9 research outputs found
Recommended from our members
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
- Author
- Abraham S.
- Adam A.
- Adedoyin T.
- Adjei S.
- Ahearn D.
- Al-Nufoury H.
- Albutt J.
- Alison M.
- Allain T.
- Allen J.
- Allen K.
- Almedilla K.
- Alty J.
- Anderson A.
- Anderson D.
- Anderson L.
- Anderson S.
- Andrews K.
- Andrews T.
- Angus C.
- Ansari A.
- Appleton S.
- Aram J.
- Arnold C.
- Asandei D.
- Au P.
- Awan M.
- Baggs A.
- Bailey H.
- Bailey S.
- Bajracharya A.
- Bamford J.
- Bassford N.
- Bath A.
- Beames S.
- Beaton G.
- Bedford R.
- Beesley K.
- Behan T.
- Belshaw R.
- Bennett C.
- Benson J.
- Bibby L.
- Birch J.
- Birt J.
- Blachford K.
- Bobeldijk S.
- Borthwick S.
- Boughey A.
- Boyd S.
- Brady M. C.
- Bramley S.
- Bretag G.
- Brooke J.
- Brown K.
- Browning C.
- Buccoliero R.
- Burnay T.
- Burns J.
- Burton C.
- Bushell J.
- Butterworth S.
- Campbell K.
- Campbell S.
- Cann J.
- Cassidy L.
- Caulfield M.
- Cavanagh J.
- Cherriman A.
- Chick K.
- Choudhury R.
- Church A.
- Clarke A.
- Clarke C.
- Clarke C. E.
- Clewley K.
- Cochrane J.
- Colnet J.
- Conroy A.
- Conway S.
- Cooper S.
- Cooter C.
- Cosgrove J.
- Cottam L. J.
- Cottrell S.
- Coull S.
- Cox S.
- Craw S.
- Crow N.
- Cunnington A. L.
- Curran A.
- Dallas J.
- Dalton C.
- Daly P.
- Daniell A.
- Daniels T.
- Darbyshire A.
- Davey A.
- Davies A.
- Davies D.
- Davies S. E.
- Davis E.
- Davy R.
- Dawber J.
- De Selincourt G.
- Dealing S.
- Dean J.
- Dewar M.
- Dhanarante M.
- Dickson S.
- Dobbs M.
- Donaldson A.
- Donaldson S.
- Done B.
- Donnelly L.
- Douglas C.
- Dowling F.
- Downie P.
- Drayson C.
- Duff U.
- Duggan-Carter P.
- Duncan G.
- Dunn C.
- Eggers R.
- Elliott N.
- Evans A.
- Evans C.
- Evans L.
- Evans M.
- Evison L.
- Falconer A.
- Farrow-Jones M.
- Findlay H.
- Findlay N.
- Finlayson J.
- Fitzsimmons F.
- Fleming V.
- Foden A.
- Foster E.
- Fountain A.
- Fowley P.
- Fraser D.
- Freimann L.
- Funaki A.
- Furey S.
- Gall L.
- Gallagher C.
- Gandecha D.
- Ganderton D.
- Garfield-Smith J.
- Gaylard J.
- Gethin L.
- Gibson J.
- Gillies L.
- Gilmour-Graham A.
- Goodhand H.
- Graham J.
- Graham M.
- Green D.
- Griffin H.
- Grobler S.
- Grosset D.
- Guy J.
- Hackworth J.
- Hall J.
- Hankin A.
- Hare H.
- Hare M.
- Harmer M.
- Harrison J.
- Hawthorne H.
- Hayes S.
- Henderson E.
- Henderson S.
- Hernandez Y.
- Hewat P.
- Hewitt S.
- Hickey C.
- Hindle J. V.
- Holbrook C.
- Holland D.
- Holland M.
- Horsfield G.
- Howard L.
- Howieson L.
- Hughes C.
- Hughes M.
- Hughes R.
- Humphreys R.
