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Clinical Practice Guidelines We Can Trust (2011)

Chapter: 5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process

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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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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 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

development process: establishing evidence foundations for and rating 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 benefits 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 judgments regarding the quality of evidence and strength of a recommendation has often been unclear. As a result, many CPG developers 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 “quality 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 emphasized 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 numerals, 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 evidence to a patient with particular characteristics; the quantity (i.e., volume and completeness) and consistency (i.e. conformity of findings 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).

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

Clinical practice recommendations typically are based on consideration of a body of evidence, as well as clinical judgments extending from experience and potential variation in patient preferences. 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 anticoagulation 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 recommendation 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 common 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 confidence 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

al., 2002). Judgments employed in translating evidence into a clinical recommendation are even more variable than those applied to evidence 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 developers 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 understand 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 clinical 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

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 development. These systems range from the simple, founded exclusively on research design, and ignoring methodological details of studies, consistency 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 limitations, observational studies, case series) of the available evidence. The second component they share is a strategy for rating recommendation 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 beneficial 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 regarding 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 development group (GDG) confidence that benefits of a recommendation outweigh harms or vice versa. On the other hand, a weak recommendation 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

a vast majority of GDGs apply one, we noted earlier the specific challenges in their application (Schünemann et al., 2006a). In addition, there is widespread agreement that the area of appraisal overall is “besieged with problems” (Kavanagh, 2009). In 2004, Atkins and colleagues conducted a comparison of six well-respected systems, those of the American College of Chest Physicians, Australian 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 Evaluation (GRADE) was published in 2004 (Atkins, 2004). GRADE has been adopted “unchanged or with only minor modifications” by a

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

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., prevention 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’ derivation (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 rating 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 individual 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 recommendations 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 multiple 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 recommendations. 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

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 driving support of or opposition to clinical action, the ACP rates the recommendation 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 recommendation 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 recommendations’ derivation extending from consideration of evidence quality, in contrast to an unsystematic, implicit, non-transparent, intuitive approach. With this, these strategies allow for inspection of the methods and judgments involved in translating evidence into clinical 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 ultimately 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 addressing the same topic may vary among guidelines. This is especially the case in the setting of low-quality evidence because judgment is more likely to come into play when evidence is limited or of low quality (Burgers et al., 2002).

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

TABLE 5-1 Interpretation of the American College of Physicians’ Guideline Grading System

Grade of Recommendation

Benefit Versus Risks and Burdens

Methodological Quality of Supporting Evidence

Interpretation

Implications

Strong recommendation; high-quality evidence

Benefits clearly outweigh risks and burden or vice versa

Randomized Clinical Trials (RCTs) without important limitations or overwhelming evidence from observational studies

Strong recommendation; can apply to most patients in most circumstances without reservation

For patients, would want the recommended course of action and only a small proportion would not; a person should request discussion if the intervention was not offered

Strong recommendation; moderate-quality evidence

Benefits clearly outweigh risks and burden or vice versa

RCTs with important limitations (inconsistent results; methodological flaws; indirect, imprecise, or exceptionally strong evidence from observational studies)

 

For clinicians, most patients should receive the recommended course of action For policy makers, the recommendation can be adopted as a policy in most situations

Strong recommendation; low-quality evidence

Benefits clearly outweigh risks and burden or vice versa

Observational studies or case series

Strong recommendation, but may change when higher quality evidence becomes available

 

Weak recommendation; high-quality evidence

Benefits closely balanced with risks and burden

RCTs without important limitations or overwhelming evidence from observational studies

Weak recommendation; best action may differ depending on circumstances or patients’ or societal values

For patients, most would want the recommended course of action, but some would not—a decision may depend on an individual’s circumstances

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

Grade of Recommendation

Benefit Versus Risks and Burdens

Methodological Quality of Supporting Evidence

Interpretation

Implications

Weak recommendation; moderate-quality evidence

Benefits closely balanced with risks and burden

RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies

 

For clinicians, different choices will be appropriate for different patients, and a management decision consistent with a patient’s values, preferences, and circumstances should be reached

For policy makers, policy making will require substantial debate and involvement of many stakeholders

Weak recommendation; low-quality evidence

Uncertainty in the estimates of benefits, risks, and burden; benefits, risks, and burden may be closely balanced

Observational studies or case Series

Very weak recommendations; other alternatives may be equally reasonable

 

Insufficient

Balance of benefits and risks cannot be determined

Evidence is conflicting, poor quality, or lacking

Insufficient evidence to recommend for or against routinely providing the service

For patients, decisions based on evidence from scientific studies cannot be made; for clinicians, 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).

