Abstract
BackgroundParkinson’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/designPD 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.DiscussionThe 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.Trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.
Highlights
Parkinson’s disease (PD) affects approximately 145,519 people in the UK
The trial will test the hypothesis that Speech and Language Therapy (SLT) is effective for the treatment of speech or voice problems in people with PD compared to no SLT
It will further test whether National Health Service (NHS) SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions
Summary
The PD COMM trial is already the largest trial of SLT in PD to date (as of 10 September 2019, 329 participants have been recruited). There will be benefits beyond the immediate trial results: the group has developed a research network of speech and language therapists in 42 sites around the UK, participated, and provided training in, LSVT LOUD® (courtesy of Dr Lori Ramig), trials, other aspects of PD and research into SLT and information on best practice. This project will lay the foundation for further trials in SLT and lower the barriers to future research.
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