CBD, on rates of HAIs in the healthcare environment were included. Reviews on the cleaning or disinfection of body surfaces or disinfection of invasive medical devices were excluded. Quality assessment was not conducted. Data extraction was performed using a pro forma.Results:The literature search resulted in 356 titles. From ninety-four potentially relevant abstracts, fifty-seven full-texts were evaluated: fifty-one were excluded (eight non-English) and six were included. All review authors cautioned that the evidence was low level, methodologically poor, subject to confounding, and didn't address adverse outcomes. The reviews identified eight relevant primary studies, three of which compared disinfectant-detergents with detergent and found no difference in rates of HAI. Five studies compared QAC with CBD. All five demonstrated that CBD was superior to QAC and reduced Clostridium difficile infection rates in outbreak contexts. Furthermore, QAC may induce sporulation and microbial resistance.Conclusions:Low-level evidence suggested that: there is no advantage in using disinfectant-detergents for routine cleaning of noncritical surfaces; CBD is superior to QAC-based disinfection in reducing clostridial infections; and QAC agents may induce sporulation or microbial resistance.
PP75 Genetic Testing For Bladder And Kidney Cancer: An Interactive Evidence Map
Authors: Treadwell Jonathan , Tsou Amy 
Published: January 2019

Introduction:Recently, voluminous research and commentary have touted genetic and molecular testing to improve the management of urologic cancer. The purposes of such testing include screening, risk assessment, diagnosis, prognosis, pharmacogenetics, and monitoring (for example, recurrence, predicting treatment response). An interactive graphical tool (“evidence map”) would help policy makers examine the current state of research, identify prevailing trends, and prioritize research efforts.Methods:A professional information specialist searched MEDLINE/EMBASE for articles published in 2010 or later that primarily focused on genetic/molecular testing and either kidney or bladder/urothelial cancer. Two research analysts classified all relevant abstracts regarding to cancer type, genetic marker(s), clinical purpose(s), assay methods, publication type, and author country/region. We created an interactive map using HTML5 and JavaScript.Results:We identified 4,731 articles, 828 (18 percent) of which met our inclusion criteria. Our map has interactive filters which allow flexible selection of articles and automatic updating of the counts. For example, one can quickly redraw the map to focus only on U.S./European systematic reviews and meta-analyses. Research on bladder/urothelial cancer focuses on both diagnosis and prognosis, with some interest in monitoring. In kidney cancer, research on prognosis outweighs research on diagnosis. Overall, research on genetic/molecular markers is in an exploratory phase, e.g. for kidney cancer prognosis alone, 173 empirical studies considered hundreds of different markers.Conclusions:Assessing prognosis is a common purpose of genetic tests for both bladder/urothelial and kidney cancer. Increased research on the monitoring of bladder/urothelial cancer may be due to its high recurrence rates, whereas lower interest in genetic tests to diagnose kidney cancer may be due to effective imaging tests. For policy makers, evidence maps can inform decisions about the scope of commissioned systematic reviews as well as the targets for recommendation statements. Interactive features allow maps to be redrawn to align with users’ specific interests.
PP123 Triangulate, Converge, Assess, And Recommend (TCAR): Evaluation Method
Authors: Beauchamp Sylvie , Drapeau Martin , Dionne Carmen 
Published: January 2019

