Professor David Burn
PVC Medical Sciences
- Email: firstname.lastname@example.org
- Telephone: +44 (0)191 208 7003
- Fax: +44 (0)191 208 6621
- Address: Faculty of Medical Sciences
The Medical School
Newcastle upon Tyne
Roles and Responsibilities
Honorary Consultant Neurologist, Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinical Director, Parkinson's UK
Theme Lead – Dementia, NIHR Newcastle Biomedical Research Centre
BiopicProfessor David Burn took up the position of Pro-Vice-Chancellor of the Faculty of Medical Sciences on the 1st February 2017. The Faculty delivers impact through excellence in and close integration of research, teaching and engagement across seven research institutes and four teaching schools.
Professor Burn is also Professor of Movement Disorders Neurology and Honorary Consultant Neurologist for Newcastle upon Tyne Hospitals NHS Foundation Trust. His first degree was at Oxford (Physiological Sciences), returning to his native North East for clinical training and early medical jobs, including neurology. After further neurology training and undertaking research in London (National Hospital for Neurology and Neurosurgery, Queen Square and Hammersmith Hospital) he was appointed as a Consultant Neurologist and Senior Lecturer in Newcastle in 1994.
Professor Burn has an international reputation for research in dementia associated with Parkinson’s. He is an NIHR Senior Investigator, chairs the NIHR Translational Research Collaboration for Dementia and is National Clinical Director for Parkinson’s UK.
My research aims to improve the diagnosis and management of Parkinson’s disease, the Lewy body dementias and Progressive Supranuclear Palsy (PSP). I played a key role in an International Task Force to develop the first set of Diagnostic Criteria for Dementia associated with Parkinson's disease and the International Consortium to define new diagnostic criteria for Dementia with Lewy Bodies. My group is identifying predictors of dementia in Parkinson's disease, supported by a programme grant from Parkinson's UK to identify people with Parkinson's disease at high risk of incident dementia (ICICLE-PD). Recent outputs from this work have highlighted the high burden of non-motor symptoms, and a putative cholinergic basis underpinning impaired gait speed and attention, in early Parkinson’s. More recently, my work has involved the study of apomorphine as a putative anti-amyloid agent (using clinicopathological methods) and ghrelin as a biomarker for cognitive impairment in Parkinson's.
I have contributed towards the development of new treatments for patients with movement disorders including a multi-centre randomised controlled trial of rivastigmine in the treatment of dementia in Parkinson's. The results from this trial were incorporated into 2006 NICE-PD guidelines. I lead a multicentre NIHR HTA-funded study to establish the clinical and cost effectiveness of donepezil in early dementia associated with Parkinson's disease (MUSTARDD-PD). My work in dementia with Lewy bodies has shown that physicians may prescribe levodopa safely to people with this disorder, although motor response may be sub-optimal.
I have made a significant impact in our understanding of the neurodegenerative disease PSP (average life-span 6-7 years). My work has highlighted the prevalence of PSP in the UK, its protean clinical features at presentation and the natural history. The PSP (Europe) Association used outcomes from this work to raise public and professional awareness of the disorder, to lobby parliament, and establish a UK-wide “best clinical care” model for people.
1. Co-applicant: Establishment of a Clinical Ageing Research Unit (CARU). Wellcome Trust: 2006 (£7.5 million) (G Ford, D Burn, JT O'Brien, R Taylor, IG McKeith, J Edwardson, T Kirkwood).
2. Co-applicant: The role of mitochondrial DNA in the pathogenesis of Parkinson’s disease. Parkinson’s Disease Society, UK: June 2007- May 2010 (£181207) (Chinnery PF, Burn DJ).
3. Co-applicant: Does cueing improve gait in people with Parkinson’s disease with dementia? Parkinson’s Disease Society, UK: August 2007 - July 2008 (£8184) (Rochester L, Burn DJ, Nieuwboer A).
4. Lead investigator: Visual symptoms in Parkinson’s disease and Parkinson’s disease dementia: Association with ocular and retinal pathology, visuo-perceptual deficits and impact on daily living and quality of life. Parkinson’s UK: November 2007-October 2010 (£206,446) (Archibald N, Mosimann UP, Clarke MP, Burn DJ).