- Hunter J.
- Hurren H.
- Hussain S.
- Hutton C.
- Hyne L.
- Irving R.
- Isaacs L.
- Isles C.
- Ives N.
- Jackson S.
- James C.
- James R.
- Jamieson S.
- Javed A.
- Jha A.
- Johnson F.
- Johnson L.
- Johnson M.
- Johnston V.
- Jones A.
- Jones S.
- Joseph R.
- Jowett S.
- Joyce C.
- Joyce O.
- Joyce T.
- Juada J.
- Kamath S.
- Karbownicki L.
- Kasti M.
- Kaur J.
- Kaur S.
- Kelly A.
- Kendall A.
- Kerr J.
- Killin L.
- Killourhey C.
- King K.
- King L.
- Kinnear S.
- Kirk J.
- Kissick A.
- Kittridge L.
- Kruszynska D.
- Kulkarni S.
- Kunsteinaite K.
- Leahy K.
- Lennox G.
- Letham E.
- Lewis A.
- Little L.
- Lomas E.
- Loraine N.
- Lord S.
- Lowe A.
- Lyell V.
- Ma Q.
- MacKenzie K.
- Maclachlan S.
- MacPhee C.
- Magennis U.
- Mahon S.
- Majeed A.
- Majeed T.
- Makawa L.
- Malone T.
- Maloney L.
- Mamutse G.
- Marrinan S.
- Marshall C.
- Martin-Forbes P.
- Masterson-Algar P.
- Matthews L.
- Mavroudis I.
- McAllister R.
- McAlpine A.
- McBrearty C.
- McCallum L.
- Mcclure H.
- McCormack M.
- McCoy I.
- McDonald D.
- McEntee A.
- Mcgee A.
- McGhee D.
- Mcilroy T.
- McLeod E.
- Meikle H.
- Mellows K.
- Melville J.
- Mercer L.
- Messeder E.
- Micabel K.
- Mills S.
- Milne K.
- Mohamed B.
- Molloy S.
- Moores-Poole H.
- Moreira C.
- Morgan H.
- Morris L.
- Moss H.
- Mournfield D.
- Mpofu P.
- Mullan D.
- Mulligan P.
- Murphy T.
- Murrow S.
- Muzerengi S.
- Nashed R.
- Neale W.
- Nelson C.
- Nelson D.
- Newcombe E.
- Newman E.
- Newman J.
- Nicholl D.
- Nicoll A.
- Niepage L.
- Niruban A.
- Noble S.
- Northover S.
- Norton R.
- Oo M. T.
- Oppetit A.
- Oprea M.
- Orr S.
- Ovayolu D.
- Page V.
- Pal S.
- Parmar E.
- Patel S.
- Pavel C.
- Pawley C.
- Peacock L.
- Pegler S.
- Peters A.
- Picken J.
- Pilborough K.
- Pimbblet F.
- Pinkney M.
- Pinnell S.
- Pointon K.
- Poku P.
- Polverino K.
- Pope K.
- Prados L.
- Price J.
- Price V.
- Queen V.
- Raby P.
- Rahman S.
- Ralph G.
- Randall P.
- Raw J.
- Rayner H.
- Reed B.
- Richardson K.
- Riches J.
- Richfield E.
- Richmond A.
- Rick C.
- Ridley J.
- Ritchie A.
- Roberts A.
- Roberts J.
- Roberts L.
- Roberts Z.
- Robinson H.
- Roebuck L.
- Rogers F.
- Round J.
- Rowbottom C.
- Rowsell K.
- Russell T.
- Sackley C. M.
- Sacre E.
- Saha R.
- Saifee T.
- Salisbury V.
- Sammler E.
- Sautin L.
- Sharp S.
- Sharratt D.
- Shearer L.
- Sheridan R.
- Short J.
- Sidney M.
- Silverdale M.
- Slade S.
- Smith C. H.
- Smith L.
- Smith P. F.
