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Wickwar, Sadie 
ORCID: https://orcid.org/0000-0001-9307-4532, McBain, Hayley, Newman, Stanton P., Hirani, Shashivadan P., Hurt, Catherine, Dunlop, Nicola, Flood, Chris and Ezra, Daniel G.
(2016)
Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: Study protocol for a randomised controlled trial.
Trials, 17.
ISSN 1745-6215
Abstract
Background: Blepharospasm and hemifacial spasm are debilitating conditions that significantly impact on patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary relief, but the duration of treatment efficacy is variable. The standard model of patient care defines routine fixed-time based scheduled treatment cycles which may lead to unnecessarily frequent treatment for some patients and experience of distressing symptoms in others, if symptoms return before the scheduled follow-up period. Methods/Design: A randomised controlled trial will compare a patient-initiated model of care, where patients determine botulinum toxin treatment timing, to the standard model of care in which care is scheduled by the clinical team. A sample of 266 patients with blepharospasm or hemifacial spasm will be recruited from Moorfields Eye Hospital (MEH), London. The trial will be accompanied by a mixed-methods evaluation of acceptability of the new service. Patients who meet eligibility criteria will be assessed at baseline and those in the intervention group will be provided with instructions on how to book their own treatment appointments. Patients in both groups will be followed up 3 and 9 months into the trial and all patients will be returned to usual care after 9 months to meet safety protocols. Primary outcome measures include disease severity (questionnaire), functional disability (questionnaire) and patient satisfaction with care (questionnaire). Secondary outcomes include disease-specific quality of life (questionnaire), mood (questionnaire), illness and treatment perceptions (questionnaire and semi-structured interviews), economic impact (questionnaire) and acceptability (questionnaire and semi-structured interviews). Discussion: This trial will assess the effectiveness and cost-effectiveness of a patient-led care model for botulinum toxin therapy. If the new model is shown to be effective in reducing distress and disability in these populations and is found to be acceptable to patients, whilst being cost-effective, this will have significant implications for service organisation across the NHS. Trial registration: UK Clinical Research Network (UKCRN) Portfolio 18660. Clinicaltrials.gov ID NCT102577224(registered 29 October 2015).
| Item Type: | Article |
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| Additional Information: | Funding Information: This study is funded by Merz Pharma and the NIHR Biomedical Research Centre (BRC) at Moorfields Eye Hospital NHS Foundation Trust. DGE is part funded by the NIHR BRC. The authors have no further competing interests. The funders have no influence on the design, collection of data, analysis or interpretation of the results of this study or the decision to submit the manuscript for publication. Funding Information: This study is funded by Merz Pharma and the NIHR Biomedical Research Centre (BRC) at Moorfields Eye Hospital NHS Foundation Trust. DGE is part funded by the NIHR BRC. Publisher Copyright: © 2016 Wickwar et al. |
| Uncontrolled Keywords: | acceptability,blepharospasm,botulinum toxin,hemifacial spasm,illness perceptions,patient-led care,protocol,quality of life,randomised controlled trial,medicine (miscellaneous),pharmacology (medical) ,/dk/atira/pure/subjectarea/asjc/2700/2701 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 04 Sep 2024 13:36 |
| Last Modified: | 25 Sep 2024 18:07 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/96560 |
| DOI: | 10.1186/s13063-016-1263-y |
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