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.
Esther M. Pogatzki-Zahn, Sarah De Lucia, Claudia Weinmann, Hauke Heitkamp, Lone Hummelshoj, Hiltrud Liedgens, Winfried Meissner, Katy Vincent, Jan Vollert, Peter Zahn, the IMI-PainCare PROMPT Consensus Panel, Ulrike Kaiser, Daniela C. Rosenberger
Disease Category: Anaesthesia & pain control
Disease Name: Postoperative pain
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Management of care
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Researchers
- Service providers
- Service users
- COS Patient Reported Outcomes
- Consensus meeting
- Delphi process
- Systematic review
- Literature review
- Semi structured discussion
Systematic reviews for domains and measurement instruments (PROMs)
Consensus for domains: Presence meeting with semi structured schedule (break out groups, plenary)
Consensus for PROMs: Presence meeting with semi structured schedule (break out groups, plenary) or delphi online exercise