Abstract
IntroductionEvidence 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.MethodsA 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).
Highlights
Evidence synthesis of clinical trials requires consistent outcome assessment
General considerations Rationale and design for the consensus process within the PROMPT project are guided by the COMET recommendations ([12], see Fig. 1) referring to postoperative pain in adult patients undergoing breast surgery, sternotomy, total knee arthroplasty, and surgery for endometriosis and receiving perioperative pain management investigated in any clinical and observational trial as well as in clinical practice, consisting of two parts— one for identifying core outcome domains and one for the corresponding core outcome measurement instruments
The framework recommended by OMERACT is matching purpose and need of PROMPT, providing a frame for medically oriented clinical trials and will be applied in order to arrange and structure relevant outcome domains to relevant core areas during the consensus meeting [36]
Summary
General considerations Rationale and design for the consensus process within the PROMPT project are guided by the COMET recommendations ([12], see Fig. 1) referring to postoperative pain in adult patients undergoing breast surgery, sternotomy, total knee arthroplasty, and surgery for endometriosis and receiving perioperative pain management investigated in any clinical and observational trial as well as in clinical practice (scope), consisting of two parts— one for identifying core outcome domains and one for the corresponding core outcome measurement instruments. Measurement instruments corresponding to IMI PROMPT outcome domain definitions, developed as patient-reported outcome and with a similar target population (postoperative, acute pain; similar characteristics as observed in TKA, BS, St, and EM) will be chosen for further investigation of psychometric properties regarding the COSMIN quality criteria for creating a list of potential PROMs. COSMIN search strings will be applied [41] for subsequent systematic literature reviews in the abovementioned data sources, concerning at least one of the psychometric properties regarding content validity, construct validity, reliability, and sensitivity to change. Systematic reviews and research between 08/2018 and 08/2020 (SLRs are submitted to PROSPERO, search strategy is completed, screening of title/ abstract and full text is completed for scoping review on corresponding measurement instruments, SLR for psychometric properties is in preparation)
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