TY - JOUR
T1 - Assessing the trustworthiness of health guidelines recommendations
T2 - the transparent, rigorous, useable, standardized, and trustworthy guide (TRUSTGUIDES) tools development
AU - TRUSTGUIDES Collaborative
AU - Arienti, Chiara
AU - Neumann, Ignacio
AU - Akl, Elie A.
AU - Pinto, Bernardo Sousa
AU - Cruz, Manuel Marques
AU - Boutron, Isabelle
AU - Devane, Declan
AU - Whaley, Paul
AU - Parmelli, Elena
AU - Saulle, Rosella
AU - Cinquini, Michela
AU - Lazzarini, Stefano Giuseppe
AU - Wiercioch, Wojtek
AU - Alonso-Coello, Pablo
AU - Alper, Brian S.
AU - Azzam, Muayad
AU - Awah, Noella
AU - Bala, Malgorzata M.
AU - Barker, Timothy Hugh
AU - Bartolomeos, Kidist Kebede
AU - Bognanni, Antonio
AU - Brennan, Sue S.
AU - Bruno, Velia
AU - Bruschettini, Matteo
AU - Capobussi, Matteo
AU - Carrasco-Labra, Alonso
AU - Chang, Stephanie
AU - Choi, Miyoung
AU - Clyne, Barbara
AU - Coclite, Daniela
AU - Cruciani, Fabio
AU - Cuello, Carlos
AU - Dahm, Philip
AU - Darzi, Andrea J.
AU - Dewidar, Omar
AU - Fei, Yutong
AU - Feller, Daniel
AU - Gartlehner, Gerald
AU - Germini, Federico
AU - Glick, Michael
AU - Gonzalez-Lorenzo, Marien
AU - Hassan, Cesare
AU - Khan, Haya
AU - Klugar, Miloslav
AU - Kredo, Tamara
AU - Langendam, Miranda
AU - Liang, Changhao
AU - Meerpohl, Joerg
AU - Minozzi, Silvia
AU - Xia, Jun
N1 - Publisher Copyright:
Copyright © 2026. Published by Elsevier Inc.
PY - 2026/9
Y1 - 2026/9
N2 - Background and Objectives Health guidelines play a central role in informing clinical practice, public health measures and health policy. But their trustworthiness may be undermined by factors such as insufficient methodological rigor, lack of transparency, conflicts of interest, and inconsistent application of established standards. Existing appraisal tools address selected aspects of guideline quality but do not comprehensively assess the trustworthiness of individual recommendations, nor do they adequately reflect recent advances in guideline methodology, including living guidelines, Grading of Recommendations, Assessment, Development, and Evaluation, adaptation, and the use of artificial intelligence (AI). This study aims to develop and validate Transparent, Rigorous, Useable, Standardized, and Trustworthy Guide (TRUSTGUIDES), a globally applicable, flexible set of tools to assess the trustworthiness of health guideline recommendations. We define trustworthiness as distinct from methodological quality: it encompasses not only rigorous methods but also transparency, independence, and applicability, which together determine whether a recommendation merits user confidence. Methods TRUSTGUIDES will be developed through a multistep, mixed-methods process. First, a scoping review and expert consultation will identify existing guideline appraisal tools and inform domains and items generation. Using deductive and inductive approaches, domains and items will be generated and may be refined through focus groups and selected through iterative Delphi surveys involving an international, multidisciplinary working group. TRUSTGUIDES will be validated by assessing internal consistency, inter-rater reliability, content validity, and construct validity, including comparisons with established instruments such as the Grading of Recommendations, Assessment, Development, and Evaluation certainty domains, AGREE II, and PANELVIEW. Psychometric properties will be examined using factor analysis and, as necessary, item response theory models. AI will be integrated both as an object of assessment and as methodological support for tool application, with large language models evaluated against a human reference standard. Conclusion TRUSTGUIDES will be designed to evaluate the trustworthiness of individual guideline recommendations across key factors, including transparency and credibility, and to address relevant domains such as the certainty of evidence, strength of recommendations, conflicts of interest, applicability, adaptability, currency, certification, and the appropriate use of AI. TRUSTGUIDES addresses critical gaps in current guideline appraisal by offering a comprehensive, recommendation-level assessment of trustworthiness aligned with the World Health Organization guideline standard methodology. By integrating AI, our tools will support efficient, transparent, and future-ready guideline evaluation within an evolving health evidence ecosystem.
AB - Background and Objectives Health guidelines play a central role in informing clinical practice, public health measures and health policy. But their trustworthiness may be undermined by factors such as insufficient methodological rigor, lack of transparency, conflicts of interest, and inconsistent application of established standards. Existing appraisal tools address selected aspects of guideline quality but do not comprehensively assess the trustworthiness of individual recommendations, nor do they adequately reflect recent advances in guideline methodology, including living guidelines, Grading of Recommendations, Assessment, Development, and Evaluation, adaptation, and the use of artificial intelligence (AI). This study aims to develop and validate Transparent, Rigorous, Useable, Standardized, and Trustworthy Guide (TRUSTGUIDES), a globally applicable, flexible set of tools to assess the trustworthiness of health guideline recommendations. We define trustworthiness as distinct from methodological quality: it encompasses not only rigorous methods but also transparency, independence, and applicability, which together determine whether a recommendation merits user confidence. Methods TRUSTGUIDES will be developed through a multistep, mixed-methods process. First, a scoping review and expert consultation will identify existing guideline appraisal tools and inform domains and items generation. Using deductive and inductive approaches, domains and items will be generated and may be refined through focus groups and selected through iterative Delphi surveys involving an international, multidisciplinary working group. TRUSTGUIDES will be validated by assessing internal consistency, inter-rater reliability, content validity, and construct validity, including comparisons with established instruments such as the Grading of Recommendations, Assessment, Development, and Evaluation certainty domains, AGREE II, and PANELVIEW. Psychometric properties will be examined using factor analysis and, as necessary, item response theory models. AI will be integrated both as an object of assessment and as methodological support for tool application, with large language models evaluated against a human reference standard. Conclusion TRUSTGUIDES will be designed to evaluate the trustworthiness of individual guideline recommendations across key factors, including transparency and credibility, and to address relevant domains such as the certainty of evidence, strength of recommendations, conflicts of interest, applicability, adaptability, currency, certification, and the appropriate use of AI. TRUSTGUIDES addresses critical gaps in current guideline appraisal by offering a comprehensive, recommendation-level assessment of trustworthiness aligned with the World Health Organization guideline standard methodology. By integrating AI, our tools will support efficient, transparent, and future-ready guideline evaluation within an evolving health evidence ecosystem.
KW - Automation
KW - Conflict of interest
KW - Decision-making
KW - GRADE
KW - Guidelines
KW - Healthcare
KW - Recommendations
KW - Trustworthiness
UR - https://www.scopus.com/pages/publications/105042557193
U2 - 10.1016/j.jclinepi.2026.112348
DO - 10.1016/j.jclinepi.2026.112348
M3 - Article
C2 - 42203175
AN - SCOPUS:105042557193
SN - 0895-4356
VL - 197
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
M1 - 112348
ER -