2
Background and Key Stakeholders in Guidelines Development and Use

Abstract: Before specific consideration of standards for trustworthy clinical practice guidelines (CPGs), the committee examined the history of evidence-based medicine and guideline development. This chapter provides a brief review of modern applications of scientific evidence in the development of clinical care and evolution of CPGs in the United States and internationally, as well as a review of the major guideline developers and users today. The chapter is by no means an exhaustive history of guideline development or a complete list of current stakeholders; instead it aims to present the reader with a general overview of the guideline landscape.

BACKGROUND

“Clinical practice guidelines are now ubiquitous,” observed Weisz and colleagues in 2007 (p. 691). The Guidelines International Network database currently lists more than 3,700 guidelines from 39 countries. Its U.S.-based counterpart, the National Guideline Clearinghouse (NGC), accepted 722 guidelines to its database in 2008 alone, bringing its total collection to nearly 2,700.1 Furthermore, numerous other clinical guidance statements (e.g., the Centers for Disease Control and Prevention [CDC] rapid response recommen-

1

Personal communication, M. Nix, 2010. Project officer for National Guideline Clearinghouse.



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2 Background and Key Stakeholders in Guidelines Development and Use Abstract: Before specific consideration of standards for trustwor- thy clinical practice guidelines (CPGs), the committee examined the history of evidence-based medicine and guideline development. This chapter provides a brief review of modern applications of sci- entific evidence in the development of clinical care and evolution of CPGs in the United States and internationally, as well as a review of the major guideline developers and users today. The chapter is by no means an exhaustive history of guideline development or a complete list of current stakeholders; instead it aims to present the reader with a general overview of the guideline landscape. BACKGROUND “Clinical practice guidelines are now ubiquitous,” observed Weisz and colleagues in 2007 (p. 691). The Guidelines International Network database currently lists more than 3,700 guidelines from 39 countries. Its U.S.-based counterpart, the National Guideline Clear- inghouse (NGC), accepted 722 guidelines to its database in 2008 alone, bringing its total collection to nearly 2,700.1 Furthermore, numerous other clinical guidance statements (e.g., the Centers for Disease Control and Prevention [CDC] rapid response recommen- 1Personal communication, M. Nix, 2010. Project officer for National Guideline Clearinghouse. 29

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30 CLINICAL PRACTICE GUIDELINES WE CAN TRUST dations) and tools (e.g., computerized physician order entry sys- tems) are created to aid clinical care decisions each year. As stated in Chapter 1, clinical practice guideline (CPG) development has evolved dramatically in the 20 years since the Institute of Medicine (IOM) first became involved in this area. This chapter provides a brief review of modern applications of scientific evidence in the development of clinical care and evolution of CPGs. It then offers an overview of many participants in current CPG development and use, providing selected examples. Healthcare Decision Making Prior to Evidence-Based Medicine (EBM) Before the end of the 20th century, clinical decisions were based largely on experience and skill (the “art” of medicine); medical teaching and practice were dominated by knowledge delivered by medical leaders (Davidoff, 1999; Eddy, 2005; Evidence-Based Medi- cine Working Group et al., 1992). Although some form of evidence has long contributed to clinical practice, there was no generally accepted, formal way of ensuring a scientific, critical approach to clinical decision making (Daly, 2005). The 1992 Evidence-Based Medicine Working Group, primarily McMaster University profes- sors, who created a training program to teach EBM to internal medi- cine residents, described the historical paradigm of medical decision in the following sentences: • “Unsystematic observations from clinical experience are a valid way of building and maintaining one’s knowledge about patient prognosis, the value of diagnostic tests, and the efficacy of treatment. • The study and understanding of basic mechanisms of dis- ease and pathophysiologic principles are a sufficient guide for clinical practice. • A combination of thorough traditional medical training and common sense is sufficient to allow one to evaluate new tests and treatments. • Content expertise and clinical experience are a sufficient base from which to generate valid guidelines for clinical practice.” (Evidence-Based Medicine Working Group et al., 1992, p. 2421) The modern commitment to EBM dates to the 1970s, when a growing body of health services research refuted long-held assump-

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31 BACKGROUND AND KEY STAKEHOLDERS tions about the quality of medical care practiced by U.S. physi- cians. In 1973, John Wennberg documented wide variations in practice patterns among local provider communities (hospital mar- ket areas) with seemingly similar patient populations (Wennberg and Gittelsohn, 1973). Then, the RAND Health Services Utiliza- tion Study showed that three common procedures (coronary angi- ography, carotid endarterectomy, and upper gastrointestinal tract endoscopy) were applied inappropriately at a rate of 17, 32, and 17 percent, respectively (Chassin et al., 1987; Davidoff, 1999). Around the same time, a major study in the New England Journal of Medicine (NEJM) concluded that indications for permanent pacemakers were inadequate or undocumented for 20 percent (77 of 382) of implant cases (Greenspan et al., 1988). To many health policy leaders, the RAND, NEJM, and other complementary investigational findings demonstrated that large proportions of procedures performed by physicians were deemed inappropriate even by experts in associated fields, and that one quarter to one third of all medical care may be unnecessary (Eddy, 2005; Woolf, 1990). In 1990, Steven Woolf wrote in reaction to the above findings that “the perception is that at least some of the variation reflects excessive (or inadequate) use of proce- dures by physicians in certain areas” (Woolf, 1990, p. 1812). The Expansion of the Evidence Base The first randomized controlled trial (RCT) in the health sci - ences was published in 1948 and demonstrated the efficacy of streptomycin in the treatment of tuberculosis. Since the 1970s there has been an exponential increase in RCTs and in observa - tional research. From 1978 to 2001, 8.1 million journal articles were indexed in MEDLINE, with nearly half occurring from 1994 to 2001. The proportion of MEDLINE RCT articles also grew, from 1.9 percent or 5,174 per year from 1978 to 1985, to 6.2 percent or 24,724 per year from 1994 to 2001 (Druss and Marcus, 2005). Health sci - ences literature growth was concentrated in clinical research, with an increase in the percentage of studies with human subjects, and Medical Subject Headings (MeSH) in MEDLINE that shifted from basic science to clinical care and public health (Druss and Marcus, 2005). The introduction in the mid-1990s of the ACP (American College of Physicians) Journal Club and the journal Evidence-Based Medicine, which contain quality-evaluated article abstracts selected from hundreds of primary publications, illustrated the dramatic increase in the evidence base and its intended use among practic - ing physicians (Daly, 2005).

