Evidentiary Review and AUC Creation and Modification Process
Multidisciplinary Teams
Each Multidisciplinary Team is formulated from members drawn from the Steering Committee and/or the UC AUC Pool, a group of physicians and scientists from across UC who have volunteered to participate on Multidisciplinary Teams. Additional members of UC are recruited into the UC AUC Pool as needed to meet the needs of the Multidisciplinary Teams that the Steering Committee establishes.
In concordance with the AUC Rule, each Multidisciplinary team includes at least 7 members, including at least one practicing physician with expertise in the clinical topic, related to the appropriate use criterion being developed or modified, at least one practicing physician with expertise in the relevant imaging studies, related to the appropriate use criterion, at least one practicing primary care physician (as described in sections 1833(u)(6),1833(x)(2)(A)(i)(I), and 1833(x)(2)(A)(i)(II) of the Act) and experts in clinical trial design and statistical analysis.
Each Multidisciplinary Team has autonomous governance, decision-making authority and accountability for the AUC developed, modified or endorsed by that team, independent of the Steering Committee and UC. The Steering Committee monitors the progress of each Multidisciplinary Team and ensures that the Team adheres to the UC AUC Program Evidentiary Review and AUC Creation and Modification Process (detailed below). In cases where progress is unreasonably delayed or a Team fails to adhere to UC AUC Program policies despite guidance from the Steering Committee, the Steering Committee may revise the composition of the Team or reconstitute the Team. This level of oversight allows the Steering Committee to maintain quality across the Multidisciplinary Teams without compromising their autonomy and independent decision-making authority.
Evidentiary Review and AUC Creation and Modification Process
Multidisciplinary teams follow the process described below when creating or modifying AUC. This process is published on the UC AUC Program website for public review. The process may be amended by the Steering Committee, within the limitations imposed by law, the AUC Rule and any additional CMS rules or guidance that may become available. When and if amended, the amended process will be published on the UC AUC Program website.
Literature search
A collection of publications is assembled for each relevant clinical presentation and/or condition in the Multidisciplinary Team’s identified area or areas. Medical databases, primarily the National Library of Medicine PubMed are searched with complex search strategies related to the clinical presentation and/or condition and relevant imaging modalities. Searches are limited to human subjects and publications in English language. In general searches are limited to the preceding 15 years; this period may be extended if there are insufficient results in the preceding 15 years. Additionally, professional medical society guidelines and appropriateness criteria applicable to the area are searched and reviewed. Bibliographies for these guidelines are reviewed and cited references are added to the literature collection if not already included. Relevant published consensus statements by professional medical specialty societies, including consensus statements included in professional medical society guidelines, recommendations and appropriateness criteria that are not otherwise supported by the primary literature are also included in the collection.
Literature review and evidence grading
Publications and consensus statements (“manuscripts”) identified in the literature search, including relevant published consensus statements by professional medical specialty societies, are assigned to members of the Multidisciplinary Team for review. Each member of the team is assigned manuscripts for review, and each manuscript is assigned to at least two members of the team. In cases where manuscripts have already been reviewed and graded by recognized experts, such as the Harvard Medical School eLibrary of Medical Evidence, these reviews and grades may be used as a starting point by team members.
Members reviewing manuscripts identify discrete pieces of evidence from each manuscript. A piece of evidence is defined by indications, including any limitations by population, history, prior imaging, signs, symptoms and/or lab values; the associated imaging study, including any particular protocol or modification of the study; and the information that the imaging study is expected to yield. A manuscript may include zero, one or more pieces of evidence.
Each member reviewing the manuscript independently assigns the Level of Evidence using the Oxford Centre for Evidence-Based Medicine (“OCEBM”) system. OCEBM uses levels 1-5, where 1 is the highest Level of Evidence. The members reviewing each manuscript compare their identification of evidence and resolve discrepancies by discussion and consensus; any discrepancies not resolved through this process are resolved by vote of the multidisciplinary team.
AUC development
Based on pieces of evidence identified and identified consensus statements of professional medical societies, AUC are proposed by the multidisciplinary team linking specific clinical scenarios with one or more imaging services and an assessment of the appropriateness of each service for the indication or condition. Specific clinical scenarios are represented by indications or conditions, including restrictions based on population, history, prior imaging results, signs, symptoms or lab values, where relevant. Consideration is given to the clinical utility of the information obtained by an imaging service; e.g. a service that has high sensitivity and specificity for a diagnosis but that does not affect management or outcomes may not be appropriate. When clinical utility is unclear, additional literature search and review using the procedure described above is performed to establish an evidentiary basis for clinical utility. A majority of the members of the Multidisciplinary Team must agree with the proposed evidence-based AUC for the AUC to be adopted and approved by the Multidisciplinary Team.
Each clinical scenario in each adopted AUC is designated with an associated grade of evidence that supports the appropriateness assessment for that clinical scenario; these are considered the key points of the AUC. Grades of evidence are based on the highest Level of Evidence of the reference from which it is derived. Grades of evidence are assigned based on the highest Level of Evidence based on the following OCEBM Grade of Recommendation:
Grade A = Level 1
Grade B = Level 2
Grade C = Level 3 or less
Where there is evidence to support it, AUC that include assessments of generally not appropriate include recommendations for more appropriate alternatives. When there is strong, complete consensus across the multidisciplinary team regarding an AUC that does not yet have evidence in the literature suggesting that it is or is not appropriate, AUC may be adopted based on the consensus expert opinion of the team. We seek to minimize development of such AUC.
Review of AUC
Each Multidisciplinary Team reviews each AUC it has created or modified no less frequently than once per year. Reviews may be performed more frequently when new evidence that seems likely to affect an AUC is published. The literature search process described above is repeated and any new publications or consensus statements identified are reviewed according to the procedure described above. The Multidisciplinary Team reviews the AUC taking into consideration all the available evidence, including newly identified and previously reviewed evidence and updates or modifies the AUC if appropriate in light of any new evidence identified.
Please contact Peter.Vigil@ucsf.edu to submit comments and to request changes to the AUCs.