Since 2012, all drugs dispensed in the Brazilian Unified Health System (SUS) must be incorporated by the National Committee for Health Technology Incorporation (CONITEC). However, the characteristics of budget impact analyses (BIA) of incorporated drugs for chronic degenerative and rare diseases are unclear. Thus, our aim was to identify the profile of BIA of these drugs in the SUS between 2012 and 2024.

Based on the 2012 to 2024 public reports of the CONITEC, data were collected on proposals for the incorporation of drugs for chronic degenerative and rare diseases into the SUS. The proposals were categorized by the type of incorporation proponent (public or private) and disease (rare or other chronic), by the presence of BIA, and by adoption of measured demand and active comparator. In addition, the median values of the eligible population and market share (first and fifth years) were calculated.

Among the 153 incorporated drugs, 53.6 percent (n=82) were proposed by private institutions, 36.6 percent (n=56) were for rare diseases, and 69.3 percent (n=106) presented a budget impact analysis. Among all BIA, 68.7 percent (n=79) adopted measured demand, frequently in other chronic diseases (76.1% [n=51] versus 58.3% [n=28]), and 25.0% (n=29) had no active comparator, more often in rare diseases (41.7% [n=20] versus 13.2% [n=9]). The median of the estimated population was higher for the other chronic diseases (27,237 versus 1,550). The median market share values were higher for rare diseases in both the first and fifth years (41.3% and 70.0% versus 20.0% and 50.0%).

Most of the proposals presented BIA. The BIA for rare diseases used measured demand less frequently, had fewer active comparators, and smaller population medians, which may justify the higher market share rates. Since drugs for chronic degenerative and rare diseases are often high cost, knowing the profile of BIA is essential to improve CONITEC’s decision-making and to ensure the sustainability of the SUS.

Health technology assessment (HTA) is essential for informed, transparent, and efficient resource allocation in Mexico’s health system. Despite efforts by institutions like the General Health Council and the National Center for Health Technology Excellence (CENETEC), formal prioritization methods are lacking. This study aimed to develop a prioritization framework, based on the EVIDEM model, via a Delphi panel, integrating clinical, economic, ethical, and social criteria to enhance decision-making.

Conducted between May and December 2024, this project was initiated by the Interinstitutional HTA Working Group to develop a preliminary multi-criteria decision analysis (MCDA) framework for prioritizing health technologies in Mexico. Phases included a systematic literature review, the formation of a multidisciplinary expert panel, and consensus rounds to select key criteria based on the EVIDEM model, ensuring non-redundancy and independence. The process and results were documented in a manuscript for publication in 2025, aiming to strengthen decision-making in Mexico’s health system.

In the first phase, 10 key studies were identified through a comprehensive search protocol, 60 percent of which utilized MCDA for prioritization. These studies averaged 19 relevant criteria, many of which were aligned with the EVIDEM framework, negating the need for new criteria. In the second phase, a multidisciplinary panel of 20 experts from key Mexican public health institutions was formed. Through two consensus rounds in the third phase, 10 of 25 fundamental criteria were selected, including disease severity, comparative effectiveness, costs, and evidence quality. Notably, 80 percent of the selected criteria aligned with the core EVIDEM model.

The proposed MCDA framework marks an initial step toward a structured tool for prioritizing health technologies in Mexico. While validation is needed to confirm its applicability, implementation of the framework has the potential to optimize equitable, criteria-based decision-making, benefiting both the health system and the population.

Influenza is an acute infectious disease that is highly transmissible and affects the respiratory system. It impacts the health system and society by reducing a patient’s productivity and quality of life. The population group most susceptible to complications and death is adults older than 65 years and children younger than five years.

The analysis was performed from the perspective of the Unified Health System (SUS) as the funder. The eligible population was estimated based on epidemiological data from population projections by the Brazilian Institute of Geography and Statistics for a five-year time horizon. The assumption of 90 percent vaccination coverage was adopted as market share. Analyses were performed by scenarios that varied market share and added costs with clinical benefits. Costs were estimated on a national basis, considering the price of the technology, inputs, and waste. Hospitalization costs and their confidence intervals were obtained from the SUS Hospitalization Authorization database.

