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Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process

Abstract: This chapter is devoted to the remaining steps in the guideline development process, including standards for establishing evidence foundations for and rating of strength of recommendations, articulation of recommendations, external review, and updating. The committee believes clinical practice guidelines (CPGs) should comply with all eight proposed standards contained within Chapters 4 and 5 to be considered trustworthy. The committee recommends that CPG developers adhere to these standards, and that CPG users adopt CPGs compliant with these standards. However, the committee is sympathetic to the time and other resource requirements the standards require. Complying with the full body of standards may not be feasible immediately for guideline developers, and a process of evolutionary adoption over time may be more practicable. Importantly, whether evidence is lacking or abundant in a particular clinical domain, the committee expects guideline development groups to aspire to meet all standards.

INTRODUCTION

Like Chapter 4, Chapter 5 arose from the committee’s adoption of standards-setting methodologies elaborated in Chapter 1. This chapter is devoted to the remaining domains of the guideline



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5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process Abstract: This chapter is devoted to the remaining steps in the guideline development process, including standards for establish- ing evidence foundations for and rating of strength of recommen- dations, articulation of recommendations, external review, and updating. The committee believes clinical practice guidelines (CPGs) should comply with all eight proposed standards contained within Chapters 4 and 5 to be considered trust- worthy. The committee recommends that CPG developers adhere to these standards, and that CPG users adopt CPGs compliant with these standards. However, the committee is sympathetic to the time and other resource requirements the stan- dards require. Complying with the full body of standards may not be feasible immediately for guideline developers, and a process of evolutionary adoption over time may be more practicable. Impor- tantly, whether evidence is lacking or abundant in a particular clinical domain, the committee expects guideline development groups to aspire to meet all standards. INTRODUCTION Like Chapter 4, Chapter 5 arose from the committee’s adop- tion of standards-setting methodologies elaborated in Chapter 1. This chapter is devoted to the remaining domains of the guideline 109

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110 CLINICAL PRACTICE GUIDELINES WE CAN TRUST development process: establishing evidence foundations for and rat- ing strength of recommendations, articulation of recommendations, external review, and updating. ESTABLISHING EVIDENCE FOUNDATIONS FOR AND RATING STRENGTH OF RECOMMENDATIONS Appraising Evidence Quality and Recommendation Strength: Fundamentals Clinical practice guidelines (CPGs) fundamentally rest on appraisal of the quality of relevant evidence, comparison of the ben- efits and harms of particular clinical recommendations, and value judgments regarding the importance of specific benefits and harms. Historically, value judgments regarding potential outcomes have been made implicitly rather than explicitly, and the basis for judg - ments regarding the quality of evidence and strength of a recom- mendation has often been unclear. As a result, many CPG develop- ers now apply formal approaches to appraising both the evidence quality and the strength of recommendations (Ansari et al., 2009; Schünemann et al., 2006a; Shekelle et al., 2010). Although much has been written about the concept of “qual- of “qual- ity of evidence,” there continues to be considerable variability in what the term is used to describe. Ultimately the term “quality of evidence” is used to describe the level of confidence or certainty in a conclusion regarding the issue to which the evidence relates. And, historically, as detailed hereafter, the notion of quality has empha- sized research design, so that evidence quality evaluations arose from the inherent rigor (e.g., RCT vs. uncontrolled case series) of study designs. This certainty or confidence is frequently expressed by assigning a score, rating, or grade (typically in the form of numer- als, letters, symbols, or words) to the quality of evidence. Although critically important, it must be underscored that evidence quality as it often has been construed, is not the only factor that needs to be considered when drawing a conclusion regarding optimal clinical practice. Other considerations include the relevance of available evi- dence to a patient with particular characteristics; the quantity (i.e., volume and completeness) and consistency (i.e. conformity of find - ings across investigations) of available evidence; and the nature and estimated magnitude of particular impacts of an individual clinical practice and value judgments regarding the relative importance of those different impacts (Verkerk et al., 2006).

