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7.5 - Theme 4. Building Trust in Science and Transforming Health Systems through Guidelines

Thursday, September 18, 2025
4:40 PM - 5:40 PM
Room K

Speaker

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Mrs Annick Nonneman
Research Assistant
Working group Development of Primary Care Guidelines

How to ensure credibility and consistency of subgroup Analyses in meta-Analyses: Best practices for guideline development

4:40 PM - 4:48 PM

Abstract

Background:
Clinical practice guidelines (CPGs) require precise, context-specific recommendations to address the growing prevalence of comorbidities and the diverse ways of administering interventions or therapies. Subgroup analyses in meta-analyses (MAs) and randomized controlled trials (RCTs) play a crucial role in understanding treatment effect variability across different populations or conditions. When rigorously conducted and interpreted, they can enhance guideline precision. However, their credibility, consistency, and clinical relevance depend on robust critical appraisal process to avoid over-interpretation and potential biases.

Objective:
This workshop aims to explore key challenges in assessing subgroup analyses and apply best practices for their critical appraisal in the context of guideline development.
Format:
This interactive workshop will include:
- Kickoff presentation (15 min):
A brief presentation outlining the role, challenges, and impact of subgroup analyses in guideline development, along with an introduction to appraisal tools that will be used, such as ICEMAN and SUN 2012
- Reflecting (45 min) :
Small-group exercises where participants will critically assess subgroup findings from five selected meta-analyses using the appraisal tools.
- Completion of the workshop (30 min):
An expert-led discussion to identify key criteria for assessing the credibility and consistency of subgroup findings and, exploring their applicability to guideline development, while minimizing the risk of misinterpretation and improving decision-making.

Participants will gain a structured approach for evaluating subgroup analyses. The workshop will conclude with pratical recommendations to enhance transparency and methodological rigor in evaluating subgroup evidence.

Paper Number

286

Biography

Pharmacist with practical background. Currently a research assistant at WOREL, responsible for literature surveillance on pharmacological approaches in WOREL guidelines to support decision-making on update priorities.She is, also, Actively involved in the development of clinical practice guidelines for pharmacological interventions. Additionally, she is a research assistant at the Academinc Center of General Medicine at UCLouvain, leading a research project focused on contextualizing clinical practice guidelines for primary care through qualitative research. Her expertise bridges practical background, evidence-based medicine, and qualitative methodologies, ensuring the relevance and applicability of guidelines in real-world primary care settings.
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Miss Willemijn Irvine
Phd-candidate / Methodologist
Erasmus Mc - Sophia Children’s Hospital

Supplementing Published Evidence With Structured Observation of Cases From a Clinical Audit Registry: A Pilot

4:48 PM - 4:52 PM

Abstract

Background: Research evidence is often lacking in rare diseases, complicating the development of evidence-based guidelines. Therefore, exploration of innovative methodological strategies is crucial.

Objective: To evaluate the added value of registry data as supplementary evidence in a rare disease guideline.

Methods: to develop this guideline, the GIN-McMaster Guidelines 2.0 was followed. Additionally, registry data was provided to clinical experts for clinical questions in which published evidence was scarce. The perceived effectiveness of the interventions was evaluated by clinical experts using structured observation forms (SOFs).

Results: Adequate supplementary data from the EPSA were available in seven of the twelve clinical questions selected for this guideline (58%). In four out of seven clinical questions (57%), evaluation of supplemental evidence using SOFs contributed to the panel’s decision on a recommendation. Reasons to disregard the supplementary evidence during the formation of a recommendation were uncertainty about the validity of the observations due to small sample sizes, and doubt about the association between the observed outcomes and the intervention due to missing of an intention to treat in the registry data.

Conclusion: This study shows a first evaluation of an innovative methodology for guideline development in rare diseases, highlighting both the challenges and benefits this method has to offer.

Discussion: Although the methodology requires refinement and the dataset used must be optimized, we believe this technique holds significant promise as a tool for developing guidelines for rare diseases.