- Smith S.
- Smith V.
- Sophia R.
- Squire C.
- Sritharan M.
- Stafford S.
- Stapleton N.
- Steiger M.
- Stemp C.
- Stevens B.
- Stewart A.
- Stock K.
- Stockley J.
- Stockwell J.
- Stone M.
- Sturdy E.
- Sudlow S.
- Sutherland D.
- Sutherland S.
- Sveinbjornsdottir S.
- Swift A.
- Sykes A.
- Talbot L.
- Taylor A.
- Taylor J.
- Taylor M.
- Tearney C.
- Telford C.
- Teo A. Ling Zhi
- Thomas E. C.
- Thomas K.
- Thomas S.
- Thompson C.
- Thomson D.
- Thornley H.
- Ticehurst S.
- Timms K.
- Timoroksa A.
- Treloar H.
- Treloggen A.
- Turner E.
- Turner M.
- Turner P.
- Tyler J.
- Van Duyvenvoorde G.
- Vennard C.
- Vernall R.
- Vickers C.
- Waggett S.
- Wales E.
- Wallis M.
- Ware L.
- Warner S.
- Waszkiewicz C.
- Watkins C.
- Watson J.
- Watt A.
- Weller R.
- Westcott C.
- Wheeldon R.
- Whitcher A.
- White E.
- Whittaker R.
- Whone A.
- Whyte L.
- Wilkinson C.
- Williams E.
- Williams S.
- Williams T.
- Wilson M.
- Wilson N.
- Wilson R.
- Wiltshire A.
- Wiseman C.
- Wishart S.
- Wood A.
- Woolley R.
- Woolven D.
- Wright C.
- Wright P.
- Young C.
- Young F.
- Young K.
- Publication venue
- Trials
- Publication date
- 06/06/2020
- Field of study
Get PDFAbstract: Background: Parkinson’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/design: PD 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 registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016
Recommended from our members
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
- Author
- Abraham S.
- Adam A.
- Adedoyin T.
- Adjei S.
- Ahearn D.
- Al-Nufoury H.
- Albutt J.
- Alison M.
- Allain T.
- Allen J.
- Allen K.
- Almedilla K.
- Alty J.
- Anderson A.
- Anderson D.
- Anderson L.
- Anderson S.
- Andrews K.
- Andrews T.
- Angus C.
- Ansari A.
- Appleton S.
- Aram J.
- Arnold C.
- Asandei D.
- Au P.
- Awan M.
- Baggs A.
- Bailey H.
- Bailey S.
- Bajracharya A.
- Bamford J.
- Bassford N.
- Bath A.
- Beames S.
- Beaton G.
- Bedford R.
- Beesley K.
- Behan T.
- Belshaw R.
- Bennett C.
- Benson J.
- Bibby L.
- Birch J.
- Birt J.
- Blachford K.
- Bobeldijk S.
- Borthwick S.
- Boughey A.
- Boyd S.
- Brady M. C.
- Bramley S.
- Bretag G.
- Brooke J.
- Brown K.
- Browning C.
- Buccoliero R.
- Burnay T.
- Burns J.
- Burton C.
- Bushell J.
- Butterworth S.
- Campbell K.
- Campbell S.
- Cann J.
- Cassidy L.
- Caulfield M.
- Cavanagh J.
- Cherriman A.
- Chick K.
- Choudhury R.
- Church A.
- Clarke A.
- Clarke C.
- Clarke C. E.
- Clewley K.
- Cochrane J.
- Colnet J.
- Conroy A.
- Conway S.
- Cooper S.
- Cooter C.
- Cosgrove J.
- Cottam L. J.
- Cottrell S.
- Coull S.
- Cox S.
- Craw S.
- Crow N.
- Cunnington A. L.
- Curran A.
- Dallas J.
- Dalton C.
- Daly P.
- Daniell A.
- Daniels T.
- Darbyshire A.
- Davey A.
- Davies A.
