Background & Aims

Effective perioperative pain management is crucial to prevent patient suffering, delayed recovery, chronic postsurgical pain (CPSP) and long-term opiate use. However, heterogeneous use of outcome measures in clinical trials hinder evidence synthesis and may result in overlooking critical aspects of postsurgical pain, making it difficult to identify the best treatment options. This can be addressed by developing a core outcome set (COS) assessing the effectiveness and efficacy of perioperative pain treatment. COS are consensus-driven sets of essential outcomes that should be assessed and reported in all studies in a given health area. The IMI PainCare PROMPT subproject aimed to develop a COS for domains and respective measurement instruments (i.e. patient-reported outcome measures (PROMs)) to assess effectiveness in perioperative pain management for 4 types of surgery (breast surgery (BS), sternotomy (ST), total knee arthroplasty (TKA), endometriosis related surgery (ES)).

Methods

In 2018, a COS of domains was completed, consenting on the following domains/subdomains: pain intensity in general, pain intensity at rest, pain intensity during activity, physical function, self-efficacy and adverse events [1]. To identify the most appropriate PROMs for these domains, a second consensus process with 36 participants mainly from Europe (including anesthesiologists, surgeons, pain specialists, physiotherapists, psychologists, pain nurses, researchers, health technology experts, people with lived experience (PWLE); 15 females) was conducted. After an initial meeting, a handbook was provided with background information to enable judgement of the PROMs. In a two-round survey, stakeholders and PWLE rated PROMs according to their suitability (e.g. psychometric properties, feasibility) for inclusion in the COS. Comments and newly suggested PROMs from the first round were included in the second round. Finally, a consensus meeting was hold to decide on the final COS of PROMs.

Results

The final COS consists of one or two PROMs per domain/subdomain to be recommended for all types of surgical procedures: the PROMs “pain intensity on average” and “worst pain intensity” for pain intensity in general, the PROM “pain intensity at rest” for pain intensity at rest, the PROM “pain interfering with activities in bed” for physical function, the PROM “Arthritis Self-Efficacy Scale (ASES) IMI PROMPT adaption” for self-efficacy and the PROM “Opioid-Related Symptom Distress Scale (OR-SDS) IMI PROMPT adaption“ for adverse events. For some (sub-)domains (i.e. physical function and pain intensity during activity), one PROM was selected for procedure –specific assessment within the four surgical procedures. For the domains self-efficacy and adverse events, the selected PROMs were only included under the condition of immediate replacement as soon as a PROM with adequate psychometric properties (content validity) is available due to lack of content validity.

Conclusions

While there is still a need for the development of new PROMs, this consensus process involving many different stakeholders as well as PWLE, developed a valuable and applicable set of PROMs to be assessed in clinical trials, observational studies, and clinical practice investigating perioperative pain management. This COS will harmonize outcome assessment in clinical trials and clinical practice related to perioperative pain management, facilitate comparisons between pain studies to optimize resources and accelerate patient-centered research, to ultimately improving pain care. Future research should focus on the development of PROMs with better psychometric quality to assess self-efficacy and adverse events after surgery.

References

[1]Pogatzki-Zahn EM, Liedgens H, Hummelshoj L, Meissner W, Weinmann C, Treede RD, Vincent K, Zahn P, Kaiser U; IMI-PainCare PROMPT consensus panel. Developing consensus on core outcome domains for assessing effectiveness in perioperative pain management: results of the PROMPT/IMI-PainCare Delphi Meeting. Pain. 2021 Nov 1;162(11):2717-2736.

Presenting Author

Daniela C. Rosenberger

Poster Authors

Daniela Rosenberger

MD, Msc.

University Hospital Münster

Lead Author

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Daniela C. Rosenberger

MD

Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster

Lead Author

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Claudia Weinmann

MSc

Jena University Hospital

Lead Author

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Hiltrud Liedgens

PhD

Grunenthal GmbH, Aachen, Germany

Lead Author

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Winfried Meissner

Jena University Hospital, Friedrich Schiller University, Jena, Germany

Lead Author

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Katy Vincent DPhil BSc MBBS MRCOG

University of Oxford

Lead Author

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Jan Vollert

University of Exeter

Lead Author

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Peter Zahn

MD

Department of Anaesthesiology, BG university hospital, Ruhr University Bochum, Germany

Lead Author

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Ulrike KAISER

PhD Dr

University Hospital Schleswig-Holstein, Clinic for Anesthesiology / Intensive Care Medicine, Lübeck

Lead Author

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Esther Pogatzki-Zahn

University Clinic Muenster, Germany

Lead Author

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Topics

  • Assessment and Diagnosis