An RCT of a patient-initiated treatment service for BEB and HFS
Research type
Research Study
Full title
A randomised controlled trial to explore the effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial Spasm compared to treatment as usual
IRAS ID
166955
Contact name
Daniel Ezra
Contact email
Sponsor organisation
Moorfields Eye Hospital
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
Blepharospasm and hemifacial spasm are debilitating eye conditions that involve forced, involuntary closure of the eyelids or spasms across one side of the face caused by muscle contraction. Both conditions can lead to social embarrassment and isolation, depression and poor quality of life.
Repeated botulinum toxin injections temporarily relieve symptoms, but do not offer a lasting cure. Research suggests that patient response to this treatment is variable, ranging from no benefit to 96% of patients reporting a significant relief in symptoms. Evidence for the duration of benefit provided by repeated treatment is also inconsistent and research to date has not been able to explain such inconsistencies. Despite this a standardised treatment regimen, of injections on average 3 times a year, is currently used across all patients at Moorfields Eye Hospital and is typical throughout the UK. This may mean that some people are left experiencing debilitating symptoms until their next scheduled appointment and some are being seen too often, hence alternative models of care need to be considered.
Research trialling patient-initiated services, where the patient rather than healthcare professional initiates treatment and care, have shown promise. These services provide patients with information on when and how to access treatment, rather than having regular scheduled appointments. The present study aims to compare a patient-initiated model of care, whereby patients determine the timing of their botulinum toxin injections with the standard model of care in a two-arm randomised controlled trial. It is expected that patients able to initiate their own treatment will experience less variation in disease severity and disability than those in standard care, along with improved satisfaction with the service and quality of life.
REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/0439
Date of REC Opinion
21 Apr 2015
REC opinion
Further Information Favourable Opinion