Critical quality assessment of the WHO Tuberculosis Guidelines 2025 using the AGREE II instrument
DOI:
https://doi.org/10.16921/pfr.v10i3.388Keywords:
clinical practice guideline; tuberculosis; AGREE II; methodological quality; inter-rater reliability; evidence-based medicine; World Health OrganizationAbstract
Objective: To assess the methodological quality of the WHO Consolidated Guidelines on Tuberculosis (Module 4: Treatment and Care, 2025) using the AGREE II instrument.
Methods: A descriptive cross-sectional methodological appraisal was conducted. Three independent raters (JWAI, JMPV, JCCO), certified experts in the AGREE II instrument, scored all 23 items on a 7-point Likert scale. Scaled domain scores were calculated according to the official AGREE II formula, along with descriptive statistics (mean, standard deviation, range) and inter-rater reliability using Fleiss’ kappa coefficient.
Results: The clinical practice guideline (CPG) demonstrated high methodological quality. Mean scaled scores were: Domain 1: Scope and Purpose, 100.0% (SD=0.0); Domain 2: Stakeholder Involvement, 88.89% (SD=6.43); Domain 3: Rigor of Development, 95.14% (SD=4.17); Domain 4: Clarity of Presentation, 100.0% (SD=0.0); Domain 5: Applicability, 80.56% (SD=6.29); Domain 6: Editorial Independence, 91.67% (SD=14.43). Overall inter-rater reliability was good (Fleiss’ kappa κ=0.65). Significant discrepancies were observed in Item 14 (Update procedure, κ=0.35) and Item 22 (Funder influence, κ=0.18, rated as “poor”). The overall quality rating was 7/7, unanimous, with a majority recommending use without modifications (2/3 raters).
Conclusions: The WHO TB 2025 CPG represents a gold standard for international clinical practice guideline development. Its methodological rigor (95.14%), editorial transparency (91.67%), and clarity of presentation (100.0%) make it highly reliable for global practice. Improvement areas include integrating implementation tools (Domain 5: 80.56%) and clarifying prospective update procedures. Discrepancies in Editorial Independence (Domain 6) highlight interpretive ambiguity in AGREE II regarding how to assess funder independence when documentation is implicit rather than explicit.
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References
Lv H, Wang L, Zhang X, Dang C, Liu F, Zhang X, et al. Further analysis of tuberculosis in eight high-burden countries based on the Global Burden of Disease Study 2021 data. Infect Dis Poverty. 2024 Sep 30;13(1):70.
Nahid P, Mase SR, Migliori GB, Sotgiu G, Bothamley GH, Brozek JL, et al. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline. Am J Respir Crit Care Med. 2019 Nov 15;200(10):e93–142.
Dartois VA, Rubin EJ. Anti-tuberculosis treatment strategies and drug development: challenges and priorities. Nat Rev Microbiol. 2022 Nov 27;20(11):685–701.
Nakkazi E. New TB drug could increase treatment success with shorter regime. Nature Africa. 2022 Dec 4;
Sarkies MN, Jones LK, Gidding SS, Watts GF. Improving clinical practice guidelines with implementation science. Nat Rev Cardiol. 2022 Jan 19;19(1):3–4.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. Can Med Assoc J. 2010 Dec 14;182(18):E839–42.
WHO consolidated guidelines on tuberculosis. Module 4: Treatment and care. Geneva; 2025.
Maes-Carballo M, García-García M, Martín-Díaz M, Estrada-López CR, Iglesias-Álvarez A, Filigrana-Valle CM, et al. A comprehensive systematic review of colorectal cancer screening clinical practices guidelines and consensus statements. Br J Cancer. 2023 Apr 6;128(6):946–57.
Hoffmann-Eßer W, Siering U, Neugebauer EAM, Brockhaus AC, Lampert U, Eikermann M. Guideline appraisal with AGREE II: Systematic review of the current evidence on how users handle the 2 overall assessments. PLoS One. 2017 Mar 30;12(3):e0174831.
Hoffmann-Eßer W, Siering U, Neugebauer EAM, Brockhaus AC, McGauran N, Eikermann M. Guideline appraisal with AGREE II: online survey of the potential influence of AGREE II items on overall assessment of guideline quality and recommendation for use. BMC Health Serv Res. 2018 Dec 27;18(1):143.
Brożek JL, Akl EA, Alonso‐Coello P, Lang D, Jaeschke R, Williams JW, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines. Allergy. 2009 May;64(5):669–77.
Gallardo CR, Rigau D, Irfan A, Ferrer A, Caylà JA, Bonfill X, et al. Quality of tuberculosis guidelines: urgent need for improvement. Int J Tuberc Lung Dis. 2010;14(9):1191–1198.
Huang T, Chen Q, Wu G, Tang S. Interpretation of the World Health Organization consolidated guidelines on tuberculosis Module 4: treatment and care (2025 Edition). Chinese Journal of Tuberculosis and Respiratory Diseases. 2025 Aug 12;48(8):708–18.
