Pain is complex and difficult to measure
To evaluate the benefits of new pain treatments, we need to be able to accurately measure pain. There is no simple scan or blood test that we can use to do this; we are reliant on patient-reported outcome measures (PROs).
Current PRO reality
PROs normally come in the form of a questionnaire, scale or diary that patients use to report on the status of their health condition. However, many of the current PROs used for pain are too simple – the most commonly accepted scales by regulatory authorities are the visual analogue scale or numeric rating scale, where patients are asked to rate their ‘usual level of pain on a scale of 0–10’. They do not measure other aspects such as pain quality or impact on quality of life and are limited by factors such as recall bias.
0-10 Numeric Pain Rating Scale
Understanding the unmet need for novel PRO tools in vulvodynia
Vulvodynia is a highly prevalent condition of the vulva leading to painful sex and chronic pelvic pain. Current PROs specific to vaginal and vulval health focus primarily on sexual quality of life with little focus on pain, lacking granular questioning on patient pain. There is an unmet need for a new instrument that includes quality of life measures and the impact of pain on patient outcomes, such as the ability to use tampons or wear tight trousers.
"Pain limits, isolates, and slows down lives; a 0–10 scale does not apply"
Future PRO reality
We want to change the current PRO reality. As innovators, we are committed to improving the health environment beyond developing new drugs and devices. In partnership with patients and experts, we are developing novel disease-specific PROs and new ways to assess functional outcomes.
Development of a fit-for-purpose PRO in chronic low back pain
Chronic low back pain is an extremely common disorder that is associated with long-term pain and disability. Grünenthal recognised that PRO instruments measuring its impact on patients would often present pain as a single overall concept, which may not fully capture the pain sensations of this condition. We therefore used this unmet need as an opportunity to develop the Patient Assessment for Low Back Pain–Symptoms (PAL-S), a PRO assessment tool designed to specifically reflect the pain sensations experienced by patients with chronic low back pain. Read more about the mixed-methods development of this tool here.