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

Eisinger and coauthors (1999) investigated U.S. and French consensus statements regarding breast and ovarian cancer that identified 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 demonstrations 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 prophylactic 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 perform 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 preferences and participatory decision making are highly valued. However, 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 demonstrate there is little consistency in studies selected for review. References 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 citations 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

BOX 5-1

Guidelines with Conflicting Recommendations

The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPHGAN), the National Institutes of Health (NIH) Consensus Development Conference on Celiac Disease, and the American Gastroenterological Association’s recommendations conflict on the common scenario of whether to screen an asymptomatic sibling of a patient recently diagnosed with celiac disease. The likely cause of discrepancy is differing positions on how to value benefits of screening (reduced risk of lymphoma, reversal of undetected nutritional deficiency, and improvement in general well-being) against potential harms (inconvenience of maintaining a gluten-free diet and adverse psychological effects of chronic disease diagnosis) to an asymptomatic individual. NASPHGAN concludes that benefits outweigh potential harms and thus recommends screening, while the NIH concludes the opposite, and the American Gastroenterological Association resides between the two, advocating shared decision making between provider and patient.


SOURCES: Elson et al. (2004); Hill et al. (2005); Rostom et al. (2006).

relevant to clinical decision making” (Burgers et al., 2002, p. 1937). Michie et al. (2007) also discussed an investigation conducted by Hemingway and colleagues that led to the discovery that two independent expert panels provided with identical research evidence on angina derived contrasting therapeutic recommendations. Of note, the authors identified a twofold difference between panels in their estimates of therapeutic underuse for some patient subgroups (Michie et al., 2007).

Hence, the literature asserts that guideline recommendations do not always emerge directly from empirical evidence reviewed by a GDG. Bodies of complementary work offer some explanatory insight regarding this phenomenon, as well as the variety of strategies that GDGs might employ to address it. In an exploration of the relationship between research evidence and GDG clinical judgment, Raine and coauthors (2004) found agreement between the evidence and clinical judgments 51 percent of the time. Factors identified as influential in the divergence of evidence and recommendations included: weak or non-applicable evidence; clinical experience; patient preferences; treatment availability; and clinician values. Overall, in examining explanations for the disagreement, the authors found greater concordance if evidence upheld clinical experience and beliefs. Acceptance of evidence was more likely if

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

it agreed with current clinical practice. With inconsistency between clinical experience and beliefs, and the scientific evidence, the former appeared to prevail. These authors concluded, “Our findings support the idea that evidence is used to confirm preexisting opinions rather than change them. Guidelines cannot be deduced from research evidence alone. Statements about what should be done in particular circumstances necessarily depend on interpretation of the evidence and on clinicians’ experience, beliefs, and values” (Raine et al., 2004, p. 436).

More specifically, the literature addresses the influence of particular scientific evidentiary contexts on recommendation-related decision making. Typically, when the science clearly demonstrates that there is a substantial net benefit (benefit minus harms) of an intervention (e.g., coronary artery bypass graft for left main coronary artery disease), or that an intervention is ineffective or harmful (e.g., bone marrow transplant for breast cancer), the need to consider values and preferences may be less important. However, two circumstances commonly occur in guideline development that require sensitivity to personal preferences and subjective judgments.

First, when evidence is unclear, judgments about magnitude of intervention effects are often swayed by subjective impressions regarding study quality or alternative weights applied to benefits and harms. For example, a number of randomized controlled trials have evaluated the effectiveness of screening mammography in detection of breast cancer, with widely varying effect sizes (Nelson et al., 2009). This variation may explain why, for two decades, experts with differing opinions about randomized clinical trial methodology have reached discordant conclusions regarding quality of evidence and mammography-related, age-specific mortality reduction (Woolf, 2010).

