9.7 - Theme 5. A Unified Framework for Health Decision-Making and Informing Research
Friday, September 19, 2025 |
9:15 AM - 10:45 AM |
Speaker
Lena Fischer
Brandenburg Medical School
Methods for the Development and Integration of Patient Decision Aids in the Context of Clinical Practice Guidelines: A Scoping Review
Abstract
Background. Patient decision aids (PDAs) support shared decision-making (SDM) by facilitating discussions between healthcare professionals and patients. However, their development is complex and resource-intensive. Linking the development processes of PDAs and clinical practice guidelines (CPGs) may improve efficiency and ensure consistency in the use of evidence.
Objective. To review methods for developing and integrating PDAs in the context of CPGs.
Methods. We conducted a scoping review by searching bibliographic databases (PubMed, Embase; until December 2023), grey literature, and reference lists, as well as consulting experts to identify relevant literature on methods for developing guideline-based PDAs and linking them to CPGs. Two reviewers independently selected eligible reports. Findings were synthesized narratively.
Results. We included 24 reports describing multiple methodological approaches, categorized into four key topics: (1) selecting CPG recommendations where PDAs are most relevant, with uncertainty/variability in patient preferences and trade-offs between options being the most frequently mentioned selection factors; (2) developing guideline-based PDAs, such as forming a multidisciplinary development group that includes healthcare professionals and patient representatives, and updating CPGs and PDAs in parallel; (3) user testing PDAs iteratively and assessing PDA quality, with PDAs approved by relevant interest groups, including the CPG group; and (4) linking CPGs and PDAs, often using digital methods.
Discussion. Methods for developing and integrating PDAs in the context of CPGs are heterogeneous. More methodological guidance is needed for the linked development of CPGs and PDAs. Empirical testing is required to determine feasibility and usefulness of identified methods.
Objective. To review methods for developing and integrating PDAs in the context of CPGs.
Methods. We conducted a scoping review by searching bibliographic databases (PubMed, Embase; until December 2023), grey literature, and reference lists, as well as consulting experts to identify relevant literature on methods for developing guideline-based PDAs and linking them to CPGs. Two reviewers independently selected eligible reports. Findings were synthesized narratively.
Results. We included 24 reports describing multiple methodological approaches, categorized into four key topics: (1) selecting CPG recommendations where PDAs are most relevant, with uncertainty/variability in patient preferences and trade-offs between options being the most frequently mentioned selection factors; (2) developing guideline-based PDAs, such as forming a multidisciplinary development group that includes healthcare professionals and patient representatives, and updating CPGs and PDAs in parallel; (3) user testing PDAs iteratively and assessing PDA quality, with PDAs approved by relevant interest groups, including the CPG group; and (4) linking CPGs and PDAs, often using digital methods.
Discussion. Methods for developing and integrating PDAs in the context of CPGs are heterogeneous. More methodological guidance is needed for the linked development of CPGs and PDAs. Empirical testing is required to determine feasibility and usefulness of identified methods.
Paper Number
142
Biography
Lena Fischer holds a double master's degree in Health Economics (University of Cologne, Germany) and Healthcare, Policy, Innovation and Management (University of Maastricht, The Netherlands) and has a keen interest in person-centered and evidence-based healthcare. Since 2023, she has been working as a health scientist on a multi-stage project aimed at developing a tool to support guideline developers in systematically identifying and prioritizing guideline recommendations where shared decision-making is most relevant.
Dr Hamed Movahed
Iran
Student
McMaster University
Thresholds Applied in Certainty Ratings Using the GRADE Approach: A Systematic Survey of Systematic Reviews
Abstract
Background: Systematic review authors using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework establish thresholds to assess certainty of evidence. There are currently debates among GRADE leaders about the relative merits of the use of the available thresholds and in particular about the merits of using the null as a threshold.