Paper Number

19

Biography

After 5 years of working as a methodologist for several rare disease networks I am now combining my work as a methodologist with a research position in the hopes of solving some of the issues around creating high-quality guidelines for rare diseases.
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Ms Daniëlle Conijn
Senior policy officer/ Guideline developer
Royal Dutch Society for Physical Therapy (KNGF)

Integrating Patient Needs into Cardiac Rehabilitation Guidelines: Strengthening Evidence through Qualitative Findings

4:52 PM - 4:56 PM

Abstract

BACKGROUND
Cardiac rehabilitation is a strongly recommended intervention for patients with coronary artery disease (CAD) and chronic heart failure (CHF). To enhance patient engagement, it is essential to align rehabilitation programs with patient needs. The revision of the Dutch physiotherapy guideline on cardiac rehabilitation aimed to optimize cardiac rehabilitation to improve adherence and completion.
OBJECTIVE
We integrated qualitive and quantitative data to asses how rehabilitation programs could be structured to enhance adherence and completion among patients with CAD and CHF by integrating patient needs into guideline development.
METHODS
Two systematic reviews were performed: (1) a qualitative, meta-ethnographic synthesis to explore the rehabilitation needs of patients with CAD, CHF, or thoracic aortic dissection, using GRADE-CERQual; and (2) a meta-analysis assessing the effectiveness of interventions to enhance adherence and completion of cardiac rehabilitation using GRADE. The integration of both reviews informed the evidence-to-decision process.
RESULTS
The qualitative review identified five lines-of-arguments presenting patient needs: safety without overprotection, involvement of significant others, peer support, personalized care, and meaningful future planning. The integration of qualitative findings influenced the recommendations not only by shaping patient preferences and values within the evidence-to-decision process but also by carrying additional weight due to the nature of the clinical question. This resulted in a stronger emphasis on patient-centered approaches in the guideline recommendations.
DISCUSSION
Our findings suggest that when patient needs are central to guideline development, qualitative research should be considered as crucial evidence. These insights will be used to adapt the methodology for guideline development.

Paper Number

63

Biography

Danielle Conijn is an experienced professional in guideline development, with a background in healthcare and quality improvement. She works at the Royal Dutch Society for Physical Therapy (KNGF), where she is involved in the development and implementation of clinical guidelines. Her expertise includes project management, evidence-based practice, and facilitating multidisciplinary collaboration. With a master’s degree in health sciences, Danielle has contributed to improving clinical practices and patient care by promoting quality standards in healthcare.
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Dr Marta Souto Maior
Coordinator
Conitec

Rare Diseases Clinical Practice Guidelines developed in the context of the Brazilian Public Health System in Thirteen years.

4:56 PM - 5:00 PM

Abstract

Background: Rare Diseases (RD) affect up to 65 people out of 100,000 individuals. In Brazil, approximately 13 million people have RD. Clinical practice guidelines (CPG) are especially important to guide diagnoses and treatment of RD patients. The National Committee for Health Technology Incorporation (Conitec) advises Brazilian Ministry of Health (MoH) in CPG development.
Objective: To present RD CPG published by MoH and developed in Brazil public health context in the last thirteen years.
Methods: Descriptive qualitative study about RD CPG development and update by Conitec in Brazilian Unified Health System context. Data collection and analyses used Excel 2010 software.
Results: MoH has published 64 RD CPG, such as Cystic Fibrosis and Fabry disease. In 2012-2024 period, 100 RD CPG were published: 31 (31%) new CPG, 75 (75%) updates and 6 (6%) revoked. The annual average for RD CPG was 7.7. The largest number of CPG (n=13) were published in 2013 and 2018 and the smallest number (n=1) in 2023. New CPG were mostly published in 2019 and 2020. CPG revocations occurred in 2018 (n=1), 2021 (n=1) and 2022 (n=4).
Conclusions: Developing and updating CPG, based on the best scientific evidence available, contributes to better health outcomes in this population.
Brazilian Ministry of Health has been investing in production and updating CPG with a view to qualifying the health care provided to people with rare diseases throughout the country. Developing and updating CPG, based on the best scientific evidence available, contributes to better health outcomes in these populations.