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32 CLINICAL PRACTICE GUIDELINES WE CAN TRUST Exploitation of observational research methods as supplements to the RCT has long held traction among EBM’s top proponents. Observational in this context refers exclusively to “quantitative, epidemiological methods and not qualitative, sociological meth- ods. The principal observational epidemiological methods are non-randomized trials, cohort studies (prospective and retrospec- tive), and case control methods,” wrote Black in 1996 (p. 1215). Experimentation may be inadequate as an evidentiary base for clini- cal practice due to questionable external validity. More recently, Berwick and others have asserted that healthcare has much to gain if the view of EBM is broadened to include sources of observational data such as registries and electronic health records (Berwick, 2005). Overall, study designs and methods of analysis in support of EBM have become increasingly more sophisticated, and now include deci- sion analysis, systematic review of the literature (including meta- analysis), and cost-effectiveness analysis (IOM, 2001). This increase in knowledge was accompanied by a broad pattern of decentralization, both in sources of funding and authorship. The largest source of nongovernmental funding, by far, was industry in order to support Food and Drug Administration (FDA) approvals of drugs and devices (Druss and Marcus, 2005). Clinical Epidemiology and Evidence-Based Medicine Clinical epidemiology and evidence-based medicine emerged as solutions to failings of the traditional approach to medical deci - sion making. Alvan Feinstein and David Sackett were the first to introduce clinical epidemiology as a distinct clinical discipline at Yale University (1968) and McMaster University (1970) respectively. In the late 20th century, the field of clinical epidemiology, defined by Sackett as “the application, by a physician who provides direct patient care, of epidemiologic and biostatistical methods to the study of diagnostic and therapeutic processes in order to effect an improvement in health” (Sackett, 2002, p. 1162), not only survived, but thrived, and its leaders were placed in highly influential posi - tions in departments of medicine, journal editorships, and profes- sional societies (Berwick, 2005). Major figures in the rise of EBM included Archie Cochrane, Iain Chalmers, Murray Enkin, and Mark Keirse. Cochrane, a British epidemiologist, promoted the RCT as the best means of assessing medical technologies and practices, as early as the 1950s and 1960s. His work later gave rise to the Cochrane Collaboration (IOM, 2001). Chalmers, Enkin and colleagues, created the Oxford Database of

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33 BACKGROUND AND KEY STAKEHOLDERS Perinatal trials, which compiled, first in hard copy (1988) and then in an electronic version (1990), all clinical trials data pertaining to effective care in pregnancy and childbirth (Chalmers, 1988, 1990). In addition, Chalmers, Enkin, and colleagues published Effective Care in Pregnancy and Childbirth, an overview of best pregnancy and childbirth evidence with a compendium of systematic reviews, and corresponding summary guide of the results. This work inspired the establishment of the Cochrane Collaboration, described later in this chapter (Chalmers et al., 1989; Enkin et al., 1989). These leaders, as well as others, fostered a new generation of scholars in healthcare, who focused their careers on clinical practice research (Berwick, 2005). “As a result, over the last several decades, the standards for evidence have become more stringent, and the tools for its assembly and analysis have become more powerful and widely available,” according to Davidoff (1999) (IOM, 2001, p. 147). The term “evidence-based medicine,” coined in 1990, is defined by Daly as “the application of scientific method in determining the optimal management of the individual patient” (Daly, 2005, p. 89). In 1992 the EBM Working Group described the emergent paradigm of Evidence-Based Clinical Decision Making: • While clinical experience and skill are important, system- atic attempts to record observations in a reproducible and unbiased fashion markedly increase the confidence one can have in knowledge about patient prognosis, the value of diagnostic tests, and the efficacy of treatment. • In the absence of systematic observation, one must be cautious in the interpretation of information derived from clinical experience and intuition, for it may at times be misleading. • The study and understanding of basic mechanisms of disease are necessary but insufficient guides for clinical practice. • Understanding certain rules of evidence is necessary to cor- rectly interpret literature on causation, prognosis, diagnos- tic tests, and treatment strategy. (Evidence-Based Medicine Working Group et al., 1992, p. 2421) Additionally, the EBM Working Group asserted that clinicians must accept uncertainty and the notion that clinical decisions are often made with scant knowledge of their true impact. The EBM paradigm assigns reduced weight to authority of experts, instead valuing physician understanding of underlying rigorous, high qual- ity scientific evidence in patient care provision (Evidence-Based

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34 CLINICAL PRACTICE GUIDELINES WE CAN TRUST Medicine Working Group et al., 1992). Importantly, more recent definitions also emphasize that clinical expertise and patient pref - erences remain vital to clinical decision making, and clarify that scientific evidence refers not only to RCT findings, but to those arising from research designs such as nonrandomized cohort trials and case control studies (IOM, 2001). The development of CPGs, detailed in the next section, is an important extension of EBM (Luce et al., 2010). Evolution of Clinical Practice Guideline Development Clinical practice guidelines (CPGs) have enjoyed a presence in medical practice since the early 20th century; many sources cite the American Academy of Pediatrics’ Redbook of Infectious Diseases (1938) as one of the first CPGs produced in the United States (IOM, 2008). Most early guidelines were developed by expert panels or individuals who had gained authority status within specific medical specialties. As research evidence in support of, and methodologies for implementing, EBM had yet to be developed, these CPGs rarely were informed by systematic interpretation of the scientific evidence (IOM, 2008). By the 1990s, the evolution in research methods and expansion of the scientific evidence base detailed above increased both the need for and ability of CPGs to reflect the latest EBM trend. Physi- cians could no longer keep up with the growing knowledge base: An internist would have to read 33 articles 365 days a year to stay up to date (Sackett, 2002). Furthermore, the validity of much of the grow- ing body of evidence was suspect. “These two situations combined to place clinicians at increasing risk of ‘drowning in doubtful data,’ ” Sackett wrote in 2002 (p. 1164). Critically appraised, synthesized information such as systematic reviews and CPGs became necessary tools for clinicians desiring to practice EBM (IOM, 2008). The IOM entered the conversation during this time with the two previously mentioned (in Chapter 1) reports, Clinical Practice Guidelines: Direc- tions for a New Program (1990) and Guidelines for Clinical Practice: From Development to Use (1992) (IOM, 1990, 1992), which were requested by Congress to help inform a new government entity, then called the Agency for Healthcare Policy and Research (AHCPR), tasked with CPG development. David Eddy, an early pioneer in guideline development methods, influenced the work of AHCPR, Blue Cross- Blue Shield Association’s TEC program, as well as others. His book, A Manual for Assessing Health Practices and Designing Practice Policies: The Explicit Approach, established a foundation for patient-centered

