Glossary
Useful definitions of common terms in our work
CER compares the effectiveness of two or more interventions or approaches to health care, examining their risks and benefits. CER findings assist clinicians, patients, and other stakeholders in making informed decisions that improve health care. Comparing two or more interventions distinguishes CER from other types of clinical research. It can both validate a particular intervention and identify which treatments best meet a certain population’s needs. https://www.pcori.org/
Health Equity is the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes. https://www.cms.gov/pillar/
Multi-Criteria Decision Analysis (MCDA) is a structured deliberative approach used to evaluate different options based on multiple, and sometimes conflicting, criteria and priorities to identify the preferred solution in decision-making (e.g., select the best treatment by weighing time to relief, duration of relief, and out-of-pocket cost).
The Innovation and Value Initiative uses the term “patient” or “patient advocate” to refer to a person who has had an encounter with the healthcare system and has lived expertise in the healthcare system. We do not suggest that a person is their disease or that it is a person’s only area of experience or expertise. We use this term in recognition of their lived experiences and the importance of this experience to improving the healthcare system.
Board Approved, 7/18/203 based on recommendations from the Patient Advisory Council
- Being guided by the core principles of patient-centricity, health equity, and transparency.
- The involvement of patients (and their families and caregivers) throughout the HTA process, including co-leadership in the process, strategy, and governance and partnership with decisionmakers in reviewing and applying results.
- The assurance that patient preferences, patient-preferred outcomes and goals, and lived experience inform HTA methodology (e.g., formation of research questions, model design, and incorporation of evidence) so that assessment models and results reflect what patients value.
A health outcome directly reported by the patient who experienced it. This is in contrast from clinical or other outcomes reported by physicians, nurses, or other individuals.
Quality-Adjusted Life-Year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number. The QALY calculation is simple: the change in utility of value (i.e., quality of life) by the treatment is multiplied by the duration of the treatment effect to provide the number of QALYs gained. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY. This parameter can be used to compare the cost-effectiveness of any treatment. Prieto L, Sacristan JA. Problems and solutions in calculating quality-adjusted life-years (QALYs). Health Qual Life Outcomes. 2003 Dec 19;1:80. DOI: 10.1186/1477-7525-1-80. PMID: 14687421; PMCID: PMC317370. (Link to IVI’s position on the QALY)
Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. https://www.fda.gov/science-
Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. https://www.fda.gov/science-