Paper Number

515

Biography

Pharmacist. Has a master's degree and PhD in Public Health. Works at Conitec.
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Mr Heath White
Director, Evidence And Methods, ALEC
Monash University

Co-designing the future of Living Guidelines to meet the needs of all regions

5:00 PM - 5:08 PM

Abstract

Background
Living guidelines are increasingly being used to ensure health decision-makers have access to reliable, up-to-date summaries of evidence when they need them. The WHO 14th General Programme of Work commits to continuing ‘to produce and maintain evidence-based, methodologically rigorous, up-to-date, quality-assured and living public health guidelines and other normative products’ with many current examples of WHO Living Guidelines, including for maternal and perinatal health. To support global uptake of living guidelines there is a need to continue to evolve intuitive, accessible, technology-enabled solutions that meet the needs of diverse users at the country level.

Objective
This workshop will explore the needs and understanding of diverse stakeholders (e.g. technical units, guideline developers, clinicians, consumers, policymakers) of living guidelines, to support a global conversation on the requirements for a global living evidence architecture. The work builds on engagements conducted in Australia and Indonesia with WPRO and SEARO regional stakeholders to understand the future needs of guideline developers and users, and on work conducted by Product Design and Impact Unit, WHO Quality Assurance, Norms and Standards to understand country needs for guideline adaptation.

Methods
Using a combination of co-design and futuring approaches, this workshop will engage participants to envisage a future technology-enabled evidence infrastructure to meet the needs of diverse users in country contexts. The workshop will immerse participants in global health scenarios (e.g. infectious diseases, NCD) to ideate on technology-enabled approaches to support a world in which all health decisions are rapidly, regularly and reliably informed by research evidence.

Paper Number

396

Biography

Leah Heiss is the Eva and Marc Besen International Research Chair in Design at Monash University, Australia. She is a leader in co-designing health systems including in global health, transfusion medicine, and mental health and addiction. She worked with the WHO Product Design and Impact Unit (Science Division) to bring together 15 countries to develop the ‘WHO Design Principles and Tools to support use and impact of WHO Guidelines’, launched in 2024. In 2025 Leah is working with the Australian Living Evidence Collaboration to convene WPRO and SEARO input to the development of a Global Living Evidence Architecture.
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Emily Senerth
Evidence Foundation

Applying GRADE Guidance for Optimal Integration of RCTs and NRS to Formulate Practice-changing Recommendations for Antithrombotic Therapy After Percutaneous LAAO

5:08 PM - 5:12 PM

Abstract

Background: Conventional antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is oral anticoagulation (OAC). However, large procedural registries also report data for patients who receive less expensive and less intensive treatment with dual antiplatelet therapy (DAPT).

Objective: We applied strategies for the integration of randomized (RCT) and non-randomized (NRS) studies during a systematic review and meta-analysis comparing post-procedural OAC versus DAPT.

Methods: Study-level risk of bias (RoB) was assessed using the RoB in NRS of Interventions (ROBINS-I) tool, and the Cochrane RoB tool for randomized trials (RoB 2). Overall certainty of evidence (CoE) was assessed using the GRADE approach. We assessed the congruence of pooled results from RCTs with CoE concerns and pooled results of NRS to explore whether NRS could improve overall CoE.

Results: We had very low certainty in the RCT evidence due to serious concerns with RoB and very serious concerns with imprecision. Results from the RCTs and NRS were congruent, demonstrating no meaningful difference in device-related thrombus and major bleeding between DAPT vs. OAC. The NRS had serious concerns with RoB but pooled estimates were more precise, resulting in moderate certainty. We selected higher certainty evidence from NRS to inform critical outcomes for decision-making after determining that these estimates mitigated concerns with imprecision from congruent RCTs.

Conclusion: NRS evidence was instrumental to inform new recommendations for post-LAAO antithrombotic therapy, replacing very low certainty RCTs and introducing the option for a less expensive and intensive treatment.

