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Poster Session 9 - Theme 5. A Unified Framework for Health Decision-Making and Informing Research

Thursday, September 18, 2025
12:45 PM - 1:25 PM

Speaker

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Dr Beatriz León-salas
Health Technology Assessment Technician and Researcher
SESCS

Evaluating Bioelectrical Impedance Analysis in Primary Care: Evidence Gaps and Future Research Directions

Abstract

Background
Health decision-making for adopting new technologies in primary care (PC) must rely on robust evidence. Body mass index (BMI) and waist circumference (WC) are widely used for obesity risk assessment, while bioelectrical impedance analysis (BIA) remains restricted to specialized settings. Understanding its clinical value, cost-effectiveness, and feasibility is crucial before widespread implementation.
Objectives
We assessed the clinical effectiveness, safety, and cost-effectiveness of BIA in PC and identified key research gaps.
Methods
We searched MEDLINE, EMBASE, CENTRAL, CINAHL, and WOS (up to October 8, 2024) for randomized controlled trials (RCTs), non-randomized trials, or observational studies and economic evaluations. The risk of bias was assessed using ROB-2, and ROBINS-I/E. Meta-analysis was conducted using Review Manager 5.4 and R. Certainty of evidence was assessed using GRADE. A partial economic analysis estimated BIA’s direct costs in the Spanish national health system.
Future prospects for project presentations
We identified 19 longitudinal studies (839,203 patients) assessing associations between BIA-derived and anthropometric measures and health outcomes. No RCTs or economic evaluations were found. BIA-derived measures showed no significant association with health outcomes, while traditional indices demonstrated stronger predictive value: BMI (↑14% cardiovascular events), WC (↑5% all-cause mortality), waist-to-hip ratio (↑10% all-cause mortality, ↑16% cardiovascular events), and waist-to-height ratio (↑9% all-cause mortality, ↑23% cardiovascular events). Estimated BIA costs: €1,600 per PC center/year, with a 5-year budget impact of €219 million.
BIA offers no clear advantage over traditional measures. The lack of RCTs and economic evaluations highlights the need for future studies on cost-effectiveness and effectiveness in PC.

Paper Number

522

Biography

Beatriz holds a PhD in Health Sociology (Complutense University of Madrid) and is an expert in Applied Social Research and Data Analysis (Center for Sociological Research), Meta-analysis and Systematic Reviews: Evidence-Based Decision-Making in Psychology, Medicine, and Education (UNED), and Geriatrics and Gerontology (ESSSCAN). She currently works as a researcher at the Canary Islands Health Research Institute Foundation (FIISC), linked to the Evaluation Service of the Canary Islands Health Service (SESCS). She has extensive training and experience in the evaluation of health services and technologies, health outcomes assessment, the development of systematic reviews, and clinical practice guidelines.
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Mrs Cathrien Kager
Gp-researcher
Nivel

Facilitators and barriers for implementing watchful waiting in cystitis in general practice: experiences of Dutch healthcare professionals and patients.

Abstract

BACKGROUND Healthy, non-pregnant women with cystitis may recover within a week without antibiotic (AB) use with limited risk of complications. Therefore, the Dutch College of General Practitioners guideline recommends discussing watchful waiting with the patient. Experiences of healthcare professionals (HCPs) and patients and what factors play a role in the decision-making process regarding this recommendation are unknown.
OBJECTIVE To gain insight into the attitudes, experiences, and preferences of HCPs and patients that play a role in the decision-making process regarding watchful waiting in healthy, non-pregnant women with cystitis.
METHOD Two focus group discussions with in total 11 HCPs (GPs and GP assistants) were held as well as 12 semi-structured interviews with healthy non-pregnant women with a recent history (<1 year) of cystitis. Results were analysed thematically.
RESULTS GPs indicated that they often do not know what a patient wants because they don’t have direct contact with patients who have cystitis. To prescribe AB is seen as a quick fix. It is difficult to make prescribing-agreements within the HCPs team. However, GPs also mentioned that when they discuss a wait-and-see policy, patients seem positive. Therefore GPs wish more time for shared decision making is available. This coincide with the patients’ perspective. Patients experienced a lack of conversation about treatment choices and often AB were prescribed without discussing it. Their expectations of watchful waiting were limited. Patients were positive regarding a wait-and-see policy but wish to be involved in the decision-making.
DISCUSSION Improving HCP-patient communication is needed to better implement wait-and-see policy.



