Monitoring the effectiveness of knee and hip arthroplasties could be useful at the clinical, economic, and patient levels. In Catalonia, there is currently no systematic monitoring of the different prostheses available. The aims of this study were to propose an approach for the systematic identification of knee and hip prostheses with the highest revision rates, and to identify those with the poorest outcomes.

Data recorded from January 2005 to December 2016 were considered from 53 out of the 61 public hospitals in Catalonia included in the Catalonian Arthroplasty Register (RACat). Specific prostheses were classified by joint, type, fixation, and, in total hip prostheses, the bearing surface. Prostheses with the worst outcomes were identified using a three-step approach, based on previous literature: (i) screening using Poisson models; (ii) comparison of prostheses using adjusted Cox models; and (iii) consensus-based review by a panel of orthopedic surgeons to detect possible sources of bias. After this process, selected prostheses were provisionally labeled as having the poorest outcomes. This process will be repeated periodically within the RACat to definitively classify the prostheses.

After first two steps, ten knee prostheses and eight hip prostheses were identified. After the panel discussion (third step), one knee and one hip prosthesis were excluded from the final list. The knee prosthesis was excluded because it was a unicompartmental implant, while the hip prosthesis was excluded because it was a monoblock implant. Finally, nine knee prostheses and seven hip prostheses were provisionally identified as having the worst results relative to other available prostheses. These results await confirmation in subsequent analyses.

This study contributed to the current need to identify hip and knee prostheses whose outcomes might be worse than expected. This identification could have an impact at the patient, surgeon, industry, and stakeholder levels.

Full health technology assessment (HTA) reports discuss not only the safety and efficacy of a technology, but also the economic, ethical, legal, socio-cultural, and organizational aspects. INTEGRATE-HTA is a completed European Union project that developed concepts and methods for a patient-centered, integrated assessment of complex technologies. Technologies can be considered complex if they are characterized by a large number of interacting components, a wide variability of outcomes, or a high degree of flexibility. In contrast to the usual linear approach of addressing individual HTA domains separately, the INTEGRATE-HTA methodology is based on the assumption that different aspects of the domains interact. From the very beginning, these interactions are captured systematically using various tools. Continuous reflection and compaction of these relations can lead to an extended perspective on a technology. As a result, complexity and mechanisms of action open up, helping to channel public discussion and implementation. We investigated whether using the INTEGRATE-HTA methodology improves the understanding of individual domains and their interactions.

According to the methodology, an initial logic model for rasterstereography in patients with scoliosis was developed and successively expanded. A synoptic table, showing multiple maps of individual aspects to domains, and a complexity checklist were used. In addition, harvest plots were created and the socio-cultural impact of the disease was highlighted as a semantic complex. A final logic model and an interaction figure were established to initiate discussion.

Having been classified as slightly complex in the beginning, rasterstereography turned out to be highly complex after using a variety of tools and a final graphical representation; the multiple mapping of individual aspects to domains resulted in a high density of interactions.

The INTEGRATE-HTA methodology helped to identify interactions between domains and significantly expanded the perspective on a technology. It improved patient-centered understanding and facilitated the discussion of single aspects.

Psoriasis 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.

A 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.

The 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).

MetS 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.

Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory skin disease characterized by painful nodules and abscesses. HS has a strong impact on patient quality of life. In Brazil, the prevalence of HS is estimated at 0.4 percent. Medical and surgical treatments have low effectiveness and disease recurrence is common, which affects health system costs. This study aimed to assess how HS patients utilize medical care (emergency and inpatient care) in Brazil and to describe the all-cause costs.

Data were retrieved from a public healthcare claims database (DATASUS), which provides access to information regarding health services and costs. Data from DATASUS were used to perform a cost-identification analysis on patients with HS who used health services over a two-year period. A retrospective bottom-up approach was used to estimate direct costs, multiplying the amount of each medical resource consumed by its unit cost.

