INTEGRATE-Pain, the “IMI-NIH Transatlantic Emphasis Group on Research And Translation-to-care Efforts for Pain,” was established in 2019 by the IMI-PainCare and the NIH HEAL initiative to foster transatlantic cooperation in the field of pain research. To improve the understanding, management, and treatment of pain, both teams have prioritized common opportunities in preclinical and clinical research, ultimately accelerating the discovery and development of new non-addictive treatments and improving the management of pain.
One objective of INTEGRATE-Pain is harmonization of data standards in clinical trials as well as clinical routine – an issue that is of major interest in the IMI-PainCare project, e.g. within Work Package 2 (WP2) of IMI-PainCare. Thus, one working group within Integrate-Pain, the Integrate-Pain domain working group (Co-leads: Laura Wander, Program Director at NIH, and Esther Pogatzki-Zahn, co-lead of IMI-PainCare WP2 as well as Giulia Bova, NIH and Ulrike Kaiser, IMI-PainCare) primarily focus on harmonizing outcome assessment in clinical trials and clinical practice in the U.S.A. and Europe, ultimately worldwide.
As part of this effort, the INTEGRATE consortium domain subgroup held a virtual meeting on June 14, 2022 which brought together researchers, patients, and stakeholders from around the world to discuss the need for an overarching core outcome set (also known as a COS, an agreed-upon set of the most critical domains to be measured for a health condition) to be assessed for use in clinical studies, clinical trials, clinical practice. A standardization of data, such as an overarching COS of patient reported outcomes (or otherwise known as pain domains) for acute pain, the transition from acute to chronic pain, recurrent/breakthrough pain, and chronic pain would enable comparability of data across studies, reduce reporting bias related to outcomes, and would assess the impact of a treatment from a more biopsychosocial perspective, reflecting patients’ needs more appropriately.
The 4hour meeting was held virtually and more than 80 invited people participated; attendees were all invited based on their previous work within the field of COS related to any pain – related disease (based on ICD-11 criteria) and/ or their work in this area. In addition, patient representatives from the US as well as Europe were invited as well. With the help of a steering board (NIH and IMI-PainCare representatives) as well as an advisory board (COS initiative experts as well as patient representatives), several aspects related to COS and their importance were introduced and addressed first. In addition, the INTEGRATE domain team has been conducting a systematic literature review about existing pain COS to help inform the meeting discussion surrounding pain domains and the potentiality of COS development. By using predefined search strings and in- and exclusion criteria, 160 studies were identified related to COS from which 62 articles recommended a core outcome set of domains for clinical trials and/or daily routine care. From these studies, all outcome domains from the COS were extracted, organized based on the pain conditions (acute pain, the transition from acute to chronic pain, recurrent/breakthrough pain, and chronic pain) and presented to the meeting attendees within four breakout sessions. Meeting attendees then discussed the “pro’s” and “con’s” of developing overarching core outcome sets for use in clinical studies, clinical trials and clinical practice for the four conditions separately. As a result, all four groups identified a need for a COS.
At the end of the meeting, INTEGRATE-Pain was asked to work on coordinating an overarching COS that could be used with acute pain, acute to chronic pain transition, recurrent/breakthrough pain, and chronic pain. Importantly, condition-specific outcome domains should be separately assessed depending on the type of pain, but the minimum overarching COS should be used comprehensively throughout the pain condition. Therefore, INTEGRATE-Pain, with the help of COS initiatives and patients, is now reaching out to COS research panels and patient networks, and is conducting a Delphi voting process to reach consensus on pain domains that would form an overarching core outcome set for each of the aforementioned pain groups.
All material related to the meeting on the 14th of June 2022 (including all recorded talks) can be found here: https://integrate-pain-domain-meeting.com/
