Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson's disease (PD COMM): pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial

To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson's disease. Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial. The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020. 388 people with Parkinson's disease and dysarthria. Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants' needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle. The primary outcome was total score at three months of self-reported voice handicap index. People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (-8.0 points (99% confidence interval -13.3 to -2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (-3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (-9.6 points (-14.9 to -4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded. LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy. ISRCTN registry ISRCTN12421382. [Abstract copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson’s disease (PD COMM):pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial

Objectives: To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson’s disease.Design: Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial.Setting: The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020.Participants: 388 people with Parkinson’s disease and dysarthria.Interventions: Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants’ needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle.Main outcome measures: The primary outcome was total score at three months of self-reported voice handicap index.Results: People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (−8.0 points (99% confidence interval −13.3 to −2.6); P&lt;0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (−3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (−9.6 points (−14.9 to −4.4); P&lt;0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded.Conclusions: LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy.Trial registration: ISRCTN registry ISRCTN12421382.</div

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson's disease: a pilot randomised controlled trial (PD COMM pilot)

Background: Speech-related problems are common in Parkinson's disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®). Methods: The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6-8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings. Results: Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: - 12.5 points; 95% CI - 26.2, 1.2) and SLT (difference at 3 months compared with control: - 9.8 points; 95% CI - 23.2, 3.7) which needs to be confirmed in an adequately powered trial. Conclusion: Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial. Trial registration: International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: a pilot randomised controlled trial (PD COMM pilot)

Background: Speech-related problems are common in Parkinson’s disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®).Methods: The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6–8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings.Results: Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: − 12.5 points; 95% CI − 26.2, 1.2) and SLT(difference at 3 months compared with control: − 9.8 points; 95% CI − 23.2, 3.7) which needs to be confirmed in an adequately powered trial.Conclusion: Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial.Trial registration: International Standard Randomised Controlled Trial Number Register: ISRCTN75223808.registered 22 March 2012

The PD COMM process evaluation: describing interventions and implementation in a UK pragmatic randomised controlled trial of speech and language therapy for people with Parkinson’s-related dysarthria

BackgroundAs people with Parkinson’s experience progressive communication changes, effective, implementable speech and language therapy (SLT) interventions are needed. Process evaluations alongside pragmatic randomised controlled trials (RCTs) are of clinical value if they describe, compare and understand implementation of trial interventions. This paper reports the PD COMM process evaluation.PD COMM was a large, UK multi-centre phase III pragmatic RCT of SLT in the National Health Service (NHS). It recruited 388 people with Parkinson’s who were randomised to Lee Silverman Voice Treatment (LSVT), Standard NHS SLT, or no dysarthria intervention.AimsTo describe and compare the content and service delivery components of the PD COMM SLT interventions; understand experiences of implementing LSVT; explain trial outcomes; and reflect on implications for practice and research.Methods &amp; ProceduresWe took a pragmatic, mixed methods approach. The intervention description team used a sub-sample of routine therapy notes and trial record forms, the Template for Intervention Description and Replication (TIDieR) and simple descriptive statistics to compare Individual Participant Therapy Data (LSVT n=51; Standard NHS SLT n=54). In parallel, informed by Normalisation Process Theory (NPT), the implementation team conducted qualitative interviews with a sub-sample of therapists (n=20) and participants (n=24) to understand the additional work of implementing LSVT. The core process evaluation team met to integrate the findings in relation to the trial outcomes.Outcomes &amp; ResultsLSVT was largely delivered per protocol, tailored to participants’ interests and interactions. Dosage was a key difference between the two interventions, commonly achieved by two or more therapists delivering LSVT. Effective mechanisms were LSVT’s structured design, repetitive and social nature, practise requirements and focus on volume. Standard NHS SLT was eclectic, reflecting a range of clinical approaches at a lower intensity, including some techniques and activities in common with LSVT. Although focused on impairment therapy, including specific voice therapy techniques, it also featured cognitive-linguistic and psychosocial targets and low technology augmentative and alternative communication (AAC). The trial design may have limited opportunities for group intervention.Conclusions &amp; implicationsAny LSVT roll-out needs service support and coordination and should take an inclusive approach. Future research of Standard NHS SLT should explore a rationale for dosage and more explicit tailoring to individuals and their families. There is also a pressing need to deliver the benefits of LSVT in a cost-effective manner and to develop a range of evidence-based, implementable alternatives as people’s communication support needs change