In the presence of scientific uncertainty, judgments based on other considerations often, and sometimes legitimately, assume greater importance. So, guideline developers commonly consider clinical experience, expert opinion, and personal judgments regarding potential harms of the intervention versus potential harms of inaction. These judgments inevitably color their characterization of the evidence and derivation of recommendations (Woolf and George, 2000). In some instances, groups opt for neutrality, stating that evidence is insufficient to make a recommendation (Calonge and Randhawa, 2004). In other circumstances, such as when the condition poses great risk or there is little potential intervention harm, the GDG may recommend the intervention despite inadequate evidence. Given the opposite situation, when concerns about potential

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

harms are heightened, a GDG may recommend against an intervention pending more convincing evidence (Cuervo and Clarke, 2003).

Second, even when effect size is large and clear, the judgment of whether benefits outweigh harms can be subjective (Kassirer and Pauker, 1981). Individuals given identical data regarding probabilities of benefits and harms can reach contrasting conclusions about net benefit due to different values, or utilities, assigned to outcomes (Kassirer, 1994; Pauker and Kassirer, 1997; Shrier et al., 2008). For example, the risk of developing urinary incontinence from surgery for prostate cancer may be less disconcerting to an oncologist or patient focused on the hazard of cancer than to a clinician or patient more concerned about quality of life than life expectancy. These subjective judgments are neither right nor wrong, but they importantly influence conclusions about net benefit and hence a panel’s recommendations.

Whatever choices are made, it is best for developers to be transparent and explicit about value judgments (Carlsen and Norheim, 2008). The rationale for concluding that evidence is strong, weak, or equivocal should be detailed. Additionally, concerns about study methodology, including outcomes assessment, should be outlined to explain the GDG’s rationale and direct future research in addressing evidentiary limitations. For example, guideline developers’ recent citing of contamination of control groups as weaknesses in intervention studies should encourage future investigators to devise methodological innovations to overcome this problem (Shekelle et al., 2010).

Dealing with Close Calls

Panels have two options for dealing with close calls and recommendations involving difficult benefits/harms trade-offs. First, the GDG, with deep knowledge of the clinical topic and underlying science, can attempt to infer how most patients, faced with the same information, would react. Here guideline developers act as proxies for patients; the advantage of this approach is that the GDG has mastery of relevant details often beyond most patients’ ability to digest or most busy clinicians’ ability to explain. The disadvantages are its inherent paternalism and the risk of GDG misjudgments (Laine and Davidoff, 1996). Guideline developers may not be representative of ordinary clinicians or patients, may have backgrounds and biases skewing perspectives about intervention safety or benefits, and may do a poor job of inferring patient reaction (Bruera et al., 2002; Holmes et al., 1987; Teno et al., 1995). Studies have docu-

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

mented considerable heterogeneity in patient preferences (Ogan et al., 2001; Pignone et al., 1999). Across a sample of patients faced with identical information, individuals will make different choices about the relative importance of pros and cons and clinical options preferred. Hence, a panel deciding on behalf of patients will inevitably advocate an option that a subset or subsets of patients would not prefer (Woolf, 1997).

The second option for addressing close calls is to eschew a blanket recommendation and instead encourage shared or informed decision-making, in which patients discuss trade-offs with their clinicians and make individual decisions based on personal preferences (Braddock et al., 1999; Frosch and Kaplan, 1999; Kassirer, 1994). The advantage of this approach is its respect for individual choice; here, guidelines become tools for patient empowerment, engagement, and activation (Coulter, 2002; Hibbard, 2003; Sox and Greenfield, 2010). Moreover, a large body of literature devoted to determinants of individual health behavior demonstrates that, relative to the uninformed, well-informed patients who actively participate in their care make improved decisions and engage in other positive health-related behaviors (Gochman, 1988). Additionally, in their 2010 commentary in JAMA on quality of care, Sox and Greenfield further note that “Informed choice under uncertainty is an ideal to strive for, especially because it enhances the exercise of the patient’s right of self-determination, which is a cornerstone of medical ethics. A well informed decision also incorporates the difficult to measure variables—an individual’s probabilities and preferences” (p. 2403).

The disadvantage of shared decision making is that patients and clinicians may not embrace these roles or may be incapable of fulfilling them (Deber et al., 1996; Strull et al., 1984). Some patients appreciate making their own decisions; others find it overwhelming, preferring clinicians or “experts” to guide them. Absorbing necessary information—understanding the health condition, available options, scientific evidence, and the probability and magnitude of benefits and harms—is challenging (Wills and Holmes-Rovner, 2003; Woloshin et al., 2001). Decision aids have been developed—in written, video, electronic, and online forms—to present such information in a scientifically accurate, understandable, and balanced way (O’Connor et al., 2005). Accessibility and usefulness of decision aids is an active area of research (Kaplan and Ware, 1995; O’Connor et al., 2009).

