Developing consensus on core outcome domains and measurement instruments for assessing effectiveness in perioperative pain management after sternotomy, breast cancer surgery, total knee arthroplasty and surgery related to endometriosis

Evidence synthesis of clinical trials requires consistent outcome assessment. For pain management after surgery inconsistency of effectiveness assessment is still observed. A subproject of IMI PainCare (Innovative Medicine Initiatives, www.imi-paincare.eu) aims for identifying core outcome domains and measurement instruments for effectiveness and efficacy of perioperative pain management after surgery in four surgical fields (sternotomy, breast cancer surgery, total knee arthroplasty and surgery related to endometriosis) in order to harmonize outcome assessment for perioperative pain management.

Methods
A multifaceted process will be performed according to existing guidelines (Core Outcome Measures in Effectiveness Trials (COMET), COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)). In a first step, outcome domains will be identified via systematic literature review and consented on during a one-day consensus meeting by 10 stakeholder groups, including patient representatives, forming an IMI PROMPT consensus panel. In a second step outcome measurement instruments regarding the beforehand consented core outcome domains and their psychometric properties will be searched for via systematic literature review and approved by COSMIN checklist for study quality and scale quality separately. In a three step online survey the IMI PROMPT consensus panel will vote for most suitable measurement instruments. The process is planned to be conducted between 11/2017 (systematic literature review on common outcome domains) and 3/2023 (final voting on core outcome measurements).

Protocol: https://link.springer.com/article/10.1186/s13063-020-04665-9

Contributors

Prof. Dr. Esther Pogatzki-Zahn, Dr. Ulrike Kaiser, Dr. Hiltrud Liedgens, Prof. Dr. Winfried Meissner, Prof. Dr. Peter Zahn

1. Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany;
2. Comprehensive Pain Center, University Hospital Carl Gustav Carus Dresden, Germany
3. Grünenthal GmbH, Aachen, Germany
4. Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany
5. Department of Anaesthesiology and Intensive Care Medicine; Palliative Care Medicine and Pain Management, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH Bochum, Ruhr University Bochum, Germany

Further Study Information

Current Stage: Ongoing
Date: November 2017 - March 2023
Funding source(s): The PROMPT IMI Group is funded by 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. (www.imi.europa.eu; www.imi-paincare.eu, 30th March 2020)


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

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

- 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