A Study to Assess the Correlation Between Harvey Bradshaw Index and Patient Reported Outcome 2 in Crohn's Disease Patients Enrolled in Large Scale Randomized Controlled Trials

Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that is characterized by repeated episodes of abdominal pain, diarrhea, and weight loss. This disease predominantly affects the young, resulting in poor quality of life and can lead to severe consequences including colorectal cancer.

The Impact Report by Crohn’s and Colitis Canada in 2012 conservatively estimated the total annual direct and indirect costs of inflammatory bowel disease at $11,900/person. In 2012, 104,000 Canadians were living with CD, equating to a total national cost of over $1.5 billion annually; thus, effective strategies are needed for optimizing medical care for CD while reducing the risk of side effects and minimizing costs. The use of drug concentrations enables optimization of therapies.

Several clinical indices are available for use when treating the disease, including the Harvey Bradshaw Index (HBI) and Patient Reported Outcome 2 (PRO2). However it is not clear which index is best for use in clinical practice. This study will assess how closely the two indices agree with each other and with other markers of disease activity to help guide tools in practice. It will also help clinicians interpret data.

The authors proposed to assess data from large trials that have been published to assess the correlation between the clinical indices and other markers of disease activity. Since these data have been already been collected it will provide an answer relatively quickly.