GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction

In the evaluation of therapeutic interventions, structured methods of analysis and reporting are increasingly being proposed, particularly in the field of oncology. In 2015, a task force of oncologists coordinated by the American Society of Clinical Oncology (ASCO) developed a complex consensus document (1,2) that examines - - through a fully structured approach - - the main determinants of effectiveness and of cost for current anti-cancer treatments. In the same year another project with similar characteristics was carried out by the European Society for Medical Oncology (ESMO) with a more specific focus on the magnitude of clinical benefits and no examination of costs (3). The GRADE method (4-6), firstly described in 2004, remains, however, the most widely recognised structured tool to devise therapeutic guidelines for any type of health-care intervention and to generate recommendations directed at clinicians or institutions. The recent article by Alonso-Coello et al (7) is of great interest because this paper tries to extend the application of the GRADE method and starts to cover also the field of decision-making.

In this framework, however, one reason of concern is suggested by an overview of the literature on this topic focused on a specific point of controversy (8). This overview showed that most applications of the GRADE method refer to studies conducted by academic researchers in a scientific context (typically, a systematic review or a meta-analysis undertaken for purely scientific purposes) whereas the use of this method is still limited to the level of decision-makers of health-care systems (8). As regards the experience conducted by the most authoritative institution that has adopted the GRADE method (i.e. WHO), a recent paper by Alexander and colleagues (9) has pointed out that many recommendations issued by WHO were not compliant with the criteria set by GRADE. One reason for this negative result might be that WHO panelists had a poor familiarity with GRADE (9). Even more interestingly, if one considers the ESMO tool or the ASCO method, virtually all of the published papers dealt with the description of the method, but no real-life applications of these tools have yet been reported in the literature (Messori and Trippoli, 2016, unpublished observations).

Alonso-Coello and colleagues (7) have pointed out that “more than 100 organisations globally, including the World Health Organization, the Cochrane Collaboration, and the National Institute for Health and Care Excellence (NICE) now use or have adopted the principles of the GRADE system”. However, despite the apparently large acceptance of this method by clinicians or institutions, the current literature only reports a limited number of experiences in which this method has been employed to make decisions in the context of a health-care system.

References

1. Schnipper LE, Davidson NE, Wollins DS, et al: American Society of Clinical Oncology statement: A conceptual framework to assess the value of cancer treatment options. J Clin Oncol 2015;33:2563-2577.

2. Schnipper LE, Davidson NE, Wollins DS, et al: Updating the ASCO value framework: Revisions and reflections in response to comments received. J Clin Oncol 2016, doi: 10.1200/JCO.2016.68.251

3. Cherny NI, Sullivan R, Dafni U, et al: A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol 2015;26:1547-1573.

4. Atkins D, Best D, Briss PA, et al. GRADE Working Group. Grading quality of evidence and strength of recommendations.BMJ 2004;328:1490.

5. Guyatt GH, Oxman AD, Vist GE, et al. GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ2008;336:924-

6. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol2011;64:383-94.

7. Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: asystematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016.

8. Trippoli S, Messori A. Structured methods of analysis and reporting: a quick literature analysis (Comment), PubMed Commons, published 30 June 2016. http://www.ncbi.nlm.nih.gov/pubmed/27353417#cm27353417_16441 Accessed 30 June 2016.

9. Alexander PE, Gionfriddo MR, Li SA, Bero L, Stoltzfus RJ, Neumann I, Brito JP,Djulbegovic B, Montori VM, Norris SL, Schünemann HJ, Thabane L, Guyatt GH. A number of factors explain why WHO guideline developers make strong recommendations inconsistent with GRADE guidance. J Clin Epidemiol. 2016 Feb;70:111-22.

Address correspondence to: Dr.Andrea Messori, HTA Unit, ESTAR, Regional Health Service, 50100 Firenze (Italy) Email: andrea.messori.it@gmail.com