A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial

Sackley, C. M.; Rick, C.; Au, P.; Brady, M. C.; Beaton, G.; Burton, C.; Caulfield, M.; Dickson, S.; Dowling, F.; Hughes, M.; Ives, N.; Jowett, S.; Masterson-Algar, P.; Nicoll, A.; Patel, S.; Smith, C. H.; Woolley, R.; Clarke, C. E.; on behalf of the PD COMM Collaborative Group

Abstract

Background
Parkinson’s disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals’ needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive.

Methods/design
PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation.

Primary outcome: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson’s Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation.

The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK.

Discussion
The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions.

Citation

Sackley, C. M., Rick, C., Au, P., Brady, M. C., Beaton, G., Burton, C., Caulfield, M., Dickson, S., Dowling, F., Hughes, M., Ives, N., Jowett, S., Masterson-Algar, P., Nicoll, A., Patel, S., Smith, C. H., Woolley, R., Clarke, C. E., & on behalf of the PD COMM Collaborative Group. (2020). A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial. Trials, 21, Article 436. https://doi.org/10.1186/s13063-020-04354-7

• Journal Article Type: Article
• Acceptance Date: Apr 27, 2020
• Online Publication Date: May 27, 2020
• Publication Date: May 27, 2020
• Deposit Date: May 28, 2020
• Publicly Available Date: May 29, 2020
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Article Number: 436
• DOI: https://doi.org/10.1186/s13063-020-04354-7
• Public URL: https://nottingham-repository.worktribe.com/output/4523769
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04354-7
• Additional Information: Received: 19 February 2020; Accepted: 27 April 2020; First Online: 27 May 2020; : The trial received ethical approval from the West Midlands NHS Research Ethics Committee (15/WM/0443) prior to all trial activity in NHS sites. The ethical approval covers all participating centres. All participants in the trial will provide informed consent prior to any trial procedure.; : Not applicable – no individual’s data is included.; : The authors declare that they have no competing interests.