Paper Number

123

Biography

2020- present: GP researcher at Nivel, Utrecht, The Netherlands 2013- present: General Practitioner 2010-2013: GP training program; University of Amsterdam 2003-2010: Medicine; University of Amsterdam
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Dr, Prof Daniela de Melo
Unifesp

Therapeutic Approaches for Visceral Leishmaniasis: A Systematic Review of Efficacy and Safety

Abstract

Background: Visceral leishmaniasis (VL), caused by Leishmania infantum, is a neglected tropical disease with high morbidity, especially in endemic regions such as Southern Europe and Latin America. Despite available treatments, comparative evidence on efficacy and safety is limited, particularly for immunocompromised patients.

Objective: Systematically review VL therapies to identify evidence gaps and support guideline development.
Methods: A systematic review included randomized controlled trials (RCTs) and observational studies. Searches were conducted in multiple databases, assessing efficacy (cure, relapse) and safety (adverse events) for monotherapies (liposomal amphotericin B, miltefosine) and combination therapies. Risk of bias was assessed using RoB 2 for RCTs and ROBINS-I for observational studies.

Results: Seventeen studies (seven RCTs and ten observational) showed high heterogeneity in methods and populations. L-AmB monotherapy achieved up to 93% cure in immunocompetent patients but only 70% in immunosuppressed individuals. Miltefosine had 67% efficacy in immunocompetent children. No studies evaluated L-AmB with miltefosine, antimonials, or pentamidine. A significant risk of bias was noted, particularly in observational studies due to confounding and in clinical trials due to randomization and blinding issues, requiring cautious interpretation of results.

Discussion: L-AmB is effective in immunocompetent patients but less so in immunosuppressed individuals. Miltefosine has limited efficacy, particularly in children. The lack of studies on combination therapies highlights critical treatment gaps. Addressing these gaps is essential for evidence-based guideline development. Findings from this study may inform public health policies and decision-making frameworks, contributing to the optimization of VL treatment strategies, including in the Brazilian public health system.

Paper Number

137

Biography

PhD in Drugs and Medicines from the School of Pharmaceutical Sciences, University of São Paulo (USP), Brazil. Professor at the Federal University of São Paulo (Unifesp) and Director of the Center for Health Technology Assessment at Unifesp. Advisor in the postgraduate programs in Pharmaceutical Sciences and Translational Medicine. Researcher and professor in the fields of Health Technology Assessment, Clinical Guidelines, Pharmacoepidemiology, and Pharmaceutical Care.
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Dr Beatriz León-salas
Health Technology Assessment Technician and Researcher
SESCS

Applying the GRADE Approach When Comparative Evidence is Lacking: Insights from a Single-Centre Experience