- Davies D.
- Davies S. E.
- Davis E.
- Davy R.
- Dawber J.
- De Selincourt G.
- Dealing S.
- Dean J.
- Dewar M.
- Dhanarante M.
- Dickson S.
- Dobbs M.
- Donaldson A.
- Donaldson S.
- Done B.
- Donnelly L.
- Douglas C.
- Dowling F.
- Downie P.
- Drayson C.
- Duff U.
- Duggan-Carter P.
- Duncan G.
- Dunn C.
- Eggers R.
- Elliott N.
- Evans A.
- Evans C.
- Evans L.
- Evans M.
- Evison L.
- Falconer A.
- Farrow-Jones M.
- Findlay H.
- Findlay N.
- Finlayson J.
- Fitzsimmons F.
- Fleming V.
- Foden A.
- Foster E.
- Fountain A.
- Fowley P.
- Fraser D.
- Freimann L.
- Funaki A.
- Furey S.
- Gall L.
- Gallagher C.
- Gandecha D.
- Ganderton D.
- Garfield-Smith J.
- Gaylard J.
- Gethin L.
- Gibson J.
- Gillies L.
- Gilmour-Graham A.
- Goodhand H.
- Graham J.
- Graham M.
- Green D.
- Griffin H.
- Grobler S.
- Grosset D.
- Guy J.
- Hackworth J.
- Hall J.
- Hankin A.
- Hare H.
- Hare M.
- Harmer M.
- Harrison J.
- Hawthorne H.
- Hayes S.
- Henderson E.
- Henderson S.
- Hernandez Y.
- Hewat P.
- Hewitt S.
- Hickey C.
- Hindle J. V.
- Holbrook C.
- Holland D.
- Holland M.
- Horsfield G.
- Howard L.
- Howieson L.
- Hughes C.
- Hughes M.
- Hughes R.
- Humphreys R.
- Hunter J.
- Hurren H.
- Hussain S.
- Hutton C.
- Hyne L.
- Irving R.
- Isaacs L.
- Isles C.
- Ives N.
- Jackson S.
- James C.
- James R.
- Jamieson S.
- Javed A.
- Jha A.
- Johnson F.
- Johnson L.
- Johnson M.
- Johnston V.
- Jones A.
- Jones S.
- Joseph R.
- Jowett S.
- Joyce C.
- Joyce O.
- Joyce T.
- Juada J.
- Kamath S.
- Karbownicki L.
- Kasti M.
- Kaur J.
- Kaur S.
- Kelly A.
- Kendall A.
- Kerr J.
- Killin L.
- Killourhey C.
- King K.
- King L.
- Kinnear S.
- Kirk J.
- Kissick A.
- Kittridge L.
- Kruszynska D.
- Kulkarni S.
- Kunsteinaite K.
- Leahy K.
- Lennox G.
- Letham E.
- Lewis A.
- Little L.
- Lomas E.
- Loraine N.
- Lord S.
- Lowe A.
- Lyell V.
- Ma Q.
- MacKenzie K.
- Maclachlan S.
- MacPhee C.
- Magennis U.
- Mahon S.
- Majeed A.
- Majeed T.
- Makawa L.
- Malone T.
- Maloney L.
- Mamutse G.
- Marrinan S.
- Marshall C.
- Martin-Forbes P.
- Masterson-Algar P.
- Matthews L.
- Mavroudis I.
- McAllister R.
- McAlpine A.
- McBrearty C.
- McCallum L.
- Mcclure H.
- McCormack M.
- McCoy I.
- McDonald D.
- McEntee A.
- Mcgee A.
- McGhee D.
- Mcilroy T.
- McLeod E.
- Meikle H.
- Mellows K.
- Melville J.
- Mercer L.
- Messeder E.
- Micabel K.
- Mills S.
- Milne K.
- Mohamed B.
- Molloy S.
- Moores-Poole H.
- Moreira C.
- Morgan H.
- Morris L.
