Background: International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines.
Objective: To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development.
Methods: The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers.
Results: The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach’s alpha 0.64–0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (p<0.005). Guidelines with technical documentation had higher scores on that domain (p<0.0001).
Conclusions: This is the first time an appraisal instrument for clinical practice guidelines has been developed and tested internationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.
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Writing group: Françoise Cluzeau (FC), St George’s Hospital Medical School, London, UK; Jako Burgers (JB), University of Nijmegen, The Netherlands; Melissa Brouwers (MB), McMaster University and Cancer Care Ontario, Hamilton, Ontario, Canada; Richard Grol (RG), University of Nijmegen/University of Maastricht, The Netherlands; Marjukka Mäkelä (MM), Finnish Office for Health Care Technology Assessment, Finland; Peter Littlejohns (PL), National Institute for Clinical Excellence, London, UK; Jeremy Grimshaw (JG), Health Services Research Unit, University of Aberdeen, UK; Claire Hunt (CH), Institute of Psychiatry, London, UK.
FC, JB, RG and PL developed the first draft of the instrument and designed the field study. FC and JB drafted the paper and undertook the analyses with CH. MB, MM, RG, PL and JG helped write the final draft.
Contributors: The following individuals provided input into the design and field testing of the AGREE instrument and commented on earlier drafts of the paper: José Asua, Basque Office for Health Technology Assessment, Spain; Anne Bataillard, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France; George Browman, Hamilton Regional Cancer Centre, Hamilton, Canada; Bernard Burnand, Institut Universitaire de Médecine Sociale et Préventive, Lausanne, Switzerland; Pierre Durieux, Hôpital Européen Georges Pompidou, Paris, France; Béatrice Fervers, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France; Roberto Grilli, Agenzia Sanitaria Regionale, Bologna, Italy; Steven Hanna, McMaster University, Hamilton, Ontario, Canada; Pieter ten Have, Utrecht, The Netherlands; Albert Jovell, Fundacio Biblioteca Josep Laporte, Barcelona, Spain; Niek Klazinga, Academisch Medisch Centrum University of Amsterdam, The Netherlands;
Funding: The research was funded by a grant from the EU BIOMED2 Programme (BMH4-98-3669). The work in Switzerland was funded from the Swiss Federal Office for Education and Science (OFES 97.0447). The Health Services Research Unit, University of Aberdeen is funded by the Chief Scientist Office of the Scottish Executive Department of Health. The views expressed are those of the authors and not the funders.
Conflict of interest: none.
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