bluuebunny/crossref_metadata_2025 huggingface dataset:
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.
PP159 Making Health Technology Assessment A Common Language In Controversies: A Hidden Role For The National Evidence-Based Healthcare Collaborating Agency
Authors: Park Jeong-eun , Lee Min Ji , Park Eunkyo , Kim Miseong , Park Jooyeon
Published: January 2019

Introduction:

In order to improve research planning it is critical to understand how decision makers have used previous health technology assessment (HTA) results, and what expectations policy makers and health professionals have in HTA programs. In this study, we aimed to examine how HTA results have been used by decision makers, and explore complex relationships between the National Evidence-based Healthcare Collaborating Agency (NECA) and various decision-making bodies in Korea.

Methods:

Three areas of healthcare decision in which NECA has been extensively involved were selected: prevention programs, single technology reimbursement, and clinical guidelines. We conducted in-depth interviews with two or three key informants from decision making bodies in each selected area. The interview participants included clinicians and government officials. We also conducted interviews with the researchers who participated in the related research to better capture the context. The interviews were analyzed using qualitative content analysis.

Results:

Eight interviews with decision makers and five interviews with researchers were conducted and analyzed. Three main themes were revealed in the data. Firstly, it was revealed that NECA was primarily expected to be an intermediary between clinicians and government. Both government and clinicians had referred to NECA's HTA results, which are expected to be scientific and impartial, when they need to reach one another on controversial topics. Secondly, there was a high need for deliberative process to resolve the conflicting interests regarding HTA results. Lastly, they wanted the HTA process to be more responsive to fast changing healthcare environments by introducing a form of rapid review.

Conclusions:

Lack of effective communication channels between government and healthcare providers in Korea has made a room for HTA to be a common language for both sides. It is time to give up the ‘one-size-fits-all’ approach to conducting HTA research and tailor the research process to various needs of decision makers.
PP163 The Cost-Reimbursement Mismatch For Heart Transplant In Brazil
Authors: Neyeloff Jeruza , Zeilmann Laís , Goldraich Lívia , Oliveira Vanessa , Ghisleni Eduarda , Hastenteufel Laura , Clausell Nadine
Published: January 2019

Introduction:

There is an important mismatch in the number of heart transplants performed and the patients in need of a new heart in Brazil, despite a large public transplant program providing universal health coverage for organ transplantation. It is unclear whether the limited number of heart transplants could be related to the high costs of the procedure and potential underpayment from public agencies. We sought to investigate costs of heart transplant in Brazil from the perspective of a transplant center and to compare results to the values reimbursed by the public health system.

Methods:

All adult heart transplants performed in an academic center from Jul/2015-Jul/2017 were reviewed. Both absorption costing and time driven activity based costing techniques were used to detail costs related to the transplant index admission. Patients’ electronic records were reviewed, involved professionals were interviewed, and the hospital electronic system was queried. Costs associated with infrastructure, personnel, surgical materials, medications, laboratory and imaging were calculated. Brazilian Reais were converted to US Dollars using 2016 purchasing power parity data from OECD.

Results:

All 27 patients who underwent heart transplants in the time period were included. Survival at 30 days was 94 percent. Average and median cost for the transplant admission was USD 62,336.27 and USD 47,105.52, respectively, while the current reimbursement value is USD 29,675. The lowest cost accrued by the hospital was USD 21,568.90, while the highest was over USD 300,000. Almost 70 percent of costs were related to personnel and hospital structure and not to direct consumption of medications, exams or materials. Total cost was highly dependent on the length-of-stay, particularly days spent in intensive care units.

Conclusions:

The value currently reimbursed by the public system in Brazil for heart transplants is below the average costs for the procedure in a reference center. This large cost-reimbursement mismatch might limit the increase in the number of transplants that is needed to meet current demands.
PP166 RedETS: 10 Years Of Economic HTA (Medical Devices) In Spain, 2006–2016
Authors: Garcia Emmanuel Gimenez , Espallargues Mireia , Dedeu Toni
Published: January 2019

Introduction:

RedETS, created in 2006, is the Spanish network of health technology assessment agencies. The objective of this work is to describe and assess the quality of the full economic evaluation reports on medical devices (FEEMD) carried out by RedETS.

