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

Pain, vol. 162, pp. 2717–2736

Abstract

ABSTRACT: Postoperative pain management is still insufficient, leading to major deficits, including patient suffering, impaired surgical recovery, long-term 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-café 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 self-efficacy, 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.

Authors 8

1. Esther Miriam Pogatzki-Zahn corresponding

   University of Münster · University Hospital Münster

   Affiliation as printed

   Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany

2. Hiltrud Liedgens Aachen Grünenthal GmbH

   Grünenthal Group (Germany)

   Affiliation as printed

   Grünenthal GmbH, Aachen, Germany

3. Lone Hummelshøj

   Endometriosis UK · World Endometriosis Research Foundation

   Affiliation as printed

   Endometriosis.org, United Kingdom; World Endometriosis Society, Vancover, Canada; World Endometriosis Research Foundation, London, United Kingdom

   Endometriosis.org, United Kingdom

   World Endometriosis Society, Vancover, Canada

4. Winfried Meißner

   Jena University Hospital

   Affiliation as printed

   Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany

5. Claudia Weinmann

   Jena University Hospital

   Affiliation as printed

   Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany

6. Rolf‐Detlef Treede

   Heidelberg University · Medizinische Fakultät Mannheim

   Affiliation as printed

   Neurophysiology, Medical Faculty Mannheim, University Heidelberg, Heidelberg, Germany

7. Katy Vincent

   University of Oxford

   Affiliation as printed

   Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, United Kingdom

8. Peter K Zahn

   BG University Hospital Bergmannsheil Bochum · Ruhr University Bochum

   Affiliation as printed

   Department of Anaesthesiology and Intensive Care Medicine, Palliative Care Medicine and Pain Management, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH Bochum, Ruhr University Bochum, Bochum, Germany