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35 BACKGROUND AND KEY STAKEHOLDERS outcomes based guideline development in the United States (Eddy, 1992). Early groups applying systematic evidence reviews to CPG recommendations were the Canadian Task Force on the Periodic Health Examination (1976), the U.S. Preventive Services Task Force (USPSTF) (1984), and the American College of Physicians Clinical Efficacy Assessment Project (1980) (IOM, 2008). The involvement of specialty societies in practice guidelines development increased dramatically throughout the 1980s and 1990s. In 1990 Steven Woolf stated that, “Societies with previously limited activity have now revised their internal organizational structure, have established new committees to develop guidelines, and have adopted formal proce - dures to guide their efforts” (Woolf, 1990, p. 1814). By 1989, more than 35 medical societies and physician organizations had devel - oped at least one CPG. Umbrella organizations such as the American Medical Association (AMA) and the Council of Medical Specialty Societies also became active participants in the guideline develop- ment movement, mostly in the role of coordinators and guideline development process “standardizers” (Woolf, 1990). While U.S. federal agencies such as the USPSTF and the National Institutes of Health’s (NIH’s) Consensus Development Program had been making practice recommendations, federal efforts increased dramatically in 1989, when Congress passed a series of bills that increased funding for “effectiveness research” and called for cre- ation of a formal public health service agency with responsibility for development and dissemination of CPGs (Woolf, 1990). Orga - nized medicine, including the AMA and many medical specialty societies, embraced the legislation and employment of guidelines as alternatives to proposed stricter expenditure targets, endorsed by the George H. W. Bush Administration and certain congressional leaders, for curbing increases in healthcare spending (Woolf, 1990). The newly created AHCPR developed approximately 20 guidelines across a wide spectrum of clinical areas over the next several years (Lohr et al., 1998). The AHCPR’s direct involvement in CPG devel - opment was short lived, however, due to political opposition in 1995 from back surgeons who disagreed with the agency’s guidelines for the treatment of lower back pain (IOM, 2009). Following congres - sional threats to withdraw its funding, the agency, renamed the Agency for Healthcare Research and Quality (AHRQ), limited its responsibilities to financial support of Evidence-based Practice Cen - ters’ (EPCs’) production of systematic reviews. In 2008, AHRQ’s 14 EPCs produced systematic reviews that government agencies (e.g., the NIH and USPSTF), professional societies, and other organiza-

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36 CLINICAL PRACTICE GUIDELINES WE CAN TRUST tions could access in their development of CPGs. AHRQ remains involved in guideline dissemination via the National Guideline Clearinghouse, a web-based collection of CPGs from around the world. These activities are discussed in the upcoming section. CURRENT MAJOR STAKEHOLDERS IN GUIDELINES DEVELOPMENT AND USE As the preceding background section indicates, numerous stake- holders are involved in the development and use of CPGs. The next two sections discuss examples from stakeholder classes: government agencies, clinical specialty societies, disease-specific societies, and other private and international organizations that develop guide - lines and are key players. The examples illustrate the variety of organizations involved with CPGs, and are not intended to be all- inclusive. Also, the examples focus on organizations’ CPG-related activities and do not provide a full description of each organization as a whole. Guideline Developers Government Agencies A few national agencies have contributed significantly to guide- line development, both financially and intellectually (NGC, 2010d). The USPSTF has been a CPG developer since the 1980s. It is noted for its early use of transparent standards and inclusion of multidis- ciplinary experts in the development process. This body was created by the U.S. Public Health Service in 1984 and has been supported by AHRQ staff and funding since 1998. The USPSTF is composed mainly of individuals from primary care specialties, such as inter- nists, pediatricians, nurses, family physicians, methodologists, and some subspecialists. Its preventive care guidelines include topics for screening, counseling, immunizations, and preventive medications and services (AHRQ, 2010a). Because of its prevention focus, its perspective reflects that of primary care for asymptomatic people (Atkins, 2010). The USPSTF relies on systematic reviews (SRs) of rel- evant literature conducted by AHRQ staff, AHRQ’s EPCs, or outside experts (AHRQ, 2010b). It has 60 CPGs in the NGC (NGC, 2010b). The USPSTF updates its CPGs at least every 5 years (AHRQ, 2010b). To promote adoption of its guidelines, the USPSTF has devel- oped relationships with a group of partners, including primary care associations and specialty societies; policy, quality improvement,

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37 BACKGROUND AND KEY STAKEHOLDERS and population groups (e.g., AARP); and selected federal agencies. These organizations serve as technical experts, peer reviewers, and disseminators (AHRQ, 2010a). The NIH also has been involved heavily with guidelines and related endeavors through some of its institutes and programs, as part of its mission to translate basic research into medical practice (Simons-Morton, 2010). For example, the National Heart, Lung, and Blood Institute has 12 guidelines listed in the NGC as of October 2009 (NGC, 2010b) and posts 7 CPGs covering 5 health conditions on its website (NHLBI, 2009). It lists four new guidelines and one guideline update in development. The previously mentioned Consensus Development Program of NIH issues three to five major evidence-based consensus state- ments annually, extending from highly structured conferences on controversial clinical topics of use to the broad medical community and general public (NIH, 2009). Many aspects of this consensus development process are similar to that used in development of high-quality CPGs: use of an unbiased, independent, expert panel including research investigators, health professionals, methodolo - gists, and representatives of the public without conflicts of interest; a systematic review conducted by AHRQ; and opportunities for pub- lic input. Although the statement is not updated after issuance, after 5 years it is considered “historical” and the assumption is that much of the content is of questionable validity. Although the consensus statement may prompt reassessment of medical practice, it differs from a CPG in that it merely synthesizes the latest information, often from current and ongoing medical research; it does not recommend specific clinical actions in particular circumstances. The existence of a current Consensus Statement could be important to the evidence base of a CPG. In fact, the NIH currently posts three such statements in the NGC (NGC, 2010b). The CDC is a major issuer of guidelines. The CDC Prevention Guidelines database includes more than 400 guidelines for the pre - vention and control of public health threats such as AIDS, cholera, disasters, dengue fever, suicide, vaccine-preventable diseases, lung cancer, sexually transmitted diseases, birth defects, and malaria. About two thirds of the documents in the database were originally published in the CDC’s Morbidity and Mortality Weekly Report. The others were published as CDC monographs, as books or book chap- ters, as brochures, or as articles in peer-reviewed journals (CDC, 2007). The CDC currently lists 82 CPGs in the NGC (NGC, 2010b). These guidelines are generally based on a systematic review of the literature and written in consultation with experts in the germane