Objectives: To investigate (1) how frequently systematic reviews applying GRADE have identifiable thresholds for certainty ratings; (2) the specific thresholds applied; and (3) in instances where the threshold is the null, how often point estimates are close to the null threshold, requiring a shift to the minimally important difference threshold.
Methods: We are performing a systematic survey of Cochrane and non-Cochrane systematic reviews published from 2018 onwards. Eligible reviews are those in English that assess the certainty of evidence using the GRADE approach and include a summary of findings table. We are sampling the 200 most recent eligible Cochrane reviews and 200 most recent eligible non-Cochrane reviews. Sampling will be repeated until we have collected at least 100 Cochrane and 100 non-Cochrane systematic reviews that have identifiable thresholds of certainty or until we have exhausted the available reviews.
Results: This ongoing systematic review is expected to be completed by May 2025.
Discussion: This systematic survey will offer insights into the current use of GRADE, addressing ongoing debates about the null as a threshold and drawing attention from systematic review authors, methodologists, health researchers, decision-makers, and guideline developers.
Objectives: To investigate (1) how frequently systematic reviews applying GRADE have identifiable thresholds for certainty ratings; (2) the specific thresholds applied; and (3) in instances where the threshold is the null, how often point estimates are close to the null threshold, requiring a shift to the minimally important difference threshold.
Methods: We are performing a systematic survey of Cochrane and non-Cochrane systematic reviews published from 2018 onwards. Eligible reviews are those in English that assess the certainty of evidence using the GRADE approach and include a summary of findings table. We are sampling the 200 most recent eligible Cochrane reviews and 200 most recent eligible non-Cochrane reviews. Sampling will be repeated until we have collected at least 100 Cochrane and 100 non-Cochrane systematic reviews that have identifiable thresholds of certainty or until we have exhausted the available reviews.
Results: This ongoing systematic review is expected to be completed by May 2025.
Discussion: This systematic survey will offer insights into the current use of GRADE, addressing ongoing debates about the null as a threshold and drawing attention from systematic review authors, methodologists, health researchers, decision-makers, and guideline developers.
Paper Number
505
Biography
I am a medical graduate and a licensed general practitioner in Iran. Currently, I am an MSc student and an incoming PhD student in Health Research Methodology at McMaster University, Canada. My research focuses on evidence-based medicine, particularly assessing the certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach, as well as guideline development.
Ass Prof Andrea Darzi
Assistant Professor
Mcmaster University
Consolidation and Systematic Appraisal of Guideline Recommendations for Management of Chronic Pain: A Digital Chronic Pain Recommendation Map
Abstract
Background:
Chronic pain affects 1 in 5 people; however, management remains suboptimal. There is an urgent need to improve concordance between evidence and practice.
Objectives:
To develop and mobilize a digital chronic pain recommendation map (RecMap) for opioids, cannabis, and interventional procedures.
Methods:
This project consists of three phases. Planning phase: We engaged diverse interest-holders to co-design an efficient team structure and workflow. Development phase: We systematically searched databases and websites for eligible guidelines since 2019. Pairs of reviewers are appraising guideline quality using AGREE II and AGREE REX. Next steps include extracting data (including equity considerations) and analyzing divergent recommendations. We will develop plain-language recommendations and decision-aids for trustworthy recommendations, in French, Spanish, and Mandarin. Mobilization phase: We will co-create dissemination strategies with diverse interest-holders, including those disproportionately affected by chronic pain.
Results:
We identified 210 guidelines eligible for review, and tailored RecMap interfaces for researchers, healthcare professionals, individuals with lived experience, and policymakers. The researcher interface includes an interactive map of guidelines, recommendations, and research priorities, supporting gap identification and guideline adaptation. The clinician interface provides trustworthy recommendations, divergence assessments, decision aids, and implementation considerations. The patient portal offers plain-language summaries, decision aids, and explanatory videos. A policymaker interface is in development. The project is ongoing, with additional findings expected by GIN 2025.
Discussion:
The RecMap will improve guideline transparency, promote trustworthy recommendations for chronic pain, and enhance evidence-based shared decision making.
