Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial

Pilot and Feasibility Studies

Rebecca Woolley¹  Smitaa Patel¹  Natalie Ives¹  Cath Sackley²  Sue Jowett³  Carl Clarke⁴  Tosin Lambe⁵  Caroline Rick⁶  Sarah Scobie⁷  Marion C Brady⁸  Christina Smith⁹ 

[1] Birmingham Clinical Trials Unit, Institute for Applied Health Research, University of Birmingham, Birmingham, UK;Faculty of Life Sciences and Medicine, King’s College London, London, UK;Health Economics Unit, Institute for Applied Health Research, University of Birmingham, Birmingham, UK;Health Economics Unit, Institute for Applied Health Research, University of Birmingham, Birmingham, UK;Department of Neurology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK;Institute of Population Health Sciences, University of Liverpool, Liverpool, UK;Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK;Nuffield, Trust, London, UK;Health Economics Unit, Institute for Applied Health Research, University of Birmingham, Birmingham, UK;Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK;Psychology and Language Science, University College London, London, UK;

关键词: Parkinson’s disease;    Pilot randomised controlled trial;    Speech and language therapy;    Cost-consequence analysis;   

DOI  :  10.1186/s40814-021-00888-y

来源: Springer

【 摘 要 】

BackgroundThe PD COMM pilot randomised controlled trial compared Lee Silverman Voice Treatment (LSVT® LOUD) with standard NHS speech and language therapy (SLT) and a control arm in people with Parkinson’s disease (PwPD) with self-reported problems with voice or speech. This analysis compares costs and quality of life outcomes between the trial arms, and considers the validity of the alternative outcome measures for economic evaluations.MethodsA comparison of costs and outcomes was undertaken alongside the PD COMM pilot trial involving three arms: LSVT® LOUD treatment (n = 30); standard NHS SLT (n = 30); and a control arm (n = 29) excluded from receiving therapy for at least 6 months after randomisation unless deemed medically necessary. For all trial arms, resource use and NHS, social care and patient costs and quality of life were collected prospectively at baseline, 3, 6, and 12 months. Total economic costs and outcomes (EQ-5D-3L, ICECAP-O) were considered over the 12-month follow-up period from an NHS payer perspective. Quality of life measures for economic evaluation of SLT for people with Parkinson’s disease were compared.ResultsWhilst there was no difference between arms in voice or quality of life outcomes at 12 months, there were indications of differences at 3 months in favour of SLT, which need to be confirmed in the main trial. The estimated mean cost of NHS care was £3288 per patient per year for the LSVT® LOUD arm, £2033 for NHS SLT, and £1788 for the control arm. EQ-5D-3L was more strongly correlated to voice impairment than ICECAP-O, and was sensitive to differences in voice impairment between arms.ConclusionsThe pilot did not identify an effect of SLT on disease-specific or economic outcomes for PwPD at 12 months; however, there appeared to be improvements at 3 months. In addition to the sample size not powered to detect difference in cost-consequence analysis, many patients in the control arm started SLT during the 12-month period used for economic analysis, in line with the study protocol. The LSVT® LOUD intervention was more intense and therefore more costly. Early indications suggest that the preferred economic outcome measure for the full trial is EQ-5D-3L; however, the ICECAP-O should still be included to capture a broader measure of wellbeing.Trial registrationInternational Standard Randomised Controlled Trial Number Register: ISRCTN75223808. Registered 22 March 2012.

【 授权许可】

CC BY