Health Technology Assessment (HTA) practitioners recognize the significance of qualitative methodologies that focus on how a technology is feasible, meaningfulness, acceptable, and equitable. This mapping aimed to delineate the frameworks employed to synthesize qualitative evidence and assess the quality of synthesis in HTA .

Mapping was conducted using Medline, LILACS, CINAHL, Embase, Web of Science, Scopus, PsycINFO, Cochrane Library, JBI, and ScienceDirect databases. Gray literature searches included PROQUEST, Open Grey, Canadian Agency for Drugs and Technologies in Health’s Grey Matters, Google Scholar, and HTA agency websites. The inclusion criteria were centered on global qualitative evidence synthesis frameworks. The data are presented in the tables.

Of the 2054 articles, 31 were included, mostly from Europe. Guide was the type of document more cited, and most authors are from HTA agencies and universities. Incorporating both patient and family perspectives is the most cited reason for include qualitative evidence. Regardless of the framework or tool, SPICE was the main acronym, and RETREAT was preferred for approach selection. Thematic synthesis dominated analytic methods, and CASP was the primary quality appraisal tool. GRADE-CERQual graded evidence synthesis, with ENTREQ as the top reporting guidance. The GRADE evidence-to-decision framework was mentioned for recommendations.

This mapping highlights the movement incorporate qualitative evidence in HTA employing specific frameworks. Despite the similarities among documents, most of them describe part of the process to synthesize qualitative evidence. Standardizing procedures to incorporate qualitative evidence into HTA can enhance decision-making. These findings offer essential considerations for HTA practice.

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.

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.

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

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

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

A critical element of the propagation of ECMO in Brazil and its reimbursement by public health system is the high cost and out-of-date standard payments by the Ministry of Health. Effort to implement a trustworthy method to guide decisions of SUS for the adoption and financing new technologies is essential to contribute to the optimization of public health policies in a country with a universal health system and limited resources dedicated to health sectors.

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.

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.

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.

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.

Chagas disease (ChD), also known as American trypanosomiasis, is a neglected tropical disease caused by the protozoan parasite Trypanosoma cruzi. About 6 to 7 million people worldwide are estimated to be infected, most in Latin America. Health-related quality of life (HRQoL) and utility measures are still poorly employed for assessment of ChD lifetime impairments. Brazilian HRQoL published data showed that the cardiac subgroup of patients have worse scores than other ChD chronic groups. For the time being, utility scores are not available yet for the ChD population. The present study aims to assess quality of life (QoL), as utility scores, of patients with chronic Chagas Disease.

This is a cross-sectional study. Data were collected from 183 outpatients with chronic ChD in a reference center in Brazil. Information pertaining to sociodemographics, clinical status, and quality of life were collected using self-administered questionnaires. Utilities were obtained by the European Quality of Life – 5 Dimensions (EQ-5D) questionnaire. Comparisons were made between clinical subtypes and population normative values. Continuous variables were compared using t-test or ANOVA, and categorical variables were compared using Chi-square test. Associations between QoL and patient characteristics stratified by demographics, clinical status were identified by linear regression models.

Most subjects were female (61 percent). The average age of men was 53.3 years and women 56.6. When analyzing the EQ-5D utility scores, it was observed that the results were lower for cardiac patients (0.610–95% CI 0.582–0.638) in comparison to indeterminate form patients (0.659–0.632–0.687). When comparing patients with the general population of the same age and sex, patients with ChD showed lower utility scores than normative values (0.624–95% CI 0.596–0.652).

Chronic ChD causes a negative impact on quality of life, physical functioning, as well as psychosocial function, with the impairment becoming worse in cardiac patients.

Chagas disease, caused by the protozoan parasite Trypanosoma cruzi, is a neglected chronic condition with a high burden of morbidity and mortality. It affects about 6 million people in twenty-one countries of Latin America, and has recently become a global health concern (1), especially due to immigration from endemic areas into the developed world. Cardiac arrhythmias are common in patients with Chagas cardiomyopathy and amiodarone has been widely used as an antiarrhythmic drug. Amiodarone has been recommended as the treatment of choice for all patients with sustained ventricular tachycardia (2). The objective of this systematic review is to evaluate the effect of amiodarone in arrhythmia patients with the cardiac form of chronic Chagas disease.

Searches was conducted in MEDLINE (PubMed), EMBASE and LILACS from the inception to December 2016. Studies regarding the use of amiodarone to treat arrhythmia in patients affected by Chagas disease were included, and the outcomes were arrhythmia, adverse effects and sudden death. Selection of articles and data extraction were made by two independent reviewers.

The database search found 378 articles but only 9 studies with 373 subjects fulfilled the eligibility criteria. The nine studies selected were composed of case series (two), crossover clinical trials (two), and clinical trials (five). Results showed that amiodarone reduced ventricular extrasystoles in all studies and ventricular tachycardia in eight studies. During treatment with amiodarone, patients in eight studies had side effects. Corneal microdeposits and gastric discomfort were the most common adverse effects present in studies. Three studies reported sudden death during follow-up.

Amiodarone seems to be an effective antiarrhythmic drug for Chagasic patients, reducing uncomfortable symptoms such as tachycardia. This information can be useful in the primary care context, supporting general practitioners to manage Chagas cardiopathy, mainly when specialized cardiologic consultants are not available.

Chagas disease, caused by the parasite Trypanosoma cruzi, affects more than seven million people worldwide and it is considered by the World Health Organization (WHO) a neglected tropical disease (1). About one third of Chagas patients develop gastrointestinal disorders, such as dysphagia and achalasia. Management of the disease focuses on symptom improvement and drugs that relax the lower esophageal sphincter pressure (LESP), such as isosorbide and nifedipine. However, the use of these therapies is doubtful because of their side effects and palliative approach (2). The objective of this systematic review is to assess the effectiveness of isosorbide and nifedipine on gastrointestinal manifestation of Chagas disease.

We searched MEDLINE, EMBASE and LILACS databases to retrieve potentially relevant articles from inception to December 2016. Inclusion criteria: clinical trials, cohorts or cross-sectional design; adults (>18 years old); assessment of effects of isosorbide or nifedipine on gastrointestinal symptoms in Chagas patients. Two reviewers independently screened titles and abstracts, selected eligible studies and extracted data from each study. PROSPERO registration number: CRD42017055143.

Eight studies were included (two case series, two clinical trials and four crossovers). Three studies evaluated the effect of isosorbide in LESP and three in esophageal emptying. All of them found that isosorbide rapidly reduces LESP and increases esophageal emptying rates, improving dysphagia. However, several patients reported collateral effects, such as gastroesophageal reflux, headaches and dizziness. One study evaluated the effect of nifedipine on LESP and one on esophageal emptying. Nifedipine decreased LESP, but there was no effect on esophageal emptying.

The available evidence shows isosorbide is effective in the management of gastrointestinal symptoms. Frequently health care of Chagas disease patients is delivered by primary care physicians. So, information on effectiveness of interventions can be aggregated to clinical guidelines, having an important value to inform general practitioners on the decision-making process regarding treatment of this group of patients, avoiding referencing to a specialized care.

Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.

A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.

Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.

Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.