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Background

Clinical guidelines, defined as' systematically developed statements to assist both practitioner and patient decisions in specific circumstances', have become an increasingly familiar part of clinical care. Guidelines are viewed as useful tools for making care more consistent and efficient and for closing the gap between what clinicians do and what scientific evidence supports. Interest in clinical guidelines is international and has its origin in issues faced by most healthcare systems: rising healthcare costs; variations in service delivery with the presumption that at least some of this variation stems from inappropriate care; the intrinsic desire of healthcare professionals to offer, and patients to receive, the best care possible. Within the UK, there is ongoing interest in the development of guidelines and a fast-developing clinical-effectiveness agenda within which guidelines figure prominently. Over the last decade, the methods of developing guidelines have steadily improved, moving from solely consensus methods to methods that take explicit account of relevant evidence. However, UK guidelines have tended to focus on issues of effectiveness and have not explicitly considered broader issues, particularly cost. This report describes the methods developed to handle benefit, harm and cost concepts in clinical guidelines. It reports a series of case studies, each describing the development of a clinical guideline; each case study illustrates different issues in incorporating these different types of evidence.