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

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.

Contributors

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

Publication

Journal: British journal of Anaesthesia
Volume: 132
Issue: 1
Pages: 96 - 106
Year: 2024
DOI: 10.1016/j.bja.2023.10.020

Further Study Information

Current Stage: Completed
Date:
Funding source(s): 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.


Health Area

Disease Category: Anaesthesia & pain control

Disease Name: Postoperative pain

Target Population

Age Range: 18 - 99

Sex: Either

Nature of Intervention: Management of care

Stakeholders Involved

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Other

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.