New methods for generalizability and transportability: the new norm

Excerpt

Generalizability is an ever-present concern in epidemiology. Though randomized trials are often considered the gold standard, as Weiss describes there are often scenarios where results from randomized trials are not more broadly applicable and observational studies are needed to inform associations in populations not represented in randomized trials [1]. We recently completed a randomized trial that highlights the importance of generalizability and of considering the target population from the outset. The Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was designed to evaluate the effect of low dose aspirin on pregnancy loss [2]. It is hypothesized that aspirin may improve blood flow in the uterus, thus facilitating implantation, and that this may be particularly beneficial for women who have recently had a pregnancy loss. Aspirin is well known for its anti-inflammatory properties, and as it is a low cost and widely available intervention, if it could be broadly applied could have a tremendous public health impact. …