The FDA may consider approval of the cross-sex hormone estradiol for gender incongruence in adults and minors based on an observational study and not an RCT with placebo.
There are times when researchers identify a concept or phenomenon which becomes widely known and used in many areas. The construct takes on a life beyond the original scholarship. An example of this is the notion of “emotional labour” coined by Arlie Russell Hochschild to describe the work of nurses and others when regulating their responses in stressful situations, and managing the demands of patients, families, and colleagues.1 Another case is the step-like “paradigm shifts” in which science advances through radical ruptures as new truths emerge in scientific communities.2
An example that is currently breaking through to common use is the concept of “mindlines,” coined by John Gabbay and Andree le May in an article published in The BMJ in 20043 and more thoroughly developed in their subsequent book, Practice-Based Evidence .4 Starting with a small ethnographic study in one general practice, they carefully describe how clinicians use different forms of knowledge in making