The cost of vaccination with the high-dose trivalent influenza vaccine was estimated at USD119,637,999.04 in the first year and USD657,405,529.68 over a five-year time horizon. The increase in the budget was USD104,034,983.12 in the first year and USD571,747,563.22 over five years. The alternative scenario one was estimated considering vaccination coverage in 2023 of 63.3 percent, obtaining an incremental impact of USD72,824,488.19 in the first year and USD400,167,351.63 in five years. Alternative scenario two considered the reduction in hospitalizations and found an incremental impact of USD103,908,194.74 in the first year and USD570,970,948.59 in five years.

The budgetary impact was estimated at over USD571 million in five years. In absolute numbers, the reduction in hospitalizations due to influenza (0.4%) and pneumonia (0.3%) was not very significant, which generated a reduction in the incremental budgetary impact, in relation to the main scenario of the analysis, of 0.02 percent in the first year and 0.13 percent in five years.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, affecting one to 1.5 new individuals per million annually worldwide. In Brazil, there are three registered treatments: eculizumab, pegcetacoplan, and ravulizumab, while crovalimab is currently under evaluation by ANVISA, the Brazilian Health Regulatory Agency. This study examined the impact of these PNH treatments on the logistics and time required by healthcare professionals and patients for administration.

Quantitative and descriptive analysis was conducted based on information from the package leaflets of eculizumab, ravulizumab, pegcetacoplan, and crovalimab regarding the number of vials, volume, and administration time for each medication for a patient with PNH weighing between 60 and 100 kg over a period of 52 weeks.

The number of vials required for treatment over 52 weeks was 78 for eculizumab, 102 for pegcetacoplan, 70 for ravulizumab, and 26 for crovalimab. The volume to be transported would be 4,680 mL for eculizumab, 2,080 mL for pegcetacoplan, 231 mL for ravulizumab, and 52 mL for crovalimab. Regarding the time required for each infusion per year (52 weeks), it would take 14.6 hours for eculizumab, 4.7 hours for ravulizumab, 78 hours for pegcetacoplan, and 1.1 hours for crovalimab.

This study demonstrated that crovalimab can reduce the number of vials needed by 169 percent, transportation and storage volume by 344 percent, and infusion time by 331 percent. These efficiencies, applicable to both healthcare professionals and patients, highlight crovalimab’s potential to significantly enhance the sustainability of Brazilian public healthcare system and improve quality of life for patients.

The primary objective of the Handbook of EBPP is to empower professionals, researchers, students, and the public with the skills needed to read and critically interpret biomedical literature relevant to psychology. By fostering a deeper understanding of evidence-based approaches, the Handbook aims to enhance the quality and effectiveness of mental health services, ultimately improving care outcomes.

The Handbook is systematically organized into three main sections.

• • Foundations: This section explores the conceptual and historical development of EBPP, establishing its relevance and importance within psychological practice.

• • Methodology: Detailed guidance is provided on essential methodological tools, such as framing research questions with the PICO (population, intervention, comparator, outcome) model, navigating electronic databases effectively, and critically analyzing scientific literature. Emphasis is placed on the role of experimental designs, systematic reviews, and meta-analyses in evidence-based practice.

• • Interventions: The third section focuses on the efficacy, effectiveness, and safety of psychosocial interventions, highlighting their critical role in the prevention and treatment of mental health disorders.

Although quantitative assessments of the Handbook’s impact are not included in this abstract, its comprehensive approach addresses a crucial gap in the Portuguese-speaking mental health community. By presenting accessible, scientifically validated practices, it establishes itself as a cornerstone for evidence-based psychological education and care.

The Handbook of EBPP meets an urgent demand for Portuguese-language educational materials on evidence-based psychology. Adhering to the principles of the Cochrane Collaboration, it ensures that clinical guidelines are transparent, rigorously evaluated, and regularly updated. This resource is a significant step forward for the professionalization of psychological practice in Brazil, advancing ethical, evidence-based care and improving individual mental health outcomes.

Breast cancer (BC) confers a high burden on the Brazilian population. Moreover, the possible overuse of adjuvant chemotherapy in patients with a low risk of tumor recurrence may subject these individuals to harmful side effects, without offering substantial therapeutic advantages. The implementation of genomic testing for risk stratification represents a promising strategy to optimize patient care.