- Moss H.
- Mournfield D.
- Mpofu P.
- Mullan D.
- Mulligan P.
- Murphy T.
- Murrow S.
- Muzerengi S.
- Nashed R.
- Neale W.
- Nelson C.
- Nelson D.
- Newcombe E.
- Newman E.
- Newman J.
- Nicholl D.
- Nicoll A.
- Niepage L.
- Niruban A.
- Noble S.
- Northover S.
- Norton R.
- Oo M. T.
- Oppetit A.
- Oprea M.
- Orr S.
- Ovayolu D.
- Page V.
- Pal S.
- Parmar E.
- Patel S.
- Pavel C.
- Pawley C.
- Peacock L.
- Pegler S.
- Peters A.
- Picken J.
- Pilborough K.
- Pimbblet F.
- Pinkney M.
- Pinnell S.
- Pointon K.
- Poku P.
- Polverino K.
- Pope K.
- Prados L.
- Price J.
- Price V.
- Queen V.
- Raby P.
- Rahman S.
- Ralph G.
- Randall P.
- Raw J.
- Rayner H.
- Reed B.
- Richardson K.
- Riches J.
- Richfield E.
- Richmond A.
- Rick C.
- Ridley J.
- Ritchie A.
- Roberts A.
- Roberts J.
- Roberts L.
- Roberts Z.
- Robinson H.
- Roebuck L.
- Rogers F.
- Round J.
- Rowbottom C.
- Rowsell K.
- Russell T.
- Sackley C. M.
- Sacre E.
- Saha R.
- Saifee T.
- Salisbury V.
- Sammler E.
- Sautin L.
- Sharp S.
- Sharratt D.
- Shearer L.
- Sheridan R.
- Short J.
- Sidney M.
- Silverdale M.
- Slade S.
- Smith C. H.
- Smith L.
- Smith P. F.
- Smith S.
- Smith V.
- Sophia R.
- Squire C.
- Sritharan M.
- Stafford S.
- Stapleton N.
- Steiger M.
- Stemp C.
- Stevens B.
- Stewart A.
- Stock K.
- Stockley J.
- Stockwell J.
- Stone M.
- Sturdy E.
- Sudlow S.
- Sutherland D.
- Sutherland S.
- Sveinbjornsdottir S.
- Swift A.
- Sykes A.
- Talbot L.
- Taylor A.
- Taylor J.
- Taylor M.
- Tearney C.
- Telford C.
- Teo A. Ling Zhi
- Thomas E. C.
- Thomas K.
- Thomas S.
- Thompson C.
- Thomson D.
- Thornley H.
- Ticehurst S.
- Timms K.
- Timoroksa A.
- Treloar H.
- Treloggen A.
- Turner E.
- Turner M.
- Turner P.
- Tyler J.
- Van Duyvenvoorde G.
- Vennard C.
- Vernall R.
- Vickers C.
- Waggett S.
- Wales E.
- Wallis M.
- Ware L.
- Warner S.
- Waszkiewicz C.
- Watkins C.
- Watson J.
- Watt A.
- Weller R.
- Westcott C.
- Wheeldon R.
- Whitcher A.
- White E.
- Whittaker R.
- Whone A.
- Whyte L.
- Wilkinson C.
- Williams E.
- Williams S.
- Williams T.
- Wilson M.
- Wilson N.
- Wilson R.
- Wiltshire A.
- Wiseman C.
- Wishart S.
- Wood A.
- Woolley R.
- Woolven D.
- Wright C.
- Wright P.
- Young C.
- Young F.
- Young K.