5. Co-applicant: The role of common DNA variants in Parkinson’s disease. Wellcome Trust: February 2008 – January 2009 (£53,885) (Wood NW, Barker RA, Burn DJ, Chinnery PF, Hardy J, Morris HR, Morrison K, Clarke CE, Williams N).
6. Chief investigator: Predicting Dementia in Parkinson’s disease: A genotypic and phenotypic study (ICICLE-PD). Parkinson’s UK REF J0802, UK: October 2007 – September 2012 (£1,184,209) (Burn DJ, Barker RA, Brooks DJ, O’Brien JT, McKeith IG, Chinnery PF, Owen AM, Brayne CEG, Robbins T, Sawcer S, Coleman S).
7. Co-applicant: Genome-wide association studies in Parkinson’s disease. Parkinson’s UK REF J-0804: January 2009 – December 2010 (£292,590) (Wood NW, Hardy J, Barker RA, Burn DJ, Chinnery PF, Morris HR, Morrison K, Williams NM).
8. Chief investigator: Multicentre UK Study of the acetylcholinesterase inhibitor donepezil in early dementia associated with Parkinson's disease (MUSTARDD-PD). NIHR Health Technology Assessment Programme Project REF: 08/14/13: 1st Sept 2010 – 31st Aug 2015 (£2,119,113) (Burn DJ, Barker RA, Braithwaite B, Burns A, Clarke CE, Hindle JV, Knapp M, Lees AJ, Leroi I, McColl E, McKeith IG, O’Brien JT, Steen IN, Wheatley K).
9. Co-applicant: The Parkinson’s Repository of Biomarkers and Networked Datasets (PROBAND) programme: A UK national clinical consortium linking novel biomarker research to clinical expression, and progression rates, in Parkinson’s disease. Parkinson’s UK: 2011-2015 (£1,633,503) (Grosset D, Burn DJ, Barker RA, Ben-Shlomo Y, Bajaj N, Hardy J, Wood NW, Morris HR).
10. Principal applicant: Apomorphine: A modifier of amyloid deposition in Parkinson’s disease? Parkinson’s UK REF K-1101: October 2011 - April 2012 (£29,318) (Burn DJ, Revesz T, Lees AJ).
11. Principal applicant: Clinical trial to compare cognitive scales. Michael J Fox Foundation: 1st October 2011 - 30th September 2016 ($1,480,548) (Burn DJ, Weintraub D).
12. Principal applicant: A Biomedical Research Unit in Lewy Body Dementia. NIHR: 1st April 2012 - 31st March 2017 (£4.5M) (Burn DJ, McKeith IG, O’Brien JT, Kirkwood TBL, Chinnery PF, Ford GA).
13. Principal applicant: Predicting cognitive profiles in Parkinson’s disease: A multimodal approach. Michael J Fox Foundation: 1st November 2011 - 31st October 2013 ($153,342) (Burn DJ, Rochester L, O’Brien JT, Coleman SY, Baker MR).
14. Chief investigator: Predicting Dementia in Parkinson’s disease: A genotypic and phenotypic study (ICICLE-PD Project Extension). Parkinson’s UK REF G1301: 1st June 2014 – 31st December 2015 (£174,527) (Burn DJ, Barker RA, Rochester L).
15. Local principal applicant (National Lead: John Gallacher, Cardiff University): Integrating Dementias Research across the UK – the UK Dementia Platform. MRC Clinical Research Capabilities & Technologies MR/M024806/1; Nov 2014 (total £40.7M; Newcastle component £2.77M).
16. Co-PI: Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease: a multicentric, parallel-group, placebo-controlled, randomized clinical trial of deferiprone (FAIR-PARK-II). EU H2020 REF 633190, Application total 5,998,994 Euros (£209,952 to Newcastle University). Nov 2014 – Oct 2019.
17. Principal applicant: Structural retinal changes: a biomarker for dementia in Parkinson’s? Newcastle Healthcare Charity (the Trustees): 1st September 2015 – 31st August 2016 (£39661) (Burn DJ, Innes W, Yarnall AJ).
