WFSBP guidelines on how to grade treatment evidence for clinical guideline development

Abstract

Objective and methods: This paper reviews sources of data typically used in guideline development, available grading systems, their pros and cons, and the methods for evaluating risks of bias in publications, and proposes a revised method for grading evidence and recommendations for use in development of clinical treatment guidelines.

Results: The new World Federation of Societies of Biological Psychiatry (WFSBP) grading system allows guideline developers to follow a multi-step approach of defining levels of evidence, applying criteria for grading (define the acceptability) and the grading of recommendations.

Conclusions: Further, these updated WFSBP recommendations for rating evidence and treatment recommendations provide a grading system that takes into account potential biases in sources of evidence in arriving at final ratings that are likely more clinically meaningful and pragmatic and thus should be used for the development of future treatment guidelines.

Keywords:

• evidence-based psychiatry
• guidelines
• grading evidence
• meta-analysis
• randomized controlled trial

Acknowledgements

The draft version of this manuscript was sent to all WFSBP task force leads and to all presidents of the various national societies of biological psychiatry that are members of the WFSBP for internal review; our thanks are addressed to those presidents who have sent us their comments on the guidelines. MB is supported by a NHMRC Senior Principal Research Fellowship (1059660 and 1156072).

Disclosure statement

In the last three years, Alkomiet Hasan received paid speakership by Lundbeck, Janssen-Cliag and Otsuka. He was member of advisory boards of Lundbeck, Janssen-Cilag, Roche and Otsuka. In the past 3 years, Borwin Bandelow has been on the speakers’ board for Hexal, Janssen, Lilly, and Lundbeck and on the advisory board for Mundipharma. Lakshmi Yatham has received research grants from or has been on speaker advisory boards for Allergan, AstraZeneca, Alkermes, Bristol-Myers Squibb, Canadian Institutes of Health Research, Canadian Network for Mood and Anxiety Treatments, Dainippon Sumitomo Inc, Eli Lilly & Co., Forrest, GlaxoSmithKline, Janssen, Lundbeck, Michael Smith Foundation for Health Research, Novartis, Otsuka, Pfizer, Ranbaxy, Servier, Sunovion, the Stanley Foundation, Teva and Valeant Pharmaceuticals. Michael Berk has received Grant/Research Support from the NIH, Cooperative Research Centre, Simons Autism Foundation, Cancer Council of Victoria, Stanley Medical Research Foundation, MBF, NHMRC, Beyond Blue, Rotary Health, Meat and Livestock Board, Astra Zeneca, Woolworths, Avant and the Harry Windsor Foundation, book royalties from Oxford University Press, Cambridge University Press, Springer Nature and Allen and Unwin, has been a speaker for Astra Zeneca, Lundbeck, Merck and Servier and served as a consultant to Allergan, Astra Zeneca, Bioadvantex, Bionomics, Collaborative Medicinal Development, Grunbiotics, Janssen Cilag, LivaNova, Lundbeck, Merck, Mylan, Otsuka and Servier. Peter Falkai has been an honorary speaker for AstraZeneca, Bristol Myers Squibb, Eli Lilly, Essex, GE Healthcare, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Servier and Takeda, and during the past five years, but not presently, has been a member of the advisory boards of Janssen-Cilag, AstraZeneca, Eli Lilly and Lundbeck. Hans-Jürgen Möller received honoraria for lectures or expert meetings by the following pharmaceutical companies: Lundbeck, Schwabe, Otsuka and Servier. Siegfried Kasper received grants/research support, consulting fees and/or honoraria within the last three years from Angelini, AOP Orphan Pharmaceuticals AG, Celegne GmbH, Eli Lilly, Janssen-Cilag Pharma GmbH, KRKA-Pharma, Lundbeck A/S, Mundipharma, Neuraxpharm, Pfizer, Sanofi, Schwabe, Servier, Shire, Sumitomo Dainippon Pharma Co. Ltd. and Takeda.