Paper Number

283

Biography

Emily Senerth is a consulting researcher who specializes in evidence synthesis and the integration of evidence into decision-making. Her work with Evidence Foundation, the Evidence-Based Toxicology Collaboration at Johns Hopkins University, and the GRADE Working Group is aimed at getting trustworthy data into the hands of policy-makers and helping them to account for all relevant factors when making decisions.
Zhang Lingli
China
Department of Pharmacy, West China Second University Hospital, Sichuan University, Children's Medicine Key Laboratoryof

Analysis of the Current Status of Chinese Clinical Guidelines for Children and Critical Appraisal of Evidence-Based Clinical Guidelines

5:12 PM - 5:16 PM

Abstract

Short Oral
Backgroud An incresing number of Chinese clinical practice guidelines for children have been published, but the status and quality is unknown.
Objective We aim to analysis the current status of Chinese clinical practice guidelines for children from 2010-2024, and evaluated the quality of the evidence-based guidelines.
Methods PubMed, EMbase, there Chinese database and relevant domestic and foreign guideline websites were searched to collect Chinese clinical practice guidelines for children from Jan. 1 st 2010 to July 23th 2024. Two reviewers independently screened literature, extracted data, and 4 reviewers used AGREE Ⅱ to evaluate the quality of the included evidence-based guidelines.
Results A total of 272 guidelines were included, involving 149 evidence-based guidelines. Most of the guidelines were publicated in Chinese (97.4%) and 191(70.2%) were western medicine guidelines. The guidelines cover diseases across 21 systems. And the results of quality assessment of 150 evidence-based guidelines showed average scores in 6 individual domains were 73.31%, 57.52%, 61.24%, 70.83%, 20.11%, 74.54%, the score in the region of Applicability is the lowest, followed by Stakeholder involvement. The results of subgroup analysis showed a higher score for guidelines published in journal(Mean Difference[MD] 6.80, 95%Confidence Interval[CI] 3.04-10.56) and guidelines with patient participation(MD 8.71, 95%CI 5.39-12.03) in applicability, and guidelines with patient participation(MD 11.67, 95%CI 6.51-16.83) in stakeholder invovement.
Conclusions From 2010 to 2024, the clinical practice guidelines for children in China have been continuously improved in both quantity and quality. However, it still need further improvement in the areas of applicability and stakeholder invovement.

Paper Number

513

Biography

Liu Jianing, a master's degree candidate, with the research direction of evidence-based pharmacy research and practice. Bo Zhenyan, a doctoral degree candidate, with the research direction of evidence-based pharmacy research and practice. Zeng Linan, a doctor and a professor, with the research directions of clinical evaluation of drugs and related methodology research, as well as the application and mining of medical big data. Zhang Lingli, a doctor and a professor, with the research directions of evidence-based drug decision-making and management, and evidence-based clinical pharmacy research and practice.
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Dr Cindy Stern
Senior Research Fellow
HESRI, University of Adelaide

Representation of culturally and geographically diverse populations in guidelines - do we have a problem?

5:16 PM - 5:20 PM

Abstract

Introduction:
The process of guideline development is complex and requires input from multiple stakeholders. Although a guideline can be comprehensive in its methods and produce trustworthy recommendations, it also needs to consider the target population including culturally and geographically diverse populations to ensure its relevance. It is unclear however, how often these populations are considered in guidelines and how these considerations are described.
Objective:
To describe how considerations for culturally and geographically diverse populations are described in a set of existing guidelines that address motor neurone disease (MND).
Methods:
A scoping review following JBI methodology was undertaken as part of a series of activities to map the MND literature to inform a national guideline. The review question was 'What health and social care guidelines exist that address MND?' Twelve databases/resources were searched; records were screened and data extracted and analysed.
Results:
Forty-two guidelines were included in the review. Only a small proportion of guidelines mentioned considerations for rural communities, indigenous populations and culturally and linguistically diverse groups and the level of detailed varied in length and information.
Conclusion:
Based on the results of a scoping review of guidelines that address MND care, considerations for culturally and geographically diverse populations are rarely mentioned and poorly reported. Recommendations for further research are provided.