Abstract

Background
Health technology assessments (HTA) often lack high-quality comparative evidence to address PICO questions. When direct comparisons are unavailable, evidence must come from longitudinal observational studies assessing associations with health risks. Standard GRADE evidence profiles (EPs) may not apply, requiring adaptation of prognosis-based EPs to inform recommendations.
Objectives
To present our experience adapting the GRADE approach in the absence of comparative studies within an HTA for the Spanish National Health System. This process assessed the clinical effectiveness, safety and cost-effectiveness of bioelectrical impedance analysis (BIA) versus anthropometric measures for overweight and obesity assessment in primary care.
Methods
A systematic search in MEDLINE, EMBASE, CENTRAL, CINAHL, and WOS (up to October 8, 2024) found no RCTs directly comparing BIA with anthropometric measures. Available evidence consisted of longitudinal studies evaluating associations between BIA-derived and anthropometric measures and health outcomes. Risk of bias was assessed using ROBINS-E, and meta-analysis was conducted using Review Manager 5.4 and R. Certainty of evidence was assessed using GRADE, adapting prognosis-based EPs to inform the evidence-to-decision (EtD) framework. Seven prognosis EPs were developed for key outcomes, including all-cause mortality and cardiovascular events.
Future prospects for project presentations
Adapting prognosis-based EPs enabled the EtD process despite the lack of direct comparisons, providing structured guidance for recommendations. This experience highlights the need for methodological flexibility in HTA when comparative evidence is lacking, underscoring a key research gap that calls for future RCTs on BIA effectiveness in primary care.

Paper Number

523

Biography

Beatriz holds a PhD in Health Sociology (Complutense University of Madrid) and is an expert in Applied Social Research and Data Analysis (Center for Sociological Research), Meta-analysis and Systematic Reviews: Evidence-Based Decision-Making in Psychology, Medicine, and Education (UNED), and Geriatrics and Gerontology (ESSSCAN). She currently works as a researcher at the Canary Islands Health Research Institute Foundation (FIISC), linked to the Evaluation Service of the Canary Islands Health Service (SESCS). She has extensive training and experience in the evaluation of health services and technologies, health outcomes assessment, the development of systematic reviews, and clinical practice guidelines.
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Dr Sharangini Rajesh
Senior Technical Analyst
National Institute for Health and Care Excellence

An accelerated approach to developing guideline recommendations: lessons learned from a case study on anti-D prophylaxis

Abstract

Background
In response to the request for alignment of existing NICE anti-D prophylaxis recommendations with emerging international guidelines and recent evidence, as well as potential cost-effectiveness implications for the NHS, an update was undertaken to revise the recommendations.

Objective
To evaluate an accelerated approach to updating NICE recommendations.

Methods
Due to limited high-quality evidence, no evidence review was conducted, and an external guideline on abortion care by The World Health Organization (WHO) was considered as a source of evidence. This guideline received a high AGREE II assessment score for quality and has been widely adopted by health organisations worldwide. No guideline committee was involved in the update; however, the revised recommendations underwent a consultation process with registered stakeholders to obtain input from key stakeholders, ensuring a robust process.

Results
Due to the availability of a high-quality and widely adopted WHO guideline, NICE decided to cross-refer to this guidance to ensure alignment with international best practices. Recommendations on anti-D prophylaxis were published within months. This approach saved time and resources by avoiding the need for a full evidence review and committee meetings while still producing robust guidance.

Discussion
Using external guidelines to develop recommendations can save time and resources when the guidelines align with current practice, are of good quality, and are applicable to the local setting. This approach avoids duplication, especially in areas with limited evidence, and is useful for urgent recommendations. However, it is crucial to consider the quality, relevance, applicability, and recency of the external guideline before use.

Paper Number

214

Biography

Sharangini works as a Senior Technical Analyst at the National Institute for Health and Care Excellence (NICE), UK. With 17 years of guideline development experience as a technical lead on NICE guidelines, she brings expertise from her background in dentistry and dental public health. Her research interests are diverse, and she is experienced in leading training on systematic reviews, critical appraisal, and developing methodological guidance. She has worked on novel methods in NICE guideline development, such as targeted reviews and cross referring to external guidelines. Sharangini is involved in GIN, contributing to accelerated guideline development and living guidelines working groups.
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Miss Yuanyuan Yao
Chinese
Lanzhou University

