Header image

2.7 - Theme 5. A Unified Framework for Health Decision-Making and Informing Research

Wednesday, September 17, 2025
11:30 AM - 1:00 PM
Kapa

Speaker

Agenda Item Image
Dr Bernadette van Glansbeek - Schutijser
SKILZ

Translation and Adaptation of the PANELVIEW Questionnaire for Dutch Guideline Development Processes

Abstract

Background
The PANELVIEW-questionnaire is a valuable tool for evaluating the guideline development process from the perspective of the guideline development group. Insights from the PANELVIEW-questionnaire help guideline developers improve and refine their processes. While the questionnaire is currently validated in English, Spanish, and German, a Dutch translation would provide added value. SKILZ, a Dutch foundation for long-term care guidelines, is adapting the PANELVIEW-questionnaire to enhance guideline development in the Netherlands.

Objective
To translate and adapt the PANELVIEW-questionnaire from English into Dutch, while ensuring cultural and linguistic alignment.

Methods
Following ISPOR’s Translation and Cultural Adaptation Good Practice Principles, we performed a forward translation by two independent guideline developers and ChatGPT and a backward translation by a native English speaker. After discussions, a draft version was completed. Two Delphi rounds followed: guideline developers reviewed the draft via a survey, and feedback was discussed in an online consensus meeting to finalize the questionnaire.

Results
The Dutch guideline development process differs from the approach outlined in the PANELVIEW-questionnaire. Cultural adaptations included translating ‘panel’ into ‘working group’ and ‘final panel meeting’ into ‘working group meeting in which considerations and recommendations were established’. The questionnaire was completed by 14 experts. Of the 34 items, 12 will be discussed during the consensus meeting. The final Dutch version will be completed in April 2025.

Discussion
This process highlights the importance of collaborative translation to ensure the tool is accurate and contextually relevant. Future validation of the PANELVIEW-questionnaire will further confirm its acceptability, validity and reliability.

Paper Number

25

Biography

Bernadette van Glansbeek - Schutijser is a nurse scientist. During and after her education as a nurse scientist, she worked many years as a research nurse. In 2015, she started her PhD about the safe administration of high-risk medication by nurses. After obtaining her PhD in 2021 she works as a guideline developer for SKILZ. She developed guidelines about oral care, selfmanagent support, and constipation.
Agenda Item Image
Dr Silvia Gianola
Project Officer
European Commission, Joint Research Centre, Ispra, Italy

The new integrated methodological framework for development of the European Commission Initiatives on cancer screening and care: introduction and focus on guidelines

Abstract

BACKGROUND AND OBJECTIVE
The 2022 update of the European Council's recommendation on cancer screening reaffirmed the crucial role of European guidelines and quality assurance schemes in ensuring evidence-based, cost-effective, and high-quality cancer screenings in the EU. Conscious of the importance of methodological alignment, the European Commission's Joint Research Centre reviewed its methodological framework to underpin ongoing and future cancer initiatives.

METHODS
Using the European Commission Initiative on Breast Cancer (ECIBC) experience as well as an independent expert evaluation of its methodology, gaps and areas of improvement were identified. A revised framework for guideline development, based on GRADE and its Evidence to Decision (EtD) frameworks, was proposed.

RESULTS
The new framework marks a significant shift towards integrated development of guidelines and quality assurance. Key innovations include a collaborative approach, featuring a single working group (WG) as the decision making body issuing guideline recommendations and quality requirements, supported by topic-specific groups (TSG) comprising WG representatives and external experts. The guideline development approach has incorporated enhanced methodologies like decision thresholds, quality indicators to monitor recommendations, and upfront prognostic reviews to inform risk-stratified recommendations.

DISCUSSION
The new framework aims at ensuring methodological consistency and rigour across the European Commission Initiatives on breast, colorectal, cervical, lung, prostate, and gastric cancer, and may serve as a blue-print to other efforts, including EU-funded projects on cancer and other non-communicable diseases.

