Background: Paroxysmal Nocturnal Hemoglobinuria (PNH) is an ultra-rare, life-threatening blood disorder characterized by the destruction of red blood cells and blood clots. Despite recent advancements in treatment, especially with targeted therapies, current clinical guidelines remain outdated. This gap necessitates the development of new, evidence-based recommendations to ensure clinical practices are aligned with the latest treatment advancements.

Objective: Our study aims to identify key gaps in current guidelines and explore opportunities for new, evidence-based recommendations to ensure alignment with the latest PNH treatment advancements.

Methods: We conducted a systematic review of guidelines and recommendations using The Cochrane Library, PubMed, LILACS, Embase, and Trip Database. Grey literature searches included Google Scholar and medical society websites. We included national and international guidelines, consensus statements, or clinical protocols discussing PNH treatments at any disease stage, without language or publication year restrictions. Study selection was performed in duplicate, with a third reviewer resolving discrepancies. A panel of five Brazilian PNH experts, moderated by an independent consultancy, discussed the findings and future updates.

Future Prospects: Out of 729 publications, 12 were included: 4 guidelines and 8 consensus statements, published between 2005 and 2024. Only one was international; the rest were country-specific. Eculizumab was recommended in 9 documents; new PNH treatments were rarely mentioned. Experts suggest future guidelines include response assessment criteria, vaccination schedules, patient monitoring, and standardized management of breakthrough hemolysis. This review highlights gaps in current PNH treatment guidelines. Updated guidelines should incorporate recent disease management knowledge and newly approved therapies to improve patient outcomes.

Background
A common problem experienced by guideline developers is the lack of basic clinical data needed to fully address guideline clinical questions. As guideline development is primarily focused on GRADE methodology, there is an increasing need for basic clinical research to provide the data needed to strengthen the evidence for guideline clinical questions; and subsequently provide stronger guideline recommendations.

Many guideline producing organisations already include research recommendations within their guidelines, but what can be done to encourage researchers to fill these research gaps?

Objective
To develop ideas to encourage the generation of basic clinical data needed to provide more conclusive answers to guideline clinical questions.

Methods
The British Thoracic Society (BTS) has begun collecting ideas on how these research gaps might be addressed. This list includes:

• Creating better communication between guideline producing organisations and medical research grant funding organisations.
• Funding small research projects to generate needed data.
• Encouraging senior clinicians/scientists to address basic guideline-specific questions within their research; and
• As much of these data are likely to already exist within medical records, clinicians/scientists could be encouraged to focus their student research projects on extracting these needed data.

Future prospects for project presentations
The work described above is at an early stage, but it is hoped that it will:

i) Generate discussion amongst the community; and
ii) Encourage the development of a basic clinical research framework to provide the “missing” data needed to create stronger guideline recommendations in the future.

Background: Drug-resistant tuberculosis remains a critical global health challenge, demanding innovative treatment strategies. Pretomanid, combined with bedaquiline and linezolid (BPaL) or bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM), offers a shorter, oral regimen endorsed by WHO and CDC. However, its integration into public health systems requires rigorous clinical and economic assessment.

Objective: This study evaluated the efficacy, safety, cost-minimization analysis, and budget impact of incorporating pretomanid-based regimens into the Brazilian Public Health System (SUS).

Methods: A systematic review identified one pivotal phase 2-3 randomized trial comparing BPaL and BPaLM to the current standard of care in SUS. Cost-minimization analysis and budget impact analysis were conducted from the perspective of SUS to estimate economic impact, considering both direct treatment costs and broader financial implications. Exchange rate: 1 USD = BRL 4.99.

Future prospects for project presentations:
Pretomanid-based regimens demonstrated non-inferiority in treatment success rates (BPaL: RR=0.15, CI 95%=0.06-0.39; BPaLM: RR=0.44, CI 95%=0.28-0.71) while significantly reducing severe adverse events (RR=0.33–0.54). Economic modeling projected average savings of US$ 3,499.60 per patient, with cumulative national savings estimated between US$ 17.92 million and US$ 19.20 million over five years. Additionally, the reduced treatment duration of 6–9 months enhances adherence and healthcare. These findings support pretomanid as a clinically viable option, aligning Brazil’s DR-TB treatment policies with international best practices. Its incorporation into the SUS could enhance patient outcomes, optimize resources, and strengthen sustainable health financing. The study emphasizes the importance of integrating economic evaluations into national decision-making to ensure evidence-informed policies.