Clinicians’ barriers to use of shared decision making begin with skepticism about its utility (McNutt, 2004). Clinicians, easily

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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influenced by their own subjective value judgments and memorable experiences with patients who suffered or benefitted from an intervention or its omission, may resist a guideline that gives patients options to make choices (Shekelle et al., 2010). They may also lack time and knowledge to explain evidence bases for available options, as well as decision aids or counseling staff to provide further details, and they are not compensated for extended patient discussions required by informed decision making (Bogardus et al., 1999). Many clinicians fear medicolegal liability and allegations of negligence if they accommodate patient choice that goes awry (Merenstein, 2004).

Both options for addressing close calls are applied to CPGs and both have limitations. Whichever approach a GDG adopts, transparency and clarity are crucial. If a panel acts as patient proxy, value judgments in assessing net benefit should be explained so that others can judge their merit. Furthermore, an acknowledgment of the heterogeneity of patient preferences should be explicated. Typically, the latter is achieved by pairing recommendations with “disclaimer” language for patients or clinical circumstances where recommendations might not apply. For example, a guideline might recommend a treatment with complex trade-offs but add, “the treatment may be inappropriate in certain individual circumstances” or “patients should be informed about the risks before treatment is considered” (Shekelle et al., 2010). Of course, these recommendation expressions are not only applicable to “close calls.” If the panel eschews a specific recommendation and advocates shared decision making, it is useful to have the guideline include details regarding content of the relevant patient–clinician conversation. The guideline panel is likely to have clarity respecting preference-sensitive issues influencing the benefit/harm trade-off. Hence, content relevant to shared decision making, the underlying evidence, the role of decision aids, and other suggestions for incorporating personal preferences into the decision-making process optimally are included in guideline textual discussion (Shekelle et al., 2010).

5.

Establishing Evidence Foundations for and Rating Strength of Recommendations

 

5.1

For each recommendation, the following should be provided:

 

 

An explanation of the reasoning underlying the recommendation, including

 

 

 

A clear description of potential benefits and harms

 

 

 

A summary of relevant available evidence (and evidentiary gaps), description of the quality (in

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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cluding applicability), quantity (including completeness), and consistency of the aggregate available evidence

 

 

 

An explanation of the part played by values, opinion, theory, and clinical experience in deriving the recommendation

 

 

A rating of the level of confidence in (certainty regarding) the evidence underpinning the recommendation

 

 

A rating of the strength of the recommendation in light of the preceding bullets

 

 

A description and explanation of any differences of opinion regarding the recommendation

Incorporating Patients with Comorbidity

A recent topic of interest in developing practice guidelines is consideration of patients with multiple medical conditions, an increasingly important issue as the population ages. This has given rise to a small emergent literature (Shekelle et al., 2010). Most guidelines are developed for the management of a single disease, rather than for people with several disease(s), stated Boyd and colleagues (2005) in their assessment of the applicability of clinical practice guidelines for a hypothetical 79-year-old woman with five chronic conditions: osteoporosis, osteoarthritis, diabetes, hypertension, and chronic obstructive pulmonary disease. Boyd and coauthors noted that CPGs for these conditions, with the exception of diabetes, did not discuss recommendations for management of patients with other chronic conditions. When Boyd and colleagues applied the relevant guidelines to their hypothetical patient, they found the patient would need to be advised of 7 self-management tasks, a clinician would be responsible for performing 18 tasks, the patient would be advised to take 12 separate medications in 19 doses per day, and certain medications recommended for one condition could interact with or exacerbate symptoms or medication side effects for other conditions (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] for osteoarthritis potentially raising the blood pressure in hypertension; hydrochlorothiazide for hypertension potentially raising glucose levels in diabetes). Boyd and colleagues (2005) concluded that applying current clinical practice guidelines to patients with multiple health conditions may have undesirable effects.

Since then, the challenges of developing practice guidelines for patients with multiple chronic conditions has received a great deal of discussion (the Boyd article had been cited 431 times by early 2010) and, as indicated above, a related literature is amassing. Signif-

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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icant strides have been made in tailoring clinical recommendations to comorbid conditions, particularly in certain clinical areas, such as diabetes and prostate cancer. Yet, Boyd (2010) noted as recently as 2009 that the current standards of guideline development do not induce CPG developers to provide tools for adapting their recommendations to the patient with many comorbidities or prioritize the most important recommendations within a single disease or between diseases (Boyd, 2010).

