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The c. 1847 work of Ignaz Semmelweis on the association between puerperal fever and the absence of aseptic procedures (specifically, doctors who failed to clean their hands before delivering babies) and the subsequent use of calcium hypochlorite to reduce risk, is an early example of outcomes research.
An example of practice-based evidence is found in the evaluation of a simple intervention like a medication. Efficacy is the degree with which it can improve patients in randomised controlled trials– the epitome of evidence-based practice.
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 ...
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.
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]
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 ...
Behavioral health outcome management (BHOM) involves the use of behavioral health outcome measurement data to help guide and inform the treatment of each individual patient. Like blood pressure, cholesterol and other routine lab work that helps to guide and inform general medical practice, the use of routine measurement in behavioral health is ...
The GRADE approach separates recommendations following from an evaluation of the evidence as strong or weak. A recommendation to use, or not use an option (e.g. an intervention), should be based on the trade-offs between desirable consequences of following a recommendation on the one hand, and undesirable consequences on the other.