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

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).

Assessing outcome in postoperative pain trials: are we missing the point? A systematic review of pain-related outcome domains reported in studies early after total knee arthroplasty

“…Within the IMI-PainCare PROMPT subproject, we will perform a stepwise COS development process, including consensus meetings where patients' considerations (as well as those from other stakeholders mentioned above) will be taken into account. 143 Here, domains such as “physical function” and “psychological function”, which are currently less frequently used in interventional clinical trials, could then be discussed and given more weight in designing COS.…”

“…143 Four procedures are addressed: sternotomy, breast cancer surgery, surgery for endometriosis, and TKA. 143 These procedures represent a broad spectrum of surgeries with specific perioperative pain management (eg, different types of iatrogenic trauma, tissues, and body parts affected, and various patient populations), providing the option to develop 4 separate COS or to develop an overarching COS. 143…”

“…Our primary goal was (1) to identify and analyze outcome domains assessed early after TKA, including the degree of heterogeneity, and (2) to present the identified outcome domains to the consecutive IMI-PainCare PROMPT consensus. 143…”

Systematic Review on Pain-Related Outcome Domains After Sternotomy: A First Step Toward the Development of a Core Outcome Set

“…6 Sternotomy was chosen as an example of a frequently performed, painful procedure with a complicated interaction of pain outcome including pain-related impairment of physical function (eg, breathing and coughing). 10…”

Comparison of Rebound Pain and Postoperative Tramadol Requirement in Patients Who Had Femoral Nerve Block or Adductor Canal Block for Pain After Total Knee Arthroplasty

“…Literatürde levobupivakain, ropivakain, lidokain gibi farklı lokal anesteziklerin kullanıldığı çalışmalar bulunmaktadır (6) . Bazı lokal anesteziklerin (21) ve cerrahi tiplerinin (22) rebound ağrı insidansını etkilediğine dair çalışmalar mevcuttur. Gordon ve ark (21) bupivakain ile lidokaine göre daha fazla prostoglandin E2 üretimi ve siklooksijenaz gen ekspresyonuyla daha fazla proinflamatuar etki görüldüğünü bunun da daha fazla ağrıya neden olduğunu bildirmektedir.…”