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111 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS Clinical practice recommendations typically are based on con-con- sideration of a body of evidence, as well as clinical judgments extending from experience and potential variation in patient pref - erences. For example, high-quality evidence from well-designed and -conducted clinical trials demonstrates that administration of oral anticoagulants to patients with a first spontaneous deep vein thrombosis reduces risk of recurrent thromboembolic events. Yet, differences in patient risk of bleeding complications and in patient value judgments regarding harms associated with oral anticoagula- tion therapy, including bleeding risk and the inconvenience related to taking medication and monitoring anticoagulation levels, permit only a weak recommendation regarding whether all patients with a first spontaneous deep vein thrombosis should be treated with oral anticoagulants (Buller et al., 2004). Economic value also can be included in the strength of recom- mendation decision process, as it relates to patients’ out-of-pocket costs or overall healthcare spending. For a health care intervention to have value, clinical and economic benefits need to be greater than clinical harms and economic costs. Although value is a com- mon term in health care, it has not been defined or studied in a way that is accepted well by the majority of members of the health care evidence community. Value rarely is considered in CPGs, yet the committee acknowledges that patient preferences are often based in part on out-of-pocket costs that may affect their personal decisions about alternative care options (Luce et al., 2010). Consideration of these latter factors, as well as the fact that evidence regarding several different issues needs to be considered by CPG developers, has given rise to the concept of strength of a recommendation regarding a particular patient management issue. Strength of a recommendation needs to reflect the degree of con- fidence that all patients would have so they would conclude that desirable outcomes of a recommendation outweigh the undesirable. Like evidence quality, this certainty or confidence is captured by a score, rating, or grading (commonly taking the form of numerals, letters, symbols, or words) assigned to the clinical recommendation (Swiglo et al., 2008). The appraisal of CPG evidence and recommendations presents considerable complexity, and a number of alternative strategies have been developed for these purposes. The literature demonstrates variability in rating the same evidence when employing varying appraisal systems, and variability in rating when identical systems are applied to identical evidence by different individuals (Ferreira et

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112 CLINICAL PRACTICE GUIDELINES WE CAN TRUST al., 2002). Judgments employed in translating evidence into a clinical recommendation are even more variable than those applied to evi- dence quality because their subjectivity (e.g., comparing disparate benefits and harms) is even greater (Calonge and Harris, 2010). Yet, the literature also suggests that a reduction in variability may be achieved by employment of structured, explicit approaches (Uhlig et al., 2006). Additionally, there is a consensus among most guideline devel- opers that standardized rating of evidence quality facilitates the balancing of benefits and harms requisite to healthcare decision making and guideline recommendation formulation. Furthermore, some have argued that an explicit, systematic scheme for assessing evidence quality and strength of recommendations likely results in reduced errors in judgment, increased facility in evaluating such judgments, and improved communication of related content by guideline developers (Atkins et al., 2004). CPG users need to under- stand the evidentiary basis of and value judgments associated with particular recommendations (Schünemann et al., 2006a). Over the past decade, guideline developers have recognized the value of providing an efficient summary of the strength of recommendations, and quality of evidence buttressing them, in enhancing clinicians’ comprehension of a CPG’s basic clinical message (Swiglo et al., 2008). Moreover, a small empirical literature suggests that adopters of clini- cal guidelines’ healthcare recommendations prefer detailed, explicit knowledge about the underlying quality of evidence and strength of recommendations (Akl et al., 2007; Shekelle et al., 2010). Rating Quality of Evidence and Strength of Recommendation: State of the Art Rating of healthcare recommendations, specifically, began with the Canadian Task Force on the Periodic Health Examination more than three decades ago (Anonymous, 1979). The scheme was founded on study design exclusively, with randomized controlled trials (RCTs) classified as good (Level 1) evidence; cohort and case control studies as fair (Level II); and expert opinion classified as poor (Level III) evidence. Recommendation strength was derived from the quality of evidence so that a strong recommendation (i.e., A) was based on good (i.e., Level I) evidence. The attractiveness of the Canadian Task Force approach was its simplicity and attendant ease of comprehension, application, and presentation. However, this approach did not consider how well a particular type of study (e.g., RCT) was designed or executed or the number of patients included in particular studies. Furthermore, the rating applied only to the