We assessed the economic implications of integrating the Oncotype DX Breast Recurrence Score Test® for stratifying BC patients according to their recurrence score (RS). A decision tree and Markov model estimated the long-term costs and outcomes linked to transitions between the health states of recurrence-free, distant recurrence, acute myeloid leukemia, and death. Patient distributions and probabilities of distant recurrence were obtained from the TAILORx (N0) and RxPONDER (N1) clinical trials. Local evidence on utility and overall survival was also considered. The analysis was carried out from the perspective of the Brazilian private healthcare system. Deterministic and sensitivity analyses were conducted.

Compared with clinical and pathological risk alone, adding the Oncotype DX test for all BC patients (N0 or N1) generated more quality-adjusted life years (QALYs) at lower costs (0.15 QALYs and −USD41,251.80). The three most efficient indications included: restricted to N1 (0.28 QALYs and −USD6,032.65); N0 restricted to high risk and N1 restricted to post-menopause (0.22 QALYs and −USD6,276.73); and N0 restricted to high risk (0.20 QALYs and −USD6.335,99). The main impact drivers were chemotherapy costs, chemotherapy prescription probabilities, and acute myeloid leukemia incidence rate. The sensitivity analysis indicated a high probability of the test being cost effective.

The Oncotype DX test has a high likelihood of being a cost-effective strategy from the Brazilian private healthcare perspective. Alternative scenarios and test indications did not alter these conclusions.

Rituximab is a monoclonal antibody used to treat non-Hodgkin’s lymphoma. Since the expiration of the reference rituximab’s patent, several biosimilars have been marketed. As biosimilar products are not identical to reference medicines, synthesis of evidence comparing them is needed to understand their effects and harms.

We performed a Cochrane systematic review and searched main bibliographic (CENTRAL, MEDLINE, Embase, Web of Science) and clinical trials databases up to February 2024. We included head-to-head randomized controlled trials conducted in adults with lymphoma treated with rituximab biosimilar or reference. When possible, we pooled the results of the following outcomes using random-effects meta-analyses: progression-free survival, duration of response, overall survival, serious adverse events, objective response rate, and health-related quality of life. We used the revised Cochrane risk-of-bias tool to assess the risk of bias and GRADE to evaluate the certainty of evidence of critical and important outcomes.

We included 16 studies (n=4,342 participants). The overall risk of bias was low. Rituximab biosimilar was likely similar to reference in progression-free survival, duration of response, and overall survival (moderate certainty evidence; data not pooled as survival estimates were adjusted for different factors or reported as rates); serious adverse events (risk ratio [RR] 1.03, 95% confidence interval [CI]: 0.94, 1.14]; 15 studies, n=4,197; moderate certainty evidence); objective response (RR 1.01, 95% CI: 0.98, 1.04; 15 studies, n=3,852; moderate certainty evidence); and mortality (RR 0.97, 95% CI: 0.70, 1.35; 8 studies, n=2,557; high certainty evidence). Imprecision was the main reason for downgrading certainty in the findings.

Treatment with rituximab biosimilars was likely similar to the reference in survival outcomes and rates of adverse events. The overall certainty of evidence was moderate.

Diabetes insipidus (DI) is a rare disease characterized by water balance disorders and is often associated with high morbidity. Incorporating new technologies into Brazil’s Unified Health System (SUS) requires technical rigor and public participation to ensure equitable health system. This study explored how public participation in developing a Clinical Protocol and Therapeutic Guideline (PCDT) could enhance equity and transparency in health policies.

To analyze the demographic characteristics and opinions of patients and stakeholders involved in the public consultation and to describe the transparency in handling these contributions. Contributions were collected during a 90-day open public consultation and analyzed in three stages: (i) reading all submissions; (ii) categorizing key ideas; and (iii) discussing implications. This methodology provided insights into public engagement and its influence on fairness and transparency in decision-making processes, highlighting the importance of inclusive approaches to health governance.

A total of 15 contributions were received, with 86 percent originating from individuals, predominantly white women from southern Brazil aged 25 to 39 years. Participants rated the preliminary recommendations as very good (53%), good (40%), and average (7%). Although no suggestions were incorporated, all contributions were analyzed and responded to, with positive feedback on the protocol’s clarity. The contributions underscored the importance of a PCDT in the SUS for improving rare disease management and for fostering community engagement. The findings highlighted the need for broader knowledge dissemination to stimulate public participation and enhance diversity and inclusion across the country.

