i) Purpose of the AGREE II Instrument
Clinical practice guidelines (‘guidelines’) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances (1). In addition, guidelines can play an important role in health policy formation (2,3) and have evolved to cover topics across the health care continuum (e.g., health promotion, screening, diagnosis).
The potential benefits of guidelines are only as good as the quality of the guidelines themselves. Appropriate methodologies and rigorous strategies in the guideline development process are important for the successful implementation of the resulting recommendations (4-6). The quality of guidelines can be extremely variable and some often fall short of basic standards (7-9).
The Appraisal of Guidelines for REsearch & Evaluation (AGREE) Instrument (10) was developed to address the issue of variability in guideline quality. To that end, the AGREE instrument is a tool that assesses the methodological rigour and transparency in which a guideline is developed. The original AGREE instrument has been refined, which has resulted in the new AGREE II and includes a new User’s Manual (11).
The purpose of the AGREE II, is to provide a framework to:
1. assess the quality of guidelines;
2. provide a methodological strategy for the development of guidelines; and
3. inform what information and how information ought to be reported in guidelines.
The AGREE II replaces the original instrument as the preferred tool and can be used as part of an overall quality mandate aimed to improve health care.
ii) History of the AGREE Project
The original AGREE Instrument was published in 2003 by a group of international guideline developers and researchers, the AGREE Collaboration (10) . The objective of the Collaboration was to develop a tool to assess the quality of guidelines. The AGREE Collaboration defined quality of guidelines as the confidence that the potential biases of guideline development have been addressed adequately and that the recommendations are both internally and externally valid, and are feasible for practice (10). The assessment includes judgments about the methods used for developing the guidelines, the components of the final recommendations, and the factors that are linked to their uptake. The result of the Collaboration’s effort was the original AGREE Instrument, a 23-item tool comprising 6 quality domains. The AGREE Instrument has been translated into many languages, has been cited in well over 100 publications, and is endorsed by several health care organizations. More details about the original instrument and related publications are available on the Web site of the AGREE Research Trust (http://www.agreetrust.org/), the official body managing the interests of the AGREE Instrument.
As with any new assessment tool, it was recognized that ongoing development was required to strengthen the measurement properties of the instrument and to ensure its usability and feasibility among intended users. This led several members of the original team to form the AGREE Next Steps Consortium (Consortium). The objectives of the Consortium were to further improve the measurement properties of the instrument, including its reliability and validity; to refine the instrument’s items to better meet the needs of the intended users; and to improve the supporting documentation (i.e., original training manual and user’s guide) to facilitate the ability of users to implement the instrument with confidence.
The result of these efforts is the AGREE II, which is comprised of the new User’s Manual and 23 item tool organized into the same six domains, described here. The User’s Manual is a significant modification of the original training manual and user’s guide and provides explicit information for each of the 23 items. Table 1 compares the items of the original AGREE to the items in the AGREE II.
i) Which guidelines can be appraised with the AGREE II?
As with the original instrument, AGREE II is designed to assess guidelines developed by local, regional, national or international groups or affiliated governmental organizations. These include original versions of and updates of existing guidelines.
The AGREE II is generic and can be applied to guidelines in any disease area targeting any step in the health care continuum, including those for health promotion, public health, screening, diagnosis, treatment or interventions. It is suitable for guidelines presented in paper or electronic format. At this stage, the AGREE II has not been designed to assess the quality of guidance documents that address health care organizational issues. Its role in the assessment of health technology assessments has not yet been formally evaluated.
ii) Who can use the AGREE II?
The AGREE II is intended to be used by the following stakeholder groups:
• by health care providers who wish to undertake their own assessment of a guideline before adopting its recommendations into their practice;
• by guideline developers to follow a structured and rigorous development methodology, to conduct an internal assessment to ensure that their guidelines are sound, or to evaluate guidelines from other groups for potential adaptation to their own context;
• by policy makers to help them decide which guidelines could be recommended for use in practice or to inform policy decisions; and
i) AGREE Research Trust
The AGREE Research Trust (ART) is an independent body established in 2004 at the conclusion of the activities of the original AGREE Collaboration. ART endorses the AGREE II and manages the interests of the AGREE enterprise, supports a research agenda regarding its development, and serves as the holder of its copyright.
The AGREE Research Trust web site http://www.agreetrust.org provides:
• free downloadable copies of AGREE II
• links to the AGREE II on-line training tool
• reference lists citing AGREE II and the original AGREE Instrument
• free downloadable copies of the original AGREE Instrument
• information about AGREE projects, the AGREE Next Steps Consortium and the original AGREE Collaboration
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