INTEGRATE-Pain and June 14, 2022 Pain Domain Meeting

INTEGRATE-Pain, the “IMI-NIH Transatlantic Emphasis Group on Research And Translation-to-care Efforts for Pain,” was established by the NIH HEAL initiative and IMI-PainCare to foster cooperation and consensus in the field of pain research. Dedicated to improving 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.

The objectives of INTEGRATE-Pain are knowledge sharing, harmonization of data standards, combination of infrastructures, and coordination of data collection in order to improve the statistical power of data interpretation in future pain research. Given these common objectives, the INTEGRATE-Pain Consortium is currently focused on the development of a common set of Patient Reported Outcomes (PROs), or pain domains (aspects of a disease), as part of Core Outcome Sets (COS) for acute, chronic, the transition from acute to chronic, and episodic/breakthrough pain that are relevant and meaningful to all stakeholders, including patients.

INTEGRATE-Pain held a virtual meeting in August 2020 to discuss opportunities for collaboration in the field of pain research, after which the INTEGRATE-Pain team undertook a systematic literature review to identify papers related to developing COS for pain or pain-related conditions and to determine whether the COS initiatives and researchers should be invited to participate in the June 2022 meeting. The INTEGRATE-Pain Consortium also met with NIH and EU pain leadership in September of 2020, who requested that our team create four overarching pain COS that can be utilized by researchers in the US and EU, and eventually throughout the world.

In preparation of the upcoming pain domain meeting, INTEGRATE-Pain 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. During the meeting on June 14, 2022, COS initiative and study representatives, patient advocacy representatives, and the INTEGRATE-Pain steering committee will meet to discuss whether there is a need for four sets of overarching COS for acute pain, chronic pain, the transition from acute to chronic pain, and episodic/breakthrough pain.

The results of the systematic literature review will also be discussed, and input will be solicited from the advisory board about the literature review and the merits of COS for pain research. After ample discussion (including breakout groups for acute, chronic, the transition from acute to chronic, and episodic/breakthrough pain), meeting attendees will determine whether four separate COS are needed for: acute pain, chronic pain, the transition from acute to chronic pain, and episodic/breakthrough pain. If COS are deemed necessary by attendees of the pain domain meeting, then the INTEGRATE-Pain steering committee will explain the Delphi voting process for developing a COS, and representatives from COS initiatives will receive further instructions about engaging their respective initiative members in the Delphi voting process.