Addressing guideline and policy changes during pragmatic clinical trials.

ABSTRACT: While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-

SUBMITTER: Curtis LH 

PROVIDER: S-EPMC6663617 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature