Defining New Outcomes in Pain Trials – Beyond Pain Intensity

Sebastian Straube

Pain intensity and pain relief are logical and appropriate primary outcomes of choice in clinical trials that investigate treatments for painful conditions. However, painful conditions, especially if chronic, affect patients in a number of ways over and above generating the experience of pain, impacting on diverse domains of life including social functioning, work ability, and metal well-being. This lecture will explore the relationship between the directly pain-related outcomes, pain intensity and pain relief, and important trial outcomes that reflect other domains of life. Typically, responder pain outcomes are predictive of outcomes in other domains. A particular focus will be placed on work ability, as being able to work can contribute positively to life in a number of ways over and above receiving financial compensation. The reporting of work-related outcomes in pain trials is generally poor, however, even though data on work ability are collected as part of questionnaires commonly used in such trials. Implications for future trial design and reporting will be discussed.