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Autobiographical memory (AM) dysfunction has been proposed as a neurocognitive mechanism underlying the development and maintenance of depression. However, case–control neuroimaging studies investigating the neural correlates of AM in depression have yielded inconsistent findings. The present study utilized neuroimaging meta-analyses to identify robust neural markers of AM dysfunction in depression and characterize the associated behavioral and network-level mechanisms. A preregistered neuroimaging meta-analysis (https://osf.io/35xtf) was conducted, incorporating data from 341 patients with unipolar depression, 82 individuals at risk of depression, and 261 healthy controls across case–control functional magnetic resonance imaging studies examining AM processing. Meta-analytic network-level and behavioral decoding analyses were performed to aid interpretation of the findings. Compared with controls, the depression group displayed increased activation in the right paracingulate cortex (dorsal anterior cingulate [dACC]) and precuneus, and decreased activation in the anterior insula during AM recall. Exploratory valence-specific analyses revealed that negative AM recall was associated with increased activity the dACC and precuneus. Meta-analytic decoding linked the dACC to the salience network and to domains related to negative affect and executive control, while the precuneus was associated with the default mode network and with processes related to social cognition and AM. Findings do not support prevailing models emphasizing altered amygdala and hippocampal function in AM deficits in depression. Instead, they highlight the involvement of core regions within the salience and default mode networks as key neural substrates of AM dysfunction. These regions may contribute to affective, social-cognitive, and mnemonic disturbances that shape the valence-specific nature of AM deficits in depression.
Initial symptoms of benign prostatic hyperplasia (BPH) include difficulty urinating and low urinary flow. Worsening of BPH can lead to acute urinary retention and renal failure. Although it is fully treatable in urban centers, indigenous and remote area people are severely impacted. The experience presented herein shows how minimally invasive treatments can promote access to health care even in remote areas.
Methods
In October 2024, after 48 hours of travel—two flights and more than six hours by boat—a team of six people in association with a specialized non-governmental organization arrived at the community of Assunção do Içana, in the middle of the Brazilian Amazon rainforest. Screening of the community population with BPH was initiated a year earlier and eligibility was double-checked with the lower urinary tract symptoms visual score and ultrasound. Patient interest in undergoing the procedure was a criterion. A mobile surgical center was set up in the community. Waterproof and thermally insulating materials were used to create a controlled environment, with adequate temperature and sterile conditions.
Results
A general practitioner specialized in indigenous health initially screened 180 patients, and 14 procedures were performed by a urologist. The mean room time (from patient entry to discharge) and time from anesthesia to the placement of the catheter were 55 minutes and 29 minutes, respectively. The mean urologist’s field time was 20 minutes, while mean time for use of the Rezūm water vapor therapy disposable delivery device was four minutes. Challenges faced during the expedition were power outages, lack of full leg braces (making patient positioning more difficult), and an error in oxygen delivery. All issues were quickly resolved and did not affect patient care.
Conclusions
In areas where it can take days to reach the nearest hospital, minimally invasive therapy that does not require hospitalization may be the only option. The Rezūm device has proven to be an effective and adaptable solution. Simplicity of the procedure and minimal need for resources were key to treatment success. This expedition highlighted the transformative potential of innovative technologies.
Patients with a life-threatening illness and their family caregivers are often affected by biopsychosocial factors that contribute to suffering and burden-sharing and affect quality-of-life.
Objectives
To compare anxiety and depression levels between patients with incurable cancer and caregivers, investigate the association between perceived burdensomeness and psychological outcomes over time, and evaluate factors associated with perceived burden.
Methods
Secondary analysis of a larger prospective, longitudinal study. Patients with incurable cancer and their family caregivers were interviewed every 3 months, from study enrollment to 12 months, to assess psychological factors. Anxiety and depression were measured with Hospital Anxiety and Depression Scale (HADS) and perceived of burden was assessed using distinct questions directed to patients and caregivers about feeling or perceiving caregiving as a burden. For the data analysis, generalized estimating equations were applied to assess the impact of patient and family caregiver related variables on HADS over time, considering anxiety and depression scores as binary variables.
