Advertisement

A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations

Published:September 22, 2021DOI:https://doi.org/10.1016/j.jclinepi.2021.09.028

      Abstract

      Objective

      To propose a taxonomy and framework that identifies and presents actionable statements in guidelines.

      Study design and setting

      We took an iterative approach reviewing case studies of guidelines produced by the World Health Organization and the American Society of Hematology to develop an initial conceptual framework. We then tested it using randomly selected recommendations from published guidelines addressing COVID-19 from different organizations, evaluated its results, and refined it before retesting. The urgency and availability of evidence for development of these recommendations varied. We consulted with experts in research methodology and guideline developers to improve the final framework.

      Results

      The resulting taxonomy and framework distinguishes five types of actional statements: formal recommendations; research recommendations; good practice statements; implementation considerations, tools and tips; and informal recommendations. These statements should respond to a priori established criteria and require a clear structure and recognizable presentation in a guideline. Most importantly, this framework identifies informal recommendations that differ from formal recommendations by how they consider evidence and in their development process.

      Conclusion

      The identification, standardization and explicit labelling of actionable statements according to the framework may support guideline developers to create actionable statements with clear intent, avoid informal recommendations and improve their understanding and implementation by users.

      Key Words

      Abbreviations:

      TB (Tuberculosis), COVID-19 (Coronavirus Disease 2019), WHO-GTB (World Health Organization Global TB Programme), GRADE (Grading of Recommendations Assessment, Development and Evaluation), GDG (Guideline Development Group), GRC (Guideline Review Committee), NTP (National TB Programme), PICO (Population, Intervention, Comparator, Outcome), ASH (American Society of Haematology, PICO, Population Intervention Comparator Outcome(s)), NA (Not Applicable)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Clinical Epidemiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Cochrane Collaboration
        PICO Ontology.
        Cochrane Collaboration Linked Data. 2021; (https://linkeddata.cochrane.org/pico-ontology, [Accessed 30 May 2021])
        • Andrews J
        • Guyatt G
        • Oxman AD
        • Alderson P
        • Dahm P
        • Falck-Ytter Y
        • et al.
        GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations.
        J Clin Epidemiol. 2013; 66: 719-725
        • Alonso-Coello P
        • Oxman AD
        • Moberg J
        • Brignardello-Petersen R
        • Akl EA
        • Davoli M
        • et al.
        GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines.
        BMJ. 2016; 353: i2089
        • Alonso-Coello P
        • Schünemann HJ
        • Moberg J
        • Brignardello-Petersen R
        • Akl EA
        • Davoli M
        • et al.
        GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction.
        BMJ. 2016; 353: i2016
        • Qaseem A FF
        • Macbeth Fergus
        • Ollenschläger Phillips
        • S P vdW
        Guidelines international network: toward international standards for clinical practice guidelines.
        Ann Intern Med. 2011; 156: 525-531
        • Shekelle P
        • Woolf S
        • Grimshaw JM
        • Schunemann HJ
        • Eccles MP.
        Developing clinical practice guidelines: reviewing, reporting, and publishing guidelines; updating guidelines; and the emerging issues of enhancing guideline implementability and accounting for comorbid conditions in guideline development.
        Implement Sci.: IS. 2012; 7: 62
        • Schunemann HJ
        • Wiercioch W
        • Etxeandia I
        • Falavigna M
        • Santesso N
        • Mustafa R
        • et al.
        Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise.
        Can Med Assoc J. 2014; 186: E123-E142
        • Schunemann HJ
        • Best D
        • Vist G
        • Oxman AD
        • Group GW.
        Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations.
        Can Med Assoc J. 2003; 169 (CMAJ): 677-680
        • Oxman AD
        • Fretheim A
        • Schunemann HJ.
        Improving the use of research evidence in guideline development: introduction.
        Health Res Policy Syst. 2006; 4: 12
        • Guyatt GH
        • Alonso-Coello P
        • Schunemann HJ
        • Djulbegovic B
        • Nothacker M
        • Lange S
        • et al.
        Guideline panels should seldom make good practice statements: guidance from the GRADE Working Group.
        J Clin Epidemiol. 2016; 80: 3-7
        • Guyatt G
        • Oxman AD
        • Akl EA
        • Kunz R
        • Vist G
        • Brozek J
        • et al.
        GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.
        J Clin Epidemiol. 2011; 64: 383-394
        • Schunemann HJ
        • Wiercioch W
        • Brozek J
        • Etxeandia-Ikobaltzeta I
        • Mustafa RA
        • Manja V
        • 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
      1. World Health Organization. Available from: https://tuberculosis.evidenceprime.com/recommendation/WHO_CDS_TB_2020_72_9.