One justification for omission of patients with comorbidity from CPGs is that clinical trials commonly used as evidence bases often exclude patients with multiple chronic conditions (Tinetti et al., 2004). At the same time, determining whether the result of a trial applies to an individual with comorbidity can be difficult, even when these patients are not explicitly excluded. A trial’s summary results may not apply to all patients in the trial, and how to make average trial results applicable to complex patients has not yet been sufficiently resolved, particularly in those with comorbidity (Boyd, 2010).

Consequently, little literature addresses the effect(s) that other health conditions may have on treatments and outcomes of care for a particular condition—knowledge that likely would translate into differences in guideline treatment recommendations. The exception to this rule is diabetes, where data are available regarding outcome differences for patients with hypertension and cardiovascular disease, for optimal blood pressure control and LDL levels. For example, a 2009 study of patients with Type 2 diabetes found that those with high levels of comorbidity are likely to receive diminished cardiovascular benefit from intensive blood glucose control (Greenfield et al., 2009). These data have been translated into differential treatment recommendations in clinical practice guidelines.

Likewise, Boyd and colleagues have developed a framework for conceptualizing disease severity in older adults, which includes the effect of disease severity on other diseases (Boyd et al., 2007). Because treating one condition optimally (e.g., using increased doses of NSAIDs for osteoarthritis) may cause an increased risk of side effects (gastrointestinal bleeding) that can be mitigated by adding another medication (proton pump inhibitors) that has a possible deleterious impact on outcomes of another health condition (use of clopidogrel in patients who have had coronary artery revascularization interventions), weighing the risks and benefits of treatments across a patient’s health conditions is necessary, and likely will involve discussion with the patient about the relative importance of different potential outcomes. Guideline development incorporating

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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patient viewpoints has been advocated (Krahn and Naglie, 2008). Tinetti et al. discuss the tension between one major goal of guidelines, to reduce practice variation among providers, and the necessity of appropriate variation in care due to differing disease burden and preferences of patients. Emerging evidence suggests that older patients and those with multiple morbidities value health outcomes such as long-term survival, risk of physical and cognitive morbidity, and risk of adverse effects differently from other populations (Tinetti et al., 2004).

Boyd (2010) further advises that when guideline developers are in the process of developing guidelines, they should explicitly discuss patients with multiple morbidities by considering the following questions (Boyd, 2010):

  • Were individuals with multiple morbidities in the studies considered?

  • What is the quality of evidence for those with comorbidities?

  • Is there within-trial heterogeneity of treatment effect?

  • What are goals of therapy?

  • What are highest priorities if recommendations cannot all be done in a person with comorbidities?

  • How should patient preferences be discussed and incorporated?

  • What interactions are common or important given highly prevalent comorbid conditions?

  • What is the complexity of the recommended medication regimen?

  • What is the burden of therapy?

The literature suggests that developers with sufficient resources may wish to go further:

  • Determine the most relevant chronic conditions coexisting with the condition of guideline topic (these data normally come from descriptive studies of frequencies of health conditions). Attempt to assess the importance of a coexisting condition by capturing how commonly it exists and how severely it may interfere with the management of the CPG related disease.

  • Search for evidence about the effect(s) that presence of one of these common comorbidities or their management has on management of the topic condition.

  • Report on the presence or absence of such evidence.

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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  • Specifically search for and report on evidence about patient values.

  • Explicitly consider the available evidence exploring comorbidities management options and patient values (Shekelle et al., 2010).

ARTICULATION OF RECOMMENDATIONS

An important aspect of developing recommendations favorably influencing care is the wording used for them. Guideline users have lamented recommendations that are vague or nonspecific, using what they refer to as “weasel words,” as in “Patients with such and such should be offered the intervention if clinically appropriate” or “Clinicians should follow up with patients given the intervention every 4 weeks, or sooner if necessary.” In such instances clinicians attempting to use the guideline may have difficulty applying it, or be uncertain about what constitutes “clinically appropriate” or “if necessary.” Grol and colleagues found that among Dutch general practitioners, vague or nonspecific guideline recommendations were followed 35 percent of the time, while “clear” recommendations were followed 67 percent of the time (Grol et al., 1998). An experimental study using vignettes of patients with back pain found that specific guidelines produced more appropriate and fewer inappropriate orders for electrodiagnostic tests (tests that measure the speed and degree of electrical activity in muscles and nerves to diagnose damage) than did vague guidelines (Shekelle et al., 2000). Michie and Johnston, using evidence from psychological research, went so far as to conclude that the “most cost-effective intervention to increase guideline implementation is rewriting guidelines in behaviorally specific terms” (Michie and Johnston, 2004, p. 328).