Over the two-year period, 90 patients (16%) with HS received inpatient care (151 procedures) at a total cost of BRL 83,520 (USD 21,715). Surgeries were the most frequently performed (73% of total) and expensive procedures, costing BRL 73,122 (USD 19,011; 88% of total costs), followed by clinical treatments (BRL 8,354 [USD 2,172]; 10%), and physician consulting (BRL 1,659 [USD 431]; 2%). For the 500 patients treated in the emergency department (total cost BRL 3,027 [USD 787]), the most frequently received services were physician consulting (34%), nursing care (12%), and minor surgeries (11%). Each patient received, on average, three procedures over the two-year period.

HS is a high-burden disease, as demonstrated by the high healthcare resource utilization among patients. Since DATASUS is a public database, the costs presented reflect a government reference price and do not consider local costs, which is a limitation of this study. Health managers should be aware of this finding, although further research is needed to investigate the effect of healthcare utilization on patient outcomes.

Dysphagia 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.

We 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.

Of 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.

Results 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.

The Early Access to Medicines Scheme (EAMS) aims to provide access to medicines prior to market authorization for patients with severe, life-threatening diseases who do not have adequate treatment options. An EAMS designation enables the potential collection of United Kingdom-specific real world evidence (RWE) prior to health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE). This research evaluates whether RWE is being gathered through the EAMS and utilized to support HTA submissions.

All EAMS designations as of 7 November 2018 were identified from the Medicines and Healthcare products Regulatory Agency website. For products with final NICE guidance, all publicly-available NICE documentation was reviewed.

Sixteen product and indication pairings with an EAMS designation were identified, with 12 having received final NICE guidance (11 were recommended, 3 were recommended for temporary reimbursement via the Cancer Drugs Fund, and 2 were not recommended). Of the 11 recommended products, seven had references to the number of patients or sites with product access through the EAMS, but only one (dupilumab for atopic dermatitis) had detailed data collected during the EAMS period. The manufacturer of dupilumab reported baseline demographics and disease characteristics from a cohort of 35 patients treated under the EAMS to inform the generalizability of trial populations for clinical practice. Follow-up results from this cohort demonstrated that real-world data on dupilumab effectiveness was comparable with the clinical trial data, despite a higher proportion of patients in the real-world cohort receiving immunosuppressant therapy, which makes improvements in efficacy harder to achieve. The committee also noted that the RWE presented supported the understanding of dupilumab's long-term clinical effectiveness and informed assumptions for the economic model.

To date, the majority of products receiving an EAMS designation have not presented RWE at NICE reappraisal. The case of dupilumab illustrated how RWE collected through the EAMS can be used to reduce uncertainty around how clinical trial data can be translated into clinical practice. In the future, RWE may increasingly be used to help inform NICE decisions.

The trend of growing healthcare expenditures is unsustainable in many countries. The increasing pressure on healthcare budgets due to, for example, population ageing, increasing numbers of patients with chronic diseases (including multimorbidity), and the introduction of new pharmaceutical innovations, leads to political and societal debate. In particular, the introduction of expensive pharmaceutical innovations causes a lot of discussion and uncovers various paradoxes and dilemmas. There is a societal demand for innovation focused on existing medical needs (e.g., oncological, immune-mediated inflammatory, and orphan diseases), but the price of pharmaceutical innovations is a barrier to patient access. As a consequence, systems try to introduce measures or incentivize market forces to improve access for patients, while also containing budget impact. This does not always lead to better access and affordability. The aim of this study was to develop and test a conceptual decision-making framework for pharmaceutical innovations.

A retrospective study was conducted to identify the successes and challenges of decision-making systems across Europe. A conceptual decision-making framework, including proposed procedures, criteria, and health technology assessment (HTA) requirements (including tools), was developed and tested based on specific case examples (e.g. oncology and hepatitis C).

The conceptual decision-making framework comprised an algorithm for relevant decision-making criteria (e.g. clinical evidence, medical need, cost-effectiveness, and budget impact). The algorithm was developed hierarchically and ranked the criteria in order to optimally inform various types of investment decisions. This novel approach to conducting budget impact analyses resulted in more realistic predictions of the burden of pharmaceutical innovations on healthcare budgets, and can be used as part of horizon-scanning processes to inform healthcare decision making. Results from selected case examples are presented.

The conceptual decision-making framework and proposed method for budget impact predictions will allow for more balanced future healthcare investment decisions.

Within early benefit assessment of pharmaceuticals in Germany, addenda can be commissioned by the Federal Joint Committee (FJC) to the health technology assessment (HTA) agency, mainly as a result of a hearing. Our aim was to analyze the issues for and impact of commissioned addenda, as well as the agreement between HTA agency recommendations and FJC decisions.

All available relevant documents on addenda commissioned up to the end of 2017 were screened and their essential content extracted. Differences between the HTA agency and FJC recommendations were tested, and concordance was analyzed using agreement statistics (Cohen's kappa and Fleiss’ kappa).

Most of the 90 addenda commissioned up to the end of 2017 concerned oncological products. In all contingent comparisons, positive changes in added benefit or evidence level on a subpopulation basis (n = 124) were more common than negative changes. Agreement of assessments, addenda, and appraisals reached a moderate strength for added benefit (Fleiss’ kappa 0.47, range 0.41 - 0.54). Overall agreement between addenda and appraisals on a binary nominal basis was poor for added benefit (Cohen's kappa 0.18, range 0.01 - 0.36) and fair for evidence quality (Cohen's kappa 0.35, 0.19–0.52). Cohen's kappa ranged from “less than by chance” (respiratory diseases) to “perfect” (neurological diseases), but was only statistically significant for neurological and other diseases. Three addenda are presented in detail as examples.

Addenda have a high impact on decision-makers’ appraisals, offering additional analyses of supplementary evidence submitted by the manufacturers. Nevertheless, the agreement between addenda and appraisals varies, highlighting different methodological approaches and decision-making factors between the HTA agency and the FJC.

A range of innovative, targeted anti-cancer therapies have been developed over the past 20 years. More recently, companies have been developing combinations of these drugs. While this promises substantial efficacy benefits, dual-brand oncology therapy combinations may potentially create substantial economic burden. Obtaining a positive health technology assessment (HTA) recommendation and public reimbursement can be a major challenge, and may be more difficult when each constituent monotherapy is marketed by a different company. We evaluated whether dual-brand oncology therapies developed by a single manufacturer had faster or better outcomes than those developed by two separate manufacturers.

Recent combination oncology drug products were screened in November 2018 to identify whether one or two manufacturers were involved. The websites of various HTA organizations were screened and the relevant data extracted.

A total of 78 recommendations for dual-brand oncology treatments were identified across the HTA agencies screened: 26 of these were for combinations by the same manufacturer and 52 were for combinations with two manufacturers. Dual-brand therapies developed by a single manufacturer were more likely to receive full or optimized/conditional recommendations (58% “recommended” and 12% “optimized/conditional”) than those marketed by two separate manufacturers (42% “recommended” and 8% “optimized/conditional”). Dual-brand therapies with two manufacturers were more likely to receive negative HTA recommendations than those marketed by a single manufacturer (50% versus 31%). However, the median time from marketing authorization to recommendation in European countries was the same (6 months), regardless of whether each constituent monotherapy was marketed by one or two manufacturers.

HTA agencies were more likely to issue negative recommendations for dual-brand oncology treatments marketed by two separate companies, compared with those marketed by a single company. A single company may have more flexibility in price setting, which may facilitate more positive HTA recommendations.

In the context of limited healthcare resources and high healthcare expenditures, the introduction of new, cost-intensive medicines forces decision-makers to prioritize drug funding, especially in the areas of orphan diseases and oncology. In democratic societies, health policy decisions need to be evidence-based, transparent, fair, and efficient. Therefore, in some countries standardized (transparent) processes exist. In Austria, decisions on the reimbursement of new medicines have not been made for a long time. The aim of the present study was to develop different scenarios for a standardized, centralized reimbursement process for expensive hospital drugs in Austria that favors democratic decisions.

A multi-stage approach was undertaken. Firstly, the reimbursement processes (only for original preparations) in Austria and other selected countries were investigated. Secondly, the strengths and weaknesses of these processes were analyzed based on predefined criteria, following the concepts of “accountability for reasonableness” (A4R) and “deliberative decision making”. Thirdly, scenarios for an Austria-wide uniform reimbursement process for hospital drugs were developed.

Three scenarios were identified: (i) a reimbursement process for hospital drugs that follows the existing reimbursement process in the outpatient sector in Austria; (ii) a cooperative of decentralized Pharmaceutical and Therapeutics Committees for procurement, use, and reimbursement decisions for hospital drugs; and (iii) an adaptation of the existing reimbursement process of non-drug, highly specialized technologies to pharmaceutical interventions.

According to the concepts of A4R and deliberative decision making, a transparent, evidence-based, fair, and efficient allocation of limited healthcare resources is indispensable for justifying decisions on health funding priorities in democracies. However, these criteria can be diametrically opposed. For example, methods, processes, and decisions can be evidence based, transparent, and fair, but also significantly more time consuming. Thus, a balance between the individual options for action is necessary, and priorities must be set.

Constantly rising healthcare costs and the increasing incidence of antimicrobial resistance represent a growing burden on public health, affecting patients, physicians, payers, and health authorities. This analysis assessed the economic impact of improved diagnostic accuracy among septic patients.

A cost-consequence model was developed to evaluate two different scenarios for the treatment of severe sepsis: scenario one represents the current status of diagnostic performance used for an antimicrobial treatment; scenario two is based on the assumption that a more accelerated diagnostic process results in 15 percent more patients being treated with an efficient antimicrobial drug early in their therapy. Data for the average patient-related cost for diagnostics (EUR 1,182) and overall cost (EUR 12,090), length of hospital stay (average 18.7 days), and number of patients affected annually (n = 771) were derived from the German Diagnosis-Related Group Catalog for 2017. Further, the impact of optimal versus inadequate therapeutic approaches on length of hospital stay (38% decrease), hospitalization cost (40% decrease), and mortality rate (28% decrease) were derived from published sources.

By using more efficient tests to enable earlier detection of sepsis in patients who otherwise would not receive appropriate treatment, 36 additional patients were appropriately treated. The overall annual length of hospital stay can be shortened by 319 days and the number of sepsis-related deaths reduced by three. The overall annual costs in scenarios 1 and 2 amounted to EUR 11.4 and EUR 11.2 million, respectively. The main savings resulted from reduced expenses for hospital stay, drugs, readmissions, and progression to septic shock.

Increasing cost pressure and the rise in multi-resistant germs are a burden, which will increase over the next decade. The present analysis showed that a willingness to intervene early and stop detrimental developments, and to invest in effective technologies, can promote affordable health care.

Due to epidemiological transition, a rise in hepatitis A outbreaks among adults in the state of Kerala, India has been noted. This has intensified the need for hepatitis A vaccination (HAV), but evidence regarding the cost effectiveness of HAV, which is essential to guide policy decisions, is lacking. This study was undertaken to evaluate the cost effectiveness of HAV among adults in Kerala state.

To determine the cost effectiveness of HAV from a societal and a payer perspective, a Markov model was constructed with a cycle length of two months. The lifetime costs and outcomes for HAV and no vaccination were compared using a discount rate of 3 percent. Data for the model input parameters of cost, coverage, and effectiveness were derived from the published literatures. One-way and probabilistic sensitivity analyses were applied. A threshold based on the per capita gross domestic product (GDP) was used (1 GDP = INR 127,702.48 [USD 1,886.03]).

The incremental cost-effectiveness ratios for both societal and payer perspectives were negative, indicating that HAV was dominant, being less costly and more effective than no vaccination. The discount rates and utility values for adults with HAV were the most sensitive parameters.

A HAV strategy would be cost-saving, compared with no vaccination, in the Kerala state of India.

There are multiple antidiabetic drugs available in China, which vary in their efficacy and safety. However, no study exists that compares all the classes of antidiabetic drugs simultaneously. This study aimed to estimate and compare the efficacy of alternative classes of antidiabetic drugs for Chinese patients with type 2 diabetes, either in a monotherapy regimen or combined with metformin.

A systematic literature review was conducted by searching various literature databases to identify relevant randomized controlled trials published from 1990 to 2016. A meta-analysis was conducted to compare the efficacy of antidiabetic drug monotherapy and placebo or lifestyle interventions (i.e., diet and exercise), and antidiabetic drug plus metformin versus metformin alone, in Chinese patients with type 2 diabetes. An indirect comparison was used to estimate the efficacy of antidiabetic drug plus metformin versus placebo or lifestyle-intervention using metformin as the common comparator.