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113 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS quality of evidence. The Canadian Task Force made no effort to rate the strength of their recommendations (e.g., balance of benefits and harms) (Atkins et al., 2004). Numerous systems for appraising quality of evidence and strength of recommendations have evolved since, representing efforts of multiple, varied entities involved in guideline develop- ment. These systems range from the simple, founded exclusively on research design, and ignoring methodological details of studies, con- sistency of effects, and clinical relevance and generalizability of the patient population that was studied, to the more structured, which move beyond research design to the complexity of methods and the subjectivity of their appraisal. These schemes also vary with respect to the audiences and clinical foci they address. However, overall, the approaches include a strategy for rating the evidence, resulting in the assignment of an ordinal score (e.g., good, fair, poor; A, B, C; 1++, 1+, 1–, 2++, 2+, 2–, 3, 4) driven by methodological quality (e.g., RCTs without important limitations, RCTs with important limita- tions, observational studies, case series) of the available evidence. The second component they share is a strategy for rating recommen- dation strength resulting in assignment of a dichotomous or ordinal score (e.g., strong recommendation, weak recommendation; A, B, C, D; GRADE I, GRADE II, GRADE III) derived from consideration of evidence quality and the trade-offs between recommendation benefits and harms. In general, when CPG developers are confident that the ben- eficial effects of a recommendation adherence outweigh the harms, a strong recommendation can be made. A strong recommendation commonly depends on high- or moderate-quality evidence regard- ing important patient outcomes. Much less often, CPG developers may offer strong recommendations on the basis of low- to very low- quality evidence. This occurrence is the result of guideline develop- ment group (GDG) confidence that benefits of a recommendation outweigh harms or vice versa. On the other hand, a weak recom- mendation commonly arises from development group judgment that the benefits of a recommendation outweigh harms; however, their confidence in this balance is not high (e.g., benefits and harms closely balanced, uncertain balance of benefits and harms). Hence, low or very low, or even very high evidence quality may result in weak recommendations due to a complex or uncertain benefits/ harms trade-off (Swiglo et al., 2008). Further specifications of rating schemes are captured within a selection of prominent approaches provided in Appendix D. Although the literature argues in support of a mechanism for scoring quality of evidence and strength of recommendations, and

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114 CLINICAL PRACTICE GUIDELINES WE CAN TRUST a vast majority of GDGs apply one, we noted earlier the specific challenges in their application (Schünemann et al., 2006a). In addi- Schünemann et addi- tion, there is widespread agreement that the area of appraisal over- all is “besieged with problems” (Kavanagh, 2009). In 2004, Atkins and colleagues conducted a comparison of six well-respected sys- tems, those of the American College of Chest Physicians, Austral - ian National Health and Medical Research Council, Oxford Center for Evidence-Based Medicine, Scottish Intercollegiate Guidelines Network, U.S. Preventive Services Task Force, and U.S. Task Force on Community Preventive Services (Atkins et al., 2004). Atkins and colleagues (2004) identified a number of additional systems in use by 51 organizations, which have developed from 2 to greater than 10 CPGs and applied an explicit scheme to assess the quality of evidence or strength of recommendations. These additional systems reflect those six approaches fully investigated by the authors, with slight variations. The authors’ findings are based on assessments of all 6 systems by 12 independent evaluators applying 12 indicators of system “sensibility” or overall utility. These authors’ analyses uncovered poor agreement among assessors (Atkins et al., 2004), and still others claim the discord is indicative of the questionable validity of any unique scheme (Kavanagh, 2009). Atkins and coauthors (2004) offer detailed qualitative insight into the state of the art of evidence quality and recommendation strength assessment. Their evaluation indicates the following: 1. No one system was uniformly endorsed as clear and simple, and the clearer a system, the less likely it was simple to apply. 2. For most approaches data necessary to employ them would at least sometimes be unavailable. 3. All systems were missing at least one critical dimension. 4. Although certain systems were considered to have some ability to discriminate, none of the systems was regarded as likely to clearly articulate the difference between quality of evidence and strength of recommendations. 5. There was uncertainty regarding the reproducibility of the assessment using any of the tools (Atkins et al., 2004). Based on these findings and in pursuit of an improved strategy for evidence quality and strength of recommendations appraisal, the Grades of Recommendation Assessment, Development and Evalu- ation (GRADE) was published in 2004 (Atkins, 2004). GRADE has been adopted “unchanged or with only minor modifications” by a

