Addressing guideline and policy changes during pragmatic clinical trials.

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.

Adherence, Persistence, and Expenditures for High-Cost Anti-Inflammatory Drugs in Rheumatoid Arthritis: An Exploratory Study.

Background: Drugs for inflammatory conditions are one of the highest expenditure therapeutic classes for health plans. Published literature for adherence, persistence, nonadherence risk factors, and health care costs are incomplete for newer biologic agents.

Objectives: To (a) examine differences in adherence, persistence, switch patterns, and health care costs among high-cost specialty anti-inflammatory medications and (b) suggest risk factors for nonadherence in rheumatoid arthritis.