- Publication venue
- 'Organisation for Economic Co-Operation and Development (OECD)'
- Publication date
- 27/05/2021
- Field of study
Get PDFAbstract: Background: Parkinson’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/design: PD 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 registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016
Scour around spherical bodies and self-burial
- Author
- Publication venue
- 'American Society of Civil Engineers (ASCE)'
- Publication date
- 01/01/2004
- Field of study
No full textThigh-length compression stockings and DVT after stroke
- Author
- Abbas M
- Abbasi S
- Abbasi S
- Abdelaziz A
- Abdelfattah M
- Abdul B
- Abdulmumeen A
- Abdulshukkoor N
- Abdusamad K
- Aboaba A
- Abouibrahim M
- Abraham M
- Abraham T
- Abrams J
- Abung A
- Acharya D
- Acharya D
- Acheson J
- Acosta A
- Acosta A
- Acton C
- Adam M
- Adams C
- Adams K
- Adamus M
- Adegoke K
- Adenwalla S
- Adeyeye E
- Adnan A
- Agbo C
- Aggarwal S
- Agwada-Akeru J
- Agyapong K Ansu
- Ah-Chuen J
- Ahmad M
- Ahmed I
- Ahmed I
- Ahmed L
- Ahmed L
- Ahmed M
- Ahmed M Cecilia
- Ahmed N
- Ahmed N
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Get PDFControversy exists as to whether neoadjuvant chemotherapy improves survival in patients with invasive bladder cancer, despite randomised controlled trials of more than 3000 patients. We undertook a systematic review and meta-analysis to assess the effect of such treatment on survival in patients with this disease
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- American Society of Civil Engineers (ASCE)
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No full textAzithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/02/2021
- Field of study
Get PDFBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24). Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication. Funding UK Research and Innovation (Medical Research Council) and National Institute of Health Research
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- Carter E
- Carter J
- Carter M
- Carter S
- Cartlidge D
- Carungcong J
- Carvalho MCC
- Casasnovas C
- Casey M
- Castano L
- Castaño CF
- Castaño JAT
- Castelao JE
- Castillo MA
- Caswell M
- Caterson J
- Cathcart S
- Catlow L
- Cavazza A
- Cave A
- Cawley K
- Cawley K
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- Cañadas Y
- Ceballos FC
- Cha M
- Chablani M
- Chadwick R
- Chan R
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- Chapman S
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- Charris HM
- Chaux JG
- Chaves-Santiago WG
- Chechi K
- Cheema Y
- Chen J
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- Childs D
- Chiquillo-Gómez S
- Chisholm C
- Choudhr O
- Choudhury Y
- Chukkambotla S
- Chávez MEQ
- Cid-Lopez MA
- Cienfuegos-Jimenez O
- Cinquina Z
- Clamp S
- Clapham M
- Clarey E
- Claridge H
- Clark A
- Clark A
- Clark M
- Clark M
- Clark R
- Clark R
- Clark S
- Clark S
- Clark V
- Clarke N
- Clarkson M
- Clayton S
- Clement I
- Clements S
- Clohisey S
- Coates C
- Cochrane P
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- Cockrell M
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- Collins C
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- Collins V
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- Conejo IP
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- Cooke GS
- Cookson R
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- Cooper L
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- Cordero-Lorenzana ML
- Corella D
- Corin C
- Cornell S
- Cornell T
- Corner A
- Corral MA
- Corrales A
- Cortes-Sanchez JL
- Corton M
- Cosgrove D
- Cosier T
- Costa TX
- Cother N
- Coton Z
- Cottam L-J
- Cottle J
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- Coventry T
- Covernton P
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- Cowley N
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- Crew A
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- Cristiano D
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- Crowley M
- Cruz C
- Cruz MS
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- Csabi P
- Cuerda VM
- Cuesta L
- Cullum L
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- Cunningham A
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- Da Gloria EF
- Da Rocha J
- da Silva Filipe A
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- Day A
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- de Andrés R
- de Araújo JNG
- De Beger S
- de Bustamante AD
- de Gordoa LO-R
- de Heredia ML
- de Juan C
- De la Cruz Troca J
- de la Horra C
