Clinical Practice Guidelines We Can Trust (2011) / Chapter Skim
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4 Current Best Practices and Proposed Standards for Development of Trustworthy CPGs: Part 1, Getting Started
4 Current Best Practices and Proposed Standards for Development of Trustworthy CPGs: Part 1, Getting Started
Pages 75-108
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From page 75... ...
The standards and supporting text herein address several aspects of guideline development, includ ing transparency, conflict of interest, guideline development team composition and group process, and finally, the determination of guideline scope and the chain of logic, including interaction with the systematic review team. INTRODUCTION Chapters 4 and 5 detail aspects of the clinical practice guideline (CPG)
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From page 76... ...
This chapter captures aspects of the beginnings of guideline development, including transparency, conflict of interest, guideline development team composition and group process, and determining guideline scope and logic, including interac tion with the systematic review (SR) team.
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From page 77... ...
guidelines, "Guideline developers are increasingly using the GRADE (Grading Recom mendations Assessment, Development and Evaluation) approach because it includes transparent judgments about each of the key factors that determine the quality of evidence for each important outcome, and overall across outcomes for each recommendation." Even clinical decisions informed by high-quality, evidencebased CPG recommendations are subject to uncertainty.
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From page 78... ...
. Furthermore, an investigation of more than 200 clinical practice guidelines within the National Guideline Clearinghouse determined that greater than half included no information about financial sponsors of guidelines or financial conflicts of interest of guideline authors (Taylor, 2005)
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From page 79... ...
. A related investigation observed that 7 percent of guideline developers surveyed believed their relationships with industry affected their guideline recommendations; moreover, nearly 20 percent believed that guideline coauthors' recommendations were subject to industry influence (Chaudhry et al., 2002)
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From page 80... ...
. Some guideline experts have requested that professional medical organizations reject all industry funding for practice guidelines (Rothman et al., 2009)
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From page 81... ...
Although the 2009 IOM committee on COI found no systematic review of guideline development organizations' conflict-of-interest policies, the committee did identify variations in the COI policies of select organizations. Specifically, COI policies vary with regard to the specific types of information that must be disclosed, who is responsible for managing conflicts and monitoring policy compliance, and whether COI procedures are transparent.
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From page 82... ...
are described clearly as part of CPG development policy. Prospective members agree to divest any stocks or stock options whose value could be influenced by the CPG recommendations, and refrain from participating in any marketing activities or advisory boards of commercial entities related to the CPG topic.
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From page 83... ...
• Funders should have no role in CPG development. GUIDELINE DEVELOPMENT GROUP COMPOSITION AND GROUP PROCESS Guideline development involves technical processes (SRs of relevant evidence)
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From page 84... ...
In a systematic review of fac tors affecting judgments achieved by formal consensus development methods, Hutchings and colleague identified 22 studies examining the impact of individual participant specialty or profession. Overall, the authors observed that those who performed a procedure, versus those who did not, were more likely to rate more indications as appropriate for that procedure.
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From page 85... ...
In complementary fashion, the IOM Committee to Advise the Public Health Service on Clinical Practice Guidelines in 1990 offered the following rationale in support of multidisciplinary guideline development groups: (1) they increase the likelihood that all relevant scientific evidence will be identified and critically assessed; (2)
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From page 86... ...
Decisions about which categories of participants to involve in the guideline development group are then required. Here, as suggested above, guideline developers often have to weigh desire for wide representation against need for cohesiveness and efficiency.
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From page 87... ...
Moynihan and Henry surveyed international CPG or health technology assessment organizations and found that 42 percent claimed to apply formal consensus development methods (Moynihan and Henry, 2006)
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From page 88... ...
. Several formal consensus development strategies are available to clinical practice guideline developers.
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From page 89... ...
Third, consumer involvement acts as a safeguard against conflicts of interest that may skew judgment of clinical and scientific experts. The ability of consumers to resist recommendations favoring self-interest of a specialty or research enterprise can be an important countermeasure to imbalance in practice guidelines.
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From page 90... ...
To mitigate these concerns, as with any member of a practice guideline development panel, selection criteria should be applied to choose a consumer representative who can consider the evidence objectively, and make recommendations departing from preconceived views of self or interests. Little is known about how best to select consumers for such tasks, a survey of members of the Guideline International Network Patient and Public Involvement Working Group (G-I-N PUBLIC)
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From page 91... ...
In the North of England study, the workshop format was relatively resource intensive, but made it possible to explain technical elements of guideline development, enabling patients to engage in the process and make relevant suggestions. A patient advocate serving on a panel felt confident enough to speak and was accustomed to discussions with health professionals and to medical terminology (van Wersch and Eccles, 2001)
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From page 92... ...
identified no evidence for determining how best to involve consumers in CPG development, they did find support for approaches to consumer involvement in the scientific research process. More specifically, a study by Telford and colleagues (2004)
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From page 93... ...
