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Studies (prospective or retrospective) utilizing data obtained from "real world settings" , and is outside the tight controls of a clinical trial design.

Compare alternative treatments that lead to similar health outcomes.

Assess effects, costs and economic outcomes of treatment. These include cost-effectiveness models and budget impact models.

Economic evaluation in which costs and benefits (outcomes) are expressed in monetary units, to determine if the benefits of an intervention outweigh the costs.

Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder (manufacturer, payer, provider, HTA agency, etc.). See also HTA Submission.

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 to improve the delivery of care.

Measures patient's symptoms, mental, or physical effects of a disease or condition on how the patient functions, recorded by practitioner, provider, or instrument (not by patient).

Assessment of treatment processes and patterns within clinical practice.

Analyze the medical, social, ethical, humanistic, and economic considerations of a drug, medical device, or clinical procedures. Submissions are sent to regulatory agencies with different requirements that govern submissions. See also AMCP and Value Dossier.

Digital version of a patient's medical or health chart containing demographic, clinical, medical, and other treatment information.