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5 Current Best Practices and Standards for Development of Trustworthy CPGs: Part II, Traversing the Process
Pages 109-144

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From page 109...
... 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 adoption of standards-setting methodologies elaborated in Chapter 1.
From page 110...
... 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)
From page 111...
... 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)
From page 112...
... . 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.
From page 113...
... 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.
From page 114...
... offer detailed qualitative insight into the state of the art of evidence quality and recommendation strength assessment. Their evaluation indicates the following: 1.
From page 115...
... Derived from GRADE is the American College of Physicians (ACP) system for appraising evidence quality and strength of recommendations.
From page 116...
... 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.
From page 117...
... 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
From page 118...
... 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.
From page 119...
... 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)
From page 120...
... 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.
From page 121...
... 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)
From page 122...
... . 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)
From page 123...
... . The second option for addressing close calls is to eschew a blan ket 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)
From page 124...
... 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 rec ommendation, including o A clear description of potential benefits and harms o A summary of relevant available evidence (and evidentiary gaps)
From page 125...
... 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)
From page 126...
... . These data have been translated into differential treatment recommendations in clinical practice guidelines.
From page 127...
... Boyd (2010) further advises that when guideline developers are in the process of developing guidelines, they should explicitly dis cuss patients with multiple morbidities by considering the following questions (Boyd, 2010)
From page 128...
... 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)
From page 129...
... However, guideline developers adhering to evidence-based methods for formulating guideline recommendations may find evi dence foundations inadequate to justify recommendation precision. Vagueness or underspecification sometimes reflects limited available evidence.
From page 130...
... 5. Clearly and consistently assign evidence quality and recom mendation strength in proximity to each recommendation, and distinguish between the distinct concepts of quality of evidence and strength of recommendation.
From page 131...
... 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)
From page 132...
... . Conduct of External Review Guideline developers differ in processes employed for identifi cation of relevant reviewers, collection of reviewer comments, and response to reviewer recommendations.
From page 133...
... 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.
From page 134...
... 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.
From page 135...
... that may necessitate the updating of a clinical practice guideline: 1. Changes in evidence on the existing benefits and harms of interventions 2.
From page 136...
... . 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.
From page 137...
... . Similar methods have been enshrined within the processes of other guideline development programs.
From page 138...
... 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
From page 139...
... In Methodologies and policies from ACCF/AHA taskforce on practice guidelines.
From page 140...
... . Presented at IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, April 19, 2010.
From page 141...
... and French clinical recommendations for women at in creased risk of breast and ovarian cancer. The Lancet 353(9156)
From page 142...
... 2009. 2009 Focused update: ACCF/AHA guidelines for the diagno sis and management of heart failure in adults: A report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines: Developed in collaboration with the International Society for Heart and Lung Transplantation.
From page 143...
... In Committee on Standards for Trustworthy Clinical Practice Guidelines commissioned paper .
From page 144...
... 2006. Grading evidence and recommendations for clinical practice guidelines in nephrology.


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