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

Thursday, September 18, 2025
1:15 PM - 2:15 PM

Speaker

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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

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.
Mrs Thais Piazza de Melo
Conitec

Guideline implementation strategies: an update on the evidence

Abstract

Background: The implementation of clinical practice guidelines (CPG) has been a challenge in health care and requires the development of strategies to reduce the know-do gap. An overview carefully evaluated studies published up to the beginning of 2019 on this topic, but since then new evidence has been published.
Objective: To analyze CPG implementation strategies published as of 2019 in scientific literature.
Methods: An overview to identify systematic reviews (SR) that evaluated CPG implementation strategies and published between 08/10/2019 and 08/28/2024 was conducted. Structured research was conducted in four databases and the same criteria used in the previously published overview were followed. After screening the records, the characteristics of the studies and implementation strategies were extracted.
Results: Of the 2886 records retrieved, seven SR were included. One SR was published in 2019, three in 2020 and three in 2024. Two SR focused on CPG implementation strategies in specific professional areas (dental care and nursing), three in specific clinical areas (cancer, knee osteoarthritis and pain/delirium) and two in general clinical areas. The Effective Practice and Organization of Care (EPOC) was the most used taxonomy to categorize strategies (n=3), followed by the Mazza (n=2), Expert Recommendations for Implementing Change (ERIC) (n=1) and Mindspace framework (n=1). Several implementation strategies were described, among them the educational strategies for healthcare workers (supporting materials, meetings and others) were observed in all studies.
Discussion: The new findings provide evidence of CPG implementation strategies that can be adapted by different stakeholders and healthcare settings.

Paper Number

297

Biography

Pharmacist. Has a master's degree and PhD in Public Health. Works at Conitec.
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Miss Zijun Wang
CHINA
Lanzhou University

Multimorbidity and guideline-based decision making: a semi-structured interview study

Abstract

Background The implementation of guidelines in multimorbidity care poses significant challenges. With limited multimorbidity guidelines, managing such patients often requires applying multiple disease-focused guidelines together, which may result in potential disease and drug interactions adversely impacting patient health.
Objective We aimed to collect and analyze the opinions of key experts on what should be considered when using guidelines to treat or manage multimorbid patients, and to further promote the appropriate implementation of guidelines.
Methods From September 2024 to February 2025, we invited experts in multimorbidity research and practice and guideline development to participate in our interview. Interviewees were selected using purposive non-systematic selection. Subject analysis using Nvivo 12 software was employed to summarize the findings.
Results We interviewed fifteen experts from nine countries. The lack of multimorbidity guidelines and the inapplicability of single-disease guidelines may lead healthcare providers to either rely solely on personal experience or rigidly follow guidelines without considering the needs of individual patients. Major barriers to guideline application include insufficient evidence and limited awareness and training among clinicians in both multimorbidity management and guideline implementation. The interviewees emphasized flexible use of guidelines, prioritizing patient values and preferences, and individualized management goals informed by (rather than strictly adhering to) guidelines.
Discussion for scientific abstracts This interview study highlights significant challenges in applying guidelines to multimorbidity care. Flexible guideline use, comprehensive assessment of the patient’s situation, and prioritizing patient preferences are critical. Future efforts should focus on generating robust multimorbidity evidence and developing decision support tools.

Paper Number

246

Biography

Zijun Wang, from the Evidence-Based Medicine Centre, School of Basic Medical Sciences, Lanzhou University, China. She is a PhD candidate, majoring in evidence-based medicine and guideline development methodology. Now she is working on a project related to guideline and multimorbidity practice.
Yang Song