Systematic Reviews of Patient Preferences and Values: An Evidence Map

Abstract

Background: Patient preferences and values have become essential considerations in determining treatment options.
Objective: Through a meta-epidemiological analysis of systematic reviews on patient preferences and values, this study aims to comprehensively analyze the current state and key characteristics of research in this field.
Methods: A systematic search of the PubMed database was conducted using keywords such as “guideline*”, “patient*”, and “Patient Preference”, with the search period spanning from database inception to February 19, 2025. Systematic reviews focusing on patient preferences and values were included. Two researchers independently screened the literature and extracted data, which encompassed publication year, the first author’s country, protocol development status, registration status, searched databases, types and number of included studies, adherence to PRISMA guidelines, and other relevant details.
Results: A total of 3,266 articles related to the study topic were retrieved, with 44 meeting the inclusion criteria. The publications spanned from 2000 to 2025, with the highest number published in 2024. The included studies originated from 18 countries, with Canada contributing the most publications. These studies encompassed over 30 diseases and research topics, such as breast cancer, venous thromboembolism, and COVID-19. Other findings will be presented at the conference.
Discussion: The number of systematic reviews on patient preferences and values has been steadily increasing each year and has been applied to a wide range of diseases and topics. Future research should place greater emphasis on this area.

The author gratefully acknowledges the support of K.C. Wong Education Foundation, Hong Kong.

Paper Number

411

Biography

Yuanyuan Yao, a PhD candidate, focuses on clinical practice guidelines. She is a member of the Secretariat of the Scientific, Transparent and Applicable Rankings tool for clinical practice guidelines (STAR) Working Group. She has participated in 5 provincial and ministerial projects and published 8 academic papers, with 4 as the first author (including co-first author).
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Ms Catharina Gross
Researcher; PhD Student
Ernst-Abbe-Hochschule Jena University of Applied Sciences

Feasibility of new guidance on the use of systematic reviews for clinical guideline recommendation development – a pilot-testing

Abstract

Background
Guideline development teams addressing prevalent diseases like stroke often face extensive literature. To navigate this effectively, a systematic analysis of existing aggregated evidence is crucial. Utilizing systematic evidence and existing clinical guidelines is recommended before exploring primary studies, yet specific guidance on using systematic reviews has been lacking until recent GRADE series publications [Klugar et al., 2024; Mathes et al., 2024]. Further optimization is needed in the selection and presentation processes for systematic evidence in guideline development.

Objective
This pilot study evaluates the feasibility of newly published guidance on using systematic reviews to enhance the efficiency of clinical guideline recommendations.

Methods
Evidence summaries based on systematic reviews were tested on practicability by team members of the TheMoS (01VSF23004) guideline development group in neurology. Feedback was collected in partly standardized online surveys focusing on literature search and selection, methodological appraisal of systematic reviews, intervention efficacy and overall quality of evidence. Anonymized transcripts from the initial workgroup meetings were systematically analyzed to evaluate these aspects in detail.

Future prospects for project presentations
Preliminary findings indicate that evidence summaries based on systematic reviews can be suitable for developing clinical guideline recommendations if key aspects of the literature search and selection, the characteristics of the included studies and the overall quality of evidence are reported in sufficient detail and transparency. Required minimum information will be presented.

Conflicts of interest
The author is a research associate and member of the G-BA-funded guideline team project.

Paper Number

458

Biography

Catharina is a research associate at the 'Ernst-Abbe-Hochschule Jena University of Applied Sciences' and part of the clinical guideline group developing the S3-Guideline TheMoS focussing on the therapy of mobility post-stroke.
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Dr, Prof Daniela de Melo
Unifesp

Variability in Antivenom Dosing Practices: A Scoping Review on Challenges in Antivenom Use for Snakebite Envenomation in Brazil

Abstract

Background: Snakebite envenomations from Bothropic, Crotalic, Lachesis, and Elapid species pose significant public health challenges. Antivenom therapy shows considerable dosing variability due to envenomation severity, patient condition, and regional practices.

Objective: To review current antivenom dosing practices, identify challenges in antivenom use, and suggest areas for further research to improve clinical outcomes.

