Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study

Jan Vollert; Daniel Segelcke; Claudia Weinmann; Kathrin Schnabel; Fabian Fuchtmann; Daniela C Rosenberger; Marcus Komann; Timo Maessen; Lena Sauer; Eija Kalso; Dominique Fletcher; Patricia Lavand'homme; Ulrike Kaiser; Hiltrud Liedgens; Winfried Meissner; Esther M Pogatzki-Zahn

doi:10.1016/j.bja.2023.10.020

Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study

Jan Vollert, Daniel Segelcke, Claudia Weinmann, Kathrin Schnabel, Fabian Fuchtmann, Daniela C Rosenberger, Marcus Komann, Timo Maessen, Lena Sauer, Eija Kalso, Dominique Fletcher, Patricia Lavand'homme, Ulrike Kaiser, Hiltrud Liedgens, Winfried Meissner, Esther M Pogatzki-Zahn

Klinik für Anästhesiologie und Intensivmedizin

15 Zitate (Scopus)

Abstract

BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy.

METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries.

RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures.

CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

Originalsprache	Englisch
Zeitschrift	British Journal of Anaesthesia
Jahrgang	132
Ausgabenummer	1
Seiten (von - bis)	96-106
Seitenumfang	11
ISSN	0007-0912
DOIs	https://doi.org/10.1016/j.bja.2023.10.020
Publikationsstatus	Veröffentlicht - 01.2024

Fördermittel

This project has received funding from the 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 Companies. JV received payments for advisory boards and talks outside of the submitted work from Embody Orthopaedics, UK, and Casquar, Germany. EK has received fees for advisory board or lecture activities from Oriona Pharma, Finland, Pfizer, Sweden, and GSK, Finland. WM received payments for advisory boards and talks outside of the submitted work from Kyowa Japan, Mundipharma Singapore, Grünenthal, Germany Ethypharm, France, and Spectrum Therapeutics, Germany. His institution received research support from Pfizer, USA, Mundipharma, Germany, and Grünenthal, Germany. EMPZ received financial support from Grünenthal, Germany, for research activities and advisory and lecture fees from Grünenthal, Germany, Novartis, Germany, and Medtronic, Switzerland. In addition, she receives scientific support from the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), the Federal Joint Committee (G-BA), and the 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. All money went to the institutions (WWU/UKM) EMPZ is working for. All the other authors have no conflicts of interest to declare.

Träger	Trägernummer
Pfizer
Medtronic
European Federation of Pharmaceutical Industries and Associations
European Commission
Deutsche Forschungsgemeinschaft
Bundesministerium für Bildung und Forschung
Innovative Medicines Initiative	777500

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10.1016/j.bja.2023.10.020

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Vollert, J., Segelcke, D., Weinmann, C., Schnabel, K., Fuchtmann, F., Rosenberger, D. C., Komann, M., Maessen, T., Sauer, L., Kalso, E., Fletcher, D., Lavand'homme, P., Kaiser, U., Liedgens, H., Meissner, W., & Pogatzki-Zahn, E. M. (2024). Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study. British Journal of Anaesthesia, 132(1), 96-106. https://doi.org/10.1016/j.bja.2023.10.020

@article{c9c3a3b312024939baf8ddfca2fcc359,

title = "Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study",

abstract = "BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy.METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries.RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures.CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.",

author = "Jan Vollert and Daniel Segelcke and Claudia Weinmann and Kathrin Schnabel and Fabian Fuchtmann and Rosenberger, \{Daniela C\} and Marcus Komann and Timo Maessen and Lena Sauer and Eija Kalso and Dominique Fletcher and Patricia Lavand'homme and Ulrike Kaiser and Hiltrud Liedgens and Winfried Meissner and Pogatzki-Zahn, \{Esther M\}",

year = "2024",

month = jan,

doi = "10.1016/j.bja.2023.10.020",

language = "English",

volume = "132",

pages = "96--106",

journal = "British Journal of Anaesthesia",

issn = "0007-0912",

publisher = "Elsevier Ltd",

number = "1",

}

Vollert, J, Segelcke, D, Weinmann, C, Schnabel, K, Fuchtmann, F, Rosenberger, DC, Komann, M, Maessen, T, Sauer, L, Kalso, E, Fletcher, D, Lavand'homme, P, Kaiser, U, Liedgens, H, Meissner, W & Pogatzki-Zahn, EM 2024, 'Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study', British Journal of Anaesthesia, Jg. 132, Nr. 1, S. 96-106. https://doi.org/10.1016/j.bja.2023.10.020

Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study. / Vollert, Jan; Segelcke, Daniel; Weinmann, Claudia et al.
in: British Journal of Anaesthesia, Jahrgang 132, Nr. 1, 01.2024, S. 96-106.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain

T2 - primary results from the international multi-centre PROMPT NIT-1 study

AU - Vollert, Jan

AU - Segelcke, Daniel

AU - Weinmann, Claudia

AU - Schnabel, Kathrin

AU - Fuchtmann, Fabian

AU - Rosenberger, Daniela C

AU - Komann, Marcus

AU - Maessen, Timo

AU - Sauer, Lena

AU - Kalso, Eija

AU - Fletcher, Dominique

AU - Lavand'homme, Patricia

AU - Kaiser, Ulrike

AU - Liedgens, Hiltrud

AU - Meissner, Winfried

AU - Pogatzki-Zahn, Esther M

PY - 2024/1

Y1 - 2024/1

N2 - BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy.METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries.RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures.CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

AB - BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy.METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries.RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures.CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

UR - https://www.scopus.com/pages/publications/85180240630

U2 - 10.1016/j.bja.2023.10.020

DO - 10.1016/j.bja.2023.10.020

M3 - Journal articles

C2 - 38016907

SN - 0007-0912

VL - 132

SP - 96

EP - 106

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

IS - 1

ER -

Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study

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