- de la Hoz AB
- De Martino-Rodríguez A
- de Neef M
- De Queiroz JG
- de Quirós FGB
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- de Sousa Alves Neri JL
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- Dietl B
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- Diz-de Almeida S
- Djeugam B
- Doble P
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- Docherty AB
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- España PP
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- Fernández-Rodríguez A
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- García-de-Vicuña A
- García-García I
- García-Ibarbia C
- García-Montero AC
- García-Soidán A
- García-Vázquez E
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- Publication venue
- Springer Nature
- Publication date
- 17/05/2023
- Field of study
Get PDFData availability: Downloadable summary data are available through the GenOMICC data site (https://genomicc.org/data). Summary statistics are available, but without the 23andMe summary statistics, except for the 10,000 most significant hits, for which full summary statistics are available. The full GWAS summary statistics for the 23andMe discovery dataset will be made available through 23andMe to qualified researchers under an agreement with 23andMe that protects the privacy of the 23andMe participants. For further information and to apply for access to the data, see the 23andMe website (https://research.23andMe.com/dataset-access/). All individual-level genotype and whole-genome sequencing data (for both academic and commercial uses) can be accessed through the UKRI/HDR UK Outbreak Data Analysis Platform (https://odap.ac.uk). A restricted dataset for a subset of GenOMICC participants is also available through the Genomics England data service. Monocyte RNA-seq data are available under the title ‘Monocyte gene expression data’ within the Oxford University Research Archives (https://doi.org/10.5287/ora-ko7q2nq66). Sequencing data will be made freely available to organizations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research through a data access agreement. Sequencing data have been deposited at the European Genome–Phenome Archive (EGA), which is hosted by the EBI and the CRG, under accession number EGAS00001007111.Extended data figures and tables are available online at https://www.nature.com/articles/s41586-023-06034-3#Sec21 .Supplementary information is available online at https://www.nature.com/articles/s41586-023-06034-3#Sec22 .Code availability:
Code to calculate the imputation of P values on the basis of SNPs in linkage disequilibrium is available at GitHub (https://github.com/baillielab/GenOMICC_GWAS).Acknowledgements: We thank the members of the Banco Nacional de ADN and the GRA@CE cohort group; and the research participants and employees of 23andMe for making this work possible. A full list of contributors who have provided data that were collated in the HGI project, including previous iterations, is available online (https://www.covid19hg.org/acknowledgements).Change history: 11 July 2023: A Correction to this paper has been published at: https://doi.org/10.1038/s41586-023-06383-z. -- In the version of this article initially published, the name of Ana Margarita Baldión-Elorza, of the SCOURGE Consortium, appeared incorrectly (as Ana María Baldion) and has now been amended in the HTML and PDF versions of the article.Copyright © The Author(s) 2023, Critical illness in COVID-19 is an extreme and clinically homogeneous disease phenotype that we have previously shown1 to be highly efficient for discovery of genetic associations2. Despite the advanced stage of illness at presentation, we have shown that host genetics in patients who are critically ill with COVID-19 can identify immunomodulatory therapies with strong beneficial effects in this group3. Here we analyse 24,202 cases of COVID-19 with critical illness comprising a combination of microarray genotype and whole-genome sequencing data from cases of critical illness in the international GenOMICC (11,440 cases) study, combined with other studies recruiting hospitalized patients with a strong focus on severe and critical disease: ISARIC4C (676 cases) and the SCOURGE consortium (5,934 cases). To put these results in the context of existing work, we conduct a meta-analysis of the new GenOMICC genome-wide association study (GWAS) results with previously published data. We find 49 genome-wide significant associations, of which 16 have not been reported previously. To investigate the therapeutic implications of these