Methods:

The FEEMD were identified through the RedETS website publications database. Assessments about screening technologies were not included. The characteristics of FEEMD were analyzed using a formal RedETS HTA quality checklist. The characteristics extracted were analyzed through a descriptive univariate analysis.

Results : Twenty-six FEEMD were found. The publication years were distributed quite uniformly over time (approximately 2/year), although 7 were published in 2008 and 7 in 2013. Thirteen studies analyzed cost-utility, ten cost-effectiveness but not utility, and three both. The most frequent medical devices (MD) class analyzed were “In vitro diagnosis MD” (n = 8) and Class III products (8). The most frequent sources to analyze effectiveness were literature (22) and data collected through ad hoc studies (6). The main sources of unit costs were official public tariffs (14), manufacturers direct values (10) analytical accounting of one/more centers or regions (11) and DRGs (7). In relation to the modelling used, 14 evaluations performed Markov models and 7 decision trees. The perspective of 23 studies was that of the National Health System (NHS), and the rest corresponded to the perspective of a specific region (2) or social perspective (1). All studies analyzing time horizons greater than 1.5 years, except for 1, applied discount rates in the modelling. All studies included a sensitivity analysis.

Conclusions:

The economic evaluations of MD published by the RedETS accomplish most of the quality checklist aspects and are therefore exhaustive. These FEEMD have been used in the framework of decision making for an efficient management of the NHS basic portfolio.
PD12 Economic Benefit Of Workplace Health Promotion: What Has Been Proven?
Authors: Rosian-Schikuta Ingrid
Published: January 2019

Introduction:

Maintaining people's ability to work is a priority in many European countries. Through healthier and more motivated employees, companies should benefit from lower absenteeism and increased productivity. The public sector expects savings in health care costs, an increase in the employment rate and avoidance of early retirement. Employees benefit from improving their health and well-being. The aim of the study is to investigate whether there is empirical economic evidence for the benefit of workplace health promotion.

Methods:

Systematic literature search in electronic databases and handsearch for systematic reviews, meta-analyses and economic studies with predefined inclusion and exclusion criteria.

Results:

Literature search provided two meta-analyses (with 84 primary studies), three systematic reviews (with 36 primary studies) and one model calculation (with 6 primary studies). There are relatively few empirical studies available to prove the economic benefit, often with inadequate methodological quality. Most of them are conducted in the United States of America. Only a few are from Europe, and those are mainly from Scandinavia. The available studies show a positive return on investment for companies however with a width range. Benefits for the health and social services have also been proven in a model calculation.

Conclusions:

The positive results must be interpreted with caution. Firstly, there is a lack of good primary studies on the effectiveness of measures on which economic analyses could be based; secondly, the methodological quality and comparability of economic analyses can still be improved and thirdly, the transferability of the results is often limited due to differences in health care systems.
PD18 Cost-Effectiveness Of Extracorporeal Life Support In Cardiogenic Shock
Authors: Bertoldi Eduardo , Polanczyk Carisi , Cruz Luciane , Etges Ana , Cardoso Liane , da Rosa Priscila , Rohde Luis Eduardo
Published: January 2019

Introduction:

Venoarterial extracorporeal life support (ECLS) is increasingly used in patients during cardiogenic shock, due to favorable results in this very high-risk scenario. However, it is a costly intervention that requires heavy financial investment and specialized human resources.

Methods:

Cost-effectiveness analysis to evaluate ECLS in the perspective of the Brazilian public health system (SUS) in the population of adult patients with cardiogenic shock. A decision tree comparing ECLS and usual care was built, using efficacy data from a systematic review of literature, and cost data from SUS reimbursement values. Impact of parameter variability and uncertainty were ascertained with deterministic and probabilistic sensitivity analysis.