Paper Number

426

Biography

Dr Cindy Stern is a Senior Postdoctoral Research Fellow within HESRI. She has actively contributed to the field of evidence-based health care for over two decades, largely in the area of evidence synthesis and methodology. Dr Stern is an experienced researcher having been involved in the conduct of diverse types of systematic reviews and evidence syntheses related to health.
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Dr Aili Langford
Lecturer, NHMRC Emerging Leadership Fellow
The University of Sydney

End-user’s perspectives on the challenges and considerations in developing gabapentinoid deprescribing guidelines: a preliminary analysis

5:20 PM - 5:24 PM

Abstract

Background. Gabapentinoids (pregabalin, gabapentin), originally marketed for epilepsy, have become widely prescribed for neuropathic pain, and other off label conditions. However, concerns about harms that outweigh benefits have prompted some prescribers to reconsider their use. Understanding stakeholders’ perspectives is crucial in developing a gabapentinoid deprescribing guideline.
Objective. To understand perspectives of consumers and health professionals on the need and scope of developing a gabapentinoid deprescribing guideline.
Methods. A qualitative study with a grounded theory approach was undertaken with a purposive and snowball sample of consumers and health professionals. Semi-structured interviews were conducted, audio recorded, and transcribed verbatim, with inductive thematic analysis, from a functional perspective of role theory. Recruitment began on February 3, 2025, and is ongoing.
Results. Preliminary results from interviews included seven consumers, one GP, and one hospital pharmacist. Consumers perceived that GPs were the central coordinators of care, responsible for prescribing, monitoring, adjusting dosage, and tapering gabapentinoids. Consumers expressed concerns about withdrawal effects and the lack of resources to guide deprescribing. Other specialists were seen as peripheral consultants in gabapentinoid management, except neurologists who were actively involved in prescribing. Consumers perceived pharmacists as only responsible for medication supply, overlooking their cognitive and structural roles. Participants were open to greater pharmacist involvement when informed about their potential roles in deprescribing. All participants agreed that a deprescribing guideline for gabapentinoids would provide helpful guidance.
Discussion. Consumers are fearful of deprescribing and feel inadequately informed. Clear, evidence-based deprescribing guidelines for gabapentinoids could improve the safe and appropriate use of gabapentinoids.

Paper Number

399

Biography

Dr Aili Langford is a pharmacist, Lecturer and National Health and Medical Research Council (NHRMRC) Emerging Leadership Research Fellow at the University of Sydney Pharmacy School. Dr Langford’s research focuses on reducing medication-related harm through deprescribing (medication dose reduction or cessation), particularly for high-risk medicines such as opioid analgesics.
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Dr Marta Souto Maior
Coordinator
Conitec

Rapid update of Clinical Practice Guidelines in the Brazilian Unified Health System – a summary of the process

5:24 PM - 5:28 PM

Abstract

Background: Brazilian public and universal health system ensure the entire population receive health care through organized health actions and services. By force of law, Brazilian Ministry of Health (MoH), advised by the National Committee for Health Technology Incorporation (Conitec), must develop and update clinical practice guidelines (CPG) to orientate adequate access to health care. National normatives and MoH methodological guidelines regulate CPG elaboration/updating. Considering the increase in incorporation of medical technologies’ incorporation, keeping evidence-based guidelines updated is a challenge.
Objective: To describe CPG’s rapid update the context of the Brazilian Public Health System.
Methods: Descriptive study of CPG’s rapid update process developed by Conitec/MoH.
Results: A guideline update uses a rapid update process when punctual changes are necessary, such as an inclusion of new technology. International guidelines and scientific evidence are consulted to support changes in text. Then, in order to identify possible critical points, a expert and, later, Conitec’s Subcommission analyze the CPG. After initial evaluation by Conitec, the CPG is made available for public consultation to receive contributions by society. These contributions are evaluated and included in the CPG, if it is possible. The final version is evaluated by Conitec, which issues a final recommendation for the updated CPG.
Conclusions: The increase in health technology incorporation in Brazil’s public health system becomes a challenge for updating guidelines in a timely manner. Therefore, adopting a rapid updating process was an important strategy to ensure quick CPG review, to maintain these documents’ quality and to guarantee access to these technologies.

Paper Number

516

Biography

Pharmacist. Has a master's degree and PhD in Public Health. Works at Conitec.
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Dr Beatriz Carmona-Hidalgo
Postdoctoral Researcher
Andalusian Health Technology Assessment Area, Seville, Spain.

Consensus Statement in the field of Rare Neurological Diseases: Efficacy of Deep Brain Stimulation as therapy in Monogenic Dystonias.

