Publications 2014 to 2022

A list of publications.

2022

[Cardiac Care] Henriksen PA, Hall P, Oikonomidou O, MacPherson IR, Maclean M, Lewis S, McVicars H, Broom A, Scott F, McKay P, Borley A, Rowntree C, Lord S, Collins G, Radford J, Guppy A, Payne JR, Newby DE, Mills NL, Lang NN. Rationale and Design of the Cardiac CARE Trial: A Randomized Trial of Troponin-Guided Neurohormonal Blockade for the Prevention of Anthracycline Cardiotoxicity. Circ Heart Fail 2022; doi: 10.1161/CIRCHEARTFAILURE.121.009445:PMID: 35766037.

[CERMU CITE] Matovu B, Takuwa M, Mpaata N, Denison F, Kiwanuka N, Lewis S, Norrie J, Ononge S, Muhimbise O, Tuck S, Etuket MD, Ssekitoleko RT. Review of Investigational medical devices’ clinical trials and regulations in Africa as a benchmark for new innovations. Frontiers in Medical Technology 2022.

Link: Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations 

[DEFINE COVID] Quinn TM, Gaughan EE, Bruce A, Antonelli J, O'Connor R, Li F, McNamara S, Koch O, MacKintosh C, Dockrell D, Walsh T. Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics. EBioMedicine. 2022 Feb 1;76:103856.

[EXACT] Urquhart DS, Cunningham S, Taylor E, Vogiatzis I, Allen L, Lewis S, Neilson AR, Soleimezi D, Akooji N, Saynor ZL. Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial. NIHR Open Res 2022, 2:64 

Link: Exercise as an Airway Clearance Technique in people with Cystic Fibrosis (ExACT-CF): rationale and study protocol for a randomised pilot trial

[GI-ACP] Canny A, Mason B, Stephen J, Hopkins S, Wall L, Christie A, Skipworth RJE, Bowden J, Graham L, Kendall M, Weir CJ, Boyd K. Advance care planning in primary care for patients with gastrointestinal cancer: feasibility randomised trial. British Journal of General Practice 2022; DOI:

Link: Advance care planning in primary care for patients with gastrointestinal cancer: feasibility randomised trial 

[Methodology] Parker, R.A., Weir, C.J. Multiple secondary outcome analyses: precise interpretation is important. Trials 2327 (2022). 

Link: Multiple secondary outcome analyses: precise interpretation is important 

[Methodology] Rodriguez A, Tuck C, Dozier M, Lewis SC, Eldridge S, Jackson T, Murray A, Weir CJ. Current recommendations/practices for anonymising data from clinical trials in order to make it available for sharing: A scoping review. Clinical Trials 2022

[NACKKD] Sandilands EA, Rees JMB, Raja K, Dhaun N, Morrison EE, Hickson K, Wraight J, Gray T, Briody L, Cameron S, Thompson AP, Johnston NR, Uren N, Goddard J, Treweeke A, Rushworth G, Webb DJ, Bateman DN, Norrie J, Megson IL, Eddleston M. Acetylcysteine has No Mechanistic Effect in Patients at Risk of Contrast-Induced Nephropathy: A Failure of Academic Clinical Science. Clin Pharmacol Ther. 2022 Jun;111(6):1222-1238. doi: 10.1002/cpt.2541.

[PhD student] The value of in vivo reflectance confocal microscopy as an assessment tool in chemotherapy-induced peripheral neuropathy: A pilot study. Ramnarine, S., Dougherty, P., Rolke, R., Williams, L. J., Alessi-Fox, C., Coleman, A., Longo, C., Colvin, L. A. & Fallon, M. T., 1 Aug 2022, In: The Oncologist. 27, 8, p. e671-e680

[PhD Student] Mesa-eguiagaray, I., Wild, S. H., Bird, S. M., Williams, L. J., Brewster, D. H., Hall, P. S. & Figueroa, J. D., Breast cancer incidence and survival in Scotland by socio-economic deprivation and tumour subtype. 1 Jun 2022, In: Breast cancer research and treatment. 194, 2, p. 463-473

[PIONEER] Hazelton, C., Thomson, K., Todhunter-brown, A., Campbell, P., Chung, C. S., Dorris, L., Gillespie, D. C., Hunter, S. M., Mcgill, K., Nicolson, D. J., Williams, L. J. & Brady, M. C., Interventions for perceptual disorders following stroke. 3 Nov 2022, In: Cochrane Database of Systematic Reviews. 2022, 11, CD007039.

