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Outcome Measures for Functional Neurological Disorder: A Review of the Theoretical Complexities
Timothy R Nicholson1, Alan Carson1, Mark J Edwards1
1The Institute of Psychiatry, Psychology and Neuroscience, King's College London (T. Nicholson, Goldstein, Pick); the Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom (Carson, Stone); the Department of Rehabilitation Medicine, Astley Ainslie Hospital, Edinburgh, United Kingdom (Carson); the Neuroscience Research Centre, St. George's University of London (Edwards, Nielsen); Human Motor Control Section, the National Institute of Neurological Disorders and Stroke, Bethesda, Md. (Hallett); FND Hope International, Banbury, United Kingdom (Mildon); the National Hospital for Neurology and Neurosurgery, University College London, and Hospitals National Health Service Foundation Trust, London (C. Nicholson); and the Departments of Neurology and Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston (Perez).
Developing standardized outcome measures for functional neurological disorder (FND) is complex. Patient-reported outcomes are crucial for this common, disabling condition, necessitating a new core outcome set.
Area of Science:
- Neuroscience
- Clinical Medicine
- Psychiatry
Background:
- Standardized outcome measures are vital for evidence-based medicine and clinical trials.
- Functional Neurological Disorder (FND) presents unique challenges for outcome measurement due to symptom heterogeneity and associated physical/psychological comorbidities.
- Existing outcome measures are often designed for other neurological disorders and may not adequately capture FND's clinical complexity.
Purpose of the Study:
- To review the process of developing and selecting optimal outcome measures for clinical trials.
- To address the specific challenges in developing a core outcome set for Functional Neurological Disorder (FND).
- To propose a research agenda for optimizing outcome measurement in FND.
Main Methods:
- Review of outcome measure development principles in evidence-based medicine.
- Analysis of FND's clinical characteristics influencing outcome measure selection.
- Discussion of the role of patient-rated versus clinician-rated measures in FND.
- Introduction of the FND Core Outcome Measure (FND-COM) group's initiative.
Main Results:
- The complexity of FND necessitates a departure from the typical prioritization of objective measures.
- Self-report measures are likely to be more clinically meaningful for assessing FND outcomes.
- There is a significant gap in research on outcome measures specifically for FND.
Conclusions:
- A consensus-driven core outcome set is needed for FND clinical trials.
- The development of appropriate outcome measures requires careful consideration of FND's unique features.
- Further research is essential to optimize outcome measurement for this complex neuropsychiatric disorder.