A rapid review of stated requirements for national guideline adaptation programs

Abstract

Background: Guideline adaptation modifies or adopts existing guidelines for local, regional, or national contexts. Despite numerous frameworks, their application varies, and no unified guidance exists for national adaptation programs.
Objective: To identify key requirements for establishing and implementing national guideline adaptation programs, focusing on structures, processes, capacities, and resources.
Methods: A rapid scoping review was conducted using searches in MEDLINE, EMBASE, Google, guideline organization websites, and literature references. Key terms included "guideline," "recommendation," and "adapt." We included empirical and non-empirical studies on national adaptation programs focused on modifying nationally or internationally developed guidelines. The review covers adaptation handbooks, frameworks, methodologies, experiences, and challenges. Content analysis summarized findings.
Results: Thirty-four documents (2011–2024) were included, 17 on adaptation frameworks and 17 on methodology for establishing guideline adaptation programs. Thirteen studies focused on Low- and Middle-Income Countries (LMICs), while five focused on High-Income Countries (HICs), and five on broader regions, such as the Eastern Mediterranean. Four key thematic areas emerged: (1) structured governance, planning, and collaboration with clear timelines and transparency; (2) systematic allocation of financial, technological, human, and infrastructure resources; (3) stepwise adaptation processes and context-tailored framework utilization; (4) strategic implementation, monitoring, evaluation, and updates. Each thematic area includes several subthemes.
Discussion for scientific abstracts: National guideline adaptation programs need clear structures, resources, and processes to adapt international guidelines to local contexts. There is a gap in identifying these requirements, highlighting the need for structured guidance to establish and implement effective adaptation programs.

Paper Number

341

Biography

Dr Wang Qi holds a Ph.D. in Health Policy (Politics) from McMaster University, along with a Master of Medicine (Integrated Western and Chinese Medicine) and a Bachelor of Medicine (Anesthesiology) from Lanzhou University, China. Dr Wang is the Secretariat Head for the RIGHT Collaboration, member of the GRADE Working Group and Cochrane. Her research focuses on evidence-informed decision-making in health systems, evidence synthesis methodologies, and health guidelines. Dr Wang has published 80 papers. She has contributed to over 10 national and international practice guidelines and participated in over 40 projects, including WHO guideline implementation, and Cochrane Reviews.
Dr Madeline Flanagan
Monash University

Research Integrity in Guidelines and evIDence synthesis (RIGID): a framework for assessing research integrity in guideline development and evidence synthesis

Abstract

Background: Clinical guidelines must be underpinned by sound evidence to inform patient care. Despite rising research integrity concerns, there are no processes for assessing evidence integrity in guideline development.

Objective: In response to this crucial gap, we developed the Research Integrity in Guidelines and evIDence synthesis (RIGID) framework, an innovative and transparent six-step approach, with a central integrity committee.

Methods: Co-developed with international input from 80 multidisciplinary experts, and consumers, the RIGID framework follows six key steps: (1) Review processes are adopted, in line with approved evidence synthesis methodologies; (2) Exclude studies which have been retracted, and note those with expressions of concern for further evaluation; (3) Assess remaining studies for integrity using an appropriate tool and allocate an initial integrity risk rating (low, moderate, high); (4) Discuss assessment results among integrity committee members with votes to determine final study integrity risk ratings; (5) Establish contact with authors for clarification of studies ranked as moderate or high risk; (6) Reassess studies for inclusion using the RIGID author response algorithm.

Findings: An illustrative case study demonstrates how RIGID was successfully implemented in an influential international guideline endorsed by 39 societies across six continents. Here, 45 of the 101 eligible studies (45%) were not included in the guideline due to integrity concerns. The RIGID framework has since been successfully implemented in two further guidelines in women's health.

Discussion: Based on the latest literature and international expertise, the RIGID framework represents an important advancement in best practice standards for guideline development.