Results:

Usual care resulted in thirty percent probability of survival, at an average cost of 3,000 international dollars (Int$/USD); the strategy that includes ECLS resulted in sixty-two percent survival rate, and average cost of Int$ 23,000, with incremental cost-effectiveness ratio (ICER) of Int$ 62.215 per averted in-hospital death. Results were sensitive to device cost, and survival difference between strategies. In probabilistic sensitivity analysis, ECLS was consistently more costly and more effective than usual care; based on a willingness-to-pay of three times Brazilian gross domestic product (GDP) per capita (Int$ 45,000), there was twenty-seven percent probability of ECLS being cost-effective.

Conclusions:

ECLS has the potential to increase survival for cardiogenic shock, but would significantly increase costs. In the Brazilian public health system, the cost per averted in-hospital death is 4.1 times the domestic GDP per capita.
PD22 Behavioral Factors Mediating Between Socioeconomic Status And Obesity
Authors: Gu Yuxuan , Dong Hengjin , Huang Minzhuo
Published: January 2019

Introduction:

China has the largest obese population in the world and its prevalence is increasing faster and faster. The researchers are investigating the association between the socioeconomic status (SES) and obesity in several ways. However, SES may not only play a direct impact on obesity but influences health behaviors which, in turn, affect obesity. The mediating factors have rarely been studied. This study investigates the association between SES and obesity mediated by behavioral factors among adults in China.

Methods:

The longitudinal data including 110,449 individuals were obtained from the eight waves of the China Health and Nutrition Survey from 1991–2011. The outcome of obesity was measured using Body Mass Index (BMI). The SES factors include education and income (low, medium and high). Mediating factors include alcohol consumption, smoking status, diet and physical activity. A variety of statistical models were used to investigate the association between SES and obesity. Age/gender-adjusted prevalence of obesity was calculated and multiple-logistic regression was used.

Results:

To some extent, SES influenced BMI directly, positively in men and inversely in women, respectively. SES may also operate through behavioral factors. These associations were not always straightforward, and changes in SES might create some offsetting risks. Behavioral factors including alcohol consumption, smoking status, diet and physical activity were associated with SES indicators in all groups. In addition, the prevalence was higher in urban areas than rural areas in China. Several pathways for different SES groups leading to obesity were simulated.

Conclusions:

Higher SES groups are more likely to have higher BMI compared to lower SES groups. Different SES groups have different significant mediating risk factors. The pathways between SES and obesity are complex. This study suggests that it is necessary to apply different interventions to different SES individuals especially focused on the disadvantaged populations according to their different behaviors and preference.
PD30 Cost-Effectiveness Of Stereo-Electroencephalography For Refractory Epilepsy
Authors: Garcia-Lorenzo Borja , del Pino-Sedeño Tasmania , Trujillo-Martin Maria M. , Zuniga Rodrigo Alberto Rocamora , López Juan Erviti , Toledo-Chávarri Ana
Published: January 2019

Introduction:

Stereo-electroencephalography (SEEG) has been shown to be a valuable tool for the anatomo-electroclinic definition of the epileptogenic zone (EZ) in some patients with medically refractory epilepsy considered for surgery. In Spain, many of those patients are not offered this diagnostic procedure. The objective of our health technology assessment (HTA) report was to evaluate the effectiveness, safety and cost-effectiveness of SEEG to define the EZ in patients with refractory epilepsy considered for surgery compared to no SEEG intervention (i.e. remaining with further antiepileptic drugs).

Methods:

We undertook a systematic review with meta-analyses on the effectiveness and safety of SEEG. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals for a lifetime horizon from the perspective of the Spanish National Health Service (NHS). The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis.