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38 CLINICAL PRACTICE GUIDELINES WE CAN TRUST field. The CDC also produces many recommendations in response to rapidly evolving public health concerns, such as the influenza epidemic. Given the urgent nature of these issues, these recommen- dations are rarely based on a systematic review of the evidence2 (Briss, 2010). The Department of Defense (DoD) and the Veterans Adminis- tration (VA) develop guidelines for their unique populations, and undertake efforts to implement them within their health systems and cost constraints, while also employing CPGs derived by others (Atkins, 2010). The VA and DoD list 25 CPGs in the NGC, predomi- nantly directed to primary care conditions. The VA uses guidelines to improve quality of care and minimize unjustified variation in practice across geographic areas. Sometimes the VA embeds CPGs in its electronic health record and uses the CPGs to develop clinical performance measures (Atkins, 2010). In addition to federal agencies, some states, such as Massa- chusetts, Washington, and New York, have taken responsibility for developing guidelines for their Medicaid and other state programs (NGC, 2010b). Clinical Specialty Societies Many medical societies and organizations of other healthcare professionals have taken responsibility for CPG development in responding to members’ requests for guidance on best treatment practices and as an opportunity to provide continuing education. Some societies, such as the American College of Cardiology, or ACC (see discussion below on the American Heart Association, or AHA), are characterized by long histories of CPG development, have established development procedures, and have devoted significant financial resources to underwrite comprehensive SRs, carefully craft guidelines, and promote their implementation. The American Tho- racic Society and American College of Physicians are similarly dedi- cated to development of high-quality guidelines and have recently updated their conflict-of-interest and rating of evidence and recom - mendation policies respectively, to reflect the latest consensus on that topic (Guyatt et al., 2010; Qaseem et al., 2010). Other societies have more limited resources for guideline development, less experi- ence, and produce fewer CPGs. Most societies work independently on guidelines, although they may address the same conditions and 2 Personal communication, P. A. Briss, Chief of the Community Guide Branch, Cen - ters for Disease Control and Prevention, June 5, 2010.

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39 BACKGROUND AND KEY STAKEHOLDERS develop related CPGs. For example, an AHA guideline may have a recommendation for blood pressure treatment in persons with dia- betes, as do the American College of Physicians and the American Diabetes Association (Kahn, 2010). Some societies have collaborated in the development of CPGs, integrating contributions of multiple specialties in the treatment of particular medical conditions. For example, many of the American Society for Clinical Oncology (ASCO) guidelines were developed in partnership with other specialty societies, such as the American Society of Hematology and the College of American Pathologists. ASCO has at least 17 guidelines in the NGC (NGC, 2010b). Non-physician clinical societies such as occupational and physi - cal therapists and many nursing specialties develop CPGs as well. For example, in 1997 the American Association of Neuroscience Nurses (AANN) created a series of educational tools to aid in patient care, called the AANN Reference Series for Clinical Practice; the series’ name changed in 2007 to the AANN Clinical Practice Guideline Series to reflect the evidence-based nature of the guides. The AANN cur- rently has 10 guidelines downloadable on its website and 5 CPG summaries in the NGC (AANN, 2010; NGC, 2010b). Disease- or Population-Specific Organizations Individual disease- or population-specific organizations, some from beyond U.S. borders and some in conjunction with other pro- fessional or disease-specific societies, sponsored 202 guidelines in the NGC as of March 2009 (IOM, 2009). The breadth of focus of disease-specific societies as well as their resources and capacity for CPG production vary widely. For example, the Alzheimer’s Association has produced three guidelines currently listed in NGC, including one entitled Demen- tia Care Practice Recommendations for Assisted Living Residences and Nursing Homes: Phase 3 End-of-Life Care (NGC, 2010a). This guide- line is based on a literature review sponsored by the association and conducted by a consultant, a background paper written by association staff, and a 1-day meeting of representatives from 30 national provider, professional, and consumer advocacy organiza- tions. The guideline’s recommendations reflect expert consensus and are directed at professionals rather than patients and informal caregivers.3 3 Personal communication, K. Maslow, 2010. Former director of policy development, Alzheimer’s Association, August 27, 2010.

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42 CLINICAL PRACTICE GUIDELINES WE CAN TRUST International Organizations Organizations in several countries outside the United States also produce CPGs. Foreign organizations have contributed 895 (36 percent) of the CPGs in the U.S. NGC. Such guidelines may be developed by foreign medical societies, disease organizations, or government-related bodies. Although the attentions of this com- mittee did not extend internationally, several organizations merit highlighting because of the important roles they play. For example, the National Institute for Health and Clinical Excellence (NICE) is an independent organization that advises the UK National Health Service (NHS) on promoting health and pre- venting and treating illness (NICE, 2010). It conducts or contracts for technology assessments of new treatments and devices as well as systematic reviews and comparative effectiveness studies used to produce clinical guidance. In addition, NICE supports CPG devel- opment through accredited organizations. It accredits organizations that comply with explicit, transparent NICE standards and produce high-quality clinical guidance (see further discussion in Chapter 7). Although the guidelines and accreditation work is designed for use in England by the NHS, these processes potentially could be employed in other countries. NICE staff offer consulting services internationally to assist in adoption of NICE standards and CPG development methodologies, particularly those related to integra - tion of scientific evidence and social values in health care policy and clinical decision making. NICE also issues a suite of products for each review and guideline it produces, including shorter NICE guidelines, full guidelines with systematic reviews, consumer sum- maries, and implementation assistance (NHS, 2010). The World Health Organization (WHO) develops a large num- ber of health-related recommendations for a diverse group of target audiences, including the general public, healthcare professionals, health facility managers (e.g., hospital administrators) or regions (e.g., districts), and public policy makers. These recommendations address a wide range of clinical, public health, and health policy top- ics related to achieving WHO health goals (Oxman et al., 2007). In 2006, the WHO Advisory Committee on Health Research published a series of 16 papers advising WHO guideline developers on how to ensure that their healthcare recommendations are informed by best available research evidence (Schünemann et al., 2006). Other international developers of CPGs include the European Society of Cardiology and the Kidney Disease Improving Global Outcomes (KDIGO). The ESC Committee for Practice Guidelines was established in 1994 to address new health-related policies in

