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4 Framework for Developing Clinical Practice Guidelines
Pages 61-84

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From page 61...
... The implementation of these frameworks and the dissemination and use of CPGs after they are developed are also important steps in the CPG process. This chapter briefly addresses the entire CPG development process and provides a more in-depth discussion of the analytic framework and the evidence evaluation framework.
From page 62...
... . To address these core principles, the committee's overarching CPG development process provides a stepped process for assessing available evidence on opioid prescribing for acute pain indications, identifying research needs, and facilitating the incorporation of new knowledge into clinical practice as it becomes available (see Figure 4-1)
From page 63...
... CPGs may also address additional health care providers who are involved in a patient's care as well as the health care organizations that are key partners in the development process. As discussed at some length in the 2011 IOM report Clinical Practice Guidelines We Can Trust, the first step in creating an evidence-based CPG is to identify and assemble a group of involved and interested experts who will develop it.
From page 64...
... Together the key questions (discussed in the next section) and the PICOTS framework define the scope of the guideline, inform the analytic framework, and set the stage for the application of the evidence evaluation framework.
From page 65...
... OPIOID HEALTH PRESCRIBED INTERMEDIATE OUTCOMES OUTCOMES EVIDENCE EVIDENCE Intermediate outcomes: Patient and amount of opioid population health Patient presents used/unused, refill outcomes: with acute pain Opioid requests, opioid Long-term • Pain due to a specific prescribing EVIDENCE misuse, diversion, opioid use procedure or strategy • Function condition health costs, patterns of health care • Quality of life utilization • Work or school • Mortality/morbidity • Adverse effects FIGURE 4-2  Analytic framework for prescribing opioids for acute pain. This figure shows the evidence linkages and key questions (see Box 4-1 for a list of questions that corresponds to the numbers in the circles)
From page 66...
... 1. In patients with acute pain requiring opioid therapy, what is the comparative effectiveness of different opioid prescribing strategies on intermediate outcomes (e.g., refill requests, unused pills, misuse, or diversion)
From page 67...
... In the analytic framework, health outcomes may be linked directly to the opioid prescribing strategy (e.g., by studies comparing effects of different opioid prescribing strategies on pain, quality of life, or risk of opioid use disorder)
From page 68...
... A number of prescribing strategies have been developed based on patient-reported data on actual opioid use. For example, at the Dartmouth-Hitchcock Medical Center prescribing guidelines have been developed based on an internal assessment of postoperative prescribing practices for five inpatient surgeries and patients reports of pain management after discharge.
From page 69...
... . Intermediate outcomes can be assessed at the individual patient or health care system level, both of which may be useful for evaluating opioid prescribing strategies and clinical prescribing recommendations.
From page 70...
... Discussions of "quality" have often focused on issues related to the internal validity and risk of bias. However, as noted in the 2011 IOM report Clinical Practice Guidelines We Can Trust, the concept of quality can be broad, that is "the level of confidence
From page 71...
... For many indications, the committee expects that there will be little evidence linking a prescribing strategy to health outcomes, so that indirect evidence on intermediate outcomes will need to be used for the development of CPGs. Evidence can be used to establish the linkages between opioid prescribing strategies and health outcomes via intermediate outcomes.
From page 72...
... Given the extensive resource demands of conducting RCTs, they may most easily be designed to evaluate immediate outcomes (e.g., opioid use) or short-term health outcomes (e.g., a reduction in acute pain or improvements in patient function)
From page 73...
... Observational studies have several potential advantages over RCTs. While RCTs often enroll a relatively small number of selected participants who meet eligibility criteria, populations in observational studies may better reflect the broader range of patients seen in clinical practice.
From page 74...
... Criteria for Evaluating the Evidence Once the literature has been systematically searched and relevant studies have been identified, the next step in the CPG development process is to carry out a critical evaluation of the evidence base for each of the linkages specified in the analytic framework. Several organizations, including GRADE, ARHQ, and Cochrane, have developed formal methods to evaluate the evidence base for clinical questions in systematic reviews.
From page 75...
... . CPG developers can evaluate the evidence for each of the linkages in the analytic framework using the GRADE criteria and evaluate whether a prescribing strategy is associated with benefits (e.g., decreased overdoses)
From page 76...
... Such information can assist guideline developers in revising and updating the CPG when necessary so that it reflects the most current evidence available to ensure that patients with acute pain receive the best care. Although evidence suggests that CPGs may reduce hospitalization rates, reduce health care costs, and improve clinical outcomes, barriers often exist that limit providers from adopting and implementing them (Kroenke et al., 2019)
From page 77...
... After recommendations for opioid prescribing strategies have been developed and approved, consideration needs to be given to ensuring effective dissemination, uptake, and periodic revisions of the CPG. As discussed in the 2011 IOM report Clinical Practice Guidelines We Can Trust, these activities are part of the implementation process.
From page 78...
... As guidelines are implemented, the appropriate monitoring of patient and populations health outcomes is important to ensure that the changes in clinical practice as a result of the guideline are effective. This monitoring may include identifying such things as unresolved pain, lack of functional benefits, a continued need for opioids, conversion to chronic pain, opioid misuse, opioid diversion, and opioid-related adverse events including serious adverse events (e.g., fatal and nonfatal overdose, central nervous system depression, and respiratory depression)
From page 79...
... 2018. The effectiveness of interventions designed to increase the uptake of clinical practice guidelines and best practices among musculoskeletal professionals: A systematic review.
From page 80...
... 2019. Clinical practice guidelines and consensus statements about pain management in critically ill end-of-life patients: A systematic review.
From page 81...
... 2016. Research gaps in practice guidelines for acute postoperative pain management in adults: Findings from a review of the evidence for an American Pain Society clinical practice guideline.
From page 82...
... 2014. Pediatric clinical practice guidelines for acute procedural pain: A systematic review.
From page 83...
... 2017. Methodological quality of systematic reviews referenced in clinical practice guidelines for the treatment of opioid use disorder.
From page 84...
... 2012. Developing clinical practice guidelines: Types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations.


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