Results
A total of 190 patient-family caregiver dyads were included. Anxiety was more frequent among family caregivers than patients across all follow-up moments. No significant difference was found in mean depression scores. Feeling like a burden to their family (32.6%) was significantly associated with higher anxiety [odds ratio (OR) = 4.45] and depression scores (OR = 2.73). Poor health perception increased the likelihood of anxiety and depression for patients (OR = 11.00; OR = 38.81) and FC (OR = 2.73; OR = 4.30). Family caregivers demonstrated higher psychological distress, with active employment reducing anxiety (OR = 0.54) and depression (OR = 0.43).
Significance of results
The perceived burden experienced by patients with advanced cancer and their family caregivers over time were factors relevant in the disease process. The feeling of being a burden and poor health perception were key factors contributing to psychological distress, underlining the need for specific interventions in palliative care.
Anhedonia is a multidimensional concept, and it is not known which aspects of it are linked to the heterogeneity of treatment responses in major depressive disorder (MDD). We examine the role of anhedonia dimensions in predicting response to antidepressant medication and adjunctive pharmacotherapy.
Methods
In CAN-BIND-1, 187 adults with MDD completed the Dimensional Anhedonia Rating Scale (DARS) and the Snaith–Hamilton Pleasure Scale (SHAPS) before undergoing 8 weeks of treatment with escitalopram. At week 8, 90 nonresponders received adjunctive treatment with aripiprazole for an additional 8 weeks. Mixed-effects models tested the hobbies, food, social, and sensory subscales and items of DARS and SHAPS as predictors of change in the Montgomery-Åsberg Depression Rating Scale (MADRS).
Results
Of the four DARS subscales, sensory anhedonia predicted a worse treatment outcome with escitalopram (b = 1.14, 95%CI 0.08 to 2.20, p = 0.034) as did a three-item SHAPS sensory anhedonia subscale (b = 1.50, 95%CI 0.43 to 2.57, p = 0.006). A combined DARS–SHAPS sensory anhedonia subscale complemented the previously reported interest–activity symptom dimension to improve treatment outcome prediction. In contrast, food and social anhedonia dimensions predicted worse outcomes with adjunctive aripiprazole (b = 2.52, 95%CI 1.25 to 3.80, p < 0.001; b = 2.56, 95%CI 1.16 to 3.96, p < 0.001). Corresponding SHAPS items showed similar results.
Conclusions
The inability to enjoy sensory experiences and the lack of interest in food and social activities distinctly predict outcomes with serotonergic versus dopaminergic pharmacotherapy. These findings require replication and extension to other treatments.
Effects of sodium-glucose transport protein 2 inhibitor (SGLT2i) on diabetes, cardiovascular, and renal outcomes have been shown in the evidence, partially disaggregating results according to glomerular filtration rate (GFR) subgroups, which limits the ability to identify relevant benefits. In addition, when specific renal outcomes were analyzed, no thresholds were established to define clinical relevance. A review of evidence by specific GFR levels for critical outcomes was proposed, as defined by clinical benefit thresholds.
Methods
We conducted a systematic review using the PRISMA checklist, searching relevant databases for double-blind controlled trials of 1,000 or more patients with a duration longer than six months, SGLT2i use, and results disaggregated by GFR levels. Based on utilities, thresholds were expressed as minimum important detectable (MID) events of absolute effect reduction (AER) per 1,000 individuals for death (MID=10), GFR deterioration (MID=22), and composite renal outcome (MID=16). The Credibility of Effect Modification Analyses (ICEMAN) tool was used to assess effect modification credibility.
Results
Thirteen studies were selected (90,403 patients, 75% diabetic, mean initial estimated GFR of 61 mL/minute per 1.73 m2).
SGLT2i may have relevant effects in patients with a GFR less than 60, with slight reductions in mortality rate and improvements in clinically important composite renal outcomes. When the GFR is greater than 60, the benefits are uncertain or not clinically relevant, underlining the importance of individually tailored treatments considering renal function for each patient.
In Brazil, the health sector is a relevant contributor to the gross domestic product (GDP). On the other hand, the public health system can cause redistributive effects on household income. The objective of this study was to present an estimate of the multiplier effect of public health spending on GDP and household income.