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43 BACKGROUND AND KEY STAKEHOLDERS clinical practice, prevention, quality assurance, research programs, and health economics in cardiovascular diseases. Its committee is composed of 8 to 10 members who are elected for 2 years. It devel - oped 4 guidelines in 2009, and 36 since 2001 (ESC, 2010). KDIGO, an international guideline development organization, was established in 2003 to promote the “coordination, collaboration and integration of initiatives to develop and implement clinical practice guidelines” (Eknoyan et al., 2004, p. 1310). It is currently managed by the U.S.- based National Kidney Foundation and is supported by national kidney disease guideline development initiatives around the world (KDIGO, 2008). Other Stakeholders Related to Guideline Dissemination or Use In addition to the organizations cited above that develop CPGs, numerous government, private, and international groups partici- pate in activities vital to guideline dissemination or use. As with the above examples, the organizations below are meant to illustrate the various stakeholders and not be a complete representation. The discussion here, as well, is limited to their CPG-related activities. Federal Agencies As noted previously, AHRQ no longer develops guidelines, but helps other organizations to develop guidelines. Two previously mentioned major functions supported by AHRQ will be discussed below: the support of EPCs and the NGC. AHRQ’s network of EPCs has expertise in conducting method- ologically rigorous, independent SRs and technology assessments of scientific evidence, and research to advance SR methodologies. Reports from these centers encompass comprehensive literature reviews and research syntheses (possibly comprising meta-analyses or cost analy- ses) on priority health topics conducted by experts with a range of relevant skills. Reports include documentation of process and undergo peer review and public comment before they are made final. These reports are available to all public and private CPG developers (AHRQ, 2008). Further, medical specialty societies such as the American Col- lege of Physicians (ACP), the Renal Physicians Association (RPA) and many other guideline developers utilize the EPC’s topic nomination system to encourage the production of high quality SRs in clinical areas relevant to their guidelines (Matchar et al., 2005). AHRQ, in conjunction with the American Medical Association and America’s Health Insurance Plans, through a contract with ECRI

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44 CLINICAL PRACTICE GUIDELINES WE CAN TRUST Institute, created the NGC in 1997 to ensure no-charge availability of CPGs to clinicians, health plans, providers, purchasers, and the general public. The NGC supports dissemination, adoption, and use of CPGs through an online database of summaries of CPGs that satisfy certain minimal quality criteria (see Box 2-1 for a list of cur- rent criteria). The criteria were established to promote inclusiveness so potential adopters were granted access to a large proportion of available guidelines (Coates, 2010). BOX 2-1 Criteria for Inclusion in The National Guideline Clearinghouse (NGC) 1. The clinical practice guideline (CPG) contains systematically devel- oped statements that include recommendations, strategies, or informa- tion that helps physicians and/or other healthcare practitioners and pa- tients to make decisions about appropriate health care for specific clinical circumstances. 2. The CPG was produced under the auspices of medical specialty as- sociations; relevant professional societies; public or private organizations; government agencies at the federal, state, or local levels; or healthcare organizations or plans. A CPG developed by an individual not officially sponsored by one of the above organizations does not meet the inclusion criteria for NGC. 3. Corroborating documentation can be produced and verified to prove that a systematic literature search and review of existing scientific evidence published in peer-reviewed journals were performed during the guideline development. A guideline is not excluded from NGC if corroborating docu- mentation can be produced and verified, detailing specific gaps in scientific evidence for some guideline recommendations.a 4. The full-text guideline is available on request in print or electronic format (free or for a fee) in English. The guideline is current and the most recent version produced. Documented evidence can be produced or verified to prove the guideline was developed, reviewed, or revised within the past 5 years. a AHRQ reports the quality of supporting evidence bases for CPGs in the NGC vary substantially. Personal communication, M. Nix, 2010. Project officer for National Guideline Clearinghouse. SOURCE: NGC (2010c).

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45 BACKGROUND AND KEY STAKEHOLDERS NGC and ECRI staff scrutinize CPGs submitted by developers. If CPGs meet basic criteria, ECRI summarizes them, and posts them on a live, interactive website, www.guideline.gov. Since this web- site was opened in 1999, ECRI has summarized and posted nearly 8,000 CPGs from more than 300 U.S. and international government agencies, specialty societies, and other nonprofit organizations. Cur- rently, NGC provides more than 2,500 summaries with links to full guideline texts, as well as personal digital assistant downloads of summaries; 25 Guideline Syntheses contrasting CPGs on similar topics; an annotated guidelines bibliography; and a weekly e-mail newsletter update on recent additions (Coates, 2010). To remain in the NGC, a CPG must be updated at least every 5 years; 1,331 CPGs have been withdrawn from the NGC, mainly because they did not satisfy this criterion. The FDA is involved in developing evidence-based5 recommen- dations for drug use through its role in approving drug labeling. For example, the FDA now requires pharmaceutical firms to implement Risk Evaluation and Mitigation Strategies, which detail how the ben- efits of a drug or biological product outweigh its risks (FDA, 2009). The federal Centers for Medicare & Medicaid Services (CMS) is a particularly important user of guidelines. Because CMS spent bil - lions of dollars on healthcare services for an estimated 118.6 million Medicare, Medicaid, and Children’s Health Insurance Program ben- eficiaries (including some dual eligibles) in 2009, Medicare and Med- icaid policies have a significant impact on patient care and health - care providers’ and insurers’ revenue (HHS, 2010). CMS employs guidelines in several ways: • A guideline from the USPSTF or a Technology Assessment conducted through AHRQ’s EPC Program could support an expansion or reduction of Medicare coverage to include, for example, a screening test for beneficiaries. Under the Patient Protection and Affordable Care Act, Medicare (and commercial insurers) will be required to include coverage of preventive services that receive a highly rated recommendation from a CPG of the USPSTF.6 • Medicare’s quality improvement program, contracted through Quality Improvement Organizations in each state, 5 Evidence-based in this case does not denote that a systematic review of the evi - dence was conducted. 6 The Patient Protection and Affordable Care Act, Public Law 111-148, 111th Cong. (March 23, 2010).