[POSITIF] Mead G, Gillespie D, Barber M, House A, Lewis S, Ensor H, Wu S, Chalder T. Post stroke intervention trial in fatigue (POSITIF): Randomised multicentre feasibility trial. Clinical Rehabilitation 2022;36(12):1578-1589. doi:10.1177/02692155221113908

[RAPID-CTCA] HTA monograph: Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O’Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE, on behalf of the RAPID-CTCA Investigators. Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome: the RAPID-CTCA RCT. Health Technol Assess 2022; 26(37). 

Link: Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome: the RAPID-CTCA RCT 

[RELEASE] RELEASE Collaborators, Brady, M. C., Ali, M., VandenBerg, K., Williams, L. J., Williams, L. R., Abo, M., Becker, F., Bowen, A., Brandenburg, C., Breitenstein, C., Bruehl, S., Copland, D. A., Cranfill, T. B., Pietro-Bachmann, M. D., Enderby, P., Fillingham, J., Lucia Galli, F., Gandolfi, M., Glize, B., & 49 others, Precision rehabilitation for aphasia by patient age, sex, aphasia severity, and time since stroke? A prespecified, systematic review-based, individual participant data, network, subgroup meta-analysis. 18 May 2022

[SCARF] Walsh TS, Pauley E, Donaghy E, et al. Does a screening checklist for complex health and social care needs have potential clinical usefulness for predicting unplanned hospital readmissions in intensive care survivors: development and prospective cohort study. BMJ Open 2022;12:e056524. doi: 10.1136/bmjopen-2021-056524

2021

[BRAIN-ED] Paul M Brennan, Holly J Butler, Loren Christie, Mark G Hegarty, Michael D Jenkinson, Catriona Keerie, John Norrie, Rachel O’Brien, David S Palmer, Benjamin R Smith, Matthew J Baker, Early diagnosis of brain tumours using a novel spectroscopic liquid biopsy, Brain Communications, Volume 3, Issue 2, 2021, fcab056.

Link: Early diagnosis of brain tumours using a novel spectroscopic liquid biopsy 

[BRIDGE-IT] Cameron ST, Glasier A, McDaid L, Radley A, Patterson S, Baraitser P, Stephenson J, Gilson R, Battison C, Cowle K, Vadiveloo T, Johnstone A, Morelli A, Goulao B, Forrest M, McDonald A, Norrie J. Provision of the progestogen-only pill by community pharmacies as bridging contraception for women receiving emergency contraception: the Bridge-it RCT.Health Technol Assess. 2021 May;25(27):1-92. doi: 10.3310/hta25270.PMID: 33949940

[BRIDGE-IT] Glasier A, Baraitser P, McDaid L, Norrie J, Radley A, Stephenson JM, Battison C, Gilson R, Cameron S; Trial Steering Committee; Data Monitoring Committee; Trial steering committee. Emergency contraception from the pharmacy 20 years on: a mystery shopper study. BMJ Sex Reprod Health. 2021 Jan;47(1):55-60. doi: 10.1136/bmjsrh-2020-200648. Epub 2020 Jun 17. PMID: 32554399; PMCID: PMC7815628.

[DEXFEM] Warner P, Whitaker L, Parker R, Weir C, Douglas A, Hansen C et al. Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM). Ebiomedicine 2021;69:103434

Link: Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM)

[Historic] Anand A, Lee KK, Chapman AR, Ferry AV, Adamson PD, Strachan FE, Berry C, Findlay I, Cruickshank A, Reid A, Collinson PO, Apple FS, McAllister DA, Maguire D, Fox KAA, Newby DE, Tuck C, Harkess R, Keerie C, Weir CJ, Parker RA, Gray A, Shah ASV, Mills NL; HiSTORIC Investigators. High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial. Circulation. 2021 Mar 23. doi: 10.1161/CIRCULATIONAHA.120.052380.

1KEM Hospital Research Centre, Pune, Maharashtra, India 2Child Health Research Foundation, Department of Microbiology, Dhaka Shishu Hospital, Dhaka, Bangladesh 3Centre for Global Health, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK 4Sanofi Pasteur, Swiftwater, Pensylvania, USA 5Savitribai Phule University, Pune, Maharashtra, India Correspondence to:
Dr. Ashish Bavdekar
Consultant in Pediatric Research
Department of Pediatrics & Vadu Rural Health Program
KEM Hospital Research Centre
Rasta Peth, Pune - 411011, India
a.bavdekar@kemhrcpune.rg 04092021 2021 11 04054 Copyright © 2021 by the Journal of Global Health.

