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Assessing the trustworthiness of health guidelines recommendations: the transparent, rigorous, useable, standardized, and trustworthy guide (TRUSTGUIDES) tools development

  • TRUSTGUIDES Collaborative
  • Humanitas University
  • IRCCS Istituto Clinico Humanitas - Rozzano (Milano)
  • McMaster University
  • Pontificia Universidad Católica de Chile
  • American University of Beirut
  • University of Porto
  • Université Paris 13
  • University of Galway
  • Lancaster University
  • Johns Hopkins University
  • Department of Epidemiology Lazio Regional Health Service
  • IRCCS Istituto di ricerche farmacologiche Mario Negri - Milano, Bergamo, Ranica
  • University of Milan - Bicocca
  • IRCCS Fondazione Don Carlo Gnocchi - Milano
  • Research Institute of the Santa Creu i Sant Pau Hospital
  • Computable Publishing LLC
  • University of Kansas
  • Bamenda
  • Jagiellonian University Medical College
  • Adelaide University
  • World Health Organization
  • Monash University
  • Istituto Superiore di Sanita
  • Lund University
  • University of Milan
  • University of Pennsylvania
  • Annals of Internal Medicine
  • National Evidence-based Healthcare Collaborating Agency
  • Royal College of Surgeons in Ireland
  • University of Minnesota Twin Cities
  • University of Ottawa
  • University of Toronto
  • Beijing University of Chinese Medicine
  • Erasmus University Rotterdam
  • Provincial Agency for Health of the Autonomous Province of Trento
  • Cochrane Austria University for Continuing Education Krems Krems Austria
  • RTI International
  • Institute of Health Information and Statistics of the Czech Republic
  • South African Medical Research Council
  • Amsterdam University Medical Center
  • Amsterdam UMC
  • University of Freiburg
  • Cochrane Germany Foundation

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original languageEnglish
Article number112348
JournalJournal of Clinical Epidemiology
Volume197
DOIs
StatePublished - Sep 2026

Keywords

  • Automation
  • Conflict of interest
  • Decision-making
  • GRADE
  • Guidelines
  • Healthcare
  • Recommendations
  • Trustworthiness

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