Paper Number

345

Biography

I'm Silvia Gianola, I hold a PhD in Public Health in Milan and I have gained experience in clinical epidemiology, systematic review, and healthcare guidelines working with leading organizations, including the Istituto Superiore di Sanità in Rome and the International Agency for Research on Cancer. I've contributed to Cochrane and GRADE initiatives and recently I joined the Joint Research Center of the European Commission in Ispra, supporting cancer screening and prevention guideline development across the European Union. I'm excited to drive positive change in healthcare policy and practice.
Agenda Item Image
Miss  思念 Yueyan Li
CHINESE
Childrenʼs Hospital Of Chongqing Medical University

The use of indirect evidence in pediatric guidelines: a systematic review and bibliometric analysis

Abstract

Background
Pediatric clinical guidelines often rely on indirect evidence due to the limited availability of child-specific research, potentially compromising the reliability of recommendations. However, comprehensive analyses of indirect evidence utilization in pediatric guidelines remain scarce.
Objectives
To assess the prevalence, distribution, and characteristics of indirect evidence use in pediatric clinical practice guidelines.
Methods
We conducted a systematic search of MEDLINE (via PubMed), Web of Science, Embase, CNKI, Wanfang, and SinoMed for pediatric guidelines published between January 2022 and December 2024, supplemented by manual searches of guideline repositories. We included pediatric guidelines that used the GRADE system for grading evidence quality, featuring explicit recommendations and evidence summaries. Data extraction focused on indirect evidence prevalence, age-specific/disease-specific utilization patterns, consistency with previous indirectness evaluations, and GRADE application rigor.
Results
Among 93 eligible pediatric guidelines, encompassing 1020 clinical questions and 2009 recommendations, the total evidence base was 3468, of which 1482 were indirect. The proportion of indirect evidence use in pediatric guidelines was approximately 42.7%, with higher proportions in children (58.1%) and rare disease (60.2%) domains. Only 51.6% (n=48) of indirectness assessments aligned with established evaluation frameworks, highlighting discrepancies in evidence interpretation. GRADE implementation has demonstrated deficiencies in critical areas, including assessing individual studies rather than the body of evidence, and grading quality based merely on study type.
Conclusions
Indirect evidence constitutes a foundational component of pediatric guideline development, while our findings highlight the need for standardized approaches to evaluating and reporting indirect evidence in pediatric guidelines to ensure optimal clinical decision-making.

Paper Number

350

Biography

Yueyan Li is a Ph.D. candidate in Medical Informatics at the Children's Hospital of Chongqing Medical University and a member of the Chevidence Lab of Child and Adolescent Health research group, specializing in evidence-based pediatric medicine and the methodology of clinical practice guidelines. Has participated in the development of several clinical practice guidelines.
Agenda Item Image
Ms Jennifer Eeuwijk
Epidemiologist
P95

Exploring the use of patient journey modeling in defining health care professionals' roles and responsibilities

Abstract

Background: Evidence-based (EB) guidelines often include recommendations on roles and responsibilities (RR) of health care professionals, which are context-specific and not typically found in scientific literature. Alternative methods are needed to study RR, considering the preferences of patients and health care professionals.

Objective: To explore how the Patient Journey Modeling (PJM) can facilitate discussions on RR in EB guideline development.

Methods: A qualitative study design was employed, including individual interviews and a focus group discussion. A persona was created and tested in a guideline development process to provide guideline developers with an initial understanding of PJM's application.

Results: The study identified several benefits of using PJM in EB guideline development. PJM aids in understanding various stakeholders' perspectives, promotes equal participation among panel members, and helps professionals articulate their practice. Additionally, adjusted terminology in the guidelines enhances professionals' understanding and implementation. However, challenges include PJM being time-consuming, lacking a systematic creation method, and not being considered an evidence-based method, which can lower the guidelines' perceived value.

Discussion: This research provides insights into the potential benefits and challenges of PJM. The method could improve guideline development by integrating professionals' expertise with patients' needs and experiences. The method is promising and worth further exploration and testing in new projects.

Paper Number

129

Biography

Jennifer is an experienced epidemiologist with over 15 years of expertise in literature reviews, data synthesis and guideline development. She has contributed to nursing and paramedical guidelines and has extensive experience leading expert working groups and patient panels. As part of guideline development, she has also conducted qualitative research to identify and priortize the most urgent issues or obstacles, or find answers to the questions where peer-reviewed literature is missing.
Agenda Item Image
Prof Nicky Welton
University Of Bristol

