A patient-initiated treatment model for blepharospasm and hemifacial spasm: A randomized controlled trial

Lawes-Wickwar, Sadie ORCID: https://orcid.org/0000-0001-9307-4532, McBain, Hayley, Brini, Stefano, Hirani, Shashivadan P., Hurt, Catherine S., Flood, Chris, Dunlop, Nicola, Solly, Dianne, Crampton, Bridget, Newman, Stanton P. and Ezra, Daniel G. (2022) A patient-initiated treatment model for blepharospasm and hemifacial spasm: A randomized controlled trial. BMC Neurology, 22 (1). ISSN 1471-2377

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Abstract

Background: To test, in a two-arm, single center, superiority, randomized controlled trial, the effectiveness of and costs associated with a patient-initiated treatment model for people with hemifacial spasm (HFS) and blepharospasm (BEB) in comparison to usual care. Methods: One hundred and thirty patients with HFS or BEB, aged 18 years or over, were recruited from a nurse-led botulinum toxin type A clinic at an eye hospital in the United Kingdom (UK), completed baseline measures and were randomized (1:1). The intervention group determined their own botulinum toxin type A (BoNT/A) treatment schedule during the trial period (9 months) and received an information leaflet with a “hotline” number to book an appointment. Usual care appointments were scheduled by treating clinicians. Data analysts were blind to study group. The primary outcomes were disease severity and functional disability, as measured by the Jankovic Rating Scale and Blepharospasm Disability Index, respectively. Secondary outcomes included quality of life, anxiety and depression, satisfaction with care, confidence in the service, economic costs and employment days lost. Results: Sixty-five patients were randomized to each group. The intervention demonstrated no statistically significant difference to usual care for any of primary outcomes. On secondary outcomes the levels of anxiety differed significantly (F2, 142.39 = 1.65, p = 0.02), with the intervention arm exhibiting a decrease and the control arm an increase (Hedges’ g = − 0.26 [99% CI -0.83, 0.32]). No other statistically significant differences were found for secondary outcomes. Overall healthcare costs and costs to the patient were on average £198.95 less (95% CI -£256.76, £654.67; p = 0.10) per participant for those in the intervention compared to usual care, although this finding was not significant. Conclusions: We did not observe differences between the patient-initiated treatment model and usual care for people with BEB or HFS, on any primary outcome measure, quality of life, or depression. The patient-initiated treatment model may, however, have the potential to save healthcare costs and reduce anxiety. Patients using this new model were also equally as satisfied in the service and confident in their care as those receiving treatment as usual. Trial registration: Clinicaltrials.gov ID NCT02577224, 16th October 2015.

Item Type: Article
Additional Information: Funding Information: The authors would like to acknowledge the funding bodies who supported this research and our study participants who generously gave their time to take part in the research. Publisher Copyright: © 2022, The Author(s).
Uncontrolled Keywords: blepharospasm,botulinum toxin,dystonia,hemifacial spasm,patient-initiated services,randomized controlled trial,clinical neurology ,/dk/atira/pure/subjectarea/asjc/2700/2728
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 02 Sep 2024 13:30
Last Modified: 08 Sep 2024 06:34
URI: https://ueaeprints.uea.ac.uk/id/eprint/96420
DOI: 10.1186/s12883-022-02603-7

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