TY - JOUR
T1 - A core outcome set of measurement instruments for assessing effectiveness and efficacy of perioperative pain management
T2 - results of the international IMI-PainCare PROMPT Delphi consensus process
AU - Pogatzki-Zahn, Esther M.
AU - De Lucia, Sarah
AU - Weinmann, Claudia
AU - Heitkamp, Hauke
AU - Hummelshoj, Lone
AU - Liedgens, Hiltrud
AU - Meissner, Winfried
AU - Vincent, Katy
AU - Vollert, Jan
AU - Zahn, Peter
AU - Avian, Alexander
AU - Baron, Ralf
AU - Boesl, Irmgard
AU - Bouhassira, Didier
AU - Buhre, Karoline
AU - Chandler, Rebecca
AU - Dauben, Hans Peter
AU - Fletcher, Dominique
AU - Forget, Patrice
AU - Freys, Stephan
AU - Kocot-Kepska, Magdalena
AU - Koke, Albere
AU - Lambers, Britta
AU - Lavand'homme, Patricia
AU - Lobo, Dileep
AU - Makris, Alexandros
AU - Moloney, Niamh
AU - Mott, David
AU - Nestler, Nadja
AU - Nilges, Paul
AU - Norda, Heike
AU - Peters, Madelon
AU - Pöpping, Daniel
AU - Schnabel, Alexander
AU - Stubhaug, Audun
AU - Treede, Rolf Detlef
AU - van Boekel, Rianne
AU - Vanryckeghem, Dimitri
AU - Wittink, Harriet
AU - Zoëga, Sigridur
AU - Kaiser, Ulrike
AU - Rosenberger, Daniela C.
N1 - Funding Information:
This work was conducted as part of IMI-PainCare PROMPT (an Innovative Medicines Initiative 2 Joint undertaking under grant agreement No 777500). This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. www.imi.europa.eu; www.imi-paincare.eu . The statements and opinions presented here reflect the author\u2019s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
Funding Information:
The IMI-PainCare project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777500. This Joint Undertaking receives support from the European Union\u2019s Horizon 2020 research and innovation programme and EFPIA.
Publisher Copyright:
© 2025 The Authors
PY - 2025/5/1
Y1 - 2025/5/1
N2 - Background: Effective perioperative pain management is crucial to prevent patient suffering, delayed recovery, chronic postsurgical pain, and long-term opioid use. However, the heterogeneous use of outcomes in studies complicates evidence synthesis and might not accurately reflect the experiences of individual patients. We initiated a consensus process to establish a core outcome set (COS) of patient-reported outcome measures (PROMs) in postoperative pain, building upon the earlier consensus on a COS of domains. Methods: Potential PROMs were identified via systematic literature searches for the domains pain intensity (with subdomains at rest and during activity), physical function, self-efficacy, and adverse events, followed by appraisal of psychometric properties according to the COnsensus-based Standards for the selection of health Measurement INstruments methodology. Then, a consensus meeting was convened, followed by a Delphi process with an international, multiprofessional panel of stakeholders, including those with lived experience. A conclusive consensus meeting approved the final COS of PROMs. Results: The final COS consists of one unidimensional numerical rating scale for assessing pain intensity on average, worst pain intensity, pain intensity at rest, and procedure-specific pain intensity during activity; one unidimensional scale for pain interfering with activities in bed; one procedure-specific scale for assessing physical function; the IMI-PainCare PROMPT adaptation of the Arthritis Self-Efficacy Scale for assessing self-efficacy; and the IMI-PainCare PROMPT adaptation of the Opioid-Related Symptom Distress Scale for assessing adverse events. Conclusions: Comprehensive use of a core outcome set will help harmonise outcome assessment, facilitate comparisons between studies, promote patient-centred research, and improve postoperative pain care.
AB - Background: Effective perioperative pain management is crucial to prevent patient suffering, delayed recovery, chronic postsurgical pain, and long-term opioid use. However, the heterogeneous use of outcomes in studies complicates evidence synthesis and might not accurately reflect the experiences of individual patients. We initiated a consensus process to establish a core outcome set (COS) of patient-reported outcome measures (PROMs) in postoperative pain, building upon the earlier consensus on a COS of domains. Methods: Potential PROMs were identified via systematic literature searches for the domains pain intensity (with subdomains at rest and during activity), physical function, self-efficacy, and adverse events, followed by appraisal of psychometric properties according to the COnsensus-based Standards for the selection of health Measurement INstruments methodology. Then, a consensus meeting was convened, followed by a Delphi process with an international, multiprofessional panel of stakeholders, including those with lived experience. A conclusive consensus meeting approved the final COS of PROMs. Results: The final COS consists of one unidimensional numerical rating scale for assessing pain intensity on average, worst pain intensity, pain intensity at rest, and procedure-specific pain intensity during activity; one unidimensional scale for pain interfering with activities in bed; one procedure-specific scale for assessing physical function; the IMI-PainCare PROMPT adaptation of the Arthritis Self-Efficacy Scale for assessing self-efficacy; and the IMI-PainCare PROMPT adaptation of the Opioid-Related Symptom Distress Scale for assessing adverse events. Conclusions: Comprehensive use of a core outcome set will help harmonise outcome assessment, facilitate comparisons between studies, promote patient-centred research, and improve postoperative pain care.
KW - consensus process
KW - core outcome set
KW - Delphi approach
KW - patient-reported outcome measure
KW - postoperative pain
KW - psychometric properties
KW - questionnaire
U2 - 10.1016/j.bja.2025.01.029
DO - 10.1016/j.bja.2025.01.029
M3 - Article
SN - 0007-0912
VL - 134
SP - 1460
EP - 1473
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 5
ER -