The public consultation for the PCDT on DI emphasized the importance of transparency and community engagement in health policies. While contributions praised the protocol’s clarity, findings revealed the need to expand outreach for greater inclusivity and regional diversity. Strengthening participation processes can enhance equity, improve rare disease management, and foster more responsive and inclusive health governance in Brazil.

Horizon scanning (HS) initiatives in Brazil began in 2008. Since then, the implementation of a national HS system has shown great evolution and expansion, especially after the creation of the National Committee for Health Technology Incorporation (CONITEC), which absorbed it in 2011. This work aimed to present Brazil’s National Horizon Scanning System, conducted by CONITEC, and its most recent results.

We developed an experience report, using mixed methods, with a descriptive analysis of HS activities conducted nationally and quantification of documents produced between December 2023 and November 2024 by CONITEC.

HS reports developed by CONITEC currently support the decision-making processes regarding the: (i) incorporation of technologies into the public health system (90 reports); (ii) granting of new or emerging technologies by court order (five alerts); (iii) prioritization of topics for the elaboration or update of national clinical practice guides (28 topics); (iv) national preparation in case of public health emergencies (e.g., COVID-19 and mpox) (two documents); (v) innovation and national development (five brief syntheses); and (vi) financing of research with health technologies (one document).

The implementation of a national HS system in Brazil has evolved significantly and today it represents an important source of evidence that supports strategic decisions for Brazil’s public health system. From December 2023 to November 2024, CONITEC produced 131 HS studies to support decision-making in six different processes within the public health system.

HIV/AIDS continues to pose a significant public health challenge in Chile, despite advances in prevention and treatment. The Explicit Health Guarantees (GES) framework provides comprehensive access to antiretroviral therapy (ART) for eligible patients. This study assessed the budget impact of including bictegravir/emtricitabine/tenofovir alafenamide (BET) in first-line ART regimens for treatment-naïve adults under the Ministry of Health methodology for the GES program, evaluating its clinical benefits and financial viability.

A budget impact model was developed from the perspective of the GES system, utilizing updated public data on ART costs, therapy utilization, and demographic projections for 2025 to 2027. The analysis incorporated updated ART prices, therapy utilization frequencies, and clinical efficacy evidence. BET was evaluated as an alternative to abacavir/dolutegravir/lamivudine (ADL) using comparative evidence from clinical studies. Three scenarios were modeled: current prices, adjusted usage frequencies, and inclusion of BET in the treatment framework.

The inclusion of BET had no significant budget impact, primarily due to cost-saving efficiencies from centralized procurement by the National Health Supply Center. Updated ART prices for 2023 indicated a 34.7 percent reduction compared with the 2022 Verification of Costs Study. Projected costs for GES HIV/AIDS management, including BET, were USD259 million (2025), USD284 million (2026), and USD312 million (2027). Therapy uptake and procurement efficiencies were the primary cost drivers. The addition of BET enhanced therapeutic options without imposing additional financial burden.

The integration of BET into first-line ART regimens aligns with the GES goals of financial sustainability and clinical efficacy, offering an effective alternative for HIV management. These findings underscore the importance of evidence-based policymaking and optimized resource allocation to improve healthcare outcomes in Chile.

For the first time, worldwide digital health applications (DiGA) have been reimbursed by the German Statutory Health Insurance. For full reimbursement, the manufacturers must provide scientific evidence based on efficacy studies. This study aimed to assess the methodological quality of efficacy studies for permanently listed and reimbursed DiGA in the categories of ‘nervous system’ and ‘psyche’ within the DiGA register.

DiGA in the categories of “nervous system” and “psyche” were selected from the governmental DIGA platform. The methodological quality of the studies was assessed using the revised Cochrane risk-of-bias tool for randomized trials. The risk of bias was assessed for the primary endpoint of each study according to an intention-to-treat analysis.

Six DiGA were assessed for their methodological quality. Randomized controlled trials were conducted for all six DiGA that showed a high risk of bias, which was mainly due to a lack of blinding in the studies. In addition, dropouts were significantly higher in the intervention group than in the control group in most studies. For most of the DiGA, no published study protocol was available in advance, so an analysis of potential selective choice of the evaluation methodology was not possible.