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115 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS large number and variety of organizations, including governments, professional medical societies, and UpToDate, a medical resource accessed online that is used by a majority of U.S. academic medical centers (Schünemann et al., 2006b). GRADE’s advantages include its (1) applicability across a great variety of clinical areas (e.g., pre - vention and therapy); (2) accounting for individual preferences and values; and (3) treatment of the quality of evidence and the strength of recommendation in a transparent, explicit manner. CPGs and recommendations applying the approach typically increase users’ understanding of the rationale for CPG recommendations’ deriva- tion (Calonge and Harris, 2010). However, as in the case of the larger body of appraisal tools, criticism has been directed at GRADE, much of it reflecting the issues raised herein. As indicated above, a feature common to all rat- ing systems is the part played by individual judgment, and although judgment criteria are well specified in GRADE, the identical body of evidence can be appraised differently by judges with different indi- vidual biases or values. Furthermore, although GRADE explicitly describes the means by which a recommendation is achieved, the system may result in discordance in translating evidence into rec- ommendations among GDGs and potentially within a single group across varying clinical actions (Calonge and Harris, 2010). In fact, empirical assessment of the reliability of GRADE, conducted by the authors of the system, has resulted in findings of very low inter- rater agreement for quality of evidence judgments. Furthermore, although theoretical underpinnings of GRADE are provided in mul- tiple publications (Atkins, 2004; Atkins et al., 2004, 2005; Guyatt et al., 2006a,b, 2008b; Schünemann et al., 2006b), empirical assessment of the validity of GRADE is absent from the literature. Derived from GRADE is the American College of Physicians (ACP) system for appraising evidence quality and strength of rec- ommendations. The ACP judges evidence to be of high quality when it is based on one or more well-designed and well-conducted RCTs, giving rise to consistent findings directly applicable to the target population (Qaseem et al., 2010). Moderate-quality evidence is that derived from RCTs characterized by significant deficiencies (e.g., large losses to follow-up, lack of blinding); indirect evidence arising from similar populations; and RCTs that include a small number of subjects or observed events. Additionally, well-designed and non- randomized controlled trials, well-designed cohort or case control analytic studies, and multiple time-series designs comprise moderate- quality evidence. Low-quality evidence commonly derives from observational investigations; yet such evidence may be regarded as

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116 CLINICAL PRACTICE GUIDELINES WE CAN TRUST moderate or perhaps high, as determined by specifics of research methods (e.g., dose–response relationship, large observed effect). ACP guideline recommendations are graded as strong or weak. A strong recommendation indicates that benefits clearly outweigh harms, or harms clearly outweigh benefits. Weak recommendations result from precariously balanced benefits and harms or a high level of uncertainty regarding magnitude of benefits and harms. Lastly, in the case of a dearth of, conflicting, or poor quality of evidence driv- ing support of or opposition to clinical action, the ACP rates the rec- ommendation as “insufficient evidence to determine net benefits or risks” because the balance of benefits and harms cannot be achieved (Qaseem et al., 2010, p. 196). The ACP’s detailed interpretation of its system for grading the quality of evidence and strength of recommendations, provided in Table 5-1 below, depicts and defines elements basic to appraisal and understanding relationships between evidence quality and rec - ommendation strength. It also highlights the implications of those relationships for clinical practice. Currently available approaches to rating evidence quality and strength of recommendation are of utility, but not adequate. They provide transparent, systematic frameworks for clinical recommen- dations’ derivation extending from consideration of evidence qual - ity, in contrast to an unsystematic, implicit, non-transparent, intui- tive approach. With this, these strategies allow for inspection of the methods and judgments involved in translating evidence into clini- cal recommendations, thereby increasing trustworthiness of CPGs (Ansari et al., 2009; Calonge and Harris, 2010; Kavanagh, 2009). As one aspect of establishing evidence foundations for, and ulti- mately deriving, evidence-based, clinically valid recommendations, the committee supports adoption of systematic methods for rating quality of evidence and strength of recommendations, which include the elements discussed above. Integrating Guideline Development Group Values Explaining Variation in Evidence Interpretation CPG development usually requires interpretation of evidence regarding many different issues. Therefore, recommendations ad- dressing the same topic may vary among guidelines. This is espe - cially the case in the setting of low-quality evidence because judg- ment is more likely to come into play when evidence is limited or of low quality (Burgers et al., 2002).