Multi-treatment recommendations based on Network Meta-Analysis

Abstract

Background: Network Meta-Analysis (NMA) is used to synthesise evidence on multiple treatment options, delivering point estimates (Expected Values (EV)) of treatment effects to help decision-makers identify the best option. However, guidelines committees may wish to recommend multiple treatment options, and to take account of uncertainty in the estimates in their decision-making.
Objective: We aimed to propose a decision-rule that allows multiple treatments to be recommended, and to explore the impact of penalising uncertain estimates.
Methods: For multi-treatment recommendations, a two-stage process is proposed: first identify treatments superior to the reference treatment, and then identify treatments that are also within a Minimal Clinically Important Difference (MCID) of the best treatment. Basing recommendations on EV reflects a risk-neutral decision-maker. We introduce the Loss-adjusted EV (LaEV) to penalise uncertainty and reflect a risk-averse decision-maker. We illustrate the decision rules using 10 NMAs from past NICE Guidelines, and compare with the GRADE approach.
Results: In 10 NMAs from NICE guidelines, penalising uncertainty led to a lower number of treatments being recommended. Following the GRADE rules gave rise to anomalies. Among treatments that are superior to the reference, GRADE privileges the more uncertain ones, and in 3/10 cases GRADE failed to recommend the treatment with the highest EV or LaEV.
Discussion: A two-stage approach based on MCID ensures that EV- and LaEV-based rules recommend a clinically appropriate number of treatments. For a risk-averse decision maker, LaEV is conservative and simple to implement.

Paper Number

289

Biography

Nicky Welton is Professor of Statistical and Health Economic Modelling at the University of Bristol working on methodology for evidence synthesis and use of evidence in healthcare decision-making. She leads the Multi-Parameter Evidence Synthesis research group, is co-Director of the Guidelines Technical Support Unit for NICE, co-Director of the Bristol Technology Assessment Group, and was a member of NICE technology appraisals committee for 10 years. Nicky is associate editor for the journal Medical Decision Making and a Fellow of the Royal Statistical Society.
Agenda Item Image
Ass Prof Andrea Darzi
Assistant Professor
Mcmaster University

Chronic pain recommendation map project: a qualitative descriptive study about participants’ impressions of the online platform interfaces

Abstract

Background
One in five people globally experience chronic pain, yet management remains suboptimal, with conflicting guideline recommendations. To increase pain literacy and improve concordance between evidence and practice, we are developing a freely accessible digital Chronic Pain Recommendation Map (Chronic Pain RecMap) focusing on three areas: opioids, cannabis, and spine-related interventional procedures.

Objective
To test the RecMap interfaces mockups and information presentation by gathering participants' impressions in terms of design, usability, content relevance, and clarity to better align the platform with users’ expectations and needs.

Methods
We will collect participant feedback using a qualitative description approach and purposive sampling to recruit individual living with chronic pain, healthcare providers, researchers and policymakers. We determined a sample size of 20-30 participants based on information power. First, we will conduct focus groups with our interest holders to gather feedback and refine mockups. Then, we will carry out individual think-aloud testing through online semi-structured interviews with diverse stakeholders. We will analyze transcripts using qualitative content analysis and use findings from usability assessments to finalize content and visual updates before launching the RecMap. To ensure rigor, we will apply established qualitative descriptive techniques, including detailed data analysis, persistent observation, and method triangulation, transferability (thick data description), dependability and confirmability (transparent methods and peer review), and reflexivity.

Results
We are awaiting ethics approval and will have results in time for the conference.

Discussion
This project will identify areas for improvement in the RecMap, guiding interface adjustments to enhance usability and optimize information presentation for target users.

Paper Number

206

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.
Dr, Prof Reinhard Griebenow
European Cardiology Section Foundation

Evidence-informed language: impact on intentions to treat- results from an online survey

Abstract

Background
Current evidence suggests, that use of a large variety of linguistic expressions to differentiate between different strengths of recommendations in clinical practice guidelines lacks discriminative power.
Objective
Determine how a simplified 4 grade recommendation scheme translates into intentions to treat
Methods
Online, anonymous convenience sample survey in German speaking medical students and physicians, respectively. For each type of recommendation (strong positive- weak positive- weak negative- strong negative) respondents were asked to indicate either qualitatively (all/none- selected patients- only consider treatment) or quantitatively (from 0-100% of eligible patients on a visual analog scale) how they would translate them into intentions to treat.
Results
N=1081 physicians and n=539 medical students completed the survey.
Although 87% of respondents would treat “all” eligible patients in case of a “strong positive” recommendation, the others might treat only up to 50% (or less) of eligible patients.
Interpretation of weak recommendations showed a high variability, with no clear response pattern for intentions to treat. This applies in particular to a “weak positive” recommendation, where treatment rates of almost never to almost always were observed
Although 93% of respondents would not treat “any” patient in case of a “strong negative” recommendation, individual physicians would apply a harmful treatment in up to 25% of their patients.
Responses from physicians and medical students were largely comparable.
Discussion
These findings cast doubt on that linguistic means alone will lead to optimally targeted intentions to treat.