The results revealed the low quality of supporting evidence for DiGA recently introduced in Germany, mainly due to methodological flaws, that is, a high potential for bias. Studies of DiGA should be blinded by comparing DiGA with a sham application to reduce the risk of bias. It should be emphasized that manufacturers submitted randomized controlled trials to prove the medical benefit of the DiGA investigated.

Access to gender reassignment surgery (GRS) as an isolated process would not imply achieving clinical and satisfaction results in transgender people. Public subsystems face a shortage of trained professionals, a lack of protocols, fragmented care, and economic and geographic barriers. This review sought evidence on integrated and equitable care models for access to GRS.

A systematic review (SR) was conducted on the effectiveness and safety of GRS prevalent in Argentina (vulvovaginoplasty [VVP] and mastectomy [MRP]) in transgender people older than 16 years. The SR also considered final perceptions from an integrated and comprehensive management approach. The Web of Science and MEDLINE databases were consulted, prioritizing clinical trials, SRs, health technology assessments, and relevant individual studies from 1988 to 2024, using a rapid umbrella review methodology. The results of the evidence were ordered by relevant outcomes (aesthetic, satisfaction, complications, mental health) within the framework of integrated models applicable to inclusive and equitable health policies.

For MRP, six SRs (two specific, four general) and six cohort studies (three specific, three general) were included. For VVP, 16 SRs (nine specific, seven general) and 38 cohort studies (35 specific, three general) were included. Techniques for each surgery were described, citing results about complications (71%), quality of life (48%), mental health (16%), aesthetic aspects (58%), and satisfaction (73%), but only 0.2 percent considered them within frameworks of integrated models. With a lack of quality evidence, challenges persist in unifying classifications of outcomes over time and generalizing findings to different health systems.

The recommendations of scientific societies and current legal frameworks suggest access to GRS as an advanced step within comprehensive care processes for transgender people. The evidence showed a divergence between this approach and the findings, with data on complications and satisfaction predominating, less information on associated quality of life and mental health, and few references to integrated models.

Equity is a pivotal element in health technology assessment (HTA) to ensure fair and proportional access to healthcare needs and to mitigate health disparities. The incorporation of equity-oriented prioritization criteria into the development of clinical practice guidelines (CPGs) promotes social justice in health. This study systematically mapped equity-related criteria used to prioritize topics for CPGs.

A comprehensive scoping review was conducted in accordance with the Joanna Briggs Institute’ Manual for Evidence Synthesis and the PRISMA Extension for Scoping Reviews. The review protocol was pre-registered on the Open Science Framework. The review encompassed both peer-reviewed publications and gray literature published from 2000 onwards, without language limitations, that addressed topic prioritization criteria for CPG development. From an initial list of 22,675 records, 25 studies met the inclusion criteria. The extracted prioritization criteria were categorized into six domains and further refined into 20 distinct criterion.

Of the included studies, 48 percent mentioned the criterion “equity relevance”, within the domain of “factors related to the health condition”, and/or “impact on equity/access” within the domain of “potential impact of the intervention”. These criteria were variably characterized, encompassing aspects such as “frequency of inequality-related issues in specific population groups (e.g., children under five years old)”, “inequities in access and specific needs of vulnerable groups”, “potential of the recommendation to reduce or increase health disparities”, “impact on patient autonomy and independence,” and “user perceptions of the CPG.”

Evaluating equity considerations related to a disease or health condition and the potential of a CPG to mitigate disparities are imperative in the topic prioritization process. Incorporating this approach can optimize resource allocation, enhance care for marginalized groups, promote social justice, reduce health disparities, and foster social cohesion, thereby contributing to public health and societal well-being.

Assessing health-related quality of life (HRQoL), quality of life (QoL), and well-being (WB) are essential for measuring health outcomes. This study provided a conceptual mapping of these measures, proposed evidence-based frameworks, and linked them to widely used generic patient-reported outcome measures.

