Editor's Choice - European Society for Vascular Surgery Clinical Practice Guideline Development Scheme: An Overview of Evidence Quality Assessment Methods, Evidence to Decision Frameworks, and Reporting Standards in Guideline Development.
Antoniou, George A; Bastos Gonçalves, Frederico; Björck, Martinet al.
2022 • In European Journal of Vascular and Endovascular Surgery, 63 (6), p. 791-799
AGREE; Certainty of evidence; Clinical practice guidelines; Evidence to decision framework; GRADE; Quality of evidence
Abstract :
[en] OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Antoniou, George A; Department of Vascular and Endovascular Surgery, Manchester University NHS
Bastos Gonçalves, Frederico; Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal, NOVA Medical
Björck, Martin; Department of Surgical Sciences, Section of Vascular Surgery, Uppsala University,
Chakfé, Nabil; Groupe Européen de Recherche sur les Prothèses Appliquées à la Chirurgie
Coscas, Raphaël; Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance
Dias, Nuno V; Vascular Centre, Skåne University Hospital, Malmö, Sweden.
Dick, Florian; Department of Vascular Surgery, Kantonsspital St. Gallen, University of Bern,
Kakkos, Stavros K; Department of Vascular Surgery, University of Patras Medical School, Patras,
Mees, Barend M E; Department of Vascular Surgery, Maastricht University Medical Centre and CARIM
Resch, Timothy; Department of Vascular Surgery, Copenhagen University Hospital- Rigshospitalet,
Trimarchi, Santi; Vascular Surgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico,
Tulamo, Riikka; Department of Vascular Surgery, Helsinki University Hospital, University of
Twine, Chris P; Department of Vascular Surgery, North Bristol NHS Trust, Bristol, UK, Centre for
Vermassen, Frank; Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent,
Wanhainen, Anders; Department of Surgical Sciences, Section of Vascular Surgery, Uppsala University,
Kolh, Philippe ; Université de Liège - ULiège > GIGA ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Biochimie et physiologie générales, humaines et pathologiques ; Centre Hospitalier Universitaire de Liège - CHU > > Service des informations médico économiques (SIME)
Editor's Choice - European Society for Vascular Surgery Clinical Practice Guideline Development Scheme: An Overview of Evidence Quality Assessment Methods, Evidence to Decision Frameworks, and Reporting Standards in Guideline Development.
Publication date :
June 2022
Journal title :
European Journal of Vascular and Endovascular Surgery
Centre for Evidence-Based Medicine-University of Oxford. OCEBM levels of evidence. Available at: https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-of-evidence [Accessed 20 November 2021].
European Society of Cardiology. Recommendations for guidelines production. Available at: https://www.escardio.org/static-file/Escardio/Guidelines/ESC%20Guidelines%20for%20Guidelines%20Update%202010.pdf [Accessed 20 November 2021].
No authors listed. Introduction. Diabetes Care 40:Suppl. 1 (2017), S1–S2.
Halperin, J.L., Levine, G.N., Al-Khatib, S.M., Birtcher, K.K., Bozkurt, B., Brindis, R.G., et al. Further Evolution of the ACC/AHA Clinical Practice Guideline Recommendation Classification System: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 67 (2016), 1572–1574.
Guyatt, G., Oxman, A.D., Akl, E.A., Kunz, R., Vist, G., Brozek, J., et al. GRADE guidelines: 1. Introduction – GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 64 (2011), 383–394.
GRADE Handbook. Quality of evidence. Available at: https://gdt.gradepro.org/app/handbook/handbook.html [Accessed 20 November 2021].
Sawaya, G.F., Guirguis-Blake, J., LeFevre, M., Harris, R., Petitti, D., U.S. Preventive Services Task Force. Update on the methods of the U.S. Preventive Services Task Force: estimating certainty and magnitude of net benefit. Ann Intern Med 147 (2007), 871–875.
Ebell, M.H., Siwek, J., Weiss, B.D., Woolf, S.H., Susman, J., Ewigman, B., et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 69 (2004), 548–556.
Clark, E., Burkett, K., Stanko-Lopp, D., Let Evidence Guide Every New Decision (LEGEND): an evidence evaluation system for point-of-care clinicians and guideline development teams. J Eval Clin Pract 15 (2009), 1054–1060.
Hillier, S., Grimmer-Somers, K., Merlin, T., Middleton, P., Salisbury, J., Tooher, R., et al. FORM: an Australian method for formulating and grading recommendations in evidence-based clinical guidelines. BMC Med Res Methodol, 11, 2011, 23.
Briss, P.A., Zaza, S., Pappaioanou, M., Fielding, J., Wright-De Agüero, L., Truman, B.I., et al. Developing an evidence-based Guide to Community Preventive Services – methods. The Task Force on Community Preventive Services. Am J Prev Med 18 (2000), 35–43.
Movsisyan, A., Dennis, J., Rehfuess, E., Grant, S., Montgomery, P., Rating the quality of a body of evidence on the effectiveness of health and social interventions: a systematic review and mapping of evidence domains. Res Synth Methods 9 (2018), 224–242.
GRADE Handbook. Quality of evidence – factors that can reduce the quality of the evidence – inconsistency of results. Available at: https://gdt.gradepro.org/app/handbook/handbook.html [Accessed 20 November 2021].
GRADEpro. Guideline Development Tool (GDT). Available at: https://gradepro.org/product [Accessed 21 November 2021].