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46 CLINICAL PRACTICE GUIDELINES WE CAN TRUST can concentrate collaboration with hospitals, physicians, and other providers on guideline-recommended actions and apply guidelines-driven quality measures to track improve- ments in practice and outcomes over time. • CMS requires participating hospitals, home health agen- cies, dialysis facilities, and nursing homes to report quality measures, frequently based on CPGs. Full reimbursement or an incentive payment is linked to this reporting for se- lected providers. A voluntary Physician Quality Reporting Initiative provides incentives to physicians and group prac- tices reporting measures. The agency then posts these mea- sures and other quality data on its website, www.medicare. gov/nhcompare/, to encourage beneficiaries and other con- sumers to make careful provider choices (Jacques, 2010). • Medicare additionally has supported experimentation with Pay-for-Performance schemes that are based on quality measures derived in part from well-accepted CPGs (Jacques, 2010). International Organizations Along with organizations in many countries around the world developing CPGs, there are support organizations with functions of interest to U.S. developers too. For example, Guidelines Interna- tional Network (GIN), a Scottish-based, not-for-profit, international association of 50 individuals and 91 organizations representing 39 countries, was founded in 2002 to promote development and use of CPGs, in part by collecting published CPGs (Guidelines Interna- tional Network, 2010a). In addition to compiling a publicly acces- sible library of more than 3,700 guidelines and 3,000 related docu- ments (guideline clearing reports, methodologies, implementation tools and systematic reviews) from members (Guidelines Interna- tional Network, 2010c), the organization holds annual conferences to encourage collaboration among guideline-producing organiza- tions and experts and enhance dissemination of guidelines-related research. GIN also has a Patient and Public Involvement Working Group (G-I-N PUBLIC) of consumers, developers, and researchers that supports effective patient and public involvement in guide- line development and implementation, and has recently approved a request to establish a G-I-N affiliated U.S. interest group to foster the development and use of high-quality CPGs in the United States (Guidelines International Network, 2010b).

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47 BACKGROUND AND KEY STAKEHOLDERS Another international group, the Cochrane Collaboration, is dedicated to improving healthcare decisions through development of systematic reviews of healthcare outcomes evidence. The SRs are conducted by a network of 10,000 individuals around the globe, pre- dominantly volunteers. CPG developers in the United States often include these SRs in their evidence bases. The Collaboration has a small staff and is supported by donations, including extensive con - tribution of in-kind services from individuals and institutions and support form governments in many countries, and subscriptions to the Cochrane Library; commercial funds for SRs are prohibited. In addition to producing reviews and related abstracts and derivative products, the Collaboration has created a library of SRs and their scientific evidence foundations (The Cochrane Collaboration, 2010a). The Collaboration also has developed extensive guidance, a review- ers’ handbook, and training programs on how to conduct rigorous SRs (The Cochrane Collaboration, 2010b). Funders of CPGs Funders of CPG development play a critical role in the process; however, the committee found no systematic sources of information regarding CPG funders or their levels of financial support. Although CPGs developed by federal agencies would likely be funded from federal tax dollars, the amount spent on that function in the various agencies is unknown. A reasonable assumption is that commercial guidelines are funded, at least in part, through their sale and sales of related support products and services. Many guidelines developed by medical societies and other private organizations are self-funded, through membership dues, donations, or other means. CPGs funded by medical societies dependent on membership dues may be cause for concern regarding conflict of interest if their recommendations would likely affect their members’ income. Guidelines listed in the NGC may report support from gov- ernment, a parent professional organization, private foundations or individual donors, sales of guidelines, payers, or major health systems. Funding from medical imaging, device, or pharmaceutical industries associated with a guideline topic may also be suspect due to Conflict of Interest (COI), yet it may be difficult to discern that financial presence. A guideline might report to the NGC that it was fully funded by its sponsoring organization, but that body might or might not receive significant portions of revenue from industry. For example, the Alzheimer’s Association’s listing in the NGC for its

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48 CLINICAL PRACTICE GUIDELINES WE CAN TRUST guideline, Dementia Care Practice Recommendations for Assisted Living Residences and Nursing Homes: Phase 3 End-of-Life Care, a 2007 submis- sion (NGC, 2010a), indicates that it was funded by the Association. That, in turn, is supported by national corporations (including phar- maceutical firms), foundations, and private donations (Alzheimer’s Association, 2010). In another case, funding for the AHA’s 2008 CPG on adults with congenital heart disease came totally from AHA and ACC Founda- tions (AHA, 2010a). AHA’s funding primarily arises from individual donations (46 percent) and corporate funds (28 percent), with less than 4 percent from the medical device and drug industries; accord- ing to AHA policy, CPG development receives no direct industry support (AHA, 2010a). This chapter has briefly detailed the history of evidence-based medicine and the variety of organizations historically and currently involved with CPG development. The next chapter examines the ongoing challenges undermining the trustworthiness and impact of CPGs and potential ways to overcome them. REFERENCES AANN (American Association of Neuroscience Nurses). 2010. AANN clinical practice guideline series. http://www.aann.org/ (accessed September 9, 2010). AGS (American Geriatric Society). 2010. Prevention of falls in older persons: AGS/BGS clinical practice guideline. http://www.medcats.com/FALLS/frameset.htm (ac- cessed September 16, 2010). AHA (American Heart Association). 2010a. 2008–2009 national center support from pharmaceutical companies and device manufacturers and AHA total corporate support . http://americanheart.org/downloadable/heart/12652328691601265128050511 2008-2009%20Pharma%20Device%20and%20CorporateFunding%2011110.pdf (accessed March 7, 2010). AHA. 2010b. Performance measures. http://www.americanheart.org/presenter. jhtml?identifier=3012904 (accessed March 7, 2010). AHRQ (Agency for Healthcare Research and Quality). 2008. Evidence-based Practice Centers: Synthesizing scientific evidence to improve quality and effectiveness in health care. http://www.ahrq.gov/clinic/epc/ (accessed March 2, 2010). AHRQ. 2010a. About USPSTF. http://www.ahrq.gov/clinic/uspstfab.htm (accessed March 2, 2010). AHRQ. 2010b. Frequently asked questions. http://info.ahrq.gov/cgi-bin/ahrq.cfg/php/ enduser/std_alp.php?p_sid=sf*ffSVj&p_lva=&p_li=&p_new_search=1&p_ accessibility=0&p_redirect=&p_srch=1&p_sort_by=&p_gridsort=&p_row_ cnt=45%2C45&p_prods=&p_cats=16%2C5&p_pv=&p_cv=2.5&p_search_ text=&p_nav=head&p_trunc=0&p_page_head=1&p_page=1 (accessed March 2, 2010). Alzheimer’s Association. 2010. Current partners and sponsors. http://www.alz.org/ join_the_cause_19090.asp (accessed March 7, 2010).