Results:

The EZ was found in 92 percent of patients who underwent SEEG, 72 percent were eligible for epilepsy surgery and 33 percent were free of seizures after surgery (47 percent of those who received surgery). Any complications related to insertion and monitoring of SEEG and the subsequent intervention occurred in 1.3 percent of patients. In the base case analysis, SEEG led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio of EUR 10,368 (USD 12,217) per QALY. The sensitivity analyses showed that the results of the study were robust.

Conclusions:

SEEG is a cost-effective technology in patients with refractory epilepsy considered for surgery when compared to no SEEG intervention.
PD31 Financial Impact Of Target Molecular Therapies In A Brazilian Hospital
Authors: Ferreira Maria Angélica , Lacerda Caroline , Moreira Leila
Published: January 2019

Introduction:

The therapy using molecular-targeted (MTT) and monoclonal antibodies (MA) are examples of new therapeutic technologies in search of greater clinical effectiveness and reduction of adverse effects in the fight against frequent diseases. Generally, new technologies have a high cost impact on the health system. The objective of this study was to evaluate the financial impact generated by the use of MTT and MA therapies in the teaching Hospital de Clínicas, Porto Alegre, Brazil.

Methods:

The first 60 higher monetary spending drug items of the last 12 months were analyzed. From them, drugs which fit in the categories under study, and have been regularly used, were identified. The monthly expenditures with each item were tabulated and compared with the total expenditures on drugs, in order to calculate the budgetary impact. The major groups of diseases treated with each agent were analyzed.

Results:

Two MTT agents (gefitinib and infliximab) and three MAs (rituximab, basiliximab and abciximab) were identified. The highest expenditure items, respectively, per year, were the oncological medicines rituximab (USD127,890) and gefitinib (USD96,923), followed by the immunosuppressive basiliximab (USD88,998) and the immunomodulatory infliximab (USD68,642), and the platelet aggregation inhibitor abciximab (USD47,886). These values corresponding to, respectively, 1.1 percent, 0.8 percent, 0.8 percent, 0.6 percent and 0.4 percent of total drug expenditure per year (USD11,866,124). Trastuzumab, bortezomib and imatinib were often used, but directly supplied by the public system, in a way that didn't impact the hospital budgetary management.

Conclusions:

MTT and MA have an important impact on health budgets, and are mainly used to treat some types of cancer, cardiovascular disease and autoimmune disorders. These aspects should be considered in the management of drugs in hospitals of high complexity.
PD84 Hostile Anatomic Neck Of Abdominal Aortic Aneurysm Patients And EndoAnchor Cost Analysis
Authors: Choi Hyun-Sook , Lee Sang-Soo
Published: January 2019

Introduction:

Failure at the proximal neck for endovascular aortic repair (EVAR) in abdominal aortic aneurysm (AAA) is more common in the presence of unfavorable proximal neck anatomy. In patients with hostile neck, EndoAnchors provide proximal fixation and reduces potential type I endoleak or endograft migration. However, the population size for AAA patients with hostile anatomic neck among Korean is unknown and cost-analysis with regard to EndoAnchors has not been established.

Methods:

To figure out the population size of AAA patients with hostile neck anatomy, retrospective medical chart review was conducted from four major medical centers. Hostile proximal aortic neck was defined as any or all of neck length 28 mm, infrarenal neck angulation >60°, ≥50 percent of circumferential thrombus, ≥50 percent of calcified neck, and conical neck. Cost-analysis on EndoAnchor use for treatment purpose was conducted based on Korean National Health Insurance Claims dataset (HIRA-NIS 2015).

Results:

Two-hundred and ten patients’ anatomic data treated with EVAR were included; 130 (61.9 percent) patients met the criteria for a hostile aortic neck and 32 (15.2 percent) patients had multiple hostile anatomy parameters. Endograft migration was reported in four (1.9 percent) patients and intra or post-op type I endoleak was reported in 21 (10.0 percent) patients. Based on 1-year claims data, 1,607 patients were treated with EVAR in 2015 and the annual average medical costs for open repair were USD 16,151. Given the patients with type I endoleak or endograft migration needs open repair if not treated with EndoAnchors, the estimated annual costs for patients treated with EndoAnchor were USD 2,234,321 and those for patients without EndoAnchor were USD 2,595,508, therefore USD 361,187 can be saved annually.