Chronic pain affects 1 in 5 people; however, management remains suboptimal. There is an urgent need to improve concordance between evidence and practice.
Objectives:
To develop and mobilize a digital chronic pain recommendation map (RecMap) for opioids, cannabis, and interventional procedures.
Methods:
This project consists of three phases. Planning phase: We engaged diverse interest-holders to co-design an efficient team structure and workflow. Development phase: We systematically searched databases and websites for eligible guidelines since 2019. Pairs of reviewers are appraising guideline quality using AGREE II and AGREE REX. Next steps include extracting data (including equity considerations) and analyzing divergent recommendations. We will develop plain-language recommendations and decision-aids for trustworthy recommendations, in French, Spanish, and Mandarin. Mobilization phase: We will co-create dissemination strategies with diverse interest-holders, including those disproportionately affected by chronic pain.
Results:
We identified 210 guidelines eligible for review, and tailored RecMap interfaces for researchers, healthcare professionals, individuals with lived experience, and policymakers. The researcher interface includes an interactive map of guidelines, recommendations, and research priorities, supporting gap identification and guideline adaptation. The clinician interface provides trustworthy recommendations, divergence assessments, decision aids, and implementation considerations. The patient portal offers plain-language summaries, decision aids, and explanatory videos. A policymaker interface is in development. The project is ongoing, with additional findings expected by GIN 2025.
Discussion:
The RecMap will improve guideline transparency, promote trustworthy recommendations for chronic pain, and enhance evidence-based shared decision making.
Paper Number
290
Biography
Andrea is an Assistant Professor in the Departments of HEI and Anesthesia at McMaster University. She serves as an Associate Convenor of the Cochrane Equity Thematic Group and leads the Equity in Guidelines and Implementation Tools working group. Also, she is an active member of GRADE. Her research focuses on guideline development and knowledge mobilization and the advancement of their methodologies. Her content focus is mainly in Chronic pain and conditions. Currently, she is the Nominated Principal Investigator for the CIHR-funded Chronic Pain Recommendation Map.
Monia Marchetti
MD
SIE, AOUAL, UPO
Successful strategies for implementing GRADE in 18 hematology guidelines.
Abstract
Background.
Evidence-based clinical practice guidelines (ECPG) are essential tools for improving health-care quality and efficiency and for ranking research priorities. Diagnostic and therapeutic options for blood diseases are rapidly expanding, therefore new and updated ECPG are particularly compelling. GRADE is a robust and transparent method for developing ECPGs, but requires fine processing of the domains and the clinical questions.
Goals.
To analyze the specific strategies conceived to overcome GRADE-related hurdles in the completion of 18 ECPGs focused on hematology disorders.
Methods.
18 ECPGs (8 ones fully published and 10 ones ongoing) were targeted. The key GRADE hurdles were highlighted in each ECPG and the hurdle-solving strategies were described. A classification was proposed.
Results.
Overall 36 different hurdles were listed and solving strategies were specifically described and commented. The most frequently reported hurdle was GRADE-based management of "which patients?" questions. Breakdown of the population into different sub-PICOs was the most frequently adopted strategy. However, systematic ranking and selection of population features with a relevant decisional impact was also a successful strategy. The second most frequently faced hurdle was the comparison among "multiple therapeutic options". The most successful strategy for this hurdle was breakdown of the domain (e.g. iso-intensity therapies) in order to face only pairwise comparisons at each time.
Conclusions.
Adaptation of the GRADE framework to hematology requires fine tuning of the solutions to specific hurdles. Therefore, PICOs and hurdle-solving strategies should be shared by devoted portals: their appropriate framing and diffusion is expected to enhance future ECPG completion time.
Evidence-based clinical practice guidelines (ECPG) are essential tools for improving health-care quality and efficiency and for ranking research priorities. Diagnostic and therapeutic options for blood diseases are rapidly expanding, therefore new and updated ECPG are particularly compelling. GRADE is a robust and transparent method for developing ECPGs, but requires fine processing of the domains and the clinical questions.