18. Principle investigator in Parkinson's disease drug studies, including trials of cholinesterase inhibitors (rivastigmine and donepezil), memantine, ACP-103 (pimavanserin; UK Chief Investigator), droxidopa, rasagiline (ADAGIO UK Chief Investigator), rotigotine, istradefylline, intranasal apomorphine, entacapone, preladenant (UK Chief Investigator) and putative neuroprotective agents. Also UK Chief Investigator in NIH-funded tolerability of low dose lithium in PSP, davudenant as a neuroprotectant in PSP (Allon) studies.
Stage 2 MB BS Thoughts, Senses and Movement Course
Stage 3 MB BS Foundations of Clinical Practice
- Jansen IE, Ye H, Heetveld S, Lechler MC, Michels H, Seinstra RI, Lubbe SJ, Drouet V, Lesage S, Majounie E, Gibbs JR, Nalls MA, Ryten M, Botia JA, Vandrovcova J, Simon-Sanchez J, Castillo-Lizardo M, Rizzu P, Blauwendraat C, Chouhan AK, Li Y, Yogi P, Amin N, van Duijn CM, Morris HR, Brice A, Singleton AB, David DC, Nollen EA, Jain S, Shulman JM, Heutink P, Hernandez DG, Arepalli S, Brooks J, Price R, Nicolas A, Chong S, Cookson MR, Dillman A, Moore M, Traynor BJ, Singleton, Plagnol V, Wood NW, Sheerin U-M, Bras JM, Charlesworth G, Gardner M, Guerreiro R, Trabzuni D, Hardy J, Sharma M, Saad M, Simon-Sanchez J, Schulte C, Corvol JC, Durr A, Vidailhet M, Sveinbjornsdottir S, Barker R, Williams-Gray CH, Ben-Shlomo Y, Berendse HW, van Dijk KD, Berg D, Brockmann K, Wurster I, Matzler W, Gasser T, Martinez M, de Bie RMA, Biffi A, Velseboer D, Bloem B, Post B, Wickremaratchi M, van de Warrenburg B, Bochdanovits Z, Bonin M, Petursson H, Riess O, Burn DJ, Lubbe S, Cooper JM, McNeill A, Schapira A, Lungu C, Chen H, Dong J, Chinnery PF, Hudson G, Clarke CE, Moorby C, Counsell C, Damier P, Dartigues J-F, Deloukas P, Gray E, Edkins S, Hunt SE, Potter S, Tashakkori-Ghanbaria A, Deuschl G, Lorenz D, Dexter DT, Durif F, Evans JR, Langford C, Foltynie T, Goate A, Harris C, van Hilten JJ, Hofman A, Hollenbeck A, Holton J, Hu M, Huang X, Illig T, Jonsson PV, Lambert J-C, O'Sullivan SS, Revesz T, Shaw K, Lees A, Lichtner P, Limousin P, Lopez G, Escott-Price V, Pearson J, Williams N, Mudanohwo E, Perlmutter JS, Pollak P, Rivadeneira F, Uitterlinden AG, Sawcer S, Scheffer H, Shoulson I, Shulman J, Smith C, Walker R, Spencer CCA, Strange A, Stefansson H, Bettella F, Stefansson K, Stockton JD, Talbot K, Tanner CM, Tison F, Winder-Rhodes S, Bhatia K. Discovery and functional prioritization of Parkinson's disease candidate genes from large-scale whole exome sequencing. Genome Biology 2017, 18, 22.
- Morris R, Lord S, Lawson RA, Coleman S, Galna B, Duncan GW, Khoo TK, Yarnall AJ, Burn DJ, Rochester L. Gait Rather Than Cognition Predicts Decline in Specific Cognitive Domains in Early Parkinson’s Disease. Journal of Gerontology Series A 2017, (ePub ahead of Print).
- Lord S, Galna B, Yarnall AJ, Coleman S, Burn D, Rochester L. Have we been overestimating fall rates in Parkinson's disease?. Movement Disorders 2017, 32(5), 803-804.
