Towards a Development of an International Core Outcome Set for Post-Stroke Facial Palsy

Post-stroke facial palsy significantly impacts stroke survivors, yet there is considerable heterogeneity in assessment methods and outcome measures used in both clinical practice and research. While multiple assessment tools exist, their application in stroke populations remains largely unvalidated, leading to challenges in comparing results across studies and implementing evidence-based practice. While Dr. Crocker's broader stroke Core Outcome Set (COS) study (https://www.comet-initiative.org/Studies/Details/1114) focused on 6-month post-stroke outcomes, our work will uniquely contribute by covering both immediate and longer-term outcomes specific to facial palsy. Dr. Crocker specifically endorsed the development of our focused COS, recognising that his broader scope would not adequately address the specific complexities of post-stroke facial palsy assessment. This study represents an initial step towards developing recommendations for outcome measures in post-stroke facial palsy through an international consensus process. We are employing a two-round Delphi technique followed by a consensus meeting involving healthcare professionals and researchers. The process includes systematic reviews of existing measures and expert input, with guidance from our PPI group in developing the healthcare professional survey. This initial phase will establish preliminary recommendations for outcome measurement in this field, contributing to more effective comparison of interventions and improving the quality of both research and clinical practice. These recommendations will serve as a foundation for future work that will incorporate stroke survivors as active participants, ultimately working towards a comprehensive COS for post-stroke facial palsy.

Contributors

Principal Investigator:- Havva Sumeyye Eroglu (PhD Student, The University of Manchester)
Supervisory Team:- Dr Claire Mitchell (Principal Supervisor, The University of Manchester)- Professor Audrey Bowen (Co-supervisor, The University of Manchester)- Matthew Checketts (Co-supervisor, The University of Manchester)

Further Study Information

Current Stage: Ongoing
Date: November 2024 - November 2025
Funding source(s): No external funding sources. This study is being conducted as part of a PhD project at The University of Manchester.


Health Area

Disease Category: Neurology

Disease Name: Post-stroke facial palsy

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Survey
- Systematic review

This Core Outcome Set (COS) development study employs a multi-stage approach:

Systematic Review:
Comprehensive review of existing outcome measures used in post-stroke facial palsy research and clinical practice
Identification of potential outcome domains for inclusion in the COS

Delphi Study:
Two-round international online Delphi survey (with a potential third round if necessary)
Participants: Healthcare professionals and researchers with expertise in post-stroke facial palsy
Round 1: Participants rate the importance of identified outcomes on a 1-9 scale and suggest additional outcomes
Round 2: Participants review Round 1 results and re-rate items
Consensus in definition: =70% of participants rating an outcome 7-9 on the importance scale
Consensus out definition:<50% of ratings between 7-9 in each group

Consensus Meeting:
Virtual meeting with participants who completed both Delphi rounds
Discussion and voting on retained outcomes
Final inclusion requires =70% agreement
Establishment of the final Core Outcome Set

The study follows COMET Initiative methodology guidelines for COS development to ensure rigorous and transparent processes.

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