See Primer. Patient safety event reporting systems are ubiquitous in hospitals and are a mainstay of efforts to detect safety and quality problems. However, while event reports may highlight specific safety concerns, they do not provide insights into the epidemiology of safety problems.
The process whereby a physician informs a patient about the risks and benefits of a proposed therapy or test. Informed consent aims to provide sufficient information about the proposed treatment and any reasonable alternatives that the patient can exercise autonomy in deciding whether to proceed.
Legislation governing the requirements of, and conditions under which, consent must be obtained varies by jurisdiction. Most general guidelines require patients to be informed of the nature of their condition, the proposed procedure, the purpose of the procedure, the risks and benefits of the proposed treatments, the probability of the anticipated risks and benefits, alternatives to the treatment and their associated risks and benefits, and the risks and benefits of not receiving the treatment or procedure.
Although the goals of informed consent are irrefutable, consent is often obtained in a haphazard, pro forma fashion, with patients having little true understanding of procedures to which they have consented. Evidence suggests that asking patients to restate the essence of the informed consent improves the quality of these discussions and makes it more likely that the consent is truly informed.