mittee expects its standards to be pilot-tested and evaluated for reliability and validity (including applicability), as described in detail in Chapter 7, and to evolve as the science and experience demand.

This chapter captures aspects of the beginnings of guideline development, including transparency, conflict of interest, guideline development team composition and group process, and determining guideline scope and logic, including interaction with the systematic review (SR) team. The committee hopes its proposed standards serve as an important contribution to advancing the work of numerous researchers, developers, and users of guidelines, and help to clarify where evidence and expert consensus support best practices and where there is still much to learn. An important note is that, although textually discussed, no standards are proposed for certain aspects of the guideline development process, such as determining group processes, guideline scope, chain of logic underlying a guideline, incorporating patients with comorbidities and the impact of cost on rating the strength of recommendations, given that the committee could not conceive any standards applicable to all guideline development groups (GDGs) in these areas at this time.

ESTABLISHING TRANSPARENCY

“Transparency” connotes the provision of information to CPG users that enables them to understand how recommendations were derived and who developed them. Increasing transparency of the guideline development process has long been recommended by authors of CPG development appraisal tools (AGREE, 2001; IOM, 1992; Shaneyfelt et al., 1999) and the following leading guideline development organizations: the U.S. Preventive Services Task Force (USPSTF), National Institute for Health and Clinical Excellence (NICE), American College of Cardiology Foundation/American Heart Association (ACCF/AHA), and American Thoracic Society. However, exactly what needs to be transparent and how transparency should be accomplished has been unclear. The desire to have public access to GDG deliberations and documents must be balanced with resource and time constraints as well as the need for GDG members to engage in frank discussion.

The committee found no comparisons in the literature of GDG approaches to achieving transparency, but did inspect policies of select organizations. The American Academy of Pediatrics transparency policy calls on guideline authors to make an explicit judgment regarding anticipated benefits, harms, risks, and costs (American



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