Paper Number

79

Biography

Madeline Flanagan is a medical doctor and PhD student at Monash University, Australia. Her research interests include data integrity and individual participant data meta-analysis.
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Mr Robert Kunkle
Director, Clinical Quality Improvement Programs
American Society of Hematology

A Simple Approach To Reduce Administrative Burden and Avoid Inter-Panel Resentment About Unfair Standards When Managing Financial Conflicts of Interest During Guideline Development

Abstract

Background
Many developers require a majority of a guideline panel to have zero financial conflicts of interest. This approach has two disadvantages: First, scrupulous collection and review of sometimes trivial financial disclosures creates high administrative burden. Second, use of two standards (a stringent one for an “unconflicted” majority, and an unlimited one for a “conflicted” minority) generates resentment about unfairness. From 2020 to 2025, the American Society of Hematology (ASH) implemented a new conflict of interest policy that includes a simple rule: All participants on an ASH guideline panel must avoid direct financial payments from for-profit healthcare companies > $X per year, considering all payments for all activities in aggregate per year regardless of relevance to the guideline topic. From 2020 through 2022, X was set at $5,000 (USD); from 2023 through 2025, at $7,500.

Objective
Assess compliance with new policy

Methods
The proportion of individuals willing to adhere to the policy and the proportion who actually adhered were retrospectively assessed.

Results
From 2020 to 2025, 1,606 individuals were nominated (or self-nominated) for 12 ASH panels; of these, 789 completed a vetting survey assessing eligibility. In the survey, 80% agreed they could adhere to the policy (122 for X = $5,000; 667 for X = $7,500). Of the 271 appointed to a panel, 99% actually adhered; 4 were dismissed because they were unable to adhere.

Discussion
Using an aggregate annual threshold reduced the administrative burden of judging the relevance of direct financial relationships and avoided inter-panel resentment about unfairness.

Paper Number

368

Biography

Mr. Kunkle oversees quality improvement programs including guideline development for the American Society of Hematology.
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Ms Heather Travis
Science Manager
McMaster University/Cochrane Canada

Canadian Guidelines for Post COVID-19 Condition (CAN-PCC): Country-Wide Knowledge Mobilization Initiatives to Disseminate Long COVID Guidelines Among Health Professionals

Abstract

Background: Post COVID-19 Condition (PCC), or long COVID, has affected over 3.5 million adults across Canada. In response to this, over 80 evidence-based clinical recommendations were created as part of the Canadian Guidelines for PCC. Several knowledge mobilization (KM) activities were implemented with the aim of making the guidelines accessible to multidisciplinary health professionals across Canada.

Objective: To target health professionals to build awareness, share knowledge, and inform decision-making about PCC recommendations through a co-designed and centrally coordinated KM strategy.

Methods: Four projects from Canadian institutions were selected through a review process to raise awareness and implement the guidelines to health professionals through different activities. Through national KM committee meetings, investigators were able to centrally coordinate, collaborate, and monitor progress. A framework was developed by our committee to ensure process or health outcomes were achieved. The impact of the KM initiatives targeting health professionals will be evaluated using frameworks including the RE-AIM, Moore’s, and GRADE FACE framework.

Results: Educational activities were implemented for health professionals across Canada. These included 10 CME-accredited webinars offered through the University of Saskatchewan; a training program for 153 internationally trained health professionals offered by the EBM Connect Canada network; and a Continuing Professional Development course on strategies for PCC management led by Université de Sherbrooke/McGill University. Recommendations were also disseminated through infographics, conferences, an EMR, and newsletters with a database of over 2000 subscribers.

Discussion: Results of the evaluation, including barriers and opportunities, will inform and strengthen guideline dissemination in Canada and internationally.

Paper Number

380

Biography

Ashley Motilall is a Research Coordinator for Cochrane Canada in the Health Research Methods, Evidence and Impact (HEI) Department of McMaster University. Ashley has been instrumental in organizing the WHO TB Recommendations Map (RecMap) and coordinating the development of plain language recommendations for the COVID-19 RecMap. Her primary research interest is knowledge mobilization. Ashley aims to further her work in knowledge mobilization by bridging the gap between research and practice and making clinical guidelines more accessible to diverse interest holders.
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Ms Winnie Hui Dhing Ong
AGENCY FOR CARE EFFECTIVENESS

Mapping the use of clinical guidelines by policymakers: insights and implications

Abstract

Background: The Agency for Care Effectiveness (ACE) oversees the development of national-level clinical guidelines (known as ACE Clinical Guidances) within the Ministry of Health, Singapore. While policymakers can propose topics for these guidelines, how they apply the guidelines remains unclear.