The database search identified 354 relevant studies. Compared with placebo or lifestyle interventions, combination therapies achieved greater reductions in hemoglobin A1c (HbA1c) level (1.9% versus 0.9%), body mass index (BMI) (2.66 versus 0.98 kg/m2), and total cholesterol level (1.07 versus 0.35 mmol/L) than monotherapies. For monotherapies, the top three treatments for reducing HbA1c level were insulin, sulfonylurea, and glucagon-like peptide-1 (GLP-1) receptor agonist. The top three monotherapies for reducing BMI level were metformin, GLP-1 receptor agonist, and α-glycosidase inhibitor. The top three monotherapies for reducing total cholesterol level were metformin, GLP-1 receptor agonist, and dipeptidyl peptidase-4 (DPP-4) inhibitor. For combination therapies, the top three treatments for reducing HbA1c level were GLP-1 receptor agonist plus metformin, insulin plus metformin, and glinide plus metformin. The top three combination therapies for reducing BMI level were glinide plus metformin, GLP-1 receptor agonist plus metformin, and DPP-4 inhibitor plus metformin. The top three combination therapies for reducing total cholesterol level were insulin plus metformin, GLP-1 receptor agonist plus metformin, and α-glycosidase inhibitor plus metformin.

Pharmacological treatments had better efficacy than placebo or lifestyle interventions, while combination drug therapies were superior to monotherapies.

Colorectal cancer (CRC) is the third most common malignant neoplasm among men and the second most common among women. According to the World Cancer Report, the number of people suffering from this disease is growing steadily. In 2012, there were more than 1.36 million new cases of CRC, and approximately 694,000 people died from this disease worldwide.

A sensitive literature search identified 12 relevant publications, including: a CORRECT phase III study assessing the effect of regorafenib in patients with metastatic CRC that continued to progress despite using all standard treatment methods; a CONCUR Phase III study evaluating the clinical effect of regorafenib in Asian patients with metastatic CRC; a CONSIGN study conducted after the CORRECT and CONCUR studies that assessed the safety profile of regorafenib prior to market entry; and various systematic reviews evaluating the safety of regorafenib.

The efficacy and safety of regorafenib for treating patients with metastatic CRC was evaluated in two major clinical studies: CORRECT and CONCUR. Although the studies were randomized, double-blind, and placebo-controlled, they were conducted in different patient populations. Before treatment with regorafenib, patients received, depending on the country, fluoropyrimidines, oxaliplatin, irinotecan, or bevacizumab, and patients with the wild-type KRAS gene also received cetuximab and panitumumab. Results from both studies indicated that regorafenib had a clinically significant positive effect on rates of progression-free survival and overall survival in patients with treatment-resistant metastatic CRC.

Regorafenib can be recommended as a monotherapy for resistant metastatic CRC when there are no contraindications to use. Considering the safety profile of regorafenib, further research is needed to determine the best dosage of regorafenib and the most appropriate clinical and molecular biomarkers for determining which patients would benefit most from this treatment.

Classic health technology assessment (HTA) is based on safety, efficacy, and costs. However, in the dynamic world of medicine, “real-world” experience is used to improve HTA. Aggregating evidence is a constant challenge. Physicians are traditionally trained in professionalism (knowledge and skills) and compassion, concentrating on the patient and disease rather than the technology. Currently, medical education also emphasizes quality of care by promoting standardization, and reducing mistakes by root cause analysis. We aimed to integrate the key parameters of safety, effectiveness, quality measures, economic aspects, and assessment guidelines for real-world experience in medical education.

A group of medical students participated in a targeted HTA-orientated education program, which focused on the identification of challenges and barriers in the adoption of health technologies, and then completed a structured survey.

The program included 243 students. They raised four major emerging challenges: (i) to initiate a culture of quality and HTA-targeted perception for individual physicians; (ii) to better understand the role of different stakeholders in the health system; (iii) to be exposed to considerations of budget allocation; and (iv) to incorporate patient preferences, expectations, and engagement so that patient-centered care becomes a critical part of HTA.