Methods
This analytical study was based on the national accounts for the year 2021. A social accounting matrix (SAM) was structured using values of transactions between economic sectors. This matrix was transformed into a mathematical model to capture the impact of an impulse in one sector on the others. The model consisted of complementary matrices of endogenous and exogenous accounts. The multiplier factor of the impulse was calculated, expressed as the percentage change in GDP or household income obtained by generating a 1 percent impulse in spending.
Results
Based on the SAM 2021 constructed, it was possible to estimate that an additional one percent of resources applied to health by the government generated an additional 1.61 percent to the GDP. When estimated with the average multiplier effect of government consumption, a factor of 1.35 was found. Data suggested that 0.90 of this could be attributable to the additional workforce, possibly related to the demand for workers to respond to increased health services. The multiplier effect on household income demonstrated that every USD1.00 invested by the government in health generated USD1.23 in additional income for households.
Conclusions
The impact of social expenditure in health on GDP and household income is positive, which is a positive contribution to the debate on increasing the allocation of resources to health. Regional differences and other social determinants are very relevant in Brazil and may be analyzed to evaluate the impact of health spending on different household settings.
Scalp seborrheic dermatitis (SSD) is a chronic inflammatory condition with various treatment options, including antifungal shampoos, corticosteroids, calcineurin inhibitors, and phototherapy. This study aimed to evaluate the efficacy, safety, and evidence certainty of topical and oral treatments for SSD, highlighting the importance of this research for health technology assessment (HTA) to guide healthcare decisions and optimize resource utilization.
Methods
A systematic review (PROSPERO CRD42024537759) was conducted by searching PubMed, the Cochrane Library, and Embase databases through to 18 April 2024, using descriptors and terms related to SSD and study design. Systematic reviews evaluating evidence certainty (GRADE or Oxford Centre for Evidence-Based Medicine) for efficacy and safety outcomes of SSD treatments were included. Data selection and extraction were independently performed by two reviewers, and the risk of bias was assessed using the AMSTAR tool. A qualitative synthesis of the results was conducted.
Results
Eight systematic reviews (80 studies on SSD) were included. Evidence quality supporting topical and oral treatments for SSD varied significantly. Ketoconazole shampoo (2 to 7%; 30 studies) and ciclopirox gel (0.77 to 1.0%; 16 studies) were the most frequently studied treatments and had moderate certainty of evidence for symptom reduction, as they were assessed in better designed studies. In contrast, other treatments commonly used in daily clinical practice were graded as having low-quality evidence (e.g., bifonazole shampoo, selenium sulfide shampoo, coal tar-ciclopirox olamine combination, gluconate ointment, succinate ointment) or very low-quality evidence according to GRADE (e.g., clobetasol propionate shampoo, zinc pyrithione shampoo, hydrocortisone).
Conclusions
The review highlighted significant variability in evidence quality for SSD treatments. While ketoconazole shampoo and ciclopirox gel showed moderate evidence for symptom reduction, many commonly used treatments were supported by low or very low quality evidence. These findings underscore the importance of rigorous studies to inform HTA and support evidence-based decision-making in health care.
Oral squamous cell carcinoma (OSCC) is a public health issue due to late diagnosis, often caused by its initial silent manifestation and economic barriers. This leads to higher rates of metastasis and recurrence. Diagnosis is made through biopsy, followed by staging using imaging techniques such as neck or chest computed tomography (CT), neck magnetic resonance imaging (MRI), and positron emission tomography-computed tomography (PET-CT) for metastasis detection.
Methods
A cost-effectiveness analysis was conducted using a decision tree model with a one-year time horizon and no discount rate applied. The model included estimates of direct costs related to OSCC management and used correct diagnosis as the main outcome. The approach was based on a comparative evaluation of costs and clinical outcomes, considering the resources available in the healthcare system. Data were extracted from reliable sources, ensuring the robustness of the results and their applicability to public health practices related to the management of patients with this neoplasm.
Results
PET-CT had an incremental cost of USD362.54, an incremental effectiveness of 0.17, and an incremental cost-effectiveness ratio (ICER) of USD2,122.33 for each correct diagnosis. PET-CT was classified as a non-dominated strategy, meaning it is economically viable for improving case identification. In contrast, neck MRI combined with chest CT had an ICER of −USD1,969.85 per correct diagnosis, indicating that it is a dominated strategy—less efficient and with an unfavorable cost-benefit when compared with other diagnostic alternatives.
