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

Trials, vol. 21, pp. 773

Abstract

INTRODUCTION: 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 postoperative pain 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 1-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 3/2022 (final voting on core outcome measurement).

Authors 6

1. Ulrike Kaiser

   University Hospital Carl Gustav Carus

   Affiliation as printed

   Comprehensive Pain Center, University Hospital Carl Gustav Carus Dresden, Dresden, Germany

2. Hiltrud Liedgens Aachen Market Access

   Grünenthal Group (Germany)

   Affiliation as printed

   Market Access, Grünenthal GmbH, Aachen, Germany

3. Winfried Meißner

   Jena University Hospital

   Affiliation as printed

   Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany

4. Claudia Weinmann

   Jena University Hospital

   Affiliation as printed

   Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany

5. Peter K Zahn

   BG University Hospital Bergmannsheil Bochum · Ruhr University Bochum

   Affiliation as printed

   Department of Anaesthesiology and Intensive Care Medicine, Palliative Care Medicine and Pain Management, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH Bochum, Ruhr University Bochum, Bochum, Germany

6. Esther Miriam Pogatzki-Zahn corresponding

   University Hospital Münster

   Affiliation as printed

   Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Albert-Schweitzer-Campus 1, A1, 48149, Münster, Germany. pogatzki@anit.uni-muenster.de

   Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Albert-Schweitzer-Campus 1, A1, 48149, Münster, Germany