Developing clinical practice guidelines: types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations

Implementation Science, Jul 2012

Clinical practice guidelines are one of the foundations of efforts to improve healthcare. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearinghouses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this second paper, we discuss issues of identifying and synthesizing evidence: deciding what type of evidence and outcomes to include in guidelines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, and presentation of evidence; and moving from evidence to recommendations.

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Developing clinical practice guidelines: types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations

Steven Woolf 4 Holger J Schnemann 3 Martin P Eccles 2 Jeremy M Grimshaw 5 6 Paul Shekelle 0 1 0 Veterans Affairs Greater Los Angeles Healthcare System , Los Angeles, CA 90073 , USA 1 RAND Corporation , Santa Monica, CA 90407 , USA 2 Institute of Health and Society, Newcastle University , Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne NE2 4AX , UK 3 Departments of Clinical Epidemiology and Biostatistics and of Medicine, McMaster University , Hamilton , Canada 4 Department of Family Medicine and Center on Human Needs, Virginia Commonwealth University , Richmond, VA , USA 5 Department of Medicine, University of Ottawa , Ottawa, ON , Canada 6 Clinical Epidemiology Program, Ottawa Hospital Research Institute , Ottawa, ON , Canada Clinical practice guidelines are one of the foundations of efforts to improve healthcare. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearinghouses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this second paper, we discuss issues of identifying and synthesizing evidence: deciding what type of evidence and outcomes to include in guidelines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, and presentation of evidence; and moving from evidence to recommendations. - Background Clinical practice guidelines (hereafter referred to as guidelines) are one of the foundations of efforts to improve healthcare. The modern age of guidelines began with a 1992 Institute of Medicine (IOM) report, which defined guidelines as systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances [1]. In 1999, we authored a paper about methods to develop guidelines [2]. It covered: identifying and refining the subject area of the guideline; running guideline development groups; identifying and assessing the evidence; translating evidence into a clinical practice guideline; and reviewing and updating guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the broad context for clinical practice guidelines has changed. To help users identify and choose guidelines there has been the emergence of guideline clearing houses (such as the US Agency for Healthcare Research and Quality (AHRQ) Guideline Clearing House, www.guideline.gov) that identify and systematically characterize guidelines on a number of domains and the development of robust guideline appraisal instruments such as the AGREE tool [3,4]. There has been the appearance of large-scale guideline production organisations both at a national level (such as the UK National Institute for Health and Clinical Excellence or Scottish Intercollegiate Guidelines Network) and a condition level (such as the Ontario Cancer Guideline Program). There have also been relevant reports (that some of us have participated in) for the World Health Organisation [5] and professional societies (Schnemann HJ, Woodhead M, Anzueto A, Buist AS, MacNee W, Rabe KF, Heffner J. A guide for guidelines for professional societies and other developers of recommendations: an official American Thoracic Society (ATS) / European Respiratory Society (ERS) Workshop Report; in preparation). Such organizations and those interested in producing and using guidelines now have a high profile society in the Guidelines International Network (http://www.g-i-n.net/). Against this background it seems timely to, in a series of three articles, update and extend our earlier paper on the methods of developing clinical practice guidelines. This series is based on a background paper [6] we prepared for the IOM report Clinical Practice Guidelines We Can Trust [7]. In the first paper, we discussed target audience(s) for guidelines, identifying topics for guidelines, guideline group composition, and the processes by which guideline groups function and the important procedural issue of conflicts of interest. In this second paper, we move on to discuss issues of identifying and synthesizing evidence: deciding what type of evidence and outcomes to include in guidelines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, and presentation of evidence; and moving from evidence to recommendations. In the third paper, we will discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guidelines approach dealing with patients with comorbi (...truncated)


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Steven Woolf, Holger J Schünemann, Martin P Eccles, Jeremy M Grimshaw, Paul Shekelle. Developing clinical practice guidelines: types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations, Implementation Science, 2012, pp. 61, 7, DOI: 10.1186/1748-5908-7-61