Conclusions
PET-CT for detecting cervical and distant metastases in patients with OSCC had higher effectiveness but incurred greater costs than clinical strategies such as neck and chest CT or neck MRI combined with chest CT. While more precise, PET-CT is less favorable economically, presenting a trade-off between accuracy and cost.
Well-established within the field of Emergency Management is the Disaster Cycle: Mitigation, Preparedness, Response, and Recovery. Less standard, however, is the inclusion of pediatric considerations in efforts within each of these phases, despite the significant population share that children hold and their unique vulnerabilities to disasters. Building upon a tool designed to spur pediatric inclusion in the “Mitigation” phase of the cycle, the Regional Pediatric Hazard Vulnerability Analysis, this paper introduces a novel Pediatric After-Action Report template. This is an all-hazards template that provides emergency managers and other partners within a region a vital resource to ensure that children are effectively considered in post-event review efforts within the “Recovery” phase, whether those reviews are customary or not. The Pediatric After-Action Report presents critical questions related to pediatric needs in previously established categories, promotes the identification of areas for improvement, and facilitates the creation of actionable plans for future preparedness.
Although several studies have explored the prevalence of low back pain (LBP) in Brazilian individuals, no meta-analysis has yet been carried out to comprehensively estimate epidemiological aspects, such as the point, period, and lifetime prevalence of LBP in this population. The aim of this systematic review and meta-analysis was to investigate the one-off, annual, and lifetime prevalence of LBP in the Brazilian population.
Methods
Systematic searches were carried out in the following databases, with no restriction on publication date: MEDLINE (Ovid), Embase, Web of Science, Scientific Electronic Library Online, and LILACS. Google Scholar was also checked. The reference lists of included studies were also screened for potentially relevant studies. Prevalence rates per period were combined and calculated.
Results
Sixty-seven studies were included in the review. Eight of these studies (11.8%) were of higher methodological quality. The pooled prevalence of LBP was 23 percent (95% confidence interval: 11, 43) based on a random-effects model. Heterogeneity was extremely high (I²=99.5%; p<0.0001), indicating significant variability between studies. Each study contributed equally to the analysis (approximately 12.5% weight).
Conclusions
LBP prevalence in Brazil exceeds global averages, affecting a significant portion of the population. This study highlighted the need for policies focused on LBP prevention and management, to improve health outcomes for Brazilians and potentially benefit a large global population.
Horizon scanning is an advanced health technology assessment (HTA) tool integrated into the decision-making process to proactively inform stakeholders about new health technologies. The objective of this pilot was to conduct horizon scanning for new health technologies for HIV/AIDS that could be appropriate for Ukraine’s health system, and to assess prospects for using the horizon scanning tool in Ukraine.
Methods
The pilot project was conducted at the State Expert Centre of the Ministry of Health in Ukraine. The pilot project tested the basic horizon scanning methodology as well as the PRITECTOOLS prioritization tool using a dataset compiled from international and local databases of clinical trials, patents, academic publications, international horizon scanning and early assessment databases, media resources (including online resources), and websites of public and charitable organizations.
Results
The team identified the following new medicines that may be relevant for Ukraine: cabotegravir (long-acting injectable integrase strand transfer inhibitor—an alternative to tablet-based regimens for daily pre-exposure prophylaxis to increase patient adherence); ibalizumab. an injectable CD4 receptor inhibitor that, in combination with other antiretroviral therapy, is indicated for treatment of HIV-1 in adults with multidrug-resistant HIV (more than five lines of therapy) to expand access and coverage of HIV treatment services; and dapivirine vaginal ring, a vaginal ring used to reduce the risk of HIV-1 infection in women during sexual intercourse to increase adherence to pre-exposure prophylaxis.
Conclusions
The pilot showed that the horizon scanning tool can be used to inform the Ukrainian healthcare system about new medicines for prevention, diagnosis, and treatment of HIV/AIDS. The tool can also be one of the stages in the HTA process in Ukraine for healthcare decision-makers to proactively anticipate and plan for HTA for priority health conditions.
Brazil’s Unified Health System (SUS) ensures universal and free healthcare access. However, when technologies are unavailable in this system, users can appeal to the courts. To support such decisions, the National Council of Justice established technical support centers that provide technical-scientific reports (TRs) to evaluate health technologies. This study aimed to analyze these TRs and rank the most judicialized health conditions.
