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

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@article{503b22b151b743808a07144acc8d0f13,
title = "Lee Silverman voice treatment versus standard speech and language therapy versus control in Parkinson{\textquoteright}s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial",
abstract = "Background: The PD COMM pilot randomised controlled trial compared Lee Silverman Voice Treatment (LSVT{\textregistered} LOUD) with standard NHS speech and language therapy (SLT) and a control arm in people with Parkinson{\textquoteright}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.Methods: A comparison of costs and outcomes was undertaken alongside the PD COMM pilot trial involving three arms: LSVT{\textregistered} 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.Results: Whilst 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: £3,288 per patient per year for the LSVT{\textregistered} LOUD arm, £2,033 for NHS SLT, and £1,788 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.Conclusions: The 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{\textregistered} 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 registration: International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. Registered 22 March 2012.",
keywords = "Cost-consequence analysis, Parkinson{\textquoteright}s disease, Pilot randomised controlled trial, Speech and language therapy",
author = "Sarah Scobie and Sue Jowett and Tosin Lambe and Smitaa Patel and Rebecca Woolley and Natalie Rowland and Caroline Rick and Christina Smith and Marion Brady and Clarke, {Carl E} and Cath Sackley",
note = "Funding Information: CEC received honoraria for lectures, travel expenses for conferences, and unrestricted educational grants from AbbVie, BIAL, Britannia, Teva/Lundbeck, and UCB. The rest of the authors declare that they have no competing interests. Funding Information: Site collaborators: Central Middlesex Hospital: Dr. Sophie Molloy*, Ms. Cheryl Pavel, Ms. Clare Rowbottom, Ms. Elizabeth Tweedie; City Hospital Birmingham: Professor Carl Clarke*, Dr. David Nicholl, Dr. Fouad Siddiqui, Dr. Chandana Kanakaratna, Ms. Ruth Bennett, Mrs. Karen Blachford, Ms. Alison Boughey, Ms. Tracey Harrison, Ms. Marcina Novitzky Basso, Mrs. Jan Pooler, Ms. Julie Round, Ms. Alison Smith, Ms. Caroline Waszkiewicz; Fairfield General Hospital: Dr. Jason Raw*, Dr. Joseph Vassallo, Dr. Aamir Ansari, Ms. Kelly Birtwell, Ms. Judith Brooke, Ms. Kristy Finnigan, Ms. Natasha Gillan, Mrs. Elizabeth Johnson, Ms. Heather Jowitt, Adam Kennedy; Harrogate District Hospital: Dr. Rosaria Buccoliero*, Ms. Catherine Isles, Ms. Sue Meredith, Ms. Clare Stemp, Ms. Laura Ware; Musgrove Park Hospital: Dr. Simon Cooper*, Ms. Sarah Appleton, Ms. Helen Durman, Ms. Dawn Grey, Ms. Jane (Elizabeth) Homan, Ms. Helen Meikle, Ms. Denise Sharratt, Ms. Deborah Woolven; Norfolk and Norwich University Hospital: Kate Richardson*, Dr. Simon Shields, Dr. Paul Worth, Ms. Amelia Hursey, Ms. Stephanie Cooper; Poole General Hospital: Dr. Ralph Gregory*, Ms. Lynette Every, Alice Grogan, Clare Hookem, Rachael Middle, Alison Bush; Royal Devon and Exeter Hospital (Wonford): Dr. Raymond Sheridan*, Dr. Gill Fenwick, Dr. Sarah Jackson, Dr. Tim Malone, Dr. Vaughan Pearce, Mr. Robert James, Ms. Nicola Harding, Mrs. Lisa Roberts, Ms. Sarah Hayes; Scarborough General Hospital: Ms. Louise Brown*, Lynne Brown, Mrs. Kerry Deighton, Mr. Simon Dyer, Ms. Kirsty Haunch, Emma Temlett; Southern General Hospital: Dr. Donald Grosset*, Ms. Gillian Beaton, Dr. Jennifer Burns, Dr. Anne Louise Cunnington, Dr. Graeme MacPhee, Ms. Aileen McEntee, Ms. Carol Nelson, Ms. Geraldine Ralph, Ms. Arlene Ritchie, Ms. Lindsay Shields, Ms. Bridget St George, Dr. David Stewart, Ms. Joanna Wallace, Ms. Karina Wyburn; St James? Hospital: Kim Brown*, Dawn Carlyle, Sandra Jury, Chantel Ostler. University of Birmingham Clinical Trials Unit (in alphabetical order): Pui Au, Francis Dowling, Lauren Genders, David Hingley, Natalie Ives, Ryan Ottridge, Oliver Palin, Smitaa Patel, Caroline Rick, Keith Wheatley, Rebecca Woolley. University of Birmingham: Sue Jowett. PD COMM Pilot Independent Oversight Committee: Professor Nick Miller (chair), Dr. Katherine Deane, Dr. Louise Hiller, Dr. Simon Horton. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = aug,
day = "9",
doi = "10.1186/s40814-021-00888-y",
language = "English",
volume = "7",
journal = "Pilot and Feasibility Studies",
issn = "2055-5784",
publisher = "Springer Verlag",
number = "1",