Goals.
To analyze the specific strategies conceived to overcome GRADE-related hurdles in the completion of 18 ECPGs focused on hematology disorders.
Methods.
18 ECPGs (8 ones fully published and 10 ones ongoing) were targeted. The key GRADE hurdles were highlighted in each ECPG and the hurdle-solving strategies were described. A classification was proposed.
Results.
Overall 36 different hurdles were listed and solving strategies were specifically described and commented. The most frequently reported hurdle was GRADE-based management of "which patients?" questions. Breakdown of the population into different sub-PICOs was the most frequently adopted strategy. However, systematic ranking and selection of population features with a relevant decisional impact was also a successful strategy. The second most frequently faced hurdle was the comparison among "multiple therapeutic options". The most successful strategy for this hurdle was breakdown of the domain (e.g. iso-intensity therapies) in order to face only pairwise comparisons at each time.
Conclusions.
Adaptation of the GRADE framework to hematology requires fine tuning of the solutions to specific hurdles. Therefore, PICOs and hurdle-solving strategies should be shared by devoted portals: their appropriate framing and diffusion is expected to enhance future ECPG completion time.
Paper Number
217
Biography
Senior hematologist (h-index 41) with long-standing expertise in EBM and HTA.
Ms Jean Ryan
Senior Programme Manager
National Institute For Health And Care Excellence (NICE)
Deliberation in Action: Towards a cohesive cross-sectoral approach to NICE guidance methods and process development
Abstract
Background:
The UK’s National Institute for Health and Care Excellence (NICE) produces various types of guidance using different decision-making contexts and methodologies. This includes Technology Appraisals (mandatory guidance for the National Health Service [NHS] to make funding available for cost-effective interventions) and advisory guideline recommendations (advice on choice of effective and cost-effective treatment options). NICE is bringing its guidance together by topic to improve accessibility and usability. Initial consultation on interim methods and processes highlighted stakeholder concerns and challenges.
Objective:
To facilitate participatory engagement and open dialogue across a diverse stakeholder landscape, to foster a shared understanding of goals and challenges while establishing robust processes for governance and informed decision-making.
Methods:
An inclusive deliberative approach, based on best practice, was used to identify areas for methods and process development. An advisory stakeholder panel, representing key groups, was established to support the deliberative process. Meetings were structured to balance timeliness with a thorough review of evidence, methods, and processes while ensuring open and meaningful dialogue.
Results:
From April 2025, the panel will meet regularly to provide a framework for critically evaluating complex issues. The deliberative process will foster open dialogue to support decision-making based on an understanding of evidence, methods and processes, divergent stakeholder values and perspectives, and context-specific considerations.
Discussion:
Aligning NICE’s methods and processes to support the bringing together of our guidance will improve their usability, support uptake, and enhance patient outcomes while optimising NHS resources. Stakeholder engagement in methods development ensures diverse perspectives, resolves conflicts, and strengthens decision-making.
The UK’s National Institute for Health and Care Excellence (NICE) produces various types of guidance using different decision-making contexts and methodologies. This includes Technology Appraisals (mandatory guidance for the National Health Service [NHS] to make funding available for cost-effective interventions) and advisory guideline recommendations (advice on choice of effective and cost-effective treatment options). NICE is bringing its guidance together by topic to improve accessibility and usability. Initial consultation on interim methods and processes highlighted stakeholder concerns and challenges.
Objective:
To facilitate participatory engagement and open dialogue across a diverse stakeholder landscape, to foster a shared understanding of goals and challenges while establishing robust processes for governance and informed decision-making.
Methods:
An inclusive deliberative approach, based on best practice, was used to identify areas for methods and process development. An advisory stakeholder panel, representing key groups, was established to support the deliberative process. Meetings were structured to balance timeliness with a thorough review of evidence, methods, and processes while ensuring open and meaningful dialogue.