Paper Number

527
Agenda Item Image
Dr, Prof Thomas Piggott
Mcmaster University

Development and piloting of a checklist to assess EML application quality

Abstract

Background: The World Health Organization (WHO) Essential Medicines List (EML) serves as a vital global resource to guide the selection of essential medicines. However, the application process for new medicines has faced challenges related to completeness and quality of applications. To enhance the transparency and consistency of information submitted and available to the Expert Committee that drives decisions on applications, a structured checklist has been developed. This study aims to pilot and refine this checklist for assessing applications in the 2025 EML revision cycle.

Objective:

1. To pilot the checklist using five new EML applications.

2. To evaluate the completeness, quality, and selection criteria of new medicine applications.

3. To assess the checklist’s reliability in identifying strengths and weaknesses in applications.

4. To inform ongoing revisions to EML application procedures.

Methods: This prospective, descriptive study will assess all 2025 applications using the EML application checklist. Domains assessed include application completeness and quality drawing from other checklist/guidance and applied to the EML context. Two independent reviewers will conduct assessments, with discrepancies resolved through discussion. Data will be analyzed using descriptive statistics and qualitative thematic analysis.

Results: Findings will highlight common deficiencies in applications, inter-reviewer agreement levels, and trends across therapeutic areas. Refinements to the checklist will be proposed based on pilot testing results.

Discussion: This study will contribute to improving EML application processes by providing a validated checklist, enhancing application quality, and guiding WHO decision-making for essential medicine selection into the future.

Paper Number

310

Biography

Dr. Thomas Piggott is Medical Officer of Health/CEO with Peterborough Public Health and an assistant professor at McMaster University in the Department of Health Research Methods, Evidence, and Impact. His research focuses on health guideline methods.
Agenda Item Image
Joanne Khabsa
Lebanon
American University of Beirut

Developing recommendations about diagnostic tests and strategies: a survey of methodological guidance documents

Abstract

Background: The development and implementation of diagnostic tests play a crucial role in optimizing clinical decision-making and enhancing patient outcomes. Developing diagnostic guidelines requires the use of rigorous methodologies. However, it is unclear to what extent such methodologies have been incorporated in guideline handbooks.
Objective: To describe processes for developing recommendations about diagnostic tests and strategies as depicted in methodological guidance of guideline-producing organizations.
Methods: We compiled a comprehensive list of eligible organizations using different sources and retrieved their methodological guidance documents on guideline development. We abstracted information following the structure of the Guideline International Network (GIN)-McMaster Guideline Development Checklist, and abstracted information about risk of bias assessment.
Results: Of 130 guideline-producing organizations identified, 53 (41%) described processes for developing recommendations about diagnostic tests and strategies. Most of these organizations were professional (58%) and were at the national level (79%). The median number of topics for which of topics for which guidance specific to diagnostic tests and strategies was provided was 1 (range=1-5). The topics most frequently addressed were “judging the quality, strength, or certainty of evidence” (55%) and “question generation” (32%). Topics not addressed by any organization were “establishing guideline group processes”, “identifying target audience and topic selection”, “consumer and stakeholder involvement”, “conflict of interest considerations”, “dissemination and implementation” and “updating”. Twenty-six organizations (49%) addressed risk of bias assessment.
Discussion: A minority of guideline-producing organizations’ methodological guidance documents mention specific processes for developing recommendations for diagnostic tests and strategies, with more than half addressing assessing the certainty of evidence.

Paper Number

336

Biography

Ms. Joanne Khabsa is the coordinator of the AUB GRADE center. She is a pharmacist and holds a Master of Public Health with a concentration in Epidemiology and Biostatistics from AUB. Her research interests include conflict of interest, interest holder engagement, and methods of guideline development. She is a member of the Multi-Stakeholder Engagement (MuSE) in Guideline Development core team and an assistant convenor of the Cochrane Methods Equity group.

Chair

Kate Carroll

loading