[Nasopharyngeal pneumococcal study] Apte A, Dayma G, Naziat H, Williams L, Sanghavi S, Uddin J, Kawade A, Islam M, Kar S, Li Y, Kyaw M, Juvekar S, Campbell H, Nair H, Saha S, Bavdekar A. Nasopharyngeal pneumococcal carriage in South Asian infants: Results of observational cohort studies in vaccinated and unvaccinated populations. Journal of Global Health 2021

[RAPID CTCA] Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O’Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE, on behalf of the RAPID-CTCA Investigators. Early computed tomography coronary angiography in patients with suspected acute coronary syndrome: randomised controlled trial. BMJ 2021; 374 :n2106 doi:10.1136/bmj.n2106

[RESTART] Al-Shahi Salman R, Dennis MS, Sandercock PAG, Sudlow CL, Wardlaw JM, Whiteley WN, Murray GD, Stephen J, Rodriguez A, Lewis S, Werring DJ, White PM, for the RESTART Collaboration. Effects of Antiplatelet Therapy After Stroke Caused by Intracerebral Hemorrhage: Extended Follow-up of the RESTART Randomized Clinical Trial. JAMA Neurol. Published online September 03, 2021. doi:10.1001/jamaneurol.2021.2956

[RESULT-NOF] Gillies MA, Ghaffar S, Moppett IK, Docherty AB, Clarke S, Rea N, Stephen J, Keerie C, Ray DC, White TO, MacLullich AMJ, Mills NM, Rowley MR, Murthy K, Pearse RM, Stanworth SJ, Walsh TS. A restrictive versus liberal transfusion strategy to prevent myocardial injury in patients undergoing surgery for fractured neck of femur: a feasibility randomised trial (RESULT-NOF). Br J Anaesthesia 2021: 126(1); 77-86.

Link: A restrictive versus liberal transfusion strategy to prevent myocardial injury in patients undergoing surgery for fractured neck of femur: a feasibility randomised trial (RESULT-NOF)

[SALTIRE II] Pawade TA, Doris MK, Bing R, White AC, Forsyth L, Evans E, Graham C, Williams MC, van Beek EJR, Fletcher A, Adamson PD, Andrews PD, Cartlidge TRG, Jenkins WSA, Syed M, Fujisawa T, Lucatelli C, Fraser W, Ralston SH, Boon N, Prendergast B, Newby DE, Dweck MR. Effect of Denosumab or Alendronic Acid on the Progression of Aortic Stenosis: A Double-Blind Randomized Controlled Trial Circulation 

Link: Effect of Denosumab or Alendronic Acid on the Progression of Aortic Stenosis: A Double-Blind Randomized Controlled Trial 

[SNAP-40] Reed MJ, O'Brien R, Black PL, Lewis S, Ensor H, Wilkes M, McCann C, Whiting S. Physiological deterioration in the Emergency Department: the SNAP40-ED study. Emergency Care Journal 2021:17(3).

Link: Physiological deterioration in the Emergency Department: the SNAP40-ED study 

[So-Start] SoSTART Collaboration. Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage: a randomised, open-label, assessor-blinded, pilot phase, non-inferiority trial. Lancet Neurology 2021

Link: Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage in the UK: a randomised, open-label, assessor-masked, pilot-phase, non-inferiority trial 

[VIRADE] Schnier C, Janbek J, Williams L, Wilkinson T, Laursen TM, Waldemar G, Richter H, Kostev K, Lathe R, Haas JG. Antiherpetic medication and incident dementia: Observational cohort studies in four countries. European Journal of Neurology 2021; DOI: 10.1111/ene.14795

2020

[DIAMOND] Doris MK, Meah MN, Moss AJ, Andrews JPM, Bing R, Gillen R, Weir N, Syed M, Daghem M, Shah A, Williams MC, van Beek EJR, Forsyth L, Dey D, Slomka PJ, Dweck MR, Newby DE, Adamson PD.  Coronary 18F-Fluoride Uptake and Progression of Coronary Artery Calcification. Cardiovasc Imaging. 2020 Dec;13(12):e011438. doi:10.1161/CIRCIMAGING.120.011438.

Link:  Coronary 18F-Fluoride Uptake and Progression of Coronary Artery Calcification.

[BRIDGE-IT] Cameron ST, Glasier A, McDaid L, Radley A, Baraitser P, Stephenson J, Gilson R, Battison C, Cowle K, Forrest M, Goulao B, Johnstone A, Morelli A, Patterson S, McDonald A, Vadiveloo T, Norrie J. Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial. Lancet. 2020 Nov 14;396(10262):1585-1594. doi: 10.1016/S0140-6736(20)31785-2. PMID: 33189179; PMCID: PMC7661838.