Objective: To identify how policymakers apply ACE Clinical Guidances and its implications for guideline development and implementation.

Methods: The team conducted nine informal in-person conversations with representatives from six divisions or entities. This approach was chosen over formal interviews or surveys due to existing collegial relationships. A flexible topic guide was used, and field notes were compiled post-conversation. Document analysis was undertaken to triangulate the findings.

Results: Guideline application varied based on policymakers’ remits, target audiences, and current priorities or policy challenges. Four key applications were identified:
1. Informing decision-making (e.g. expanding disease coverage)
2. Serving as enablers within national strategies (e.g. enhancing capability of service providers)
3. Supporting programme implementation through incorporation of guideline content into clinical materials and operational handbooks
4. Providing authoritative references for enquiries on clinical management

Discussion for scientific abstracts: As hypothesised, guideline applications reflect the diverse nature of policy work. While the guidelines’ evidence-to-decision (EtD) framework cannot pre-empt all policy considerations, effort should be made to assess policy implications early and transparently balance them with other EtD factors. Timely policy engagement, from scoping to guideline panel discussions, increases understanding of potential applications and can inform evidence reviews. Synergies for guideline implementation could be explored for topics linked to national strategies or programmes.

Paper Number

45

Biography

Winnie Ong is a guideline developer at the Agency for Care Effectiveness, Ministry of Health Singapore. She has worked closely with national-level expert committees across a range of topics, from cardiovascular health to mental health. In this role, she also supports training initiatives locally to improve the efficiency and quality of clinical guidelines.
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Dr Beatrice Downing
University Of Bristol

Statistical approaches: how useful are they for increasing trust in results from evidence synthesis?

Abstract

Background: Evidence syntheses have been widely adopted in guideline development and can be crucial in bringing together a large volume of evidence. However, when aggregating information, there can be concerns about the credibility of the results, such as reliance on potentially biased results, conflicting results between different studies or a concern that the estimate from evidence synthesis may not reflect the true treatment effect for the population of interest.
There are several statistical methods that have been developed to identify, understand, and account for variation in clinical effectiveness estimates due to (i) potentially biased evidence (bias-adjustment and threshold analysis to assess the potential impact of individual RCTs on the final decision); (ii) differences between studies comparing the same treatments (subgroup analyses and (network) meta-regression); and (ii) discrepancies between direct and indirect estimates in networks of evidence (inconsistency-checking).
Statisticians can suggest the analytical approaches, but are these helpful for policy makers, clinicians, patient representatives and commissioners to build trust in the results, and what measures would increase trust?
Objective: to explore acceptability of statistical methods to increase credibility in clinical effectiveness estimates from evidence synthesis, discuss stakeholder concerns, and potential measures to increase trust.
Format: introduction to the issues, methods, and examples (10-15 minutes), followed by small-group discussions focussed on examples from guidelines (30 minutes) facilitated by workshop organisers, with a summary at the end (10 minutes). Participants would be invited to share their roles in the guideline process so that the table discussions include viewpoints from different perspectives.

Paper Number

504

Biography

Dr Bea Downing is the Statistician and Scientific Coordinator for the Technical Support Unit to NICE Guidelines at the University of Bristol. She works on methods for combining evidence to inform decision-making in guidelines.
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Linan Zeng
CHENGDU
West China Second University Hospital

Rating certainty when the target threshold is minimally important difference (MID) and the point estimate is close to the MID

Abstract

Background
When GRADE users initially choose the MID as a threshold, if the point estimate falls close to the MID, they will face two challenges. The first is that rating certainty that the true effect is important or unimportant when the underlying true effect is near the MID is misleading. The second challenge is that when the confidence interval is very narrow but crosses the MID threshold rating down for imprecision becomes counterintuitive.