Methods
This descriptive cross-sectional study was conducted at the Center of Health Technology Assessment, Hospital Sírio-Libanês, São Paulo-SP, Brazil, using the TRs available in the e-NATJus system (https://www.pje.jus.br/e-natjus/pesquisaPublica.php). The sample was limited to TRs published between 3 December 2018 and 12 November 2024. Quantitative analyses were summarized as percentages.
Results
Over 235,000 TRs were analyzed, with requests rising from 1,004 in 2019 to 71,120 in 2024. Medications represented 56.1 percent of TR demands, and 56.5 percent of the requested technologies were available in SUS. Favorable rulings occurred in 50.5 percent of cases. The most judicialized conditions were autism spectrum disorder (ASD), insulin-dependent diabetes, non-insulin-dependent diabetes, prostate cancer, and diabetic retinopathy. The main requests for ASD were aripiprazole, cannabis derivates, and applied behavior analysis therapy. Insulin glargine was the most requested drug for insulin-dependent diabetes, dapagliflozin for non-insulin-dependent diabetes, abiraterone acetate for prostate cancer, and ranibizumab for diabetic retinopathy.
Conclusions
The surge in TRs highlights growing demand for innovative treatments, many of which are unavailable in the SUS or lack robust evidence. Access challenges persist even for included therapies, emphasizing the need for equitable access and reliable evidence to guide decisions.
The Health Technology Assessment Network of the Americas (RedETSA) working groups gather members aiming to develop projects and research jointly. The Real-World Evidence (RWE) Working Group seeks to identify methodologies and approaches allowing RWE integration into health technology assessment (HTA) in the region. This collaborative initiative is crucial to enhancing evidence-based decision-making processes in the Americas, shaping regional health policies.
Methods
A survey was conducted among RedETSA members to identify RWE use in the context of HTA within the network. The survey included responses from 22 members, reflecting diverse perspectives from across the Americas. A search of official documents issued by various regulatory and HTA agencies was carried out to perform a detailed analysis of the RWE frameworks accessible online. Relevant documents published between 2013 and 2024 were selected, reviewing both the official portals of each agency and publicly accessible academic databases. Documents in English, Spanish, Portuguese, and French were searched.
Results
RWE documents from various HTA or regulatory agencies from different countries or regions were identified. The following domains were analyzed from each document: institution type, RWE definition, objective or purpose of RWE use, data quality and tools to assess RWE, data sources used, proposals for analytical methodologies, approved regulatory uses, and specific initiatives or tools. The RWE Working Group document was developed in Spanish. The document provides practical guidelines and checklists for implementing RWE, making it accessible for both specialists and general stakeholders within RedETSA.
Conclusions
The document was a helpful tool aimed at RedETSA members integrating RWE into HTA. Additional tools will include a procedure to meet regulatory and HTA expectations; and a decision tool to support a particular study design adoption. By leveraging these tools, decision-makers in the region can justify their choice of study design and align with regulatory requirements more effectively.
The EDiHTA project aims to deliver an innovative health technology assessment (HTA) framework for digital health technologies (DHT) that integrates existing methods with new ones to inform decision-making across Europe at different levels. In the development phase of the EDiHTA framework, it has been essential to identify all relevant stakeholders and their roles in the innovation process, while also capturing their needs and requirements.
Methods
The Innovation of Health Technology Assessment Methods framework was applied to identify relevant stakeholders and their needs and requirements regarding the design of the EDiHTA framework. Once stakeholders and their roles (practitioners or beneficiaries) were identified, their needs were assessed by reviewing existing and new HTA methodologies for DHT as used in 17 countries across Europe. Future scenarios were examined and gaps to be addressed were determined. Various methods were used to elicit the views of different stakeholders (policymakers, HTA agencies and bodies, industry, healthcare professionals, patients). including literature reviews, two online surveys, semi-structured online interviews, and focus groups.