Conclusions:

The population size with hostile aortic neck in Korea was comparable with those in western countries. Economically, EndoAnchor is a cost-saving treatment for type I endoleak and migration after EVAR from Korean payer.
PD85 Testing Search Filters To Retrieve Economic Evaluations In Embase
Authors: Harboe Ingrid , Desser Arna , Nordheim Lena , Glanville Julie
Published: January 2019

Introduction:

Health technology assessments (HTAs) are increasingly used by Norwegian health authorities as the evidence base when prioritizing which health care services to offer. HTAs typically consist of a systematic review of the effects and safety of two or more health care interventions, and an economic evaluation of the interventions, based on systematic literature searches in bibliographic databases. Objective: To identify the best performing of seven search filters to retrieve health economic evaluations used to inform HTAs, by comparing the cost-effectiveness analysis (CEA) filter to six published filters in Ovid Embase, and achieve a sensitivity of at least 0.90 with a precision of 0.10, and specificity of at least 0.95.

Methods:

In this filter validation study, the included filters’ performances were compared against a gold standard of economic evaluations published in 2008–2013 (n = 2,248) from the National Health Service Economic Evaluation Database (NHS EED), and the corresponding records (n = 2,198) in the current version of Ovid Embase.

Results:

The CEA filter had a sensitivity of 0.899 and precision of 0.029. One filter had a sensitivity of 0.880 and a precision of 0.075, which was closest to the objective. The filter with lowest sensitivity (0.702) had a precision of 0.141.

Conclusions:

Developing search filters for identifying health economic evaluations, with a good balance between sensitivity and precision, is possible but challenging. Researchers should agree on acceptable levels of performance before concluding on which search filter to use.
VP08 Description Of A Strategy To Face Judicialization Of The Right To Heal
Authors: Galán Ana Perez , Aleman Alicia , Irisarri Magdalena , Sosa David De , Deminco Ana , Pedrosa Daniel
Published: January 2019

Introduction:

The Ministry of Health in Uruguay has a health technology assessment division that provides decision makers with evidence-based information on the efficacy, safety, and costs of health technologies to be included in the Comprehensive Plan of Health Care. Since 2010, patients have begun to demand access to unfunded, high-cost technologies through writs of protection. Judicialization of the right to health increased rapidly from 2010 to 2014. In this context, a Technical Advisory Commission was created in 2015 to assess patient requests on a case-by-case basis. The purpose of this study was to evaluate the results obtained with a new strategy developed to face the judicialization of access to high-cost technologies.

Methods:

The methodology used to evaluate the implementation of the strategy consisted of reviewing a database of access requests from October 2016 to October 2017. The demographic characteristics, technologies requested, prescriptions, and results of the process were analyzed.

Results:

In the study period 654 technologies were requested for funding through the process. The included population had a mean age of 60 years; sixty-two percent were men. Of the technologies requested, eighty-five percent were drugs and fifteen percent were devices. The requested technologies included cancer treatments (thirty-five percent) or drugs and devices for the treatment of rheumatologic, ophthalmologic, infectious, neurologic, and cardiovascular conditions. The six most requested technologies (forty-five percent of all requests) were: abiraterone for prostate cancer; aortic endoprosthesis for vascular aneurysm; lenalidomide, rituximab, and azacitidine for oncohematologic diseases; and cetuximab for colorectal cancer. The Ministry of Health funded thirty-six percent of the requests.