However, standardized recommendation wording does not exist (Oxman et al., 2006). This deficit is reflected in results of an evaluation by Hussain and colleagues (2009) of more than nearly 1,300 randomly selected recommendations (out of over 7,500) from the National Guideline Clearinghouse. Recommendations were presented with great inconsistency within and across guidelines, and 31.6 percent did not present actions that could be executed. More than half (52.6 percent) did not indicate strength of recommendation (Hussain et al., 2009).

The editorial board of the National Guideline Clearinghouse “encourages [guideline] developers to formulate recommendation statements that are ‘actionable’ and that employ active voice, rather than passive voice” (NGC, 2010b). The UK National Institute for

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Health and Clinical Excellence (NICE) believes recommendations should be clear and concise, but include sufficient information so they may be understood without reference to other supporting material (NICE, 2009).

Rosenfeld and Shiffman’s guideline development manual asserts that the goal of clear and identifiable recommendations is achieved by designing a guideline around key action statements and elaborated by text, evidence profiles, and strength of recommendation ratings. The authors assert that recommendation statements commonly are vague, unspecified, and not ready for execution. Key action statements are defined as activity-based prescriptions for specific clinician behavior. Hence, they should imply action operations that can support performance or other quality measures. These statements should be brief and precise. Finally, Rosenfeld and Shiffman submit that recommendations should have clarity respecting under what circumstances who should do what to whom, with what level of obligation. Associated text underscores why the recommendation is important and how it should be enacted (Rosenfeld and Shiffman, 2009).

Clarity and precision in guidelines are desirable not only to facilitate implementation by clinicians and patients, but also for incorporation into decision support tools (e.g., prompts used by electronic medical records, standing orders, checklists) to facilitate guideline implementation. Programmers writing code to transform guideline knowledge often are frustrated by lack of clarity regarding whether a service is or is not recommended, the precise type of patient for whom it is recommended, and other details necessary for programming rules. The former and related notions are discussed at length in Chapter 6. Similarly, quality review organizations or payers who seek to reward guideline-consistent care find underspecified guidelines unhelpful in developing performance indicators.

However, guideline developers adhering to evidence-based methods for formulating guideline recommendations may find evidence foundations inadequate to justify recommendation precision. Vagueness or underspecification sometimes reflects limited available evidence. For example, evidence indicates that Pap smears of the cervix are effective when done every 1 to 3 years and that mammographic screening in women ages 50 and older can reduce mortality whether it is performed annually or every other year. For certain screening tests there simply is inadequate evidence to specify any interval or define risk groups for whom screening is appropriate. When research has not determined one interval is more effective than another, developing a precise recommendation may

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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satisfy demands for “clear” guidelines, assist computer programmers, and give review organizations and malpractice attorneys a clear benchmark for classifying care as inappropriate or negligent, but it departs from evidence. In articulating recommendations, the guideline developer keenly feels the constant tension between providing guidance that is as unambiguous as possible and the need to not reach beyond the science (Hussain et al., 2009).

In line with other efforts to address this struggle, the GRADE Working Group recommends semantic separation of strong and conditional (“weak”) recommendations. Hence, following the GRADE Working Group and other authors, a strong recommendation would be introduced by the terms “We recommend…” or “Clinicians should…” and a conditional recommendation would begin with the terms “We suggest…”, “We conditionally recommend…”, or “Clinicians might…” (Guyatt et al., 2008a). The population, intervention, and comparator should be included in the recommendation or be easily deduced from surrounding text. A 2010 study by Lomotan and coauthors investigated the level of obligation conveyed to clinicians by deontic terms (“should,” “may,” “must,” and “is indicated”). The authors concluded that while “must” conveyed the strongest level of obligation, guideline developers rarely use the term, except in cases of a clear legal standard or potential for imminent patient harm. “Should,” by contrast, was the most common deontic verb found in the authors’ sample, and they believe it appropriately conveys an intermediate level of obligation between “must” and “may” (Lomotan et al., 2010).