Introduction:Methods to assess evidence and to use that evidence to inform practices and policies are under developed in the area of social services. Although health professions have developed robust methods in recent decades to collect, analyze and synthesize scientific evidence and to inform clinical recommendations, the use of these methods often remains difficult in social services. A taskforce was implemented to address this and to propose a method that may be more appropriate for the social sciences.Methods:The project was comprised of four steps: (i) performing a qualitative review of discussions between experts, (ii) designing a cognitive map of the data, (iii) conducting a systematic literature search, and (iv) comparing the data from the meetings with experts with the scientific literature. These steps were completed using the grounded theory approach. In order to test the method developed, focus groups were then conducted and four case studies were used to assess the evidence and provide recommendations for youths with mental health problems and for elderly care.Results:Although robust scientific data remain crucial when developing recommendations for practice, results showed that these data are incomplete if considered alone, and that contextual (circumstances in which the intervention is delivered) and experiential data (how the intervention is perceived by stakeholders) must also be taken into consideration. A method to triangulate these three types of data is proposed. Using this technique, the value of the data is established by means of various measurements that converge towards the same result or that provide a consistent overall picture or some important nuances that need to be considered, as illustrated by the four case studies.Conclusions:The proposed method can be used to address the limitations that are inherent to the use of techniques and procedures drawn from the medical field when assessing evidence and developing recommendations for the social sciences. The case studies that the proposed method is not only a viable option to methods drawn from medicine, but also adds to the quality of the recommendations that are made and is more congruent with the epistemology of social sciences.
PP126 Alfa-Alglucosidase For Pompe Disease: Literature Review
Authors: da Costa Márcia Gisele Santos , Santos Marisa 
Published: January 2019

Introduction:Pompe disease is a rare disease, in which therapies are aimed at improving the function of the heart and skeletal muscles, and the quality of life of patients. This review aims to update and evaluate the safety and efficacy of alpha-alglucosidase therapy for treating Pompe disease.Methods:We performed a literature search of Medline, EMBASE, the Center for Reviews and Dissemination, the Latin American and Caribbean Health Sciences Literature, and Cochrane. Publications of the National Institute for Health and Care Excellence and national and international guidelines have been consulted. The quality of the evidence was assessed using the criteria of the Grading of Recommendations Assessment, Development and Evaluation - GRADE. We performed annual cost estimates of alpha-alglucosidase for the treatment of adult and pediatric patients.Results:In a randomized clinical trial comparing alpha-alglucosidase enzyme replacement therapy (20 mg / kg) with placebo for 78 weeks, the results favored alpha-alglucosidase (an increase of 28.1 ± 13.1 m in the six minute walk and an absolute increase of 3.4 ± 1.2 percent in forced vital capacity, p = 0.03 and p = 0.006, respectively). In another systematic review, it was observed that patients treated with alpha-alglucosidase had a mortality rate five times lower than untreated patients (rate ratio = 0.21, 95% CI: 0.11 − 0.41). In a pediatric population with advanced disease, biweekly infusions prolonged survival and survival free of invasive ventilation. The quality of the evidence was classified as very low. The annual treatment costs were USD 296,187.64 (adult patient with 70 kg) and USD 42,312.52 (pediatric patient with 10 kg).Conclusions:The limited available evidence suggests alpha-algalsidase is efficacious in Pompe disease patients with some clinical conditions who do not present negative cross-reactive immune material. The balance between the limited quality of the evidence and the demonstrated benefits is favorable, especially for clinical improvement, reduction of mortality and intangible benefits.
PP128 Relationship Between Hemoglobin A1c And Medical Costs
Authors: Iwasaki Kosuke , Takeshima Tomomi , Kanazawa Daiki , Kuno Yoshiyuki 
Published: January 2019

Introduction:Diabetes causes complications and collateral diseases, reducing quality of life and increasing medical costs. The Japanese government has promoted measures for the prevention of diabetes aggravation. Although glycemic control is reported to prevent the development of complications, assessment of the effects on overall medical cost is insufficient. We examined the medical cost by the analysis of hemoglobin A1c (HbA1c) level.Methods:A Japanese employee-based health insurance claims database with annual medical check-up data was analyzed. Excess medical cost was calculated as the difference between medical cost and standard medical cost (defined as the average medical cost for individuals of same age and sex). Percentage of excess medical cost was calculated by dividing excess medical cost by standard cost, and compared between individuals with or without treatment for diabetes.Results:Of 4,307,184 individuals with HbA1c data, four percent of them received treatment for diabetes. For treatment of 6.5 percent of HbA1c, excess medical cost increased to 124 percent. The medical cost increased by an additional 20.4 percent (95% CI: 17.1–23.8) when the HbA1c level increased one percent. Treatment for less than six percent of HbA1c caused an increase consistent with the HbA1c level. The relative risk of iron deficiency anemia, unspecified of those with less than six percent of HbA1c against those with seven to eight percent was the highest, 2.15.Conclusions:An increase of medical cost for individuals with treatment for high HbA1c is likely associated with diabetic complication. The raise for individuals with lower HbA1c level may be related to anemia. Despite the younger age and healthier life of the analyzed individuals, since they were insured by employee-based health insurance who took regular medical check-ups, more expensive medical cost was observed for those having higher HbA1c level.
PP131 Eliciting Implicit Value-Judgments In The HTA Process
Authors: Patenaude Johane , Kocsis-Bédard Suzanne , Béland Jean-Pierre , Bellemare Christian , Bernier Louise , Dagenais Pierre , Daniel Charles-Etienne , Gagnon Hubert , Legault Georges-Auguste , Parent Monelle 
Published: January 2019