Incorporating values of HTA-targeted quality at an early stage of medical education, while future physicians are developing their professional identity, may create a professional, quality-focused leadership group in health care. The understanding and implementation of these “new” dimensions may serve as a platform for building smart capability to ensure better decision making processes among caregivers and medical managers.

Since 2007, 23 Núcleos de Avaliação de Tecnologias em Saúde or hospital-based health technology assessment (HB-HTA) units have been established in teaching hospitals across Brazil. These units aim to promote the development of health technology assessment in hospitals, assisting the decision-making process for implementing new technologies and evaluating and promoting the rational use of widespread technologies.

An online questionnaire was sent by e-mail to all HB-HTA units registered in the Brazilian Network for Evaluation of Health Technologies. Information was acquired to comprehensively assess the activity of the units.

All 23 HB-HTA units answered the questionnaire. Of these, 65 percent had a technology prioritization process. The technologies assessed included drug therapies (73%), equipment (64%), medical devices (64%), clinical protocols (46%), and emerging technologies (27%). The dimensions of health technology assessment (HTA) evaluated by these organizations were: efficacy (76%); effectiveness (67%); safety (67%); costs (52%); cost effectiveness or cost utility (52%); and budget impact (43%). The hospital departments that required more HTA studies were: cardiology (50%); infectious diseases (45%); hospital management (45%); oncology (40%); surgery (40%); and endocrinology (20%). HTA studies supported: incorporation of new technologies (81%); protocol or guideline development (57%); new indications for already approved technologies (38%); and withdrawal of obsolete technologies (29%). Half of the institutions also conducted educational or training activities. The main difficulties reported were a lack of trained professionals (78%), funding (70%), and material resources (48%).

For low- and middle-income countries, the process of implementing HB-HTA units remains a challenge. Even though human resources and funding are scarce, HB-HTA units continue to develop. Given their importance in the decision-making process, it is imperative that every effort is made to ensure their activities continue.

In Brazil, hospital-based health technology assessment (HB-HTA) units have been implemented countrywide since early 2000 to improve decision-making processes. Multiple-criteria decision analysis (MCDA) can provide a deeper understanding of a given subject. The present study used MCDA to evaluate capacity building among HB-HTA units in Brazil.

This study analyzed preliminary data from a survey developed and sent to all HB-HTA units in Brazil in 2018. The survey comprised 116 questions covering a wide range of aspects. Initially, an expert panel was organized, and 46 objective questions (out of 116) were selected by four experts. Next, these experts classified the selected questions by weighting them according to their relative importance. A Likert scale was used to identify the levels of importance, which were converted to weights ranging from zero to one. The experts then defined a final importance score threshold of 60 percent to classify units as fully operational. Grades below this threshold indicated the need for a more detailed evaluation. Of the 80 survey questionnaires, 23 were evaluated by the proposed method.

Importance weights for each classification were defined as follows: personnel (25%); level of expertise (31%); work production (31%); and infrastructure (13%). The mean final importance score for the HB-HTA units was 68 percent. The maximum and minimum scores achieved were 95 percent and 15 percent, respectively. The HB-HTA units had been established for an average of 6 years, and ten of the 23 units were classified as fully operational.

The multicriteria method presented by this study simplified HB-HTA unit evaluation, reducing the subjectivity of results. Final importance scores for each unit's categories indicated which areas need improvement. Results from the study indicated that infrastructure and personnel could be greatly enhanced, even though the production profile was satisfactory.

China has made great achievements in health insurance coverage and healthcare financing. Nonetheless, the rate of catastrophic health expenditure (CHE) in China was 13 percent in 2008, which is higher than in some other countries. There are differences among the provinces in China in terms of the lifestyles, customs, prevalent medical conditions, and health consciousness of their populations. This study aimed to compare the proportion of households with CHE and the factors influencing this expenditure between the Zhejiang and Qinghai province in China.

Data were derived from household surveys conducted in Zhejiang and Qinghai. Sampling was based on a multi-stage, stratified random cluster method. Households with CHE were defined as those with an out-of-pocket payment for health care that was at least 40 percent of the household income. Univariate and multivariate logistic regression analyses were used to identify the factors associated with CHE.