Antoniou, S.A., Tsokani, S., Mavridis, D., López-Cano, M., Antoniou, G.A., Stefanidis, D., et al. Guideline assessment project: filling the GAP in surgical guidelines: quality improvement initiative by an international working group. Ann Surg 269 (2019), 642–651.
GRADE. Confidence in the evidence from reviews of qualitative research. Available at: https://www.cerqual.org/ [Accessed 13 February 2022].
Alonso-Coello, P., Oxman, A.D., Moberg, J., Brignardello-Petersen, R., Akl, E.A., Davoli, M., et al. GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ, 353, 2016, i2089.
Moberg, J., Alonso-Coello, P., Oxman, A.D., GRADE Evidence to Decision (EtD) Frameworks Guidance. Version 1.1 [updated May 2015], 2015, The GRADE Working Group Available at: https://ietd.epistemonikos.org/#/help/guidance. (Accessed 27 November 2021)
Rehfuess, E.A., Stratil, J.M., Scheel, I.B., Portela, A., Norris, S.L., Baltussen, R., The WHO-INTEGRATE evidence to decision framework version 1.0: integrating WHO norms and values and a complexity perspective. BMJ Glob Health, 4, 2019, e000844.
AGREE. Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II). Available at: https://www.agreetrust.org/resource-centre/ [Accessed 18 December 2021].
Chen, Y., Yang, K., Marušic, A., Qaseem, A., Meerpohl, J.J., Flottorp, S., et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med 166 (2017), 128–132.
Antoniou, G.A., Mavridis, D., Tsokani, S., López-Cano, M., Flórez, I.D., Brouwers, M., et al. Protocol of an interdisciplinary consensus project aiming to develop an AGREE II extension for guidelines in surgery. BMJ Open, 10, 2020, e037107.
Brouwers, M.C., Spithoff, K., Kerkvliet, K., Alonso-Coello, P., Burgers, J., Cluzeau, F., et al. Development and validation of a tool to assess the quality of clinical practice guideline recommendations. JAMA Netw Open, 3, 2020, e205535.
RIGHT. Right statement. Available at: http://www.right-statement.org/ [Accessed 13 February 2022].
De Maeseneer, M.G., Kakkos, S.K., Aherne, T., Baekgaard, N., Black, S., Blomgren, L., et al. European Society for Vascular Surgery (ESVS) 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. Eur J Vasc Endovasc Surg 63 (2022), 184–267.
Jongkind, V., Earnshaw, J.J., Bastos Gonçalves, F., Cochennec, F., Debus, E.S., Hinchliffe, R., et al. Editor's Choice – Update of the European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischaemia in light of the COVID-19 pandemic, based on a scoping review of the literature. Eur J Vasc Endovasc Surg 63 (2022), 80–89.
Kakkos, S.K., Gohel, M., Baekgaard, N., Bauersachs, R., Bellmunt-Montoya, S., Black, S.A., et al. Editor's Choice – European Society for Vascular Surgery (ESVS) 2021 clinical practice guidelines on the management of venous thrombosis. Eur J Vasc Endovasc Surg 61 (2021), 9–82.
Chakfé, N., Diener, H., Lejay, A., Assadian, O., Berard, X., Caillon, J., et al. Editor's Choice – European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of vascular graft and endograft infections. Eur J Vasc Endovasc Surg 59 (2020), 339–384.
Björck, M., Earnshaw, J.J., Acosta, S., Bastos Gonçalves, F., Cochennec, F., Debus, E.S., et al. Editor's Choice – European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischaemia. Eur J Vasc Endovasc Surg 59 (2020), 173–218.
Conte, M.S., Bradbury, A.W., Kolh, P., White, J.V., Dick, F., Fitridge, R., et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg 58 (2019), S1–S109.
Wanhainen, A., Verzini, F., Van Herzeele, I., Allaire, E., Bown, M., Cohnert, T., et al. Editor's Choice – European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg 57 (2019), 8–93.
Czerny, M., Schmidli, J., Adler, S., van den Berg, J.C., Bertoglio, L., Carrel, T., et al. Editor's Choice – Current options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 57 (2019), 165–198.
Schmidli, J., Widmer, M.K., Basile, C., de Donato, G., Gallieni, M., Gibbons, C.P., et al. Editor's Choice – Vascular access: 2018 clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 55 (2018), 757–818.
Aboyans, V., Ricco, J.B., Bartelink, M.E.L., Björck, M., Brodmann, M., Cohnert, T., et al. Editor's Choice – 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 55 (2018), 305–368.
Naylor, A.R., Ricco, J.B., de Borst, G.J., Debus, S., de Haro, J., Halliday, A., et al. Editor's Choice – Management of atherosclerotic carotid and vertebral artery disease: 2017 clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 55 (2018), 3–81.
Björck, M., Koelemay, M., Acosta, S., Bastos Goncalves, F., Kölbel, T., Kolkman, J.J., et al. Editor's Choice – Management of the diseases of mesenteric arteries and veins: clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 53 (2017), 460–510.
Riambau, V., Böckler, D., Brunkwall, J., Cao, P., Chiesa, R., Coppi, G., et al. Editor's Choice – Management of descending thoracic aorta diseases: clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 53 (2017), 4–52.
Wittens, C., Davies, A.H., Bækgaard, N., Broholm, R., Cavezzi, A., Chastanet, S., et al. Editor's Choice – Management of chronic venous disease: clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 49 (2015), 678–737.