- Burte F, Houghton D, Lowes H, Pyle A, Nesbitt S, Yarnall A, Yu-Wai-Man P, Burn DJ, Santibanez-Koref M, Hudson G. Metabolic profiling of Parkinson's disease and mild cognitive impairment. Movement Disorders 2017, 32(6), 927–932.
- Malek N, Lawton MA, Grosset KA, Bajaj N, Barker RA, Ben-Shlomo Y, Burn DJ, Foltynie T, Hardy J, Morris HR, Williams NM, Wood N, Grosset DG. Utility of the new Movement Disorder Society clinical diagnostic criteria for Parkinson's disease applied retrospectively in a large cohort study of recent onset cases. Parkinsonism and Related Disorders 2017, Epub ahead of print.
- Wiblin L, Sleeman I, Burn D. Embarking on a research project…or research for the absolute novice. Journal of Royal College of Physicians in Edinburgh 2016, 46(3), 182-186.
- Lawton M, Hu MTM, Baig F, Ruffmann C, Barron E, Swallow DMA, Malek N, Grosset KA, Bajaj N, Barker RA, Williams N, Burn DJ, Foltynie T, Morris HR, Wood NW, May MT, Grosset DG, Ben-Shlomo Y. Equating scores of the University of Pennsylvania Smell Identification Test and Sniffin' Sticks test in patients with Parkinson's disease. Parkinsonism and Related Disorders 2016, 33, 96-101.
- Weintraub D, Simuni T, Caspell-Garcia C, Coffey C, Lasch S, Siderowf A, Aarsland D, Barone P, Burn D, Chahine LM, Eberling J, Espay AJ, Foster ED, Leverenz JB, Litvan I, Richard I, Troyer MD, Hawkins KA, Marek K, Jennings D, Tanner C, Kieburtz K, Poewe W, Mollenhauer B, Foroud T, Galasko D, Sherer T, Chowdhury S, Frasier M, Kopil C, Arnedo V, Rudolph A, Seibyl J, Mendick S, Schuff N, Caspell C, Uribe L, Foster E, Gloer K, Yankey J, Toga A, Berlin D, Casalin P, Malferrari G, Trojanowski J, Shaw L, Russell D, Factor S, Hogarth P, Standaert D, Hauser R, Jankovic J, Stern M, Chahine L, Frank S, Seppi K, Shill H, Berg D, Mari Z, Pavese N, Espay A, Devoto J, Rowe D, Brandabur M, Alcalay R, Tolosa E, York M, Leary L, Riordan C, Rees L, Portillo A, Lenahan A, Williams K, Guthrie S, Rawlins A, Harlan S, Hunter C, Tran B, Thomas C-A, James R, Sprenger F, Willeke D, Obradov S, Mule J, Gauss K, Fontaine D, Shah B, Ranola M, Sims JR. Cognitive Performance and Neuropsychiatric Symptoms in Early, Untreated Parkinson's Disease. Movement Disorders 2015, 30(7), 919-927.
- McKeith IG, Boeve BF, DIckson DW, Halliday G, Taylor J-P, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies. Neurology 2017, 89(1), 88-100.
