Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol

Area of Science:

• • Medical Research
• • Clinical Trials
• • Patient Outcomes

Background:

• • Traumatic brachial plexus injury (TBPI) causes significant arm disability and pain, impacting quality of life.
• • Current research lacks standardized outcome measures, hindering evidence-based treatment decisions.
• • Existing studies often focus on short-term results, neglecting long-term effects and patient-reported quality of life.

Purpose of the Study:

• • To establish a Core Outcome Set (COS) for evaluating surgical and conservative management of TBPI.
• • To standardize outcome reporting in TBPI research and clinical practice.
• • To facilitate evidence synthesis and improve clinical decision-making.

Main Methods:

• • A mixed-methods approach involving systematic reviews and patient interviews to identify potential outcomes.
• • A three-round online Delphi exercise with patients and healthcare professionals to reach consensus.
• • Finalization of the COS through a consensus meeting.

Main Results:

• • Identification of a comprehensive list of patient-reported and clinical outcomes relevant to TBPI.
• • Consensus achieved on a minimum set of outcomes for effectiveness studies.
• • Establishment of a standardized COS for TBPI management.

Conclusions:

• • The developed COS will enhance research relevance and facilitate evidence synthesis for TBPI.
• • Standardized outcomes will improve the quality of care and decision-making for TBPI patients.
• • This initiative supports evidence-based practice in managing brachial plexus injuries.