Background: In 2023, the Australian Therapeutic Goods Administration rescheduled methylenedioxymethamphetamine (MDMA), permitting authorised prescribing for Post-Traumatic Stress Disorder (PTSD) outside clinical trials. With limited clinical evidence and accessibility to MDMA-assisted psychotherapy (MDMA-AP), Clinical Practice Guidelines are needed to integrate published research and interest-holder perspectives for its safe and effective prescribing.

Objective: To describe how qualitative interviews with local interest-holders with experience in MDMA-AP provided context-specific evidence for a Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) Evidence-to-Decision (EtD) framework, addressing gaps in the literature.

Methods: Participants were recruited from the Guideline Expert Group, ensuring diverse representation of clinicians, researchers, and those with lived experience. Semi-structured interviews, guided by the World Health Organisation 6-step Guide to Good Prescribing, explored perceived benefits and harms, patient and provider preferences, resourcing, equity, acceptability, and feasibility of MDMA-AP implementation. Interviews were recorded, transcribed verbatim, and thematically analysed. Findings were summarised and mapped to GRADE EtD criteria..

Results: Findings were integrated with systematic and narrative literature reviews within the GRADE EtD framework. The Guideline Development Group assessed the benefits and harms of MDMA-AP for PTSD compared to existing therapies, leading to evidence-based recommendations. This innovative approach combined qualitative interviews with the GRADE EtD framework, bridging methodological gaps to enhance guideline relevance and applicability.

Discussion: Qualitative interviews facilitated meaningful engagement with interest-holders, providing critical insights into practical MDMA-AP implementation, addressing uncertainties, and contextualising real-world evidence within the Australian setting. The GRADE EtD framework enabled systematic data integration, supporting transparent, relevant, and actionable recommendations for MDMA-AP for PTSD.

Background: Clinical practice guidelines (CPGs) are essential for evidence-based decision-making, but developing new guidelines is often limited by resource constraints. Adapting high-quality existing guidelines offers a cost-effective and efficient alternative while maintaining methodological rigor. The GRADE Evidence-to-Decision (EtD) framework provides a structured approach for contextualizing recommendations.
Objective: To describe the systematic adaptation of pulmonary rehabilitation guidelines in Spain, using the GRADE Evidence-to-Decision (EtD) framework to ensure transparency, evidence-based decision-making, and stakeholder engagement.
Methods: The Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) leads the adaptation of pulmonary rehabilitation guidelines, ensuring clinical relevance and stakeholder engagement. Cochrane Iberoamerica provides methodological support, guiding the adaptation process through a structured GRADE Evidence-to-Decision (EtD) framework to maintain rigor and transparency. Key steps include: (i) defining objectives and assembling a multidisciplinary panel of clinical experts, methodologists, and stakeholders; (ii) identifying and assessing high-quality guidelines for adaptation; (iii) structuring clinical questions using the PICO framework and prioritizing them; (iv) conducting a rapid but rigorous evidence review, synthesizing the best available data; (v)applying the GRADE EtD framework to evaluate benefits, risks, feasibility, and cost-effectiveness; (vi) validating recommendations through external stakeholder review to ensure applicability; (vi) developing a strategy for dissemination, implementation, and periodic updates.
Expected results: The adapted guideline will serve as a comprehensive and up-to-date reference for pulmonary rehabilitation in adults with chronic respiratory disease. By integrating the latest scientific evidence and aligning with healthcare system requirements, the guideline is expected to be recognized as a key resource for organizations committed to implementing evidence-based practices

Background: The World Code Against Cancer Framework (WCACF), led by the International Agency for Research on Cancer (IARC),develops global Codes Against Cancer. The European Code Against Cancer (ECAC5) builds upon the experience of its 4th edition and the 1st Latin American and the Caribbean Code Against Cancer. A key innovation in ECAC5 was the adaptation of the GRADE methodology, to enhance evidence synthesis, certainty assessment, and recommendation development.
Objective: To establish a structured, evidence-based framework for ECAC5 recommendations, ensuring scientific consistency in cancer prevention strategies.
Methods: IARC convened five multidisciplinary Working Groups (WGs) composed of European experts to critically assess available evidence. A Scientific Committee, including 12 national cancer institutes and the World Health Organization (WHO), reviewed the recommendations critically. Cochrane Iberoamerica, led systematic reviews, synthesised evidence profiles, and provided narrative reports. We adapted the GRADE methodology to assess the certainty of evidence in observational studies, balancing epidemiological considerations with feasibility and equity assessments. IARC used the Evidence to Decision (EtD) framework to ensure consistency across recommendations, with iterative refinements by experts and methodological oversight from Cochrane Iberoamerica and IARC. All draft recommendations were critical review before finalization.
Results: The five WGs developed evidence-based recommendations targeting major modifiable cancer risk factors and preventive interventions. Systematic reviews synthesized diverse findings, with the GRADE adaptation enabling clear weighting of evidence strength for practical and actionable recommendations. Conclusions: ECAC5 recommendations were developed through a structured and multidisciplinary approach. The WCACF served as a scalable model for integrating GRADE into large-scale public health initiatives.