Conclusions:

The new strategy was successful in reducing the judicialization of access to unfunded, high-cost technologies in Uruguay, and it helped to prioritize the inclusion of new drugs in the national formulary.
VP18 Antibiotics And Orthopedic Surgery Without Implant: A Meta-Analysis
Authors: Davies Sophia Campbell , Inserra Chiara , Muserra Gaetana , Bignamini Angelo , Minghetti Paola
Published: January 2019

Introduction:

According to guidelines, antibiotic prophylaxis in orthopedic surgery without implant is not recommended for the reduction of the incidence of surgical site infections (SSI); however, the evidence level is low. Surveys have shown that preoperative antibiotics for orthopedic procedures without implant are administered routinely by surgeons due to medico-legal concerns. Such practice may have an important impact on costs, side effects and the emergence of antibiotic resistance. Therefore, the objective of the review is to evaluate existing clinical evidence.

Methods:

A systematic review was performed with the use of Pubmed, EMBASE/MEDLINE, CENTRAL, SBBL-CILEA/METACRAWLER, ISRCTN Registry, ICTRP and ClinicalTrials.gov databases. Trials were initially screened by the title and abstract; secondly, full papers were analysed. The meta-analysis included randomized controlled trials (RCT) with patients undergoing surgery as treatment for any orthopedic impairment that did not need implantation. Heterogeneity analysis of the studies was conducted with chi-square. The statistical analysis of the infection rate was performed using the meta package with the R software. The effect estimate was expressed in risk ratio (RR) and pooled using a random effects model. Study quality assessment was undertaken using the Jadad scale.

Results:

Of the 184 identified papers, 129 were excluded since they did not meet inclusion criteria and 45 were discarded because they were considered to be duplicate publications. After analyzing the 10 potentially relevant studies, only two were included. The study population consisted of 1,152 patients. No heterogeneity was observed; however, the studies were outdated and associated with a high risk of bias. According to the pooled RR, the incidence of infection in the intervention group was lower than the control group favoring prophylaxis (RR = 0.39, 95% CI: 0.16−0.96, p = 0.040).

Conclusions:

The meta-analysis demonstrated, in contrast to the guidelines, that antibiotic prophylaxis can reduce the incidence of SSI in elective orthopedic surgeries without implant; however, the low number of available studies and the high risk of bias show that the effect estimate is not statistically significant. Considering that antibiotic prophylaxis is usually administered in clinical practice, RCTs are required to establish whether antibiotic prophylaxis in orthopedic procedures without implant is recommended or if this practice could cause more harm.
VP22 Future Trends For Managed Access Agreements In The UK
Authors: Walsh Sean , Tsang Ricky , Turkstra Erika , Macaulay Richard
Published: January 2019

Introduction:

In recent years, the National Institute for Health and Care Excellence (NICE) has increasingly agreed to reimburse innovative products with high levels of uncertainty as part of managed access agreements (MAAs) while new data are collected; namely, this has occurred through the new Cancer Drugs Fund (CDF) and highly specialized technology (HST) appraisal pathway. This research aimed to provide a review of ongoing data collection arrangements as part of MAAs agreed with NICE.

Methods:

We reviewed all current MAAs entered into between the National Health Service (NHS) England and manufacturers as of 24 November 2017 and extracted relevant information related to the data collection arrangements.

Results:

Thirteen MAAs were identified (10 through the CDF; 3 through HST). All MAAs involved an observational data collection agreement. The source of observational data collection was existing NHS databases (11 MAAs: 85 percent), existing independent registries (1 MMA: 8 percent [ataluren]); bespoke MAA registry maintained by manufacturer (1 MAA: 8 percent [asfotase alfa]), and registries developed as a requirement for regulatory approval and maintained by the manufacturer (1 MAA: 8 percent [elosulfase alfa]). Only 4 MAAs (asfotase alfa, ataluren, elosulfase alfa, and venetoclax) had observational data collection as the sole basis of the data collection agreement. The other 9 MAAs (69 percent; all from the CDF) also required on-going data collection from clinical trials as a key component of the data collection agreement.

