QPLEs and The Library

Literature Review and Evidence Grading Processes. In pursuit of its primary goals, the HMS Library of Evidence will initially focus on two primary functions specific to the requirements of AUC Final Rule published by CMS under PAMA.

1. A literature review process targeting a clinical decision (e.g., use of imaging in patients with right lower quadrant abdominal pain), done systematically and in a reproducible manner and
2. An evidence grading process using widely recognized methodologies.

More specifically, the HMS Library of Evidence performs systematic literature searches starting from a list of patient conditions (organized by clinical topics) and imaging studies relevant to such clinical conditions and topics. This list addresses the Priority Clinical Areas specified by CMS as well as clinical topics requested by QPLEs who work with the HMS Library of Evidence. The list will be supplemented and updated from time to time. These literature reviews focus on publicly available guidelines and their cited references as well as evidence from peer reviewed journals, such as systematic reviews, meta-analyses, randomized controlled trials, as well as local best practices submitted by QPLEs for grading. Other clinical studies or clinical decision rules recommended by experts are also reviewed. To the extent practical, the literature reviews consider and describe the analytical validity, clinical validity, and clinical utility of the specific imaging study for the specific clinical condition or topic.

The literature review process results in lists of available evidence linking specific patient conditions and relevant imaging studies. The HMS Library of Evidence assesses and grades such evidence using a methodology based on the 2009 version of the Oxford Centre for Evidence-based Medicine (CEBM)–Levels of Evidence and the U.S. Preventive Services Task Force (USPSTF) I-Scores and NS (not scoreable). The graded evidence is then presented as clinical logic statements that can be formulated as discrete appropriate use criterion by qualified Provider-Led Entities (see http://libraryofevidence.med.harvard.edu/app/public). The key components of each criterion are identified as evidence-based or consensus-based, and are graded by three independent parties – two curators and a validating clinician. Once agreement on a final grade is reached, the full record is made available to the public. As part of its core mission, the output of the Library’s literature review and evidence grading processes is posted on its website and is available for use without charge by any provider-led entity or other third party.

How QPLEs may work with the Library. The HMS Library of Evidence is open to working with QPLEs in many ways. As one example, a QPLE may access the literature review data and the evidence grading data posted by the HMS Library of Evidence on its website as a reference or comparison when evaluating the work of its own AUC teams. This level of access would typically not require a formal relationship with the HMS Library of Evidence.

Another approach would be to work more formally with the HMS Library of Evidence in an arrangement in which the Library supplements the QPLE’s AUC team to perform the literature review or evidence grading function. Under this approach, a QPLE (likely through a domain specific AUC team) would select and review the results of the literature review for specific clinical domains and the evidence grading process conducted by the HMS Library of Evidence as part of the QPLE’s program to develop or modify AUC for specific clinical conditions as required under the Final AUC Rule. While the QPLE would use the HMS Library of Evidence’s outputs as starting points in its AUC process, the QPLE would be responsible for its own formulation of the AUC, its acceptance or rejection of the literature search, and its acceptance or rejection of the evidence grade assigned to a component of an AUC (or an entire AUC) by the HMS Library of Evidence. The QPLE would also be responsible for disclosing its use of the HMS Library of Evidence resources and outputs to CMS and on the QPLE’s website (if required under the Final AUC rule or other CMS requirements).

Conflicts of Interest Process. Recognizing that QPLE will work with the HMS Library of Evidence to comply with the Final AUC Rule, the Library will work with QPLEs to confirm that all individuals who participate in the work of the Library complete the electronic Conflicts of Interest disclosure process required by Harvard Medical School and/or Partners Healthcare. If individuals who are outside these systems should participate in the work of the Library, such individuals will be asked to complete paper versions of this disclosure. The Library will make this COI information available in timely fashion to a public request for a period of not less than 5 years after the most recent published update of its information.