- Witoelar A, Jansen IE, Wang Y, Desikan RS, Gibbs JR, Blauwendraat C, Thompson WK, Hernandez DG, Djurovic S, Schork AJ, Bettella F, Ellinghaus D, Franke A, Lie BA, McEvoy LK, Karlsen TH, Lesage S, Morris HR, Brice A, Wood NW, Heutink P, Hardy J, Singleton AB, Dale AM, Gasser T, Andreassen OA, Sharma M, Nalls MA, Plagnol V, Sheerin U-M, Saad M, Simon-Sanchez J, Schulte C, Sveinbjornsdottir S, Arepalli S, Barker R, Ben-Shlomo Y, Berendse HW, Berg D, Bhatia K, De Bie RMA, Biffi A, Bloem B, Bochdanovits Z, Bonin M, Bras JM, Brockmann K, Brooks J, Burn DJ, Majounie E, Charlesworth G, Lungu C, Chen H, Chinnery PF, Chong S, Clarke CE, Cookson MR, Cooper JM, Corvol JC, Counsell C, Damier P, Dartigues J-F, Deloukas P, Deuschl G, Dexter DT, Van Dijk KD, Dillman A, Durif F, Durr A, Edkins S, Evans JR, Foltynie T, Dong J, Gardner M, Goate A, Gray E, Guerreiro R, Harris C, Van Hilten JJ, Hofman A, Hollenbeck A, Holton J, Hu M, Huang X, Wurster I, Matzler W, Hudson G, Hunt SE, Huttenlocher J, Illig T, Jonsson PV, Lambert J-C, Langford C, Lees A, Lichtner P, Limousin P, Lopez G, Lorenz D, McNeill A, Moorby C, Moore M, Morrison KE, Escott-Price V, Mudanohwo E, O'Sullivan SS, Pearson J, Perlmutter JS, Petursson H, Pollak P, Post B, Potter S, Ravina B, Revesz T, Riess O, Rivadeneira F, Rizzu P, Ryten M, Sawcer S, Schapira A, Scheffer H, Shaw K, Shoulson I, Shulman J, Sidransky E, Smith C, Spencer CCA, Stefansson H, Stockton JD, Strange A, Talbot K, Tanner CM, Tashakkori-Ghanbaria A, Tison F, Trabzuni D, Traynor BJ, Uitterlinden AG, Velseboer D, Vidailhet M, Walker R, Van De Warrenburg B, Wickremaratchi M, Williams N, Williams-Gray CH, Winder-Rhodes S, Stefansson K, Martinez M, Ferrucci L, Johnson R, Longo DL, Nalls MA, O'Brien R, Troncoso J, Van Der Brug M, Zielke HR, Zonderman A, Hardy JA, Weale M. Genome-wide pleiotropy between Parkinson disease and autoimmune diseases. JAMA Neurology 2017, 74(7), 780-792.
- Hoogland J, Boel JA, de Bie RM, Geskus RB, Schmand BA, Dalrymple-Alford JC, Marras C, Adler CH, Goldman JG, Troster AI, Burn DJ, Litvan I, Geurtsen GJ. Mild cognitive impairment as a risk factor for Parkinson's disease dementia. Movement Disorders 2017, 32(7), 1056-1065.
- Caspell-Garcia C, Simuni T, Tosun-Turgut D, Wu I-W, Zhang Y, Nalls M, Singleton A, Shaw LA, Kang J-H, Trojanowski JQ, Siderowf A, Coffey C, Lasch S, Aarsland D, Burn D, Chahine LM, Espay AJ, Foster ED, Hawkins KA, Litvan I, Richard I, Weintraub D, the Parkinson's Progression Markers Initiative (PPMI). Multiple modality biomarker prediction of cognitive impairment in prospectively followed de novo Parkinson disease. PLoS ONE 2017, 12(5), e0175674.
- Lord S, Galna B, Yarnall AJ, Morris R, Coleman S, Burn D, Rochester L. Natural history of falls in an incident cohort of Parkinson’s disease: early evolution, risk and protective features. Journal of Neurology 2017, ePub ahead of print.
- Obeso JA, Stamelou M, Goetz CG, Poewe W, Lang AE, Weintraub D, Burn D, Halliday GM, Bezard E, Przedborski S, Lehericy S, Brooks DJ, Rothwell JC, Hallett M, DeLong MR, Marras C, Tanner CM, Ross GW, Langston JW, Klein C, Bonifati V, Jankovic J, Lozano AM, Deuschl G, Bergman H, Tolosa E, Rodriguez-Violante M, Fahn S, Postuma RB, Berg D, Marek K, Standaert DG, Surmeier DJ, Olanow CW, Kordower JH, Calabresi P, Schapira AHV, Stoessl AJ. Past, present, and future of Parkinson's disease: A special essay on the 200th Anniversary of the Shaking Palsy. Movement Disorders 2017, 32(9), 1264-1310.
- O'Dowd S, Galna B, Morris R, Lawson RA, McDonald C, Yarnall AJ, Burn DJ, Rochester L, Anderson KN. Poor Sleep Quality and Progression of Gait Impairment in an Incident Parkinson’s Disease Cohort. Journal of Parkinson's Disease 2017, epub ahead of print.