Based on their review of the NGC database, Hussain and colleagues (2009) suggest the following criteria be followed in presentation and formulation of recommendations:

  1. Identify the critical recommendations in guideline text using semantic indicators (e.g., “The Committee recommends…” or “Whenever X, Y, and Z occur clinicians should…”) and formatting (e.g., bullets, enumeration, and boldface text).

  2. Use consistent semantic and formatting indicators throughout the publication.

  3. Group recommendations together in a summary section to facilitate their identification.

  4. Do not use assertions of fact as recommendations. Recommendations must be decidable and executable.

  5. Clearly and consistently assign evidence quality and recommendation strength in proximity to each recommendation, and distinguish between the distinct concepts of quality of evidence and strength of recommendation.

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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6.

Articulation of Recommendations

 

6.1

Recommendations should be articulated in a standardized form detailing precisely what the recommended action is, and under what circumstances it should be performed.

 

6.2

Strong recommendations should be worded so that compliance with the recommendation(s) can be evaluated.

EXTERNAL REVIEW

Rationale and Participants

A limited number of experts and perspectives can be represented within a GDG; hence, development groups committed to ensuring the balance, comprehensiveness, and quality of their guidelines are wise to share drafts with a spectrum of external reviewers who include not only guideline advocates, but also individuals, specialty groups, and industries expected to be critical of the GDG’s evidence characterization, recommendations, or any number of aspects of the CPG (IOM, 1992). These reviewers may be able to challenge the logic applied by the guideline panel in translating the evidence into recommendations; call attention to biases, political pressure, or other factors that may be coloring panelist judgments; provide suggestions for improving and clarifying guideline messages; and allow for debate about the guideline rationale (AGREE, 2001; Burgers et al., 2003; Cluzeau et al., 2003). Potential reviewers include

  • the nation’s (or world’s) leading investigators responsible for conduct of key studies influencing recommendations or aware of upcoming trials relevant to the guideline topic;

  • representatives from federal agencies, professional organizations, specialty societies, peer review journals, and relevant guideline panels within the United States and abroad (e.g., NICE) authoring related guidelines and/or concerned with the topic;

  • representatives from advocacy organizations, community groups, and public health organizations whose constituents may be affected by the guideline; and

  • representatives from health plans, Medicare, businesses and industry, pharmaceutical or device manufacturers, and health systems (e.g., Kaiser, Veterans Affairs) impacted by the guideline (Shekelle et al., 2010).

Reviewers aware of the realities of clinical practice and the administration of health systems may provide useful feedback on

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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how easily recommendations may be adopted by clinicians and systems of care, as well as broader policy ramifications, such as deficits of providers or technology to encourage a recommendation, implications for reimbursement or medicolegal liability, impracticalities created for information systems or performance review criteria, and upcoming legislation or policies bearing on the topic. Inviting commentary from stakeholders may also encourage “buy-in,” as specialty societies and other entities that have reviewed and improved guidelines are often willing to participate in guideline implementation activities (Shekelle et al., 2010).

Conduct of External Review

Guideline developers differ in processes employed for identification of relevant reviewers, collection of reviewer comments, and response to reviewer recommendations. Methods for identifying reviewers range from ad hoc procedures, such as eliciting suggestions from panel members, to more systematic methods to ensure comprehensiveness. The U.S. Preventive Services Task Force sends draft CPGs to its federal and primary care partners, as well as appropriate clinical specialties, and solicits comments on the clarity, clinical usefulness, and scientific accuracy of its recommendation statement (AHRQ, 2008). NICE employs a panel of reviewers consisting of four or five members—healthcare industry professionals, the UK National Health Service commissioners and managers, and a lay person—to review all of its CPGs. This review panel comments on the draft scope as well as draft guideline (NICE, 2009). The American College of Cardiology Foundation and American Heart Association classify peer reviewers as “official,” “content,” and “organizational” reviewers. Official reviewers are nominated by the partnering organizations; all other reviewers are considered content or organizational reviewers (ACCF and AHA, 2008). Reviewers who express strong unsubstantiated views are of less assistance than those who articulate a sound scientific and clinical argument for their perspectives. Panel procedures for reviewer selection should consider this when choosing harsh critics, so that their viewpoints are balanced by scientific or clinical reasoning (Shekelle et al., 2010).