}

RIS

TY - JOUR

T1 - Lee Silverman voice treatment versus standard speech and language therapy versus control in Parkinson’s disease

T2 - preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial

AU - Scobie , Sarah

AU - Jowett, Sue

AU - Lambe, Tosin

AU - Patel, Smitaa

AU - Woolley, Rebecca

AU - Rowland, Natalie

AU - Rick, Caroline

AU - Smith, Christina

AU - Brady , Marion

AU - Clarke, Carl E

AU - Sackley, Cath

N1 - Funding Information: CEC received honoraria for lectures, travel expenses for conferences, and unrestricted educational grants from AbbVie, BIAL, Britannia, Teva/Lundbeck, and UCB. The rest of the authors declare that they have no competing interests. Funding Information: Site collaborators: Central Middlesex Hospital: Dr. Sophie Molloy*, Ms. Cheryl Pavel, Ms. Clare Rowbottom, Ms. Elizabeth Tweedie; City Hospital Birmingham: Professor Carl Clarke*, Dr. David Nicholl, Dr. Fouad Siddiqui, Dr. Chandana Kanakaratna, Ms. Ruth Bennett, Mrs. Karen Blachford, Ms. Alison Boughey, Ms. Tracey Harrison, Ms. Marcina Novitzky Basso, Mrs. Jan Pooler, Ms. Julie Round, Ms. Alison Smith, Ms. Caroline Waszkiewicz; Fairfield General Hospital: Dr. Jason Raw*, Dr. Joseph Vassallo, Dr. Aamir Ansari, Ms. Kelly Birtwell, Ms. Judith Brooke, Ms. Kristy Finnigan, Ms. Natasha Gillan, Mrs. Elizabeth Johnson, Ms. Heather Jowitt, Adam Kennedy; Harrogate District Hospital: Dr. Rosaria Buccoliero*, Ms. Catherine Isles, Ms. Sue Meredith, Ms. Clare Stemp, Ms. Laura Ware; Musgrove Park Hospital: Dr. Simon Cooper*, Ms. Sarah Appleton, Ms. Helen Durman, Ms. Dawn Grey, Ms. Jane (Elizabeth) Homan, Ms. Helen Meikle, Ms. Denise Sharratt, Ms. Deborah Woolven; Norfolk and Norwich University Hospital: Kate Richardson*, Dr. Simon Shields, Dr. Paul Worth, Ms. Amelia Hursey, Ms. Stephanie Cooper; Poole General Hospital: Dr. Ralph Gregory*, Ms. Lynette Every, Alice Grogan, Clare Hookem, Rachael Middle, Alison Bush; Royal Devon and Exeter Hospital (Wonford): Dr. Raymond Sheridan*, Dr. Gill Fenwick, Dr. Sarah Jackson, Dr. Tim Malone, Dr. Vaughan Pearce, Mr. Robert James, Ms. Nicola Harding, Mrs. Lisa Roberts, Ms. Sarah Hayes; Scarborough General Hospital: Ms. Louise Brown*, Lynne Brown, Mrs. Kerry Deighton, Mr. Simon Dyer, Ms. Kirsty Haunch, Emma Temlett; Southern General Hospital: Dr. Donald Grosset*, Ms. Gillian Beaton, Dr. Jennifer Burns, Dr. Anne Louise Cunnington, Dr. Graeme MacPhee, Ms. Aileen McEntee, Ms. Carol Nelson, Ms. Geraldine Ralph, Ms. Arlene Ritchie, Ms. Lindsay Shields, Ms. Bridget St George, Dr. David Stewart, Ms. Joanna Wallace, Ms. Karina Wyburn; St James? Hospital: Kim Brown*, Dawn Carlyle, Sandra Jury, Chantel Ostler. University of Birmingham Clinical Trials Unit (in alphabetical order): Pui Au, Francis Dowling, Lauren Genders, David Hingley, Natalie Ives, Ryan Ottridge, Oliver Palin, Smitaa Patel, Caroline Rick, Keith Wheatley, Rebecca Woolley. University of Birmingham: Sue Jowett. PD COMM Pilot Independent Oversight Committee: Professor Nick Miller (chair), Dr. Katherine Deane, Dr. Louise Hiller, Dr. Simon Horton. Publisher Copyright: © 2021, The Author(s).

PY - 2021/8/9

Y1 - 2021/8/9

N2 - Background: The 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.Methods: A 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.Results: Whilst 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: £3,288 per patient per year for the LSVT® LOUD arm, £2,033 for NHS SLT, and £1,788 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.Conclusions: The 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 registration: International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. Registered 22 March 2012.

AB - Background: The 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.Methods: A 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.Results: Whilst 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: £3,288 per patient per year for the LSVT® LOUD arm, £2,033 for NHS SLT, and £1,788 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.Conclusions: The 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 registration: International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. Registered 22 March 2012.

KW - Cost-consequence analysis

KW - Parkinson’s disease

KW - Pilot randomised controlled trial

KW - Speech and language therapy

UR - http://www.scopus.com/inward/record.url?scp=85112648821&partnerID=8YFLogxK

U2 - 10.1186/s40814-021-00888-y

DO - 10.1186/s40814-021-00888-y

M3 - Article

C2 - 34372913

VL - 7

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

IS - 1

M1 - 154

ER -