findings, we infer the structural consequences of protein-coding variants, and combine our GWAS results with gene expression data using a monocyte transcriptome-wide association study (TWAS) model, as well as gene and protein expression using Mendelian randomization. We identify potentially druggable targets in multiple systems, including inflammatory signalling (JAK1), monocyte–macrophage activation and endothelial permeability (PDE4A), immunometabolism (SLC2A5 and AK5), and host factors required for viral entry and replication (TMPRSS2 and RAB2A).GenOMICC was funded by Sepsis Research (the Fiona Elizabeth Agnew Trust), the Intensive Care Society, a Wellcome Trust Senior Research Fellowship (to J.K.B., 223164/Z/21/Z), the Department of Health and Social Care (DHSC), Illumina, LifeArc, the Medical Research Council, UKRI, a BBSRC Institute Program Support Grant to the Roslin Institute (BBS/E/D/20002172, BBS/E/D/10002070 and BBS/E/D/30002275) and UKRI grants MC_PC_20004, MC_PC_19025, MC_PC_1905 and MRNO2995X/1. A.D.B. acknowledges funding from the Wellcome PhD training fellowship for clinicians (204979/Z/16/Z), the Edinburgh Clinical Academic Track (ECAT) programme. This research is supported in part by the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant MC_PC_20029). Laboratory work was funded by a Wellcome Intermediate Clinical Fellowship to B.F. (201488/Z/16/Z). We acknowledge the staff at NHS Digital, Public Health England and the Intensive Care National Audit and Research Centre who provided clinical data on the participants; and the National Institute for Healthcare Research Clinical Research Network (NIHR CRN) and the Chief Scientist’s Office (Scotland), who facilitate recruitment into research studies in NHS hospitals, and to the global ISARIC and InFACT consortia. GenOMICC genotype controls were obtained using UK Biobank Resource under project 788 funded by Roslin Institute Strategic Programme Grants from the BBSRC (BBS/E/D/10002070 and BBS/E/D/30002275) and Health Data Research UK (HDR-9004 and HDR-9003). UK Biobank data were used in the GSMR analyses presented here under project 66982. The UK Biobank was established by the Wellcome Trust medical charity, Medical Research Council, Department of Health, Scottish Government and the Northwest Regional Development Agency. It has also had funding from the Welsh Assembly Government, British Heart Foundation and Diabetes UK. The work of L.K. was supported by an RCUK Innovation Fellowship from the National Productivity Investment Fund (MR/R026408/1). J.Y. is supported by the Westlake Education Foundation. SCOURGE is funded by the Instituto de Salud Carlos III (COV20_00622 to A.C., PI20/00876 to C.F.), European Union (ERDF) ‘A way of making Europe’, Fundación Amancio Ortega, Banco de Santander (to A.C.), Cabildo Insular de Tenerife (CGIEU0000219140 ‘Apuestas científicas del ITER para colaborar en la lucha contra la COVID-19’ to C.F.) and Fundación Canaria Instituto de Investigación Sanitaria de Canarias (PIFIISC20/57 to C.F.). We also acknowledge the contribution of the Centro National de Genotipado (CEGEN) and Centro de Supercomputación de Galicia (CESGA) for funding this project by providing supercomputing infrastructures. A.D.L. is a recipient of fellowships from the National Council for Scientific and Technological Development (CNPq)-Brazil (309173/2019-1 and 201527/2020-0)
A second update on mapping the human genetic architecture of COVID-19
- Author
- Abd Elghafar MS
- Abdel-Aziz M
- Abdelrazik M
- Abdullah MS
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- Afset JE
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- Aguado JM
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- Aguilar-Salinas CA
- Aguilera-Albesa S
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- Yoshihara T
- Yoshiya K
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- Yáñez Z
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- Zamudio IPM
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- Zarate R
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- Zawadzki P
- Zawati MH
- Zborowski AC
- Zeberg H
- Zechner M
- Zhang Q
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- Zheng C
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- Zhlawi MWJ
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- Zárate RN
- Zúñiga-Ramos J
- Álvarez BG
- Ávila-Arcos MA
- Ávila-Arcos MC
- Özer O
- Überla K
- Þorsteinsdóttir U
- Publication venue
- Nature Research
- Publication date
- 21/06/2023
- Field of study
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