A total of 1,598 households were included: 995 in Zhejiang and 603 in Qinghai. The average rates of CHE in Zhejiang and Qinghai were 10 percent and 31 percent, respectively. The economic status of a household influenced the likelihood of experiencing CHE; households headed by an employed person were less likely to experience CHE. In contrast, households that included outpatients or individuals with chronic diseases had a higher risk of experiencing CHE across the two provinces. Poorer or uninsured households in Zhejiang were more likely to experience CHE, as were households in Qinghai that included outpatients or were headed by a person from a minority nationality.

This study highlighted the importance of promoting economic development, expanding employment, and adjusting policies to better protect individuals with chronic diseases and outpatients from the risk of CHE. The Chinese government should pay more attention to actual conditions in different provinces to ensure that policy decisions incorporate local knowledge.

Mitral regurgitation (MR) is the most prevalent heart valve condition in Western countries. Open-heart mitral valve reconstruction is the conventional surgical treatment for MR, whereby the valve's cords are replaced with expanded polytetrafluoroethylene cords. Novel devices have introduced minimally invasive alternatives, such as transapical beating-heart valve repair. Among these alternatives, the Harpoon™ Mitral Valve Repair System (Edwards Lifesciences LLC) may have potential advantages (a smaller diameter valve introducer to minimize bleeding and a different anchoring mechanism). This study aimed to assess the efficacy and safety of Harpoon in minimally invasive mitral valve surgery.

An early assessment of the technology was conducted by reviewing relevant literature from the following databases: PubMed, EMBASE, Web of Science, the Trip Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, the Cochrane Library, and the Centre for Reviews and Dissemination. Relevant clinical studies published up to 30 January 2018 were included.

Only two publications, by the same research group, were included: an observational study of 11 patients and the prospective, nonrandomized TRACER trial (n = 30). During the procedure, MR was reduced from severe to none in 73 to 86 percent of patients and severe to mild in 14 to 27 percent. At one month, MR was rated as mild or lower in 82 to 89 percent of patients. At six months, MR had worsened to moderate or severe in 16 percent of patients from the TRACER trial. Safety issues within 30 days (18% to 27% of patients) included intraoperative conversion to open surgery, reoperation, pleural effusion, hemopericardium, and atrial fibrillation. There were no intra- or postoperative deaths.

Current evidence on the Harpoon device is scarce. Although published studies showed improvement in MR in most patients, there are still issues regarding safety, lack of long-term results, comparability with other procedures, and costs. While promising, further research is required before recommending routine use of this technology.

Cerebrovascular disease is the most common cause of death in China, and the incidence of ischemic stroke (240 per 100,000 people) is higher than that of hemorrhagic stroke (82 per 100,000 people). More than 80 percent of strokes can be prevented by early control of risk factors. Therefore, identifying and managing high-risk groups is a top priority in preventing stroke. The CHA2DS2-VASc score is a key prediction tool for stratifying stroke risk in individuals with atrial fibrillation (AF) as follows: zero score is low risk; one is intermediate risk; and two is high risk. The present study was undertaken to evaluate the accuracy of the CHA2DS2-VASc scoring system for stratifying ischemic stroke risk in the non-AF population.

We searched PubMed, EMBASE, and the Cochrane Library in June 2018 for relevant diagnostic studies. Study selection, data extraction, and quality assessment (using the QUADAS-2 criteria) were performed independently by two authors. Methodological variation across the selected studies precluded meta-analysis, so the results were synthesized narratively.

Seven prospective studies involving 50,652 patients (6,760 with ischemic stroke) were included. The treatment threshold ranged from two to four across the studies. Three studies reported diagnostic accuracy at a threshold of two, with a sensitivity above 0.8 and a specificity ranging from 0.32 to 0.68. The diagnostic odds ratio was greater than two (seven studies). The two studies using a treatment threshold of four reported a sensitivity of 0.59 to 0.76 and a specificity of 0.43 to 0.69. One study used a threshold of three, with a sensitivity of 0.79 and a specificity of 0.39.

The CHA2DS2-VASc score may be used to predict ischemic stroke in the non-atrial fibrillation population. Treatment thresholds greater than two provide more optimal diagnostic accuracy, although the predictive performance of the CHA2DS2-VASc score may be better in patients with chronic obstructive pulmonary disease but not AF.