Vol 72, No 1 (2022)
Guidelines / Expert consensus
Published online: 2022-02-09

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Consensus on methods of development of clinical practice guidelines in oncology under the auspices of Maria Sklodowska-Curie National Research Institute of Oncology and the Agency for Health Technology Assessment and Tariff System

Jan Walewski1, Dominik Dziurda2, Mariusz Bidziński3, Barbara Bobek-Bilewicz4, Marek Dedecjus5, Iwona Hus6, Beata Jagielska7, Jacek Jassem8, Andrzej Kawecki9, Dariusz Kowalski10, Magdalena Krasztel2, Maciej Krzakowski11, Tomasz Kubiatowski12, Piotr Potemski1314, Radosław Mądry15, Piotr Rutkowski16, Anna Rychert2, Janusz Ryś17, Krzysztof Składowski18, Rafał Tarnawski4, Hanna Tchórzewska-Korba19, Andrzej Tysarowski20, Piotr J. Wysocki21, Roman Topór-Mądry2
Nowotwory. Journal of Oncology 2022;72(1):44-50.

Abstract

Introduction.As the changes leading to improvement of cancer care in Poland have shown the need to introduce clinical practice guidelines into the health care system, it has become clear that no methodological standard of the process for guidelines preparation has been established so far. The following process aims to present a unified and comprehensive clinical practice guidelines (CPGs) development methodology.

Materials and methods.A review of globally recognised methods used by guideline development groups was prepared, informing the discussion during three plenary meetings and extensive consultations in writing. The resulting document was unanimously approved by a group of 24 methodologists and clinical experts, and has been formally recognized as a standard for CPGs development by the management of the National Institute of Oncology and the Agency for Health Technology Assessment and Tariff System.

Results.Within the process, 43 recommendations were formulated to create unified and comprehensive rules for guideline development within the Polish healthcare system.

Conclusions.The presented methods are consistent with the globally recognized tools and methods of guideline development, such as GRADE and ADAPTE, and follow quality criteria described by AGREE II. The process supports the development of high-quality guidelines within a resource-constrained setting by allowing to choose between adoption, adaptation, or de novo development of either the whole document of guidelines or particular recommendations.

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References

  1. Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021; 71(3): 209–249.
  2. Hofmarcher T, Lindgren P, Wilking N, et al. The cost of cancer in Europe 2018. Eur J Cancer. 2020; 129: 41–49.
  3. Graham R. Institute of Medicine (U.S.), Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. National Academies Press, Washington 2011: xxxiv, 266.
  4. Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. The Global Rating Scale complements the AGREE II in advancing the quality of practice guidelines. J Clin Epidemiol. 2012; 65(5): 526–534.
  5. Leśniak W, Bała M, Jaeschke R, et al. Od danych naukowych do praktycznych zaleceń – tworzenie wytycznych według metodologii GRADE. Polish Archives of Internal Medicine. 2015; 125(Special Issue): 26–41.
  6. Agencja Oceny Technologii Medycznych i Taryfikacji. Metodyka opracowywania wytycznych praktyki klinicznej w onkologii. Opracowanie przygotowane w ramach projektu „Wsparcie procesu poprawy jakości w leczeniu onkologicznym oraz zmiana organizacji systemu opieki zdrowotnej w zakresie onkologii. Material not published 2020.
  7. The ADAPTE Collaboration. The ADAPTE Process: Resource Toolkit for Guideline Adaptation. Version 2.02009.
  8. Schünemann HJ, Wiercioch W, Brozek J, et al. GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: GRADE-ADOLOPMENT. J Clin Epidemiol. 2017; 81: 101–110.
  9. European Society for Medical Oncology. Standard Operating Procedures (SOPs) for Authors and templates for ESMO Clinical Practice Guidelines (CPGs) and ESMO-MCBS Scores 2021. https://www.esmo.org/content/download/77789/1426712/file/ESMO-Clinical-Practice-Guidelines-Standard-Operating-Procedures.pdf.
  10. The National Comprehensive Cancer Network. About the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 2020. https://www.nccn.org/professionals/default.aspx.
  11. Rychert A, Dziurda D, Koperny M, et al. Systems for grading the strength of recommendations in clinical practice guidelines in oncology. Material not published .
  12. Yao X, Ma J, Wang Qi, et al. A Comparison of AGREE and RIGHT: which Clinical Practice Guideline Reporting Checklist Should Be Followed by Guideline Developers? J Gen Intern Med. 2020; 35(3): 894–898.
  13. Guyatt GH, Oxman AD, Vist GE, et al. GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336(7650): 924–926.
  14. Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014; 186(3): E123–E142.



Nowotwory. Journal of Oncology