Objectives
In this workshop, we will discuss how GRADE users should proceed when they have chosen the MID as a threshold - and therefore plan to rate certainty in an important or unimportant effect - and the point estimate proves to be close to the MID.

Format
The workshop will comprise four sections: (1) A short presentation will introduce the problem in deciding the target of certainty rating when GRADE users initially target a MID threshold (i.e., interested in whether an important or unimportant effect is present). (2) Using a worked example, workshop leads will introduce a possible solution. (3) In the following discussions, participants will, given examples from real systematic reviews, work together to discuss what it is in which the participants will rate their certainty (i.e, how to decide the target of certainty rating when the point estimate is close to the MID). (4) In the final feedback and summary, workshop leads will summarize some take home messages.

Paper Number

163

Biography

Dr. linan zeng is a professor at West China Second University Hospital, Sichuan University, specializing in evidence-based pharmacy. In 2013, she was a visiting scholar at the University of Nebraska Medical Center. In 2019, she conducted postdoctoral research at McMaster University, Canada, contributing to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group’s methodology research. She also participated in the development of rapid guidelines for The British Medical Journal (BMJ). Her research focuses on integrating evidence-based approaches to enhance clinical pharmacy practice and pharmaceutical policy development.
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Ms Nashia Ali Rizvi
Pakistani
Manager
Aga Khan University

Modification of the GRADE Adolopment method to adapt clinical practice guidelines for LMICs

Abstract

Background:
The adoption of international guidelines in LMICs presents significant challenges, primarily due to resource constraints that hinder their implementation. Conversely, creating new ones is difficult due to limited high-quality evidence. This highlights the need for innovative approaches to bridge global standards with local realities for evidence-based, relevant guidelines.
Objective: Create contextually relevant CPGs through modified Adolopment process.
Methods:
To address this gap, the Centre for Clinical Best Practices (CCBP) was established in 2020 at Aga Khan University, Pakistan. Recognizing the need for a structured, evidence-based, and context-sensitive approach to guideline development, CCBP collaborated with the US GRADE Network to modify the GRADE Adolopment method.
The modified method begins with selecting a source guideline (SG) through the AGREE II tool and expert consensus, recommendations from the SG (including their level of evidence) are than extracted into a Table of Recommendations (TOR), followed by three columns: adopt, adapt and exclude. An expert panel reviews each recommendation, either adopting as is, excluding, or adapting recommendations based on local relevance. Adaptations with contextual changes are created using EtD tables in the GRADEPro software.
Results: 135 common disease conditions in the country were identified through a priority-setting exercise and ICD coding to ensure the CPGs were locally relevant. The innovative use of TORs streamlined the decision-making process for reviewers by focusing efforts on recommendations which were adapted, enabling a systematic and efficient approach. While the lack of local level 1 evidence was a limitation, CCBP successfully filled the gap by producing locally applicable CPGs.

Paper Number

477

Biography

Dr. Nashia Ali Rizvi is a healthcare professional working in evidence-based clinical guideline development and adaptation at the Center for Clinical Best Practices - at the Aga Khan University- aiming to standardize healthcare practices in Pakistan. Dr. Rizvi collaborates with both local and international partners to enhance healthcare quality. With a focus on improving patient care and clinical practices and health outcomes, Dr. Rizvi is keen on pursuing a PhD in guideline development, furthering her contribution to healthcare advancements and academic excellence.
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Dr Gonzalo Bravo-Soto
Health Research Methodology PhD student
McMaster University

Understanding the determinants of the development and implementation of evidence-based practice guidelines during health emergencies: A qualitative phase of an exploratory sequential mixed-methods study

Abstract

Background: The COVID-19 pandemic highlighted the role of evidence-based practice guidelines (EBPGs). We are conducting an exploratory sequential mixed-methods study to understand the determinants (barriers and facilitators) for developing and implementing EBPG during health emergencies. Phase I is a qualitative descriptive study.

