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Outcomes measures should be relevant to the target of the intervention (be it a single person or a target population). [2] Depending on the design of a trial, outcome measures can be either primary outcomes, in which case the trial is designed around finding an adequate study size (through proper randomization and power calculation). [1]
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 reanalysis using the original primary outcome measures still showed there was a small improvement in one of the two subjective measures at 52 weeks for the GET and CBT groups. However, this difference was not sustained in the long-term follow-up. [2]
A drug against major depressive disorder, paroxetine, was marketed for children and teenagers for years, based on a flawed trial that involved outcome switching. [9] The trial's protocol had described two primary and six secondary outcomes by which it would measure efficacy.
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).
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]
Outcome contains all the effects of healthcare on patients or populations, including changes to health status, behavior, or knowledge as well as patient satisfaction and health-related quality of life. Outcomes are sometimes seen as the most important indicators of quality because improving patient health status is the primary goal of healthcare.
The Patient-Reported Outcomes Measurement Information System [1] (PROMIS) provides clinicians and researchers access to reliable, valid, and flexible measures of health status that assess physical, mental, and social well–being from the patient perspective. PROMIS measures are standardized, allowing for assessment of many patient-reported ...