ABOUT THE LIBRARY OF EVIDENCE

The effective use of a clinical decision support system means patients get the right tests, the right medications, and the right treatment, particularly for chronic conditions.

  • Goals

    The Library is a project of the HMS Countway Library of Medicine and representatives of other HMS hospitals and Harvard institutions. It was founded in collaboration with the Center for Evidence-Based Medicine at Brigham and Women’s Hospital.

    The goal of the Library is to create a provider-led, sustainable, public repository of medical evidence to enable and promote the broad and consistent practice of evidence-based medicine in the United States in order to improve the quality of care while simultaneously reducing waste and cost.

    "The goal of the Library is to create a provider-led, sustainable, public repository of medical evidence to enable and promote the broad and consistent practice of evidence-based medicine"

    The Library has been organized to serve as a public resource for medical evidence from all sources and, therefore, will focus on the accumulation, curation, organization and functionalization of medical evidence rather than on the creation of new evidence.

  • Legislative Context

    The Library is intended to support the national imperative to encourage the practice of evidence-based medicine, including the efforts of the U.S. government to support the adoption and ‘meaningful use’ of certified electronic health records (EHR) under the Health Information Technology for Economic and Clinical Health Act (HITECH) to achieve specified improvements in care delivery.

    The HITECH Act requires, among other interventions, that healthcare providers implement clinical decision support (CDS) systems as part of certified EHRs. CDS systems are tools designed to aid directly in clinical decision making, in which characteristics of individual patients are used to generate patient specific interventions, assessments, recommendations, or other forms of guidance that are then presented to a decision making recipient or recipients that can include clinicians, patients, and others involved in care delivery. The Centers for Medicare & Medicaid Services state that CDS represents one of the most promising tools to mitigate the ever-increasing complexity of the day-to-day care practice of medicine.

    The effective use of a clinical decision support system means patients get the right tests, the right medications, and the right treatment, particularly for chronic conditions.

    While the HITECH Act provides the general context for the establishment of the Library, a more recent Federal statute known as the Protecting Access to Medicare Act of 2014 (42 USC 1395m, “PAMA”), signed into law on April 1, 2014, created a sense of urgency for this effort and identified medical imaging evidence as the initial domain focus for the Library. Starting on January 1, 2017, PAMA requires healthcare providers to use approved CDS systems to consult specified appropriate use criteria when ordering certain advanced imaging procedures. PAMA defines the term appropriate use criteria as “criteria, only developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evidence-based.”

    "The effective use of a clinical decision support system means patients get the right tests, the right medications, and the right treatment"

    PAMA instructs the U.S. Secretary of Health and Human Services (HHS) to specify the first list of approved Appropriate Use Criteria by November 15, 2015. In specifying applicable appropriate use criteria the Secretary of HHS is required to take into account whether the criteria have stakeholder consensus, are scientifically valid and evidence based and are based on studies that are published and reviewable by stakeholders.

    In response to this deadline the Harvard Medical School Library of Evidence, under the leadership of healthcare providers drawn from teaching hospitals, community hospitals and private medical practices, will initially focus on assembling and curating evidence related to the appropriate use of medical imaging, and will establish a national resource of appropriate use criteria meeting the definition in PAMA for medical imaging. The Library will seek approval for this resource by the Secretary of HHS under 42 USC 1395m (q)(2)(A), with an initial list of Appropriate Use Criteria that will be supplemented annually.
     

  • Literature Search

    The recommendations regarding appropriate use of imaging used to populate the evidence library were derived from a variety of sources and a number of publishers. Sources were identified through a literature search of MEDLINE (1980-2016) through the Ovid interface using the text search terms, “decision rule”, “decision instrument”, “clinical algorithm”, “prediction rule”, “low-risk criteria”, “high-risk criteria”, “practice guideline”, and “clinical policy” and the MeSH terms “radiography”, “radiology/standards”, “ultrasonography”, and “decision support techniques”. Specific techniques for identifying clinical prediction studies described by Wong et al were used. This literature search was augmented by reviewing the reference lists of identified articles. Each source was then individually examined to determine its eligibility for entry into the evidence library. Approximately 85% were excluded from the final collection of evidence sources because they: 1) contained non-imaging- related recommendations, 2) were duplicative of recommendations published in a previous source, or 3) contained rules and scoring systems that had not been validated since 2000.

    Imaging-related decision rules, prediction rules, and risk-assessment scores commonly utilized in current medical practice were also identified through medical calculator websites such as MDCalc and QxMD. Imaging-related clinical practice guidelines were identified through the National Guideline Clearinghouse and by searching the websites of various professional societies for published policies and statements. All relevant documentation for local best practice guidelines were also obtained from various healthcare institutions. Imaging-related AUC were obtained primarily from two public sources, the American College of Radiology Appropriateness Criteria database and the American College of Cardiology Appropriate Use Criteria list.

    From all these recommendation sources, we prioritized grading recommendations that were included in the Centers for Medicare & Medicaid Services (CMS) priority clinical conditions, and recommendations from the Choosing Wisely campaign.

  • Grading Methodology

    The Library’s evidence grading methodology is 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. Recommendations chosen from professional society guidelines, local best practices and peer-reviewed literature are converted into Health-IT consumable clinical logic and then graded by two independent parties – a curator and a validating clinician. Once agreement on a final grade is reached, the full record will be made freely available to the public.

  • Roles and Responsibilities

    • Project Manager – In consultation with the Governing Council, the project manager translates individual pieces of evidence- from guidelines, local best practices or the literature- into clinical logic to be used in the grading process.  The project manager assigns evidence to appropriate curators and validating clinicians, coordinates the grading workflow and ensures data accuracy and integrity.
    • Curator – Librarians trained in the use of the CEBM and USPSTF methodologies grade each piece of assigned evidence, record the rationale for their decision and pass the work on to a validating clinician.
    • Validating Clinician – Physicians grade each piece of evidence completed by the curators, record the rationale for their decision and, when agreement is reached, finalize the grade for public access.
  • Training Materials

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