American Recovery and Reinvestment Act (ARRA)
Stimulus funding by President Obama, appropriated $1.1 billion to comparative effectiveness research (CER) in 2009.
Cancer Genomics (CancerGen)
A collaboration between University of Washington, SWOG, and CMTP for prioritization of genetic tests in cancer.
Coverage with Evidence Development (CED)
Coverage with Evidence Development (CED) provides coverage of specific promising technologies to a requirement that the patients participate in a registry or clinical trial that will generate the additional benefit and safety information medical directors need to make an informed coverage decision.
Adapted from: Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare’s ‘coverage with evidence development’. Health Aff (Millwood) 2006;25:1218-30.
Comparative Effectiveness Research (CER)
The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.
Source: Sox HC. Defining comparative effectiveness research: the importance of getting it right. Med Care. 2010; 48(6 Suppl):S7.
Evidence Based Medicine (EBM)
The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. EBM calls for the integration of the best current evidence available with clinician expertise and the personal values of patients.
Source: Sackett, D. Evidence-based Medicine – What it is and what it isn’t. BMJ 1996; 312:71-72.
Effectiveness Guidance Document (EGD)
A core product of CMTP that provides specific recommendations on the design of prospective studies intended to inform decisions by patients, clinicians and payers. EGDs offer specific study design recommendations relevant to a defined clinical condition and/or category of clinical interventions.
External Stakeholder Advisory Group (ESAG)
A CMTP term referring to a large group of stakeholders (approx. 50 people) convened at a CER Methods Conference or other forum to review and establish guidelines and priorities.
Health Technology Assessment (HTA)
Interdisciplinary, analytic evaluation of medical technologies for their direct and indirect effects and impacts (which can be medical, economic, social, and ethical) for the purpose of informing health technology policy decisions.
Adapted from EUnetHTA: http://www.eunethta.eu/Public/About_EUnetHTA/HTA/
Medical Device Epidemiology Network (MDEpiNet)
A CMTP public-private partnership (PPP) in collaboration with the FDA, academia to involve a broad group of stakeholders in comparative effectiveness research.
Medicare data United with Simple Clinical trials Expanded (MUSCLE) Network
A CMTP collaboration with the University of Alabama to build on University of Alabama’s medicare data network to develop a research infrastructure for conducting large simple trials.
Patient and Consumer Advisory Committee (PCAC)
Advisory committee to CMTP. This committee focuses on providing guidance for ensuring CMTP’s commitment to patient-centered (and consumer) care is held accountable in all of CMTP’s activities.
Priorities with Evidence Development (PED)
CMTP term referring to activities involving the prioritization of a particular technology, disease area, or medical area.
Pragmatic Clinical Trials (PCTs)
Pragmatic clinical trials (PCTs) are randomized controlled trials (RCTs) designed to determine the risks, benefits, and costs of an intervention as they would occur in routine clinical practice. In contrast to explanatory trials, PCTs generally include a broader range of patients (by reducing the number of inclusion/exclusion criteria), a broader range of study sites (by including community-based, non-academic sites), and outcomes that are aligned with the evidence needs of decision-makers (e.g., patients, clinicians, payers, and policy makers).
Sources: Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003; 290:1624-1632.
Mullins CD, Whicher DW, Reese ES, and Tunis S. Generating evidence for comparative effectiveness research using more pragmatic randomized controlled trials. Pharmacoeconomics. 2010; 28(10):969-976.
Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967; 20:637-648.
Public/Private Partnership
A Public-Private Partnership (PPP) is an agreement from a federal agency, such as the Food and Drug Administration or Centers for Medicare and Medicaid Services, to work in concert with a nonfederal party or parties to advance mutual interests to improve health. Nonfederal parties may include patient advocacy groups, medical professional societies, manufacturers, health care payers, and other groups. Funding is typically based on contributions made by each partner, and governance, roles, and the length of the partnership relationship will vary depending on the goals and objectives of the partners.
Adapted from: National Institute of Health (NIH)
http://oma.od.nih.gov/manualchapters/management/1167/
Patient Reported Outcome (PRO)
Any report of the patient’s perspective of his/her health condition, disease or treatment that comes directly from the patient without interpretation by a clinician.
Stakeholder:
Individuals, organizations, or communities that have a direct interest in the process and outcomes of a project, policy or research endeavor.
Stakeholder Engagement
A process of actively soliciting the knowledge, experience, judgment and values of individuals selected to represent a broad range of groups having a direct interest in a particular issue for the dual purposes of 1) creating a shared understanding; and 2) making relevant, transparent, and effective decisions.
Technical Working Group (TWG)
CMTP term for small group meeting of experts (approx. 12 people) to discuss highly technical, methodological issues to advise CMTP, especially as part of the development of an Effectiveness Guidance Document (EGD).