Introduction:Eliciting implicit value-judgments (VJs) in the HTA process is one way of integrating ethics in HTA since the latter is recognized as a value-laden process. An analysis of the diversity of opinions on implicit VJs in HTA and of their role, highlights the connection there exists between VJs and the different decisions involved in the whole HTA process. Such a link is corroborated by a conceptual analysis of VJ using a speech-act philosophical approach grounded in the philosophy of language, since VJs are linked with normative speech-acts such as commands, recommendations and advices.Methods:We propose an analysis of the published citations mentioning VJs, extracted from our systematic review on the challenges of integrating ethics in HTA. In order to do so, those quotes were categorized in a chart, the latter of which presents: (i) the different steps of decision-making in the HTA process, (ii) the description of the implicit VJ(s) and (iii) the criteria involved. This chart was elaborated with the participation of the HTA local evaluators involved as co-investigators in our research group. The final version was discussed, debated and validated by the entire research group.Results:The chart shows 18 decision-making steps in the HTA process in which twenty-three implicit VJs can be observed. The range of such VJs encompasses the whole HTA process from the initial mandate to the agency presenting the decisional issues, to the dissemination of the final report. The published citations gathered for each category compile different expectations on the elicitation of the implicit VJs, thus making the latter VJs more explicit.Conclusions:This chart allows a better understanding of the expectations that are at the core of the appeal for more transparency in the HTA process, since stakeholders need to understand which value-judgments the final conclusion of a report is relying on.
PP134 The Impact Of Pan-Canadian Oncology Drug Review Coming Under The Remit Of The Canadian Agency For Drugs And Technologies In Health – Three Year Update
Authors: Macaulay Richard , Turkstra Erika , Griffiths Elizabeth 
Published: January 2019

Introduction:The pan-Canadian Oncology Drug Review (pCODR) was established in 2010 to bring consistent oncology drug assessments across Canadian provinces/territories. In April 2014, pCODR was transferred to the Canadian Agency for Drugs and Technologies in Health (CADTH). This transfer comprised two phases. In phase one, pCODR staff, processes, funding, and expertise remained intact as a program but under the government of CADTH. In phase two, beginning April 2015, better alignment of pCODR and CADTH evaluation criteria and review processes were explored. This research aims to see what effect the CADTH transfer has had on the number of appraisals conducted by pCODR and their recommendation rates.Methods:All publically available pCODR reports were extracted up to 22nd November 2017. The drug, indication, date and outcome were extracted. Statistical comparisons were made using Student's t-test.Results:Ninety-six appraisals have been conducted by pCODR, reflecting an average of 16 per year (10 in 2012, 18 in 2013, 9 in 2014, 24 in 2015, 19 in 2016, and 20 in 2017). The rate of appraisals was similar pre-CADTH transfer (14.2 per year [32 from January 2012 to March 2014]) versus post-CADTH transfer (13.7 per year [56 from April 2014 to November 2017]). Seventy-eight percent of pCODR outcomes were positive recommendations (defined as full recommendations [10 percent] or restricted/conditional recommendations [68 percent]) with 22 percent not recommended. Annually, positive recommendation rates were 70 percent in 2012, 89 percent in 2013, 78 percent in 2014, 79 percent in 2015, 74 percent in 2016, and 75 percent in 2017. There were no significant differences in recommendation rates since pCODR was transferred to CADTH irrespective if the phase one or phase two cut-off dates were used (p = 0.434 and 0.307, respectively).Conclusions:The number of appraisals and likelihood of a positive recommendation for oncology drugs has not been affected by the pCODR transfer to CADTH.
PP136 Smartphone Intervention To Promote Healthy Lifestyles Among Teenagers
Authors: Puig Elisa Puigdomenech , Gómez Santiago , Castell Conxa , Espallargues Mireia , Dedeu Toni 
Published: January 2019