5:28 PM - 5:32 PM

Abstract

BACKGROUND
Monogenic dystonias (MD) are conditions defined by muscles contractions causing impairment of motor activities. Due to the wide clinical and genetic spectrum, complexity and non-response rate due to factors such as classification, semiology, duration and aetiology, MD are considered as rare diseases with scarce synthesized evidence. Deep brain stimulation (DBS) is an effective treatment for dystonias using different brain targets. However, there are no large studies addressing DBS in specific MD.

OBJECTIVES
To describe how the Andalusian Health Technology Assessment Area methodologically supports the ERN for Rare Neurological Diseases (ERN-RND) in conducting a systematic review (SR) to synthetize the evidence to develop a clinical consensus statement for the efficacy of DBS as new therapeutic option for MD.

METHODS
The process carried out through SR consists of well-defined steps: 1) previous scientific evidence review; 2) precise PICO questions; 3) comprehensive literature searches; 4) studies screening; and 5) quality assessment of the evidence, to culminate in clinical consensus.

RESULTS
A preliminary bibliographic search performed in MEDLINE identified 529 results. The genetic confirmation of MD in the patients, 3 months of follow-up after the surgery, DBS as intervention strategy and movement scales to evaluate the clinical improvement were stablished as main inclusion criteria for data evaluation.

DISCUSSION FOR SCIENTIFIC ABSTRACTS
SRs are an essential methodology for reviewing the available scientific evidence and addressing the health-care needs of patients. It is expected that the findings offer valuable insights for researchers and clinicians in their decision-making process to improve the management of MD.

Paper Number

131

Biography

Postdoctoral researcher at the Andalusian Health Technology Assessment Area of the Regional Ministry of Health and families in Seville, Spain. I have a PhD in Pharmacology and Physiology and a specialization in Evaluation of Medicines and Health Technologies. Currently, I am working as methodologist supporting the development of clinical documents on rare diseases in the European context, and Health Technologies Reports and Clinical Practice Guidelines in the Spanish framework.
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Dr João Pedro Lima
PhD Candidate
Mcmaster University

Our experiences identifying fabricated or falsified trials in a systematic review and parallel clinical practice guideline

5:32 PM - 5:36 PM

Abstract

Background:
Fabricated or falsified research can distort evidence syntheses and compromise guideline recommendations. However, existing tools to assess risk of bias and certainty of evidence fail to capture these issues. The Trustworthiness in RAndomised Controlled Trials (TRACT) checklist aims to identify trials at high risk of fabrication, falsification or serious methodological errors.

Objective:
To share our experiences using the TRACT checklist to identify untrustworthy trials in the context of a systematic review and parallel clinical practice guideline addressing strategies for managing long COVID.

Methods:
Pairs of reviewers independently applied the TRACT checklist to assess each trial for signs of fabrication, falsification, or major errors that could seriously undermine their conclusions. The authorship group subsequently reviewed all trials flagged for concerns and identified those that they considered untrustworthy. We excluded untrustworthy trials from primary analyses but included them in sensitivity analyses.

Results:
Our review identified 24 eligible trials, of which six (25%) raised integrity concerns, including retrospective registration (2 trials; 33.3%), improbably large benefits (2 trials; 33.3%), unusually small variability in baseline/outcome data (4 trials; 66.7%), highly similar trial arms inconsistent with randomization (3 trials; 50%), and registration not reflecting study design (1 trials; 16.7%).

Conclusions:
Neglecting to consider issues related to research integrity would have produced different conclusions and recommendations about the efficacy and safety of eight unique interventions. We recommend guideline developers consider issues related to research integrity when reviewing evidence to formulate recommendations.

Paper Number

398

Biography

Dr. Lima is a physician-researcher and PhD student specializing in evidence synthesis and guideline development at McMaster University. His research focuses on the methodological challenges of evaluating treatment effects, with a strong emphasis on the GRADE framework to ensure trustworthy clinical practice guidelines. He has first-authored influential educational papers on assessing evidence quality and applicability, garnering significant readership and citations. Dr. Lima has led high-impact systematic reviews, including a network meta-analysis on pediatric analgesics, recently published in JAMA Pediatrics. His expertise contributed to the development of rigorous, evidence-based recommendations across multiple medical disciplines, ensuring the highest standards of clinical decision-making.

Chair

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Dr Lorenzo Moja
World Health Organization

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