Methods: A systematic search was conducted on May 16, 2024, in databases including MEDLINE (via PubMed), LILACS, Ministry of Health (via BVS), Scielo, Embase, Epistemonikos, Clinical Trials, medRxiv, bioRxiv, Fiocruz Institutional Repository (ARCA), and CAPES Thesis and Dissertations Catalog. Risk of Bias was assessed using the Rob 2 and Robins-I tools.

Results: Seven studies were included in the final analysis, primarily focusing on Bothropic envenomations, with fewer cases of Crotalic, Lachesis, and Elapid species. Studies revealed significant variability in antivenom dosing, influenced by envenomation severity, and differences in infusion times, often due to logistical challenges. The included studies presented a moderate risk of bias, mainly due to their retrospective design, small sample sizes, and inconsistencies in data reporting.

Discussion: The variability in antivenom dosing reflects a lack of standardized protocols, with doses ranging from 4 to 12 vials based on envenomation severity. Some studies suggest higher doses than those recommended by the Ministry of Health, driven by regional and clinical factors. Delays in treatment, particularly in rural areas, are a significant concern, highlighting the need for improved healthcare infrastructure and faster access to care. Standardizing antivenom dosing protocols and improving healthcare access could optimize treatment and patient outcomes.

Paper Number

136

Biography

PhD in Drugs and Medicines from the School of Pharmaceutical Sciences of the University of São Paulo (USP), Brazil. Professor at Federal University of São Paulo (Unifesp) and Director of the Center for Health Technology Assessment - Unifesp, Brazil. Advisor in the postgraduate programs in Pharmaceutical Sciences and Translational Medicine at Unifesp. Professor and researcher in the following areas: Health Technology Assessment, Clinical Guidelines, Pharmacoepidemiology and Pharmaceutical Care.
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Dr, Prof Airton Tetelbom Stein
Brazilian
Professor Of Public Health
Grupo Hospitalar Conceição

A UNIFIED FRAMEWORK FOR CARDIOVASCULAR RISK ASSESSMENT IN CLIMACTERIC WOMEN: BRIDGING GAPS IN HEALTH DECISION-MAKING

Abstract

Background:
Cardiovascular disease (CVD) is the leading cause of mortality in postmenopausal women. While traditional cardiovascular risk (CVR) assessment tools are valuable, they may not fully capture sex-specific factors such as gynecological history, psychosocial determinants, and hormonal influences. Enhancing current approaches with a more integrated framework could improve decision-making and preventive strategies.

Objective:
To develop a comprehensive, transdisciplinary framework that integrates scientific evidence, clinical guidelines, and contextual factors to improve CVR assessment and inform decision-making in climacteric women.

Methods:
A cross-sectional study was conducted in Brazil (2022-2023) with 218 climacteric women (aged 45-65) attending a public gynecology service. CVR was assessed using American Heart Association (AHA) criteria alongside additional sex-specific factors (e.g., gynecological history, depression, oral contraceptive use, premature ovarian insufficiency). Women with diagnosed coronary artery disease were excluded. Data were analyzed using SPSS v.25.

Prospects for project presentations:
The study has shown that most women presented low CVR (76.6%, n=131), yet a high prevalence of obesity (80.1%, n=137), depression (55.6%, n=95), and physical inactivity (52.6%, n=90) was observed. No clear association was found between sex-specific factors and CVR using conventional tools, suggesting opportunities to refine current risk models. These findings highlight the need for a framework integrating multidisciplinary evaluation, policy-making, and guideline development to enhance prevention and personalized interventions.

Future research should focus on optimizing CVR assessment tools to reflect the complexity of female cardiovascular health better. This research provides essential data to develop a guideline on this issue.



Paper Number

173

Biography

- Family Physician and Professor of Health Technology Graduation Course at Conceição Hospital Group, Porto Alegre – Brazil – www.ghc.com.br; - Full Professor of Public Health of Federal University of Health Sciences of Porto Alegre – (Ucspa) – Brazil - www.ufcspa.edu.br - From February 1999 until January 2025. From January 6th 2025 had been retired;
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