Introduction:We aimed to pilot the evaluation of the PEGASO system, a smartphone-based intervention (apps/wearables/game) to improve lifestyles and increase awareness.Methods:We conducted a before-after quasi-experimental pilot controlled study. Teenagers aged 13–16 in a 2:1 (intervention: comparative group [IG:CG]) basis from Spain, Italy and the United Kingdom were recruited. The IG had access to the apps and game for six months, and to smart sensors for the last two months. Schools were recruited by convenience sampling. Participants in both groups undertook (i) anthropometric measurements, (ii) diet (KIDMED), physical activity (PAQ-A) and sleep (HELENA study) validated questionnaires, and (iii) ad-hoc lifestyles knowledge questionnaire. PEGASO, if used, continuously recorded diet and physical activity. User experience was assessed through focus groups.Results:Five hundred and fifty-eight participants were included (IG:365 / CG:193). The mean (standard deviation; SD) age was 14.8 (0.8), and 52.3 percent were girls. At baseline, mean scores (SD) of KIDMED, PAQ-A and weekday and weekend sleep hours were 5.60 (2.41), 2.48 (0.66), 8.34 (1.07) and 9.99 (1.66), respectively. The percentage of correct answers of lifestyle's knowledge was 65.2 percent (range 13–100 percent). The IG and CG did not show differences for main outcome variables. At six months, a higher percentage of participants in the IG reported an increase of at least one point in the adherence to Mediterranean Diet (43.8 percent vs. 35.4). No differences were observed for other lifestyles. Focus group results showed a predisposition of adolescents to use mHealth for health promotion; the platform was considered to be useful and complete and personalized suggestions were positively valued. Participants reported few limited interest ion the game and several technical issues.Conclusions:Although participants were motivated and excited about their involvement in the study, and that PEGASO was something desirable for them, the system only showed some impact in specific areas – namely, diet – and could improve some its technological features. Several challenges and opportunities are associated with the implementation of mHealth.
PP140 Cancer And The Burden For Social Security System. Is It Sustainable?
Authors: Russo Simone , Migliorini Raffaele , Trabucco Marco , Mennini Francesco Saverio 
Published: January 2019

Introduction:The purpose of the study is to estimate both the number of beneficiaries and the burden of the Disability Insurance (DI) benefits provided for neoplastic diseases (ND) and for five cancer types, focusing on the expenditure by the social security system.Methods:To estimate the current DI benefits and their cost, we analyzed the databases of DI awards and the mean cost per benefit of the Italian National Social Security Institute (INPS) for two types of social security benefits: the disability benefits (DB) for people with reduced work ability and the incapacity pensions (IP) for people without work ability. A probabilistic model with a Monte Carlo simulation was developed in order to estimate the total benefits provided and costs.Results:Between 2009 and 2015, a yearly average was estimated of about 122,000 beneficiaries of DI for cancer. The total estimated expenditure for ND in the seven years, supported and provided by INPS for these social security benefits, amounted to EUR 8.1 billion (corresponding to 27.4 percent of the total expenditure for disability provided by INPS) of which 66.7 percent was associated with DB and the remaining 33.3 percent with IP. The percentage increase related to the costs show that DB have the most significant increase starting from the 2013 with 11.3 percent from 2013 to 2014 and 9.7 percent from 2014 to 2015, while. IP have an increase from 2009 to 2011, with a maximum during 2011, with a percentage difference of 7.6 percent.Conclusions:The incidence and the prevalence of the ND are expected to increase in the coming years in Italy. In order to minimize the consequences of this scenario, rapid access to innovative treatments would reduce the costs borne by the social security system, accompanied by an improvement in the effectiveness of interventions and increase in quality of life for patients.