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TABLE 5-1 Interpretation of the American College of Physicians’ Guideline Grading System Methodological Grade of Benefit Versus Quality of Supporting Recommendation Risks and Burdens Evidence Interpretation Implications Strong Benefits clearly Randomized Clinical Strong recommendation; For patients, would want the recommendation; outweigh risks and Trials (RCTs) without can apply to most recommended course of action high-quality burden or vice versa important limitations or patients in most and only a small proportion evidence overwhelming evidence circumstances without would not; a person should from observational reservation request discussion if the studies intervention was not offered Strong Benefits clearly RCTs with important For clinicians, most recommendation; outweigh risks and limitations (inconsistent patients should receive the moderate-quality burden or vice versa results; methodological recommended course of action evidence flaws; indirect, imprecise, For policy makers, the or exceptionally recommendation can be strong evidence from adopted as a policy in most observational studies) situations Strong Benefits clearly Observational studies Strong recommendation, recommendation; outweigh risks and or case series but may change when low-quality burden or vice versa higher quality evidence evidence becomes available Weak Benefits closely RCTs without Weak recommendation; For patients, most would want recommendation; balanced with risks and important limitations or best action may the recommended course of high-quality burden overwhelming evidence differ depending action, but some would not—a evidence from observational on circumstances or decision may depend on an studies patients’ or societal individual’s circumstances values 117 continued

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TABLE 5-1 Continued Methodological 118 Grade of Benefit Versus Quality of Supporting Recommendation Risks and Burdens Evidence Interpretation Implications Weak Benefits closely RCTs with important For clinicians, different choices recommendation; balanced with risks and limitations (inconsistent will be appropriate for different moderate-quality burden results, methodological patients, and a management evidence flaws, indirect, decision consistent with a or imprecise) or patient’s values, preferences, exceptionally strong and circumstances should be evidence from reached observational studies For policy makers, policy making will require substantial debate and involvement of many stakeholders Weak Uncertainty in the Observational studies or Very weak recommendation; estimates of benefits, case Series recommendations; low-quality risks, and burden; other alternatives may evidence benefits, risks, and be equally reasonable burden may be closely balanced Insufficient Balance of benefits Evidence is conflicting, Insufficient evidence For patients, decisions based on and risks cannot be poor quality, or lacking to recommend for evidence from scientific studies determined or against routinely cannot be made; for clinicians, providing the service decisions based on evidence from scientific studies cannot be made; for policy makers, decisions based on evidence from scientific studies cannot be made SOURCE: Qaseem et al. (2010).

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119 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS Eisinger and coauthors (1999) investigated U.S. and French con- sensus statements regarding breast and ovarian cancer that identi- fied important distinctions in clinical recommendations, particularly given clinical uncertainty. Both consensus statements indicated that mastectomy and oophorectomy are reasonable options for women at high cancer risk, even given inadequate evidence and demon- strations of later breast or ovarian cancer development in women undergoing the procedures. However, the recommendations are vastly different. The French guidelines assert that physicians should “oppose” prophylactic mastectomy in women under age 30 and pro- phylactic oophorectomy under age 35, and these treatment options should be considered only when a breast cancer risk is greater than 60 percent and an ovarian cancer risk is greater than 20 percent. In the United States, informed choice is adequate justification to per- form both surgeries. Eisinger and coauthors (1999) suggested that clinician opposition to delegating decision making to patients is less palatable to the French medical community. Simultaneously, this viewpoint would be perceived as paternalistic to American patients and providers who are embedded in a context where patient prefer- ences and participatory decision making are highly valued. How- ever, even within national borders, credible guideline development groups reach contrasting conclusions despite a common evidence base, as Box 5-1 illustrates. Burgers and colleagues investigated 15 Type 2 diabetes CPGs from 13 countries in an attempt to identify variables influential to clinical recommendations (Burgers et al., 2002). In essence, the authors corroborated prior findings in determining that research evidence is not always the most important contributor to practice guideline recommendation content. Instead their results demon- strate there is little consistency in studies selected for review. Ref - erences serving as evidentiary foundations for recommendations were highly variable across 15 guidelines investigated. Specifically, when considering a single CPG, only 18 percent of citations were consistent with those of any other guideline. Only 1 percent of cita- tions were overlapping across six or more guidelines. In spite of this, the level of guideline recommendation concordance was strong, with a high degree of international consensus on the clinical care of Type 2 diabetes. Burgers and coauthors assert that “Guideline development is a social as well as technical process that is affected by access to and choice of research evidence and decisions about the interpretation of evidence and formulation of recommendations . . . guidelines go beyond simple reviews of available evidence and necessarily reflect value judgments in considering all the issues