Conclusions:

This research shows that current MAAs have predominantly utilized either ongoing data collection (e.g. from RCTs) or existing registries to date for which limited additional set-up administration and costs would be required. However, NICE plan to increase the use of MAAs, with ongoing NICE consultation for changes in the appraisal process to expand MAAs to include all indications. In future, manufacturers will have more opportunities to explore and leverage innovative and bespoke MAAs to help achieve access.
VP33 Peroral Endoscopic Myotomy For Treating Achalasia: A Rapid Review
Authors: Chen Deborah , Burgess Naomi
Published: January 2019

Introduction:

The best available research and funding policy evidence regarding the regulatory status, patient selection criteria, safety, clinical effectiveness, and financial impact of peroral endoscopic myotomy (POEM) for the treatment of achalasia was synthesized for statewide decision making for a South Australian local health network.

Methods:

A comprehensive systematic search of twenty-three gray literature sources and three published literature databases for international evidence was conducted, based on a priori inclusion criteria. The methodological quality of the included studies was critically appraised. Data extraction and synthesis were conducted in narrative form.

Results:

Short-term safety and clinical data from very low-level studies showed that POEM appears to be a relatively safe and clinically effective endoscopic treatment for esophageal achalasia, compared with laparoscopic Heller myotomy (LHM). One primary safety concern consistently highlighted by the literature was gastroesophageal reflux (GER) after POEM, since no anti-reflux procedure is involved. Operative time and length of hospital stay for POEM were comparable with LHM and potentially favor POEM. The comparative long-term outcomes for the POEM procedure are not known. No studies have investigated the cost-effectiveness of POEM. Conflicting findings were reported on whether POEM is cheaper or more expensive than LHM. POEM is a technically challenging procedure with a substantial learning curve. Patients who undergo POEM may require postoperative surveillance and testing to evaluate procedural success and to identify potential complications. Current literature showed limited analysis and systematic elucidation of an optimal patient group that may best benefit from POEM.

Conclusions:

The POEM procedure should be carried out at an experimental or trial level only, with strict auditing of results. POEM procedures should ideally be performed at institutions where an adequate level of surgical and critical care backup is available to provide expert care should complications arise. Monitoring of patient outcomes, including symptom improvement, is recommended for clinical assessment and reporting to determine future adoption in the South Australian public health sector.
Disaster Health Management: Do Pharmacists Fit in the Team?
Authors: Watson Kaitlyn E. , Tippett Vivienne , Singleton Judith A. , Nissen Lisa M.
Published: January 2019

Background

In addition to the traditional logistics role, pharmacists are undertaking important new roles in disasters. Despite this, little is known about the level of acceptance of these activities by other providers.

Problem

The aim of this study was to determine the international opinion of disaster and health professionals regarding the emerging roles of pharmacists in disasters.

Methods

Delegates at the World Association for Disaster and Emergency Medicine’s (WADEM; Madison, Wisconsin USA) 20thCongress in Toronto, Canada (April 2017) were invited to complete an anonymous survey posing eight questions regarding attitudes towards pharmacists’ roles in disasters. Quantitative data were analyzed using IBM (IBM Corp.; Armonk, New York USA) SPSS statistical software version 23, and qualitative data were manually coded.

Results

Of the 222 surveys handed out, 126 surveys were completed yielding a 56.8% response rate. Of the respondents, 96.8% (122/126) believed pharmacists had a role in disasters additional to logistics. Out of 11 potential roles pharmacists could perform in a disaster, provided on a 5-point Likert scale, eight roles were given a rating of “Agree” or “Strongly Agree” by 72.4% or more of the participants. Lack of understanding of a pharmacist’s roles and capabilities was the highest described barrier to pharmacists’ roles in disaster management.

Conclusions

This multi-disciplinary disaster health “community” agreed pharmacists have roles in disasters in addition to the established role in supply chain logistics. Participants accepted that pharmacists could possibly undertake numerous clinical roles in a disaster. Several barriers were identified that may be preventing pharmacists from being further included in disaster health management planning and response.