3.3 Strategies to increase effective participation of patient and consumer representatives, including training in appraisal of evidence, should be adopted by GDGs. CLINICAL PRACTICE GUIDELINE -- SYSTEMATIC REVIEW INTERSECTION The idea that trustworthy clinical practice guidelines should be based on a high-quality SR of the evidence is beyond dispute (ACCF and AHA, 2008; AGREE, 2003; AHRQ, 2008; NICE, 2009; Rosenfeld and Shiffman, 2009; SIGN, 2008)
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From page 94... ...
Membership There is no overlap in There is generally no Selected members of The same individuals membership between the overlap in membership, the CPG team interact conduct the SR, grade the CPG team and the SR team but a member of the with the SR team to evidence, and generate the SR team may later refine the key questions, guidelines participate in the CPG define review criteria, and interpret evidence; the SR methodologists do not make CPG recommendations Theoretical Prevents biases in one Efficiency of using Ensures that at least • nsures that all issues E benefits group from influencing the presynthesized and rated the major questions of known between the CPG other group evidence the CPG team will be and SR groups will be addressed by the SR addressed in the SR • he CPG team will have T a better understanding of the evidence • fficiency of having E the same group review evidence and formulate guidelines
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From page 95... ...
Concerns • he CPG team is T • R may not fully S • imited interactions L • ay introduce bias into M limited to the questions address all of the may result in the evidence review formulated by the initial CPG panel's clinical some areas being • nlikely that the same U question-setting panel; questions. inadequately individuals have the time these questions may not • R may not include S addressed in the SR or skills to conduct both be complete or what the latest studies • he subgroup of T SRs and CPG the CPG team considers • R team working S the CPG team that important without input from interacts with the SR • he CPG team has T CPG team that will team may be biased no opportunity to use the evidence may or lack expertise in interact with SR team to not optimally structure specific topics, or it appreciate the nuances of the synthesis and may not cover all the evidence review reporting of evidence the questions and • R team working without S concerns of the entire input from CPG team that CPG subgroup will use the evidence may not optimally structure the synthesis and reporting of evidence SOURCE: Lau (2010)
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From page 96... ...
Hence, the model allows for interaction between sys tematic review teams and guideline developers in response to developers' concerns during literature review related to clinical questions or study parameters. In addition, interpretation and rat ing of the evidence requires particularly close interaction between systematic review teams and GDGs, as does derivation of clinical recommendations.
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From page 97... ...
4. Clinical Practice Guideline–Systematic Review Intersection 4.1 Clinical practice guideline developers should use sys tematic reviews that meet standards set by the Institute of Medicine's Committee on Standards for Systematic Reviews of Comparative Effectiveness Research.
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From page 98... ...
Though the committee found no one approach rose to the level of a standard, it recognizes the importance of various associated components to the guideline development process. The committee therefore considered factors important in determining guideline scope, as well as the development of an analytical model to assist in identification of critical clinical questions and key out comes, and exploration of the quality of varying evidence in a chain of reasoning.
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From page 99... ...
These principles include the need for guideline developers to take the following actions: (1) make explicit decisions at the outset of the analytic process regarding the clinical questions that need to be answered and the patient outcomes that need to be assessed in order to formulate a recommendation on a particular issue; (2)
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From page 100... ...
. Guideline developers must determine which of these outcome classes must be affected to support a recommendation.
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From page 101... ...
A common error among guideline developers is to conduct an amorphous literature search with broad inclusion criteria. Because hundreds to thousands of data sources usually are available on any guideline topic, such an approach often retrieves many irrelevant citations.
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From page 102... ...
The complexity of the quality of evidence and strength of recommendation appraisal activities is discussed fully in Chapter 5. With regard to the greater state of the art of CPGs, the analytic model highlights most important outcomes that, depending on the quality of available evidence, require consideration by future investigators in establishing effectiveness of a clinical practice and the demand for guidelines.
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From page 103... ...
2003. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: The AGREE project.
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From page 104... ...
2006. Surviving sepsis -- practice guidelines, marketing campaigns, and Eli Lilly.
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From page 105... ...
Presented at IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines meeting, January 12, Washington, DC. Lexchin, J., L
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In Committee on Stan dards for Developing Trustworthy Clinical Practice Guidelines comissioned paper . SIGN (Scottish Intercollegiate Guidelines Network)
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From page 107... ...
1991. AHCPR interim manual for clinical practice guideline development.
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