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.
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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
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