Clinical Practice Guideline Development Process
Selecting a guideline topic and Task Force
The AASM Board of Directors reviews suggested topics for clinical practice guidelines to identify those most suited for further pursuit. The Board prioritizes the topics based on a number of factors including existence of sufficient research and data to support a potential recommendation, the potential for improvement in patient outcomes, and the impact the document could have on the field of sleep medicine. The Board then invites AASM members – experts in sleep research and sleep medicine – to participate in the task force that will develop the guideline. Based on the AASM Conflict of Interest Policy, task force members are required to disclose any relevant conflicts throughout the duration of the project in order to determine the appropriate management of conflicts.
Developing questions following the PICO format
The Task Force reviews the assigned topic and determines the most important and relevant questions following the PICO format: identify the relevant Patient population, the Intervention and Comparator, and the Outcomes of interest. The Task Force focuses on patient-important outcomes, rather than surrogate outcomes, to best reflect the priorities of the target patient population. These patient-important outcomes can be either benefits or harmful effects of the intervention. The Task Force also establishes a clinical significance threshold for each outcome, the point at which a change in outcome is significant enough to warrant application (or avoidance) of the intervention.
Identifying and analyzing relevant data
In conjunction with AASM staff, the Task Force performs literature searches focusing on randomized controlled trials (RCTs) and large observational studies. The Task Force narrows this large body of evidence by applying rigorous inclusion/exclusion criteria to identify the studies specifically relevant to the PICO questions. From these included studies, the Task Force extracts all data relevant to the meta-analysis and documents information required for assessing the quality of evidence using the GRADE methodology. Comparable data sets are grouped into meta-analyses, while included data that do not meet the statistical framework for meta-analysis become supporting evidence.
Evaluating evidence using the GRADE methodology (Grading of Recommendations, Assessment, Development, and Evaluation)
After the data are analyzed via meta-analysis and summarized, the Task Force follows the GRADE methodology to rate the certainty in the evidence and to consider key factors integral to the subsequent strength of recommendation. There are four main components of GRADE: quality of the evidence, balance of benefits and harms, patient values and preferences, and resource use. The quality of the evidence reflects the confidence that the estimate of effect (e.g. meta-analyses) for a given intervention represents the true effect for patients. The balance of benefits and harms identifies the net direction and magnitude of this balance following the intervention, and takes into account the clinical significance of the benefits and harms. The consideration of patient values and preferences assesses the likelihood that the majority of well-informed patients will choose to use the intervention over the comparator based on the evidence. Lastly, resource use considers the availability and cost of the intervention to the target patient population.
After completing the systematic review and application of the GRADE methodology, the Task Force synthesizes the evidence across all four GRADE domains, weighing all of these factors to determine the direction and strength of the recommendations. A “strong” recommendation indicates something that a clinician should almost always do, while “weak” or “conditional” recommendations indicates that the clinician and patient must determine the most appropriate option, based on the balance of the quality of evidence, benefits and harms, values and preferences, and resource implications.. The Task Force writes the clinical practice guideline using standardized language to provide clear, actionable recommendation statements.