Patients affected by inflammatory bowel disease often suffer from symptoms that impact their quality of life. They range from frequent urges to defecate to the feeling of not being able to leave the house. American researchers have now set themselves the goal of developing Patient-Reported-Outcome (PRO) questionnaires. Primarily, these are to be used in clinical trials to measure the effectiveness of various therapy options on these symptoms.
The tools were developed taking into account the recommendations of the US Food and Drug Administration (FDA). Based on patient interviews, the most common symptoms affecting quality of life were documented.
Twelve individuals were interviewed for each condition to identify the most common symptoms. The answers were validated by the researchers before any symptoms found their way into the final version of the questionnaires. This approach made sure that there were no outliers and that the questionnaire was relevant for the target group.
The PRO-UC and PRO-CD are two tools developed for clinical trials that can be used to measure therapeutic effects on the symptoms that most often affect patients' quality of life. Their use in everyday clinical practice may become possible in the future.
Source:
Nag A, Romero B. Development and content validation of patient-reported outcomes tools for ulcerative colitis and Crohn's disease in adults with moderate-to-severe disease. Health Qual Life Outcomes. 2022 May 7;20(1):75. doi: 10.1186/s12955-022-01975-1. PMID: 35525935.