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134 CLINICAL PRACTICE GUIDELINES WE CAN TRUST 7. External Review 7.1 External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical ex- perts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and repre- sentatives of the public. 7.2 The authorship of external reviews submitted by individ- uals and/or organizations should be kept confidential un- less that protection has been waived by the reviewer(s). 7.3 The GDG should consider all external reviewer com- ments and keep a written record of the rationale for mod- ifying or not modifying a CPG in response to reviewers’ comments. 7.4 A draft of the CPG at the external review stage or imme- diately following it (i.e., prior to the final draft) should be made available to the general public for comment. Reasonable notice of impending publication should be provided to interested public stakeholders. UPDATING Clinical practice guideline recommendations often require updating, although how often and by what process are debated. For certain clinical areas, frequent updating may be necessary given a preponderance of new evidence affecting treatment recommen- dations. Johnston et al. concluded that for purposes of updating cancer care guidance, a quarterly literature search was appropriate, although the product of this varied across cancer guideline topical emphases (Johnston et al., 2003). A review process detailed on the National Comprehensive Can- cer Network (NCCN) website includes a continuous institutional review, whereby each NCCN panel member is sent the current year’s guideline for distribution to institutional experts for com- ment. Additionally, an annual panel review consisting of a full-day meeting takes place every 3 years and conference calls or in-person meetings are conducted for updates between meetings (NCCN, 2003). However, as alluded to above, there is evidence that recurrent updating may not be an efficient activity in all clinical areas. In a 2002 study of updated (from 1994/95 to 1998/99) primary care evidence-based guidelines of angina and asthma in adults, Eccles stated, The fact that recommendations were not overturned and only one new drug treatment emerged suggests that, over the 3-year period

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135 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS from initial development to updating, the evidence base for both guidelines was relatively stable. This, plus the fact that there were few financial savings to be made within the updating process, highlights the questions of how frequently the updating process should be performed and whether or not it should be performed in its entirety or only in new areas. (Eccles, 2002, p. 102) Shekelle et al. (2001) argued there are six situations (termed the “situational” approach) that may necessitate the updating of a clini- cal practice guideline: 1. Changes in evidence on the existing benefits and harms of interventions 2. Changes in outcomes considered important 3. Changes in available interventions 4. Changes in evidence that current practice is optimal 5. Changes in values placed on outcomes 6. Changes in resources available for health care Changes in values placed on outcomes often reflect societal norms. Measuring values placed on outcomes and how these change over time is complex and has not been systematically studied. When changes occur in the availability of resources for health care or the costs of interventions, a generic policy on updating is unlikely to be helpful because policy makers in disparate healthcare sys - tems consider different factors in deciding whether services remain affordable. Most empirical effort in this area has been directed to defining when new evidence on interventions, outcomes, and performance justifies updating guidelines. This process includes two stages: (1) identifying significant new evidence, and (2) assessing whether new evidence warrants updating. Within any individual guideline, some recommendations may be invalid while others remain current. A guideline on congestive heart failure, for example, includes 27 indi- vidual recommendations related to diagnosis (Jessup et al., 2009). How many must be invalid to require updating the entire guideline? Clearly a guideline requires updating if a majority of recommenda- tions is out of date, with current evidence demonstrating that recom- mended interventions are inappropriate, ineffective, superseded by new interventions, or no longer or newly generalizable to a particular population. In other cases a single, outdated recommendation could invalidate an entire document. Typically, Eccles reported in 2002, no systematic process exists to help determine whether, and in what areas, researchers have published significant new evidence (Eccles, 2002). Judgments about whether a guideline’s recommendation(s)

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136 CLINICAL PRACTICE GUIDELINES WE CAN TRUST requires updating typically are inherently subjective and reflect the clinical importance and number of invalid recommendations. In a relatively unusual empirical exercise, Shekelle and col- leagues (2001) applied the six situational criteria presented above to assessment of need for updating 17 clinical guidelines published by the Agency for Healthcare Research and Quality. They found seven guidelines were so out of date a major update was required; six guidelines required a minor update; three guidelines remained valid; and one guideline’s update needs were inconclusive. The authors concluded that, as a general rule, guidelines should be reevaluated no less frequently than every 3 years. Perhaps not coincidentally, in an evaluation of the need for updating systematic reviews, Shojania and colleagues found that nearly one quarter of systematic reviews are likely to be outdated 2 years after publication (Shojania et al., 2007). Shekelle and coauthors’ (2001) methods provide for a balanc- ing of guideline updating costs and benefits from the perspective that a full redevelopment is not always appropriate. Gartlehner and colleagues (2004) directly addressed this issue in comparing the Shekelle et al. “situational” approach to a “tradi - tional” updating strategy (comparable to de novo guideline devel- opment) across six topics from the 1996 U.S. Preventive Services Task Force Guide to Clinical Preventive Services (USPSTF, 1996). The authors examined completeness of study identification, importance of studies missed, and resources required. Gartlehner and coauthors demonstrated that “Although the [Shekelle] approach identified fewer eligible studies than the traditional approach, none of what the studies missed was rated as important by task force members acting as liaisons to the project with respect to whether the topic required an update. On average, the [Shekelle] approach produced substantially fewer citations to review than the traditional approach. The effort involved and potential time savings depended largely on the scope of the topic.” On the basis of these findings, Gartlehner and coauthors concluded that, “The [Shekelle] approach provides an efficient and acceptable method for judging whether a guideline requires updating” (Gartlehner et al., 2004, p. 399). From the time it publishes a CPG, the ACC/AHA Guidelines Task Force requires that a research analyst and committee chair monitor significant new clinical trials and peer-reviewed literature, and compare current guideline recommendations against latest topi- cal evidence. At the behest of the entire guideline-writing commit - tee, a full revision of the guideline is required when at least two previous focused updates and/or new evidence suggests that a significant number of recommendations require revision. Revisions

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137 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS are managed as new guidelines, except for writing committee selec - tion, where half of the previous writing committee is rotated off to allow for the inclusion of new members (ACCF and AHA, 2008). Similar methods have been enshrined within the processes of other guideline development programs. In the United Kingdom, NICE recommends a combination of literature searching and profes- sional opinion to inform the need for “full” or “partial” updates and describes related processes. Changes in relevant evidence as well as guideline scope (outcomes of important or available interventions) are emphasized. The assessment of update need occurs every 3 years. In the National Guideline Clearinghouse, admitted guidelines are required to have been reexamined every 5 years (NGC, 2010a). Overall, another point to emphasize is that “Many guidelines in current use were developed before criteria were available to evaluate guideline quality. Efforts to improve quality should not be limited to frequent updates of the underlying evidence review, but should incorporate other guideline improvements during the revision pro- cess” (Clark et al., 2006, p. 166). Moreover, attempts at harmoniza- tion of guidelines from different development groups may also be an appropriate consideration at the time of updating. 8. Updating 8.1 The CPG publication date, date of pertinent systematic evidence review, and proposed date for future CPG review should be documented in the CPG. 8.2 Literature should be monitored regularly following CPG publication to identify the emergence of new, potentially relevant evidence and to evaluate the continued validity of the CPG. 8.3 CPGs should be updated when new evidence suggests the need for modification of clinically important recom- mendations. For example, a CPG should be updated if new evidence shows that a recommended intervention causes previously unknown substantial harm; that a new intervention is significantly superior to a previously rec- ommended intervention from an efficacy or harms per- spective; or that a recommendation can be applied to new populations. CONCLUSION For a clinical practice guideline to be deemed trustworthy, the committee believes that adherence to the proposed development