- Stuart S, Alcock L, Nell J, Lawson RA, Morris R, Yarnall AJ, Burn D, Rochester L. Pro-saccades predict decline in attention over 18 months in newly diagnosed Parkinson’s disease. In: 21st International Congress of Parkinson's Disease and Movement Disorders. 2017, Vancouver, BC, Canada: John Wiley & Sons, Inc.
- Sleeman I, Aspray T, Lawson RA, Coleman S, Duncan GW, Khoo TK, Schoenmakers I, Barker R, Rochester R, Burn DJ, Yarnall AJ. The Role of Vitamin D in Disease Progression in Early Parkinson’s Disease. Journal of Parkinson's Disease 2017, 7(4), 669-675.
- Miller N, Nath U, Noble E, Burn D. Utility and accuracy of perceptual voice and speech distinctions in the diagnosis of Parkinson’s disease, PSP and MSA-P. Neurodegenerative Disease Management 2017, 7(3).
- Martin-Bastida A, Schwarz S, Xing Y, Pietracupa S, Burn D, Silverdale M, Bajaj N, Grosset D, Auer D, Paola P. Neuromelanin-sensitive Resonance Imaging As a Parkinson's disease biomarker. In: ABN (Association of British Neurologists) Annual Meeting 2016. 2016, Brighton: BMJ Group.
- Stephenson D, Hu MT, Romero K, Breen K, Burn D, Ben-Shlomo Y, Bhattaram A, Isaac M, Venuto C, Kubota K, Little MA, Friend S, Lovestone S, Morris HR, Grosset D, Sutherland M, Gallacher J, Williams-Gray C, Bain LJ, Aviles E, Marek K, Toga AW, Stark Y, Gordon MF, Ford S. Precompetitive data sharing as a catalyst to address unmet needs in Parkinson's disease. Journal of Parkinson's Disease 2015, 5(3), 581-594.
- Guidi M, Paciaroni L, Paolini S, Scarpino O, Burn DJ. Semantic profiles in mild cognitive impairment associated with Alzheimer’s and Parkinson’s diseases. Functional Neurology 2015, 30(2), 113-118.
- Tolosa E, Litvan I, Hoglinger GU, Burn D, Lees A, Andres MV, Gomez-Carrillo B, Leon T, Del Ser T, Gomez JC, Tijero B, Berganzo K, Garcia de Yebenes J, Lopez Sendon JL, Garcia G, Tolosa E, Buongiorno MT, Bargallo N, Burguera JA, Martinez I, Ruiz-Martinez J, Narrativel I, Vivancos F, Ybot I, Aguilar M, Quilez P, Boada M, Lafuente A, Hernandez I, Lopez-Lozano JJ, Mata M, Kupsch A, Lipp A, Ebersbach G, Schmidt T, Hahn K, Hoglinger G, Hollerhage M, Oertel WH, Respondek G, Stamelou M, Reichmann H, Wolz M, Schneider C, Klingelhofer L, Berg D, Maetzler W, Srulijes KK, Ludolph A, Kassubek J, Steiger M, Tyler K, Burn DJ, Morris L, Lees A, Ling H, Hauser R, McClain T, Truong D, Jenkins S, Litvan I, Houghton D, Ferrara J, Bordelon Y, Gratiano A, Golbe L, Mark M, Uitti R, Ven Gerpen J. A phase 2 trial of the GSK-3 inhibitor tideglusib in progressive supranuclear palsy. Movement Disorders 2014, 29(4), 470-478.
- Rochester L, Lord S, Yarnall AJ, Burn DJ. Falls in patients with dementia. In: Movement Disorders in Dementias. London: Springer, 2014, pp.45-60.
- Lakshminarayana R, Wang D, Burn D, Chaudhuri KR, Cummins G, Galtrey C, Hellman B, Pal S, Stamford J, Steiger M, Williams A, The SMART-PD Investigators. Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson's disease (SMART-PD): Study protocol for a randomised controlled trial (v7; 15 August 2014). Trials 2014, 15(1), 374.