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49 BACKGROUND AND KEY STAKEHOLDERS Atkins, D. 2010. Veterans Administration. Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. Berwick, D. M. 2005. Broadening the view of evidence-based medicine. Quality and Safety in Health Care 14(5):315–316. Black, N. 1996. Why we need observational studies to evaluate the effectiveness of health care. BMJ 312(7040):1215–1218. Bottles, K. 2010. Institute for clinical systems improvement (ICSI). Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. CDC (Centers for Disease Control and Prevention). 2007. CDC Wonder: CDC preven- tion guidelines. http://wonder.cdc.gov/wonder/prevguid/library/library.asp (accessed September 9, 2010). Chalmers, I. 1988. Oxford database of perinatal trials. Oxford; New York: Oxford Uni- versity Press. Chalmers, I. 1990. Oxford database of perinatal trials. Place Published: Oxford University Press (accessed September 25, 2009). Chalmers, I., M. Enkin, and M. J. N. C. Keirse. 1989. Effective care in pregnancy and child- birth, Oxford medical publications. Oxford; New York: Oxford University Press. Chassin, M. R., J. Kosecoff, R. E. Park, C. M. Winslow, K. L. Kahn, N. J. Merrick, J. Keesey, A. Fink, D. H. Solomon, and R. H. Brook. 1987. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA 258(18):2533–2537. Coates, V. 2010. National Guidelines Clearinghouse NGC/ECRI Institute. Presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. The Cochrane Collaboration. 2010a. Cochrane reviews. http://www.cochrane.org/ cochrane-reviews#reviews (accessed March 7, 2010). The Cochrane Collaboration. 2010b. Training. http://www.cochrane.org/training (ac- cessed March 7, 2010). Daly, J. 2005. Evidence-based medicine and the search for a science of clinical care , Califor- nia/Milbank books on health and the public. Berkeley, CA: University of California Press. Davidoff, F. 1999. In the teeth of the evidence: The curious case of evidence-based medicine. Mount Sinai Journal of Medicine 66(2):75–83. Druss, B. G., and S. C. Marcus. 2005. Growth and decentralization of the medical lit - erature: Implications for evidence-based medicine. Journal of the Medical Library Association 93(4):499–501. Eddy, D.M. 1992. A manual for assessing health practices and designing practice policies: The explicit approach. Philadelphia, PA: American College of Physicians. Eddy, D. M. 2005. Evidence-based medicine: A unified approach. Health Affairs 24(1):9–17. Eknoyan, G., N. Lameire, R. Barsoum, K.-U. Eckardt, A. Levin, N. Levin, F. Locatelli, A. MacLeod, R. Vanholder, R. Walker, and H. Wang. 2004. The burden of kidney disease: Improving global outcomes. Kidney International 66(4):1310–1314. Enkin, M., M. J. N. C. Keirse, I. Chalmers, and E. Enkin. 1989. A guide to effective care in pregnancy and childbirth, Oxford medical publications. Oxford [England]; New York: Oxford University Press. ESC (European Society of Cardiology). 2010. Committee for Practice Guidelines (CPG) 2010–2012. http://www.escardio.org/about/who/committees/programmes/ Pages/practice-guidelines.aspx (accessed September 16, 2010).

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50 CLINICAL PRACTICE GUIDELINES WE CAN TRUST Evidence-Based Medicine Working Group, G. Guyatt, J. Cairns, D. Churchill, D. Cook, B. Haynes, J. Hirsh, J. Irvine, M. Levine, M. Levine, J. Nishikawa, D. Sackett, P. Brill-Edwards, H. Gerstein, J. Gibson, R. Jaeschke, A. Kerigan, A. Neville, A. Panju, A. Detsky, M. Enkin, P. Frid, M. Gerrity, A. Laupacis, V. Lawrence, J. Menard, V. Moyer, C. Mulrow, P. Links, A. Oxman, J. Sinclair, and P. Tugwell. 1992. Evidence-based medicine: A new approach to teaching the practice of medicine. JAMA 268(17):2420–2425. FDA (Food and Drug Administration). 2009. FDA issues draft guidance on risk evalu- ation and mitigation strategies. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2009/ucm184399.htm (accessed October 7, 2010). Greenspan, A. M., H. R. Kay, B. C. Berger, R. M. Greenberg, A. J. Greenspon, and M. J. S. Gaughan. 1988. Incidence of unwarranted implantation of permanent cardiac pacemakers in a large medical population. New England Journal of Medi- cine 318(3):158–163. Guidelines International Network. 2010a. About G-I-N: Introduction. http://www. g-i-n.net/about-g-i-n (accessed March 7, 2010). Guidelines International Network. 2010b. Homepage. http://www.g-i-n.net/ (ac- cessed March 7, 2010). Guidelines International Network. 2010c. International Guidelines Library. http:// www.g-i-n.net/library/international-guidelines-library (accessed March 7, 2010). Guyatt, G., E. A. Akl, J. Hirsh, C. Kearon, M. Crowther, D. Gutterman, S. Z. Lewis, I. Nathanson, R. Jaeschke, and H. Schünemann. 2010. The vexing problem of guidelines and conflict of interest: A potential solution. Annals of Internal Medi- cine 152(11):738–741. HHS (Department of Health and Human Services). 2010. Data compendium: Overview. http://www.cms.gov/DataCompendium/ (accessed July 15, 2010). IOM (Institute of Medicine). 1990. Clinical practice guidelines: Directions for a new pro- gram. Edited by M. J. Field and K. N. Lohr. Washington, DC: National Academy Press. IOM. 1992. Guidelines for clinical practice: From development to use. Edited by M. J. Field and K. N. Lohr. Washington, DC: National Academy Press. IOM. 2001. Crossing the quality chasm: A new health system for the 21st century. Wash- ington, DC: National Academy Press. IOM. 2008. Knowing what works in health care: A roadmap for the nation. Edited by J. Eden. Washington, DC: The National Academies Press. IOM. 2009. Conflict of interest in medical research, education, and practice. Edited by B. Lo and M. J. Field. Washington, DC: The National Academies Press. Jacobs, A. 2010. American College of Cardiology and American Heart Association . Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. Jacques, L. B. 2010. Centers for Medicare & Medicaid Services (CMS). Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. Kahn, R. 2010. Former chief of scientific and medical officer of the American Diabetes Asso - ciation. Presented at the IOM Committee on Standards for Developing Trustwor- thy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. KDIGO. 2008. Kidney Disease: Improving Global Outcomes (KDIGO): About Us. http://www. kdigo.org/about_us.php#history (accessed January 21, 2011). Koster, M. A. 2010. Technology assessment and guidelines unit: Kaiser Permanente Southern California. Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC.