Results
We engaged policymakers from 15 European countries; 15 HTA agencies from nine European countries; 29 developers (startups and big companies) from 10 different European markets; 14 healthcare professionals from nine European countries plus eight from Brazil, Canada, and the USA; and 15 patient representatives from 10 European countries. The analysis highlighted the heterogeneity among European health systems in assessing, implementing, and reimbursing DHT. All stakeholder groups emphasized the need for a harmonized HTA framework to assess DHT efficiently and accurately, including elements specific to DHT, such as cybersecurity, economic and organizational impact, and patient-centered outcomes.
Conclusions
There is a clear need among European stakeholders for an agile, flexible, and multidimensional HTA framework that facilitates stepwise assessments across the technology life cycle and involves all relevant stakeholders in the assessment to inform decision-making. The stakeholder interaction also identified new HTA topics and domains essential for effectively addressing the unique challenges of DHT within the EDiHTA framework.
Sustainable diets can improve environmental health by supporting food security and promoting healthy living for future generations. This study aimed to assess changes over time in the consumption of foods within the national diet and diet-related environmental indicators, specifically greenhouse gas emissions (GHGE) and water footprint (WF). Individual food consumption was assessed using 24-hour dietary recalls from the Türkiye Nutrition and Health Surveys (TNHS) conducted in 2010 and 2017. Greenhouse gas emissions (GHGE) and water footprint (WF) were calculated based on these dietary data. According to the TNHS 2010 and 2017, GHGE increased by 16.1%, total WF by 17%, green WF by 19.3%, blue WF by 9.4%, and grey WF by 10.9% (p < 0.001). During the same period, the consumption of red meats (by 72%), eggs (by 42.5%), and fats (by 53.6%) increased significantly (p< 0.001). Conversely, the most notable decrease in consumption was observed for fresh vegetables and fruits, which declined by 17.5% and 6.9%, respectively (p<0.001). In 2010 and 2017, red meats (GHGE: +29.8%; total WF: +23.6%) and fats (GHGE: +14.3%; total WF: +13.6%) were the foods that increased their contribution to GHGE and total WF the most. Although the GHGE and total WF values of Türkiye’s national diet remain below the global average, both indicators increased in 2017 compared to 2010. Despite the rising consumption of animal-based foods in recent years, the predominance of cereals in the national diet has played a key role in keeping GHGE and total WF below the global average.
Ethical, legal, social, and organizational (ELSO) issues are increasingly recognized in health technology assessment (HTA). However, information retrieval methods for ELSO aspects are scarce, and there are no widely accepted standard methods for developing these analyses. Here, we present the methodology and results of the ELSO analysis included in two HTA reports developed in 2024.
Methods
Two HTA reports were developed to analyze the value of: (i) genetic testing in congenital hearing loss (cHL); and (ii) a minimally invasive tissue sampling (MITS) technique to determine cause of death. ELSO domains were considered necessary for decision-making. To address the assessment, we conducted scoping reviews to synthesize the evidence, following the PRISMA Extension for Scoping Reviews, and used a prespecified extraction sheet for defining facilitators and barriers. The literature searches included specific search filters for ELSO issues developed by HTA information specialists from the Spanish Network of Agencies for Health Technology Assessment (RedETS).
Results
The scoping review for ELSO issues in genetic testing for cHL identified 452 references. After eligibility assessment, four reports were included, providing eight ELSO issues: two organizational, two social, and four ethical. Six concerns were facilitators and two were barriers to implementing genetic testing in cHL. The scoping review for ELSO issues in the MITS to determine cause of death identified 903 references. After eligibility assessment, 25 reports were included, bringing forth 43 ELSO concerns: 18 organizational, 15 social, seven ethical, and three legal. Twenty-three issues were facilitators and 20 may be barriers to implementing MITS.
Conclusions
The analysis of ELSO domains through a scoping review provided crucial information for implementing the two selected technologies. However, challenges remain in ELSO information retrieval: (i) key concepts related to ELSO concerns could be described in a variety of ways; and (ii) ELSO terms are not being used or indexed consistently.
Assessing the risk of bias (RoB) using validated tools is an important aspect of any health technology assessment (HTA). However, many of these tools were designed with pharmaceuticals in mind. Well conducted trials of medical devices often face different challenges. Consequently, choosing the RoB tool to use in any assessment may play a large role in how evidence of such technologies is perceived.
