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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]
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 ...
The goal of outcomes research, is to measure tangible events experienced by the patient such as mortality and morbidity. [2] Patient engagement in research presents opportunities to increase outcomes of both the studies themselves as well as the patients and their medical conditions. [10]
Outcome measurement is therefore an important but neglected tool in improving quality of healthcare provision. It has been argued that it is vital that the patient has been meaningfully involved in decisions about whether or not to embark on an intervention (e.g. a test, an operation, a medicine).
The term core domain is a key aspect of health or well-being that is considered essential to define, measure and report in all clinical trials and other research studies related to a specific health condition or disease.These are considered the ‘What’ to measure in Core Outcome Sets. [5]
Outcome switching also occurs frequently in follow-up studies. [6] In an analysis of oncology trials, outcome switching was more common in studies with a male first author, and in studies funded by non-profits. [7] One study analysed outcome switching in five top medical journals, writing letters for each misreported trial outcome.
Valderas JM, Alonso J. Patient reported outcome measures: a model-based classification system for research and clinical practice. Qual Life Res. 2008; 17: 1125–35. Wiklund I., Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life, Fundam Clin Pharmacol. 2004 Jun;18(3):351-63.
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 ...