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51 BACKGROUND AND KEY STAKEHOLDERS Lohr, K. N., K. Eleazer, and J. Mauskopf. 1998. Health policy issues and applica - tions for evidence-based medicine and clinical practice guidelines. Health Policy 46(1):1–19. Luce, B. R., M. Drummond, B. Jonsson, P. J. Neumann, J. S. Schwartz, U. Siebert, and S. D. Sullivan. 2010. EBM, HTA, and CER: Clearing the confusion. Milbank Quarterly 88(2):256–276. Matchar, D. B., E. V. Westermann-Clark, D. C. McCrory, M. Patwardhan, G. Samsa, S. Kulasingam, E. Myers, A. Sarria-Santamera, A. Lee, R. Gray, and K. Liu. 2005. Dissemination of Evidence-based Practice Center reports. Annals of Internal Medicine 142(2):1120–1125. McKesson Health Solutions LLC. 2004. InterQual clinical decision support tools: Super so- lutions for improving quality and managing resources. http://www.mckesson.com/ static_files/McKesson.com/MHS/Documents/iqbroc_payor.pdf (accessed July 18, 2010). Milliman Care Guidelines. 2009. Milliman Care Guidelines® innovations spur eight-fold growth in hospital client base. http://www.careguidelines.com/company/press/ pr_111209.shtml (accessed November 12, 2009). Milliman Inc. 2009. Milliman Care Guidelines. http://www.milliman.com/expertise/ healthcare/products-tools/milliman-care-guidelines/ (accessed June 9, 2009). NGC (National Guideline Clearinghouse). 2010a. Brief summary: Dementia care practice recommendations for assisted living residences and nursing homes: Phase 3 end-of-life care: National Guideline Clearinghouse. http://www.guideline.gov/summary/ summary.aspx?doc_id=13541&nbr=006925&string=alzheimer’s (accessed March 7, 2010). NGC. 2010b. Guidelines by organization: National Guideline Clearinghouse. http://ngc. gov/browse/by-organization.aspx?alpha=C (accessed September 9, 2010). NGC. 2010c. Inclusion criteria: National Guideline Clearinghouse. http://ngc.gov/submit/ inclusion.aspx (accessed April 5, 2010). NGC. 2010d. NGC browse—organizations. http://ngc.gov/browse/browseorgsbyLtr. aspx (accessed July 15, 2010). NHLBI (National Heart, Lung, and Blood Institute). 2009. Current clinical practice guidelines and reports. http://www.nhlbi.nih.gov/guidelines/current.htm (ac- cessed December 29, 2009). NHS Evidence (National Health Service Evidence). 2010. Guidance producer subject to accreditation: British Transplantation Society. National Institute for Health and Clinical Excellence. http://www.evidence.nhs.uk/Accreditation/Documents/ Brit%20Transpl%20Soc_final%20accreditation%20report_1.6.pdf NICE (National Institute for Health and Clinical Excellence). 2010. Homepage. http:// www.nice.org.uk/ (accessed March 7, 2010). NIH (National Institutes of Health). 2009. NIH Consensus Development Program, fre- quently asked questions. http://consensus.nih.gov/FAQS.htm, http://consensus. nih.gov/ABOUTCDP.htm (accessed December 29, 2009). Oxman, A. D., J. N. Lavis, and A. Fretheim. 2007. Use of evidence in WHO recom - mendations. The Lancet 369(9576):1883–1889. Qaseem, A., V. Snow, D. K. Owens, and P. Shekelle. 2010. The development of clinical practice guidelines and guidance statements of the American College of Physi - cians: Summary of methods. Annals of Internal Medicine 153(3):194–199. Sackett, D. L. 2002. Clinical epidemiology: What, who, and whither. Journal of Clinical Epidemiology 55(12):1161–1166. Schibanoff, J. 2010. Milliman Care Guidelines. Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC.

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52 CLINICAL PRACTICE GUIDELINES WE CAN TRUST Schünemann, H. J., A. Fretheim, and A. D. Oxman. 2006. Improving the use of re - search evidence in guideline development: Guidelines for guidelines. Health Research Policy and Systems 4:13. Simons-Morton, D. 2010. National Heart, Lung, and Blood Institute. Paper presented at the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 11, 2010, Washington, DC. Weisz, G., A. Cambrosio, P. Keating, L. Knaapen, T. Schlich, and V. J. Tournay. 2007. The emergence of clinical practice guidelines. Milbank Quarterly 85(4):691–727. Wennberg, J., and Gittelsohn. 1973. Small area variations in health care delivery. Sci- ence 182(117):1102–1108. Woolf, S. H. 1990. Practice guidelines: A new reality in medicine: Recent develop - ments. Archives of Internal Medicine 150(9):1811–1818.