Objective: To identify the determinants of the development and implementation of EBPGs during health emergencies.

Methods: We are using a purposeful maximum variation sampling. We are including individuals who participated in any stage of EBPG relevant to COVID-19, including guideline developers or implementers. Using this approach, our sample size estimation is 50. For data collection, we created an interview guide and we will conduct and transcribe semi-structured individual interviews. For data analysis and interpretation, we will use a deductive (using CFIR constructs, a framework for implementation science) and inductive approach with three steps: (1) initial set of codes; (2) consensus codebook; and (3) organizing codes and themes. All team members will engage reflexivity on their perspectives and experiences to enhance rigour, specifically data credibility and dependability. Additionally, we will strengthen data credibility through data source and researcher triangulation, data dependability using multiple coders, maintain an audit trail, and transferability by providing detailed description of contexts.

Results: This project is currently in progress. We have received provisional ethics approval and are now finalizing remaining details to obtain full approval to begin interviews. During the GIN Conference, we will present our findings.

Discussion for scientific abstracts: Potential impact includes improving future health emergency preparedness and enhancing guideline development and implementation.

Paper Number

110

Biography

Gonzalo Bravo is a medical doctor from Chile, PhD student in Health Research Methodology at McMaster University, and a research assistant at the Michael G. DeGroote National Pain Center. My research interests include systematic reviews, guidelines, qualitative studies, and mixed-methods studies.
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Prof Joseph L Mathew
INDIA
Professor
P.G.I.M.E.R Chandigarh

The Zero-Budget Model to Build Trust in Evidence-based Guideline Development Projects.

Abstract

Background
Evidence-based guideline development is resource-intensive; hence guideline-developers often (inadvertently or deliberately) receive support from diverse interest-holders. This erodes trust in the process and product of such efforts.

Objective
This presentation summarizes a unique experiment of developing evidence-based guidelines with a zero-budget, to restore confidence amongst the end-users.

Methods
The experiment comprised a zero-budget guideline-development process, relying on the personal commitment of a group of healthcare professionals with no conflicts of interest. Capacity and capability were built through online training workshops during weekends. A learning-by-doing approach was adopted under the mentorship of the Chairperson

Contemporary guideline methodology steps were followed (viz. outlining the scope & purpose of the guideline, framing PICO questions, formal evidence synthesis, GRADE-ing evidence, transforming evidence-to-decisions, and drafting recommendations). In addition, several refinements to enhance efficiency were adopted. At every stage, a focus on contextual local relevance was maintained.


Results
The experiment yielded the world’s first methodologically-robust, evidence-based guideline for the management of Allergic BronchoPulmonary Aspergillosis in children. A second guideline on pediatric empyema is nearing completion. Other salient outcomes included capacity-building of a critical-mass of physicians in guideline methodology, significant financial savings, and enthusing guideline users about the feasibility of zero-budget evidence-based guideline development. End-user surveys confirmed that appreciation for the absence of funding from interested actors.
This model can be emulated in other resource-constrained settings, although long-term sustainability needs to be explored.

Conclusion
This unique zero-budget guideline development model emphasizes efficiency, economy, and excellence; and can be emulated in diverse resource-constrained settings.

Paper Number

178

Biography

Dr. Mathew is an active member of GIN since 2010. He served as a member of the Board of Trustees for two terms (2019-21, 2021-23), the Founder Chair of the GIN LMIC) Working Group (2015-2021, and Chair of the GIN Membership Committee (2019-21). He is a founding member of the South Asian Cochrane Network Centre (currently Cochrane India Network). Dr. Mathew’s main focus is the translation of research evidence to health-care practice in developing countries. He has recently developed a unique model of creating evidence-based clinical practice guidelines, without external funding; which can be emulated in diverse resource-constrained settings.
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Thomas Langer
Deputy Guideline Program Manager
German Cancer Society

Impact of retracted studies on oncological guidelines: A German perspective

Abstract

Background
Retraction of scientific studies is a critical process for maintaining the integrity of the scientific literature. Studies may be retracted due to errors, ethical issues, or falsified data. Since retracted studies can continue to be cited in subsequent research and guidelines, it is essential to evaluate their impact on clinical recommendations.