Methods
A systematic review and meta-analysis was conducted on renal denervation devices for treating uncontrolled hypertension. Only randomized controlled trials (RCTs) were included, so the revised Cochrane RoB tool was chosen to assess bias in individual studies. RoB assessments were undertaken by two reviewers.
Results
Twenty-five RCTs met the eligibility criteria for the systematic review and were assessed for RoB. Application of the revised Cochrane RoB tool resulted in some disparity in the final assessments, compared with the quality criteria for RCTs defined in previously published clinical guidelines for hypertension. Specifically, some of the sham-controlled RCTs had an overall RoB rating of “some concerns”, whereas some of the open-label RCTs had a low RoB and the tool seemed unable to distinguish between the designs. Given that sham-controlled trials can control for a potential placebo effect, this result was both unexpected and unintuitive.
Conclusions
Designing RCTs for medical devices requires substantial input, planning, and consideration from multiple stakeholders. Assessing the RoB of such studies, although necessary from a decision-maker perspective, requires careful contextual interpretation to understand and fully appreciate the nuances at play. Potential for a new RoB tool for assessing studies of medical devices is warranted.
Cutaneous leishmaniasis (CL) is a neglected endemic disease in several states in Brazil. The direct costs of CL treatment from the patient’s perspective can be significant, as can the indirect costs, which include the various non-medical expenses and loss of income incurred during treatment. The study objective was to identify the direct and indirect costs during the treatment of cutaneous leishmaniasis from the patient perspective.
Methods
A cross-sectional study was conducted at the René Rachou Institute/Fiocruz between April 2022 and April 2023 and included patients with a confirmed diagnosis of CL. Participants were interviewed during the treatment period to assess direct medical and non-medical costs as well as indirect costs associated with treatment. Direct costs were estimated using the micro-costing approach and indirect costs were estimated using the human capital method. Descriptive analyses and hypothesis tests were performed for associations between costs and sociodemographic and clinical variables, with a statistical significance level of five percent. The study had ethical approval (CAAE 28929220.0.0000.5091).
Results
The study included 68 patients, predominantly male (77.9%) with an average age of 53 years. CL was the most common clinical form (76.4%), with new cases accounting for 79.4 percent of participants. Direct costs per treatment cycle averaged USD117.36, resulting from transportation, food, and medical examinations. Indirect costs from lost workdays amounted to USD9,936.58, with an average of USD160.12 per patient. Catastrophic expenditure (>10% of monthly income) was observed in 41.9 percent of families. This was significantly associated with direct cost, bacterial infection, and sociodemographic factors such as sex, age, and distance traveled.
Conclusions
This study confirmed that treatment for CL, although free in the Brazilian health system, generates significant direct and indirect costs for patients. The highest costs are related to travel and accommodation resulting from the centralized healthcare model, where treatment is not available close to where patients live.
In 2023, we published widely cited cost-effectiveness thresholds (CETs) for 174 countries. This update refined our approach by incorporating gross domestic product (GDP) growth projections to adjust target increases in life expectancy and health expenditure. This methodology provides more precise estimates tailored to the economic and health contexts of individual countries, enabling better informed resource allocation decisions.
Methods
We revised our 2023 methodology by integrating International Monetary Fund projections of GDP growth for the next five years to establish customized targets for life expectancy (LE) and health expenditure (HE) growth. This update accommodates countries where the prior assumption of median growth within income groups was less applicable. The CETs were derived so that the effect of new interventions on the evolution of LE and HE is set within predefined goals. To provide guidance on CETs, we projected country-level HE and LE increases by income level based on World Bank data to ensure the estimates align with individual country realities.
Results
The updated thresholds yielded values consistent with our 2023 estimates, yet notable differences emerged in countries with distinct GDP growth trajectories or unique health spending patterns. For example, thresholds for India and similar countries adjusted upward to reflect ambitious yet realistic targets for HE and LE growth. Across 174 countries, most thresholds remained below one GDP per capita, confirming their relevance for guiding economic evaluations. These nuanced updates demonstrate the flexibility and applicability of our approach in diverse contexts, particularly for low- and middle-income countries.
Conclusions
By incorporating GDP growth projections, this study enhanced the precision of cost-effectiveness thresholds, ensuring their applicability across varying country contexts. These updates provide critical guidance for health systems aiming to balance efficiency, equity, and sustainability, particularly in resource constrained settings.