Background:
Antimicrobial resistance has been increased due to non-optimized use of antimicrobial agents. The emergence of new specific resistances for each context requires the efforts of all stakeholders. Updated and highest-quality clinical practice guidelines (CPGs) are needed to improve decisions about antibiotic use.
Objectives: To analyse the development of methodological materials to update the recommendations for gonococcal infections included in the Spanish Antimicrobial Therapeutic Guideline, using a problem-solving strategy to strengthen continual improvement.
Methods: Following the GRADE-ADOLOPMENT approach, we reviewed the available evidence to answer 9 clinical questions for gonococcal infections included in the original guideline. Comprehensive search strategies were carried out. COVIDENCE software was used to screen the documents, AGREE-II for assessing CPGs quality, and GRADEpro software to develop evidence profiles and Evidence to Decision frameworks (EtD).
We developed methodological materials that included the systematic review for each question, the evidence profiles, and EtD frameworks, with a proposal to update the recommendations. We requested to expert group that provided data on local gonococcal resistance and that decided to adapt or adopt the recommendations, taking into account the context of implementation.
To improve aspects in the methodological materials, we analysed the management and results of the tools used, as well as the incorporation of information provided by the expert group.
Future prospects for project presentations: The analysis carried out allowed us to assess barriers and to consider the solutions that could be useful to achieve continual improvements in future updates of the Spanish Antimicrobial Therapeutic Guideline.

Background
Developing clinical practice guidelines (CPGs) requires balancing multiple factors, including the methodology used, an understanding of the current circumstances surrounding the condition being addressed, patient needs, and the available human and economic resources within the implementation context.
Objective
This study outlines adjustments made in the literature screening phase of a systematic review for the development of a CPG for eating disorders.
Method
The GRADE-Adolopment approach was applied to guide the development of the CPG. During the protocol development phase, a scoping review was conducted, and four clinical questions were prioritised.
A structured and systematic review was performed for each one of the questions. References were screened by title and abstract focusing on CPGs, while simultaneously, we selected systematic reviews and primary studies according to the inclusion criteria. Due to the large volume of references, the systematic review was paused after completing the screening by title and abstract. CPGs identified in the scoping and systematic review were analysed to extract recommendations addressing the prioritised questions and compiled them into a document for the guideline development group (GDG).
We resumed the systematic review (full text screening phase),including studies that could update the recommendations considered by GDG.

Future prospects for project presentations
Opitmizing the systematic review process by adjusting it according to recommendations selected through GRADE-adolopment, could improve the efficiency and resources use.

Background: Snakebite accidents are on the World Health Organization's list of neglected tropical diseases. Brazil's vast territory and cultural diversity make addressing snakebites complex, requiring strategies adapted to regional and sociocultural realities.

Objective: Describe the sociodemographic profile and implications for the standardization of practices in snakebite care.

Methods: A qualiquantitative study based on a scoping review that explored the Brazilian reality regarding social aspects, beliefs, and customs related to snakebite accidents. Data from the Ministry of Health (MS), 2001-2022, were analyzed to outline the epidemiological profile of victims, considering year, location, sex, and race/color. Mortality rates were calculated as deaths/population at risk, times 1 million (2010 Census), and trend analysis used Prais-Winsten regression (p<0.05).

Results: A total of 509,275 snakebite cases were reported. The North region shows the highest increase in incidence (4.1%/year) and the highest mortality, despite a stationary trend (TIMA: 4.7%; 95% CI: 1.1-8.4; p=0.013). Cases are more common in men, Black, Brown, and rural workers, while lethality is higher in women, Indigenous, elderly, and socioeconomically vulnerable people. High exposure and barriers to healthcare access in the North worsen the impacts, with cultural factors increasing Indigenous vulnerability. MS data confirm regional differences in snakebites and highlight greater challenges for the North region.

Discussion: Brazil's continental dimension and sociocultural diversity make it difficult to create clinical guidelines, but these initiatives can serve as regional models that promote strategies adapted to local particularities, helping address public health issues in Latin America.