Results:
From April 2025, the panel will meet regularly to provide a framework for critically evaluating complex issues. The deliberative process will foster open dialogue to support decision-making based on an understanding of evidence, methods and processes, divergent stakeholder values and perspectives, and context-specific considerations.
Discussion:
Aligning NICE’s methods and processes to support the bringing together of our guidance will improve their usability, support uptake, and enhance patient outcomes while optimising NHS resources. Stakeholder engagement in methods development ensures diverse perspectives, resolves conflicts, and strengthens decision-making.
Paper Number
271
Biography
Jean Ryan is the Senior Programme Manager of the Methods and Economics team at NICE. An information scientist by background, she has held diverse roles in medical education, clinical trials research, and management across the NHS, academia, and NICE. She has extensive experience in change management, stakeholder engagement, public involvement and research governance. Jean is particularly interested in improving processes, facilitating collaboration, and driving continuous quality improvement to enhance the impact of health and care guidance.
Celeste Naude
South Africa
Stellenbosch University
“Closing the framework loop”: using a WHO guideline process as the foundation to develop a research priority agenda and six core outcome sets for wasting and nutritional oedema
Abstract
Background: The Steering Committee and methodologists for the 2023 WHO guideline on prevention and management of wasting and nutritional oedema in children, along with the Guideline Development Group (GDG), identified extensive evidence gaps during guideline development. We also experienced challenges around a lack of standardization of outcome measurement and reporting.
Objective: To develop a research priority agenda and six core outcome sets (COS) for wasting and nutritional oedema in infants and children, building on outputs and knowledge gained while developing the 2023 WHO guideline.
Methods: We are leading the development of a research priority agenda using a systematic Child Health and Nutrition Research Initiative (CHNRI) exercise. The consolidated list of research needs that emerged from GDG discussions over the three-year guideline development process is the starting point, expediting the initial priority-setting phase. We also developed six COS through a Delphi process; the prioritized outcomes for the 16 guideline questions across four populations and topics in the 2023 WHO guideline were the basis, enabling COS completion in six months.
Results: Primary research, future guideline updates, and related decision-making stand to be strengthened by the research priority agenda and the six COS for effectiveness trials on wasting and nutritional oedema, which build on the 2023 WHO guideline.
Discussion: Leveraging efforts, processes and outputs from guideline development to inform research priority-setting and COS development is enabling guideline development to not only yield recommendations, but to also “close the loop” in the unified framework by improving research for a better decision-making ecosystem.
Objective: To develop a research priority agenda and six core outcome sets (COS) for wasting and nutritional oedema in infants and children, building on outputs and knowledge gained while developing the 2023 WHO guideline.
Methods: We are leading the development of a research priority agenda using a systematic Child Health and Nutrition Research Initiative (CHNRI) exercise. The consolidated list of research needs that emerged from GDG discussions over the three-year guideline development process is the starting point, expediting the initial priority-setting phase. We also developed six COS through a Delphi process; the prioritized outcomes for the 16 guideline questions across four populations and topics in the 2023 WHO guideline were the basis, enabling COS completion in six months.
Results: Primary research, future guideline updates, and related decision-making stand to be strengthened by the research priority agenda and the six COS for effectiveness trials on wasting and nutritional oedema, which build on the 2023 WHO guideline.
Discussion: Leveraging efforts, processes and outputs from guideline development to inform research priority-setting and COS development is enabling guideline development to not only yield recommendations, but to also “close the loop” in the unified framework by improving research for a better decision-making ecosystem.
Paper Number
237
Biography
Dr. Allison Daniel is a Consultant in the Department of Nutrition and Food Safety at World Health Organization. She was involved in the WHO guideline for prevention and management of wasting and nutritional oedema and is now working on research priorities and other activities linked to the guideline. She holds a PhD in Nutritional Sciences with a Collaborative Specialization in Global Health from the University of Toronto. Her research has focused on developmental and nutritional outcomes in children with severe wasting and nutritional oedema.
