Evidence map›Paper›PMID 32460885›Full record

ArticleTrials2020

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.

C M Sackley, C Rick, P Au, M C Brady, G Beaton, C Burton, M Caulfield, S Dickson, F Dowling, M Hughes and 9 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Economic Evaluations of Speech and Language Therapy Interventions: A Scoping Review.International journal of language & communication disorders
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 1 country.

C M SackleyPopulation Health Sciences, Addison House, King's College London, Guy's Campus, London, SE1 1UL, UK.
C RickNottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK. caroline.rick@nottingham.ac.uk.ORCID http://orcid.org/0000-0001-7713-9834
P AuBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
M C BradyNMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.
G BeatonQueen Elizabeth Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.
C BurtonSchool of Allied and Public Health Professions, Canterbury Christ church University, Canterbury, CT1 1QU, UK.
M CaulfieldBangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.
S DicksonNMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.
F DowlingCambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, CB2 0QQ, UK.
M HughesBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
N IvesBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
S JowettHealth Economics, University of Birmingham, Birmingham,, B15 2TT, UK.
P Masterson-AlgarBangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.
A NicollNMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.
S PatelBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
C H SmithDivision of Psychology and Language Science, Faculty of Brain Sciences, University College London, London, UK.
R WoolleyBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
C E ClarkeInstitute for Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
PD COMM Collaborative Group
Cancer Research UK Clinical Trials Unit · GBGlasgow Caledonian University · GBBangor University · GBCanterbury Christ Church University · GBUniversity of Nottingham · GBCambridge University Hospitals NHS Foundation Trust · GBKing's College London · GBSandwell & West Birmingham Hospitals NHS Trust · GB

Funding

Chief Scientist Office SCAF/18/01Department of Health 10/135/02Health Technology Assessment Programme 10/135/02
6 · The paper itself

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. 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.

trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.

Indexed as

VoiceClinical Trials, Phase III as TopicCost-Benefit AnalysisHumansLanguage TherapyMulticenter Studies as TopicParkinson DiseaseQuality of LifeRandomized Controlled Trials as TopicSpeech TherapySurveys and QuestionnairesUnited KingdomVoice DisordersDysarthriaIdiopathic Parkinson’s diseaseLee Silverman voice treatmentRandomised controlled trialSpeech and language therapy

Identifiers

PMID32460885
PMCPMC7251680
OpenAlexW3021926858

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.