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An outcome measure, endpoint, effect measure or measure of effect is a measure within medical practice or research, (primarily clinical trials) which is used to assess the effect, both positive and negative, of an intervention or treatment. [1] [2] Measures can often be quantified using effect sizes. [3]
In a classic 1966 paper, Avedis Donabedian, the renowned public health pioneer, described three distinct aspects of quality in health care: outcome, process and structure (in that order in the original paper). [15] He had misgivings about solely using outcomes as a measure of quality, but concluded that:
Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ...
Outcomes research is a branch of public health research which studies the end results of the structure and processes of the health care system on the health and well-being of patients and populations.
Core outcome sets are commonly used by clinical investigators who conduct clinical trials for the treatment of a health condition. [2] [3] [4] The patient population associated with a particular core outcome set may vary, as some apply to all patients with that health condition and others apply to a small subset of that population. [2]
Patient-reported outcomes are important in a regulatory context. The US Food and Drug Administration (FDA) has issued formal Guidance to Industry on PROs in label claims [24] and the European Medicines Agency (EMA) has produced a reflection paper on HRQoL. [25] Increasing numbers of regulatory submissions for new drugs provide PRO data to ...
The International Initiative for Impact Evaluation (3ie) defines rigorous impact evaluations as: "analyses that measure the net change in outcomes for a particular group of people that can be attributed to a specific program using the best methodology available, feasible and appropriate to the evaluation question that is being investigated and ...
PROMIS has worked to unify the field of patient-reported outcome (PRO) measurement through the promotion of a common, systematic measurement system broadly applicable across clinical research. PROMIS measures are intended to assess the most common or salient dimensions of patient–relevant outcomes for the widest possible range of chronic ...