WatsonKE,TippettV,SingletonJA,NissenLM.Disaster health management: do pharmacists fit in the team?Prehosp Disaster Med.2019;34(1):30–37.
Increased risk of type 2 diabetes among the siblings of patients with schizophrenia
Authors: Huang Mao-Hsuan , Chen Mu-Hong , Huang Kai-Lin , Hsu Ju-Wei , Bai Ya-Mei , Cheng Chih-Ming , Su Tung-Ping , Li Cheng-Ta , Tsai Shih-Jen , Lin Wei-Chen , Yang Albert C. , Chen Tzeng-Ji
Published: January 2019

Background

Research suggests an association between metabolic disorders, such as type 2 diabetes mellitus (T2DM), and schizophrenia. However, the risk of metabolic disorders in the unaffected siblings of patients with schizophrenia remains unclear.

Methods

Using the Taiwan National Health Insurance Research Database, 3135 unaffected siblings of schizophrenia probands and 12,540 age-/sex-matched control subjects were included and followed up to the end of 2011. Individuals who developed metabolic disorders during the follow-up period were identified.

Results

The unaffected siblings of schizophrenia probands had a higher prevalence of T2DM (3.4% vs. 2.6%, p = 0.010) than the controls. Logistic regression analyses with the adjustment of demographic data revealed that the unaffected siblings of patients with schizophrenia were more likely to develop T2DM (odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.10–1.75) later in life compared with the control group. Moreover, only female siblings of schizophrenia probands had an increased risk of hypertension (OR: 1.47, 95% CI: 1.07–2.01) during the follow-up compared with the controls.

Discussion

The unaffected siblings, especially sisters, of schizophrenia probands had a higher prevalence of T2DM and hypertension compared with the controls. Our study revealed a familial link between schizophrenia and T2DM in a large sample. Additional studies are required to investigate the shared pathophysiology of schizophrenia and T2DM.
THE TWO REVOLUTIONS, LANDED ELITES, AND EDUCATION DURING THE INDUSTRIAL REVOLUTION
Authors: Leite Duarte N. , Afonso Óscar , Silva Sandra T.
Published: January 2019

Understanding the causes of the Industrial Revolution, namely the process of transition from a Malthusian equilibrium to modern economic growth, has been the subject of passionate debate. This paper contributes to insights into the process of industrialization and the demographic transition that followed. We present a model that proposes a mechanism behind the claim that landed elites had strong incentives to block education reforms. By applying the theory of interest groups to landownership, landowners could delay education. However, they could not prevent its introduction indefinitely since gains for the landed elites derived from education would at some moment surpass the costs associated with them. We also sustain that improvements in agricultural productivity prior to the Industrial Revolution may have induced a positive impact on the landowners’ decision to educate the population, which led to an earlier introduction of education reforms. The conclusions fit the patterns of the late boom of industrialization and demographic transition and help explain why some countries (e.g., Britain and The Netherlands) had accelerated education reforms and a faster process of industrialization than most continental countries. A theoretical model is presented, and numerical simulations are exhibited to illustrate our claims.
AGAINST INTOLERANCE: THE RED SCARE ROOTS OF LEGAL LIBERALISM
Authors: Weinrib Laura
Published: January 2019

This article argues that important antecedents of post-New Deal American liberalism emerged in response to the First Red Scare. As war hysteria gave way to patent antiradicalism, the pervasiveness of peacetime state-sponsored repression undermined progressive confidence in administrative governance and generated support for so-called personal rights. At the same time, the suppression of meaningful labor activity during the early 1920s buttressed conservative confidence in the judiciary and emboldened lawyers and business advocates to oppose state policing of putatively private beliefs. The result was increasing convergence around a new liberalism, defined against “intolerance,” which laid the groundwork for judicial enforcement of free speech and minority rights.