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138 CLINICAL PRACTICE GUIDELINES WE CAN TRUST standards articulated within Chapters 4 and 5 is essential, and thus recommends the following: RECOMMENDATION: TRUSTWORTHINESS OF CPG DEVELOPMENT PROCESS • To be trustworthy, a clinical practice guideline should comply with proposed standards 1–8. • Optimally, CPG developers should adhere to these pro- posed standards and CPG users should adopt CPGs com- pliant with these proposed standards. In total, the committee’s standards reflect best practices across the entire development process and thus comprise those relevant to establishing transparency, management of conflict of interest, devel- opment team composition and process, clinical practice guideline– systematic review intersection, establishing evidence foundations for and rating strength of recommendations, articulation of recom- mendations, external review, and updating. Although the committee strongly supports that CPGs comply with the eight standards proposed herein, it is also sympathetic to the time and other resource requirements the standards imply. It may not be feasible, for example, for guideline developers to immediately comply with the full body of standards, and a process of evolutionary adoption over time may be more practicable. Addi- tionally, certain standards, such as those directed to patient and public involvement in the CPG development process and external review, may appear particularly resource intensive. The committee urges developers to comply with such standards while taking care to adopt each of their key elements (e.g., adoption of strategies to increase effective participation of patient and consumer representa- tives) so that efficiencies may be increased. Finally, the committee understands that the uniqueness of guideline development contexts may seemingly preclude certain developers from fully adhering to the standards the committee has proposed. For example, certain clinical areas (e.g., rare malignant tumors) are characterized by an exceptional dearth of scientific lit- erature and an urgent need to deliver patient care. The committee recognizes that developers in this instance may conclude they are unable to comply with Standard 4.1: “Clinical practice guideline developers should use systematic reviews that meet standards set by the Institute of Medicine’s Committee on Standards for Systematic Reviews of Comparative Effectiveness Research.” However, SRs that conclude there are no high-quality RCTs or observational studies

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139 TRUSTWORTHY CPGs: PART II, TRAVERSING THE PROCESS on a particular clinical question would still fulfill Standard 4. In all cases, whether evidence is limited or abundant, GDGs should comply with the complementary Standard 5: “Establishing Evidence Foundations for and Rating Strength of Recommendations,” by pro- viding a summary of relevant available evidence (and evidentiary gaps), descriptions of the quality (including applicability), quantity (including completeness), and consistency of the aggregate avail - able evidence; an explanation of the part played by values, opinion, theory, or clinical experience in deriving recommendations; a judg - ment regarding the level of confidence in (certainty regarding) the evidence underpinning the recommendations; and a rating of the strength of recommendations. REFERENCES ACCF and AHA (American College of Cardiology Foundation and American Heart Association). 2008. Methodology manual for ACCF/AHA guideline writing committees. In Methodologies and policies from ACCF/AHA taskforce on practice guidelines. ACCF and AHA. AGREE (Appraisal of Guidelines for Research & Evaluation). 2001. Appraisal of Guide- lines for Research & Evaluation (AGREE) Instrument. AHRQ (Agency for Healthcare Research and Quality). 2008. U.S. Preventive Services Task Force procedure manual. AHRQ Publication No. 08-05118-EF. http://www. ahrq.gov/clinic/uspstf08/methods/procmanual.htm (accessed February 16, 2009). Akl, E. A., N. Maroun, G. Guyatt, A. D. Oxman, P. Alonso-Coello, G. E. Vist, P. J. Devereaux, V. M. Montori, and H. J. Schünemann. 2007. Symbols were superior to numbers for presenting strength of recommendations to health care consum - ers: A randomized trial. Journal of Clinical Epidemiology 60(12):1298–1305. Anonymous. 1979. Canadian task force on the periodic health examination: The pe - riodic health examination. CMAJ 121:1193–1254. Ansari, M. T., A. Tsertsvadze, and D. Moher. 2009. Grading quality of evidence and strength of recommendations: A perspective. PLoS Medicine 6(9):e1000151. Atkins, D. 2004. Grading quality of evidence and strength of recommendations. BMJ 328(7454):1490. Atkins, D., M. Eccles, S. Flottorp, G. H. Guyatt, D. Henry, S. Hill, A. Liberati, D. O’Connell, A. D. Oxman, B. Phillips, H. Schünemann, T. T. T. Edejer, G. E. Vist, and J. W. Williams, Jr. 2004. Systems for grading the quality of evidence and the strength of recommendations I: Critical appraisal of existing approaches. BMC Health Services Research 4(38):1–7. Atkins, D., P. Briss, M. Eccles, S. Flottorp, G. Guyatt, R. Harbour, S. Hill, R. Jaeschke, A. Liberati, N. Magrini, J. Mason, D. O’Connell, A. Oxman, B. Phillips, H. Schünemann, T. Edejer, G. Vist, J. Williams, and The Grade Working Group. 2005. Systems for grading the quality of evidence and the strength of recommen- dations II: Pilot study of a new system. BMC Health Services Research 5(1):25. Bogardus, S. T., Jr., E. Holmboe, and J. F. Jekel. 1999. Perils, pitfalls, and possibilities in talking about medical risk. JAMA 281(11):1037–1041.

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