A systematic literature review was conducted that included articles from databases and gray literature through to December 2023. Studies describing HRQoL, QoL, and WB concepts with their dimensions or domains were included, focusing on general population studies without design restrictions. Domains, subdomains, and facets were extracted and analyzed based on frequency and qualitative methods. These frameworks were then mapped to commonly used generic patient-reported outcome measures.

From 14,114 papers, 35 studies and 36 frameworks were included (HRQol=15, Qol=5, WB=16). A total of 168 first, 225 second, and 79 third-level domains were retrieved and curated into 118 unique entities: HRQoL had 82 dimensions, QoL had 49, and WB had 69. Overlap analysis revealed 26 shared dimensions, with 26 unique to WB, 29 to HRQoL, and seven to QoL. Final models included 18 HRQoL, 22 QoL (18 from HRQoL plus 4), and 10 WB dimensions. Mapping of patient-reported outcome measures showed coverage for HRQoL of 59.4 percent, QoL of 65.9 percent, and WB of 34 percent. The EuroQol Health and Wellbeing instrument had the broadest coverage for HRQoL (17/18) and WB (5/10).

Significant inconsistencies and overlaps exist among definitions and domains for HRQoL, QoL, and WB. The lack of clear conceptual and operational definitions hinders the validity of measurement tools. This study underscored the need for clearer definitions and provided an initial step toward better understanding and measurement of these essential health and policy concepts.

National healthcare systems face challenges, including rising costs, aging populations, and increasing rates of chronic diseases, especially in rural and underserved areas. Decentralized care (DC) offers healthcare services in less complex settings, reducing travel, optimizing resource use, and enhancing patient centricity. This study explored DC initiatives, implementation strategies, challenges, and outcomes in four countries to establish a scalable framework.

Four countries with strong policies and initiatives supporting decentralized care were selected (Belgium, the Netherlands, Singapore, the UK) to understand how governments can enhance clinical outcomes, optimize costs, and improve patient satisfaction through DC models. Data collection involved a review of government documents and reports, complemented by interviews with senior stakeholders from hospital systems and government bodies. The analysis focused on understanding the principles and practice of DC in these countries.

Significant progress was observed in these countries. The UK’s integrated care providers achieved a 12 percent reduction in hospital admissions, while Singapore’s MIC@Home saved 7,000 bed days and increased telemedicine usage by 40 percent. The Netherlands’ Better@Home saved EUR2 million annually and increased remote care by 20 percent. Belgium’s model reduced heart failure readmissions by 15 percent and improved rural access and appointment satisfaction by seven percent. A common framework emerged, structured around four central pillars: robust policies and regulations, advanced technology and data integration, development of infrastructure and community care, and comprehensive training for healthcare professionals.

DC is a pivotal and transformative approach that can enhance patient care and ensure sustainability of health systems, despite implementation complexities. Success hinges on robust policies, technological infrastructure, data integration, and adaptive training mechanisms. These benchmarks underscore the importance of collaboration among multiple stakeholders to implement DC, in order to sustainably meet the evolving demands and provide patient-centered care.

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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.

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.

Thirteen studies were selected (90,403 patients, 75% diabetic, mean initial estimated GFR of 61 mL/minute per 1.73 m2).

• • Mortality: GFR (<60): 22,816 patients, relative risk (RR) 0.91 (95% CI: 0.82, 1.01), AER 0.3 percent, null effect, high certainty; GFR (>60): 55,037 patients, RR 0.89 (95% CI: 0.83, 0.96), AER 1.5 percent, probable reduction, moderate certainty.

• • GFR deterioration: GFR (30 to 45): 9,335 patients, RR 0.76 (95% Ci: 0.61, 0.95), AER 3.4 percent, slight reduction, moderate certainty; GFR (45 to 60): 9,245 patients, RR 0.54 (95% CI: 0.45, 0.66), AER 1.9 percent, small or null effect, high certainty; GFR (>60): 43,635 patients, RR 0.61 (95% CI: 0.48, 0.78), AER 0.8 percent, null effect, high certainty.

• • Composite renal outcome: GFR (<60): 27,114 patients, RR 0.83 (95% CI: 0.63, 1.08), AER 1.5 percent, slight reduction, low certainty; GFR (>60): 60,422 patients, RR 0.70 (95% CI: 0.58, 0.86), AER 0.9 percent, minimal reduction, moderate certainty.

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.