After the enactment of “Protecting Access to Medicare Act of 2014” (PAMA), that tied advanced diagnostic imaging services including positron emission tomography-PET and other nuclear medicine procedures to appropriate use criteria, the society revised its AUC development methodology.
In order to provide a comprehensive library of AUC for the most common nuclear medicine procedures, the society’s Guidance Oversight Committee (GOC) has identified several high priority areas for AUC development. Following are the topics currently under development:
The goal is to develop 4-5 AUC every year for the next several years following the same process.
The process for AUC development was modeled after the RAND/UCLA Appropriateness Method for AUC development, and included a systematic review of evidence followed by development of AUC for various clinical scenarios using a modified Delphi process. Additionally, this process strove to adhere to the Institute of Medicine’s standards for developing trustworthy clinical guidance. The process included identification of relevant clinical scenarios, a systematic synthesis of available evidence, individual and group ratings of the scenarios using a formal consensus process, and document drafting based on final group ratings and discussions.
Society of Nuclear Medicine and Molecular Imaging rigorously attempts to avoid any actual, perceived, or potential conflicts of interest (COIs) that might have arisen as a result of an outside relationship or personal interest of the Expert Workgroup members or of external reviewers used to review specific documents. SNMMI also reviews the society-industry relationship policies to ensure that the ensuing process presents no perceived or actual conflicts at the society level.
All Expert Workgroup members are required to provide disclosure statements of all relationships that might be perceived as real or potential COIs. These statements are reviewed and discussed by the SNMMI staff and are updated and reviewed at the beginning of every Expert Workgroup meeting and/or teleconference. A table of disclosures for Expert Workgroup members and external literature reviewers can be found in the original guideline documents.
The society defines COIs as the following: An individual who has relationships with industry, including consulting, speaking, research, and other non-research activities that exceed $5000 in funding over the previous or upcoming 12-month period.
In addition, if external expert reviewers of the documents are either a principle investigator or other key study personnel on a study, their participation in the review would likely present a COI. All reviewers are required to complete COI forms. Document authors and sponsors are identified and then cross-checked against reviewers' financial and intellectual COIs. Conflicted individuals are noted as unable to review documents in which there is a real COI present.
Following the final MPFS rules that came out in November 2015, the society is further revising the selection of expert workgroups. Going forward these expert workgroups for AUC will have a minimum of seven members and will include a primary care practitioner, an expert in clinical trial design, and an expert in statistical analyses, along with other subject matter experts.
Every effort will be made to include other stakeholders including patient representatives, members of the industry, and other stakeholders as applicable. The society is currently collaborating with the following medical specialty societies.
The society has contracted with the Pacific Northwest Evidence-based Practiced Center (EPC) at Oregon Health & Science University (OHSU) to conduct independent and objective systematic reviews of the relevant evidence to inform the AUC workgroups. The EPC at OHSU will continue to conduct systematic reviews for the society for the next several years. EPC are the centers that also conduct systematic reviews for the Agency for Healthcare Research and Quality (AHRQ). The primary purpose of these systematic reviews is to assess the diagnostic accuracy and comparative effectiveness of selected nuclear medicine procedures on clinical decision making and clinical outcomes. The systematic reviews include evidence on analytical validity, clinical validity and clinical utility of the specific imaging study. Based on the discussion with each expert workgroup, several key research questions are formulated for each topic to guide the systematic reviews.
The inclusion and exclusion criteria for these reviews are based on the study parameters established by the expert workgroup using the PICOTS (Population, Intervention, Comparisons, Outcomes, Timing, and Setting) approach. The strength of overall evidence was graded as high, moderate, low, or very low using GRADE methods, based on the quality of evidence, consistency, directness, precision, and reporting bias.
The EPC researchers include good- and fair-quality systematic reviews, selecting those that are most relevant to the key questions and scope parameters, have the most recent search dates, and are of highest quality. Non-English language studies and studies published only as conference abstracts are excluded.
In developing these appropriate use criteria for selected nuclear medicine procedures, the workgroups used the following definition of appropriateness to guide their considerations and group discussions: “The concept of appropriateness, as applied to health care, balances risk and benefit of a treatment, test, or procedure in the context of available resources for an individual patient with specific characteristics.”
The workgroup scored each clinical scenario as appropriate, uncertain, or inappropriate on a scale from 1 to 9 using the following definitions:
Score 7-9, Appropriate: The use of the procedure is appropriate for the specific indication and is generally considered acceptable.
Score 4-6, Maybe Appropriate: The use of the procedure is uncertain for the specific indication, although its use may be appropriate and acceptable. Uncertainty implies that more research is needed to classify the indication definitively.
Score 1-3, Rarely Appropriate: Use of the procedure is rarely appropriate for the specific indication and generally is not considered acceptable.
As stated by other societies that develop AUC, the division of these scores into 3 levels of appropriateness is somewhat arbitrary, and the numeric designations should be viewed as a continuum. Additionally, if there was a difference in clinical opinion for a particular clinical scenario, such that workgroup members could not agree on a common score, that clinical scenario was given a ‘Maybe Appropriate’ score of 5 to indicate a lack of agreement on appropriateness based on the available literature and their collective clinical opinion, indicating the need for additional research.
The Guidance Oversight Committee of the society conducts periodic reviews of all clinical guidance documents including Procedure Standards and Appropriate Use Criteria that are developed by SNMMI. Based on the final MPFS rules, the GOC has decided to conduct annual reviews of each AUC developed by the society. This review will evaluate the state of medical literature used to develop AUC and will ensure that the AUC reflects the current body of evidence.
SNMMI is committed to the transparency of the process to develop quality clinical guidance documents following a rigorous and widely accepted methodology. All clinical guidance documents developed by SNMMI, including Procedure Standards and Appropriate Use Criteria are posted online. In order to provide complete transparency, the society will post all the AUC on its website for the general public and will continue to provide information on the website on the development, modification, or endorsement of these AUC.