      2. World Health Organization.Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. 2009. Accessed on 30 May 2021.

      3. World Health Organization. WHO treatment guidelines for isoniazid-resistant tuberculosis: supplement to the WHO treatment guidelines for drug-resistant tuberculosis. 2018. Accessed on 30 May 2021.

        • Wiercioch W
        • Nieuwlaat R
        • Akl EA
        • Kunkle R
        • Alexander KE
        • Cuker A
        • et al.
        Methodology for the american society of hematology VTE guidelines: current best practice, innovations, and experiences.
        Blood Adv. 2020; 4: 2351-2365
      4. World Health Organization.
        WHO Handbook for guideline development: World Health Organization. 2014;
        • Izcovich A
        • Cuker A
        • Kunkle R
        • Neumann I
        • Panepinto J
        • Pai M
        • et al.
        A user guide to the American society of hematology clinical practice guidelines.
        Blood Adv. 2020; 4: 2095-2110
        • Monagle P
        • Cuello CA
        • Augustine C
        • Bonduel M
        • Brandao LR
        • Capman T
        • et al.
        American Society of hematology 2018 guidelines for management of venous thromboembolism: treatment of pediatric venous thromboembolism.
        Blood Adv. 2018; 2: 3292-3316
        • Christof C
        • Nussbaumer-Streit B
        • Gartlehner G.
        WHO Guidelines on Tuberculosis Infection Prevention and Control.
        Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)). 2020;
      5. World Health Organization Management of physical Health conditions in Adults with Severe mental disorders: WHO guidelines. World Health Organization. 2018. https://apps.who.int/iris/bitstream/handle/10665/275718/9789241550383-eng.pdf, [Accessed 30 May 2021].

      6. World Health Organization WHO policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. World Health Organization. 2012. https://apps.who.int/iris/bitstream/handle/10665/44789/9789241503006_eng.pdf?sequence=1, [Accessed 30 May 2021].

      7. World Health Organization. Automated real-time nucleic acidamplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB. World Health Organization 2013. Report No.: 9241506334. https://apps.who.int/iris/bitstream/handle/10665/112472/9789241506335_eng.pdf?sequence=1&isAllowed=y, [Accessed 30 May 2021].

      8. World Health Organization Treatment of tuberculosis: guidelines: World Health Organization. World Health Organization 2010. https://apps.who.int/iris/bitstream/handle/10665/44165/9789241547833_eng.pdf?sequence=1, [Accessed 30 May 2021].

        • Lotfi T
        • Stevens A
        • Akl EA
        • Falavigna M
        • Kredo T
        • Mathew JL
        • et al.
        Getting trustworthy guidelines into the hands of decision-makers and supporting their consideration of contextual factors for implementation globally: recommendation mapping of COVID-19 guidelines.
        J Clin Epidemiol. 2021;
        • Andrews JC
        • Schunemann HJ
        • Oxman AD
        • Pottie K
        • Meerpohl JJ
        • Coello PA
        • et al.
        GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength.
        J Clin Epidemiol. 2013; 66: 726-735
        • Witt DM
        • Nieuwlaat R
        • Clark NP
        • Ansell J
        • Holbrook A
        • Skov J
        • et al.
        American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy.
        Blood Adv. 2018; 2: 3257-3291
        • Witt DM
        • Nieuwlaat R
        • Clark NP
        • Ansell J
        • Holbrook A
        • Skov J
        • et al.
        American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy.
        Blood Adv. 2018; 2: 3257-3291
        • Schunemann HJ
        • Cushman M
        • Burnett AE
        • Kahn SR
        • Beyer-Westendorf J
        • Spencer FA
        • et al.
        American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients.
        Blood Adv. 2018; 2: 3198-3225
        • Akl EA
        • Morgan RL
        • Rooney AA
        • Beverly B
        • Katikireddi SV
        • Agarwal A
        • et al.
        Developing trustworthy recommendations as part of an urgent response (1-2 weeks): a GRADE concept paper.
        J Clin Epidemiol. 2021; 129: 1-11
        • Munn Z
        • Twaddle S
        • Service D
        • Harrow E
        • Okwen PM
        • Schunemann H
        • et al.
        Developing guidelines before, during, and after the COVID-19 pandemic.
        Ann Intern Med. 2020; 173(12): 1012-1014
        • Schunemann HJ
        • Santesso N
        • Vist GE
        • Cuello C
        • Lotfi T
        • Flottorp S
        • et al.
        Using GRADE in situations of emergencies and urgencies: certainty in evidence and recommendations matters during the COVID-19 pandemic, now more than ever and no matter what.
        J Clin Epidemiol. 2020; 127: 202-207https://doi.org/10.1016/j.jclinepi.2020.05.030
        • Shiffman RN
        • Karras BT
        • Agrawal A
        • Chen R
        • Marenco L
        • Nath S.
        GEM: a proposal for a more comprehensive guideline document model using XML.
        J Am Med Inform Assoc. 2000; 7: 488-498