Objectives
This study investigates the impact of retracted studies on the guidelines of the German Guideline Program in Oncology (GGPO).

Methods
Using Extraction Watch, we identified retracted studies in the GGPO database by matching PMIDs or titles. For matching titles, we assessed identity via Levenshtein distance. If a match for a retracted study was found, the following information was collected: title, author, year, reasons for retraction, name of the guideline, and type of content (recommendation, text, table).

Results
As of January 16th, the GGPO contained 34 guidelines with 59,719 cited publications. Of these, 51 studies (0.0085%) were identified as retracted. The most common causes of retraction were "withdrawn (out of date)" (n=28), "removed" (n=13), "retract and replace" (n=10), and "unreliable results" (n=6). Eighteen of the 51 retracted studies were cited as the basis for recommendations.

Discussion
Our study demonstrates that a semi-automatic check for withdrawn studies can be implemented. The results reveal a marginal impact of retracted studies on oncological guidelines in Germany. Nevertheless, the review of withdrawn studies should be established as part of quality assurance in guideline development.

Paper Number

478

Biography

Thomas Langer is a deputy manager of German Guideline Program in Oncology (GGPO), which is supported by the German Cancer Society, the Association of the Scientific Medical Societies (AWMF) and German Cancer Aid. His tasks include organizational and methodological advice, supervision and support of the guideline groups as well as the methodological, organizational and technological development of the program. In this function, he was mainly responsible for developing a digital guideline format of the GGPO-guidelines and supervised the development of applications based on it.
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Prof Maria X. Rojas
Senior Researcher
Ir Sant Pau

Developing Clinical Practice Guidelines in Rare Diseases: The example of CVD related GLILD Diagnosis Guideline

Abstract

Background: The European Reference Network (ERN) aims to improve the care of patients with rare immunological disorders. In 2023, it supported the development of guidelines for a set of rare diseases, including the granulomatous-lymphocytic interstitial lung disease (GLILD) related to common variable immunodeficiency disorders (CVID), the development of which was overseen by SESCS.
Objective: To develop trustworthy recommendations for diagnosing of CVID and GLILD, using the best available evidence and GRADE-guided processes to address priority questions in rare diseases.
Methods: Once the questions to be addressed in the guideline were prioritized, a highly sensitive search was conducted with no restrictions on study design or publication year. Two researchers reviewed all records, classifying them according to treatment, diagnosis, and follow-up questions, as well as evidence informing other aspects of the EtD (e.g., patient values, economic impact). A survey was conducted in advance ammong the panel to obtain information from primary data. Additionally, efforts were made to generate "health outcomes descriptors." Two panel members were assigned to work on questions and were responsible for supporting the technical team.

Results: Prioritized diagnostic questions were initially addressed to develop the Diagnosis Guideline. The results of evidence identification and the process followed to develop the recommendations are presented. The challenges of addressing gaps in evidence and the lack of validity are discussed.
Conclusions: The strengths and pitfalls of approaches suggested by GRADE members are evaluated. The experience highlights the need for improved research, particularly the implementation of a common registry in this field.

Paper Number

507

Biography

Dr. Rojas is a clinical epidemiologist with over 25 years of experience as a professor, researcher, methodologist, and advisor. Her recent research focuses on optimizing research use in healthcare, particularly in knowledge translation (KT) and health outcomes research. She is an active member of GRADE, Cochrane, ISPOR, EuroQoL, and G-I-N. Since 2020, Dr. Rojas has led the Living Evidence to Inform Health Decisions Program, helping HTA agencies and guideline groups integrate emerging research and real-world evidence into evidence synthesis for KT products. She is also methodological advisor for HTA agencies in Spain and a consultant for WHO and European entities
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