Reviewers may be asked to provide general responses to the guidelines as a whole or specific recommendations, or to vote on each guideline recommendation and provide alternative recommendations if those drafted by the GDG are deemed unacceptable. Whatever the process, ultimately GDGs should provide reviewers

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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with clear directives for their criticism, including the requirement of evidence and citations as substantiation. Reviewers should focus on the completeness of the evidence that was reviewed, the rationale for particular recommendations, and the “implementability” of recommendations. To the extent that disagreements with recommendations are due to evidence that was not considered by the CPG panel, reviewers should submit the evidence that was not considered. Organizations disagreeing with recommendations may articulate the scientific evidence and clinical reasoning that, to their thinking, justifies a different policy than that in the draft guideline. Those with slightly different recommendations can argue for adjusting the guideline to provide greater harmonization and reduce confusion for clinicians and patients. In some instances, organizations recognize the value of endorsing the new guideline, updating their own guidelines to conform with new recommendations or issuing a guideline that is jointly supported by multiple organizations and agencies.

Critics of clinical practice guidelines can fault the review process if it is perceived that criticisms submitted to the panel were ignored. To allay such concerns, it is prudent for the development group to adopt a systematic process for responding to reviewer comments. For example, the panel might develop a table capturing each commentary from every reviewer, explaining how the guideline was or was not modified accordingly, and describing the rationale for the related course of action (Rosenfeld and Shiffman, 2009). The GDG may have to rewrite recommendations and guideline text and reapprove the final document, which could delay the process. GDGs should consider the potential necessity for revisions, and an additional post review meeting, when planning the original timeline. The public availability of such information is important to transparency; some GDGs provide related postings on their websites.

Development groups’ reactions to reviewer comments should be consistent with the methodology used in their recommendations’ derivation. For example, if a panel accepted expert opinion as a justification for recommendations, criticism by experts that the recommendation is inappropriate or subject to public or political disfavor might be sufficient justification for recommendation revision. Conversely, if a panel’s methodology insists on evidence from well-designed randomized controlled trials, neither strident expert opinions nor a lengthy bibliography of supporting cohort studies would be grounds for revising recommendations. Lastly, a brief summary of the external review process should be provided at the time of release of the draft CPG (Shekelle et al., 2010).

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

7.

External Review

 

7.1

External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public.

 

7.2

The authorship of external reviews submitted by individuals and/or organizations should be kept confidential unless that protection has been waived by the reviewer(s).

 

7.3

The GDG should consider all external reviewer comments and keep a written record of the rationale for modifying or not modifying a CPG in response to reviewers’ comments.

 

7.4

A draft of the CPG at the external review stage or immediately 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 recommendations. 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 Cancer 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 comment. 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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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 clinical 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 systems 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 individual 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 recommendations is out of date, with current evidence demonstrating that recommended 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)

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

requires updating typically are inherently subjective and reflect the clinical importance and number of invalid recommendations.

In a relatively unusual empirical exercise, Shekelle and colleagues (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 balancing 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 “traditional” updating strategy (comparable to de novo guideline development) 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 topical evidence. At the behest of the entire guideline-writing committee, 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
×

are managed as new guidelines, except for writing committee selection, 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 professional 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 process” (Clark et al., 2006, p. 166). Moreover, attempts at harmonization 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 recommendations. 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 recommended intervention from an efficacy or harms perspective; 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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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 proposed standards and CPG users should adopt CPGs compliant 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, development team composition and process, clinical practice guideline–systematic review intersection, establishing evidence foundations for and rating strength of recommendations, articulation of recommendations, 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. Additionally, 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 representatives) 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 literature 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

Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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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 providing a summary of relevant available evidence (and evidentiary gaps), descriptions of the quality (including applicability), quantity (including completeness), and consistency of the aggregate available evidence; an explanation of the part played by values, opinion, theory, or clinical experience in deriving recommendations; a judgment regarding the level of confidence in (certainty regarding) the evidence underpinning the recommendations; and a rating of the strength of recommendations.

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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Suggested Citation:"5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process." Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi: 10.17226/13058.
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Next: 6 Promoting Adoption of Clinical Practice Guidelines »
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Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes.

Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review--guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating.

Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

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