Developing consensus on core outcome domains for assessing effectiveness in perioperative pain management: results of the PROMPT/IMI-PainCare Delphi Meeting

Abstract

Postoperative pain management is still insufficient, leading to major deficits, including patient suffering, impaired surgical recovery, longterm opioid intake, and postsurgical chronic pain. Yet, identifying the best treatment options refers to a heterogeneous outcome assessment in clinical trials, not always reflecting relevant pain-related aspects after surgery and therefore hamper evidence synthesis. Establishing a core outcome set for perioperative pain management of acute pain after surgery may overcome such limitations. An international, stepwise consensus process on outcome domains ("what to measure") for pain management after surgery, eg, after total knee arthroplasty, sternotomy, breast surgery, and surgery related to endometriosis, was performed. The process, guided by a steering committee, involved 9 international stakeholder groups and patient representatives. The face-to-face meeting was prepared by systematic literature searches identifying common outcome domains for each of the 4 surgical procedures and included breakout group sessions, world-caf é formats, plenary panel discussions, and final voting. The panel finally suggested an overall core outcome set for perioperative pain management with 5 core outcome domains: physical function (for a condition-specific measurement), pain intensity at rest, pain intensity during activity, adverse events, and self-efficacy. Innovative aspects of this work were inclusion of the psychological domain selfefficacy, as well as the specific assessment of pain intensity during activity and physical function recommended to be assessed in a condition-specific manner. The IMI-PROMPT core outcome set seeks to improve assessing efficacy and effectiveness of perioperative pain management in any clinical and observational studies as well as in clinical practice.

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“…Recently, it was mutually agreed with patients and many stakeholders involved in perioperative pain management, pain-related physical function (like moving out of bed, performing physiotherapy, etc.) is the most important domain to be assessed in clinical acute perioperative pain ( 39 ). Future studies need to identify relevant mechanisms of movement-evoked pain in mice to develop effective treatment options.…”

Reply to Karlsen et al. Consensus on a core outcome set: a panel decision

“…Finally, we totally agree with you that the pain intensity rating alone is not able to define effectiveness and efficacy of a certain intervention in the perioperative pain field; however, our initiative Innovative Medicines Initiative (IMI) PainCare (and herein the subproject Providing Standardized Consented Patient Reported Outcome Measures for Improving Pain Treatment [PROMPT]) exactly targets this issue and aims to define those outcomes that should be assessed to determine whether an intervention is effective (or not) to reduce postsurgical pain, namely, physical function, pain intensity at rest and during activity, adverse event, and self-efficacy 6 and not only pain intensity ratings on its own.…”

“…The domain analgesic consumption was therefore certainly discussed by the panel during the consensus face-to-face meeting. 6 Within the therapy aim and outcome mapping process, analgesic consumption was listed and prioritized moderate to high (between 5 and 7 on a scale from 1 to 9, please compare Table 5 in Pogatzki-Zahn et al 2021 6 ) but not high enough to be considered at the end to be included in our COS. 6 As discussed by us, analgesic consumption might be considered to be assessed in addition to the 5 COS domains 6 ; a COS is only the minimum set of outcomes to be assessed in all clinical trials of a certain scope but can certainly be extended were appropriate. 7 However, our panel, especially attending patient representatives, did not find analgesic consumption important enough to be considered as most important or, in our terms, most critical.…”

“…The letter is directly related to the publication Bigalke et al, 2021. 1 The publication Pogatzki-Zahn et al, 2021 6 is part of the project IMI PainCare. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No [777500].…”

Opioid consumption as a core outcome domain in postoperative pain management

“…We read with interest the article by Bigalke et al, 1 which is a review of reported outcomes in 295 trials on postoperative pain management after total knee arthroplasty. Along with 3 similar reviews on other types of surgery, this formed the list of potential outcomes in a subsequent Delphi process by Pogatski-Zahn et al, 5 leading to a core outcome set in postoperative pain management. We strongly agree that standardized outcomes are important for trial comparisons and aggregation in meta-analyses, and applaud the initiative.…”