[MS-SMART] Solanky BS, John NA, DeAngelis F, Stutters J, Prados F, Schneider T, Parker RA, Weir CJ, Monteverdi A, Plantone D, Doshi A. NAA is a Marker of Disability in Secondary-Progressive MS: A Proton MR Spectroscopic Imaging Study. American Journal of Neuroradiology. 2020 Nov 5.

[Methodology]  Parker RA. Commentary on Willan & Thabane: Bayesian methods are valuable in pilot trials but the choice of prior needs careful consideration. Clinical Trials. November 2020. doi:10.1177/1740774520974976

[Methodology]   Parker RA, Weir CJ. Non-adjustment for multiple testing in multi-arm trials of distinct treatments: Rationale and justification. Clinical Trials. 2020;17(5):562-566. doi:10.1177/1740774520941419

[Stand-up for Health] Parker, R.A., Manner, J., Sivaramakrishnan, D. et al. Design, rationale and analysis plan for the Stand Up for Health trial in contact centres: a stepped wedge feasibility study. Pilot Feasibility Stud 6139 (2020).

Link: Design, rationale and analysis plan for the Stand Up for Health trial in contact centres: a stepped wedge feasibility study 

[RESPIRE Spirometry] Agarwal, D., Parker, R., Pinnock, H., Roy, S., Ghorpade, D., Salvi, S.,... & RESPIRE collaboration. (2020). Normal spirometry predictive values for the Western Indian adult population. European Respiratory Journal.

[cTnI monitoring] Tzolos E, Adamson PD, Hall PS, Macpherson IR, Oikonomidou O,  MacLean M, Lewis SC, McVicars H, Newby DE, Mills NL, Lang NN and Henriksen PA. Dynamic changes in high-sensitivity cardiac troponin I in response to anthracycline-based chemotherapy. Clin Oncol. 2020;32(5):292-297

Link: Dynamic Changes in High-Sensitivity Cardiac Troponin I in Response to Anthracycline-Based Chemotherapy 

[FOCUS] Dennis M, Forbes J, Graham C, Hackett M, Hankey GJ, House A, Lewis S, Lundström E, Sandercock P, Mead G, on behalf of The FOCUS Trial Collaboration. Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT. Health Technol Assess 2020;24(22).

Link: Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT 

[LACI2] Wardlaw J, Bath PMW, Doubal F, et al. Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease. European Stroke Journal 2020.

Link: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease 

[MS-SMART] Chataway J, De Angelis F, Connick P, Parker RA, Plantone D, Doshi A. Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial Lancet Neurology 2020.

Link: Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial 

[POSITIF] Gillespie DC, Barber M, Brady MC, Carson A, Chalder T, Chun Y, Cvoro V, Dennis M, Hackett M, Haig E, House A, Lewis S, Parker R, Wee F, Wu S, Mead G. Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue. Pilot and Feasibility Studies, 2020;6:84

Link: Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue 

[Scale-upBP] Hammersley V, Parker R, Paterson M, Hanley J, Pinnock H, et al. (2020) Telemonitoring at scale for hypertension in primary care: An implementation study. PLOS Medicine 17(6): e1003124.

Link: Telemonitoring at scale for hypertension in primary care: An implementation study 

[SoStart] Salman RA, Dennis MS, Adamczuk K, Innes K, Fraser R, Drever J, Dinsmore L, Williams C, Lewis S, White PM, Newby DE, Lip GY, Parry-Jones A, Lasserson D, Oliver C, Wardlaw J, Norrie J. Start or STop Anticoagulants Randomised Trial (SoSTART) after spontaneous intracranial haemorrhage. Protocols.io 2020;Feb:DOI: dx.doi.org/10.17504/protocols.io.bcw4ixgw

[TIBOP] Parker RA, Sande TA, Laird B, et al. Bayesian methods in palliative care research: cancer-induced bone pain. BMJ Supportive & Palliative Care. Published Online First: 05 March 2020. doi: 10.1136/bmjspcare-2019-002160

[TRIO] Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial. D. F. Hamilton, et al. BMJ 24 Aug 2020. 371:m3576

Link: Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial  

[ZIPP] Cronin O, Subedi D, Forsyth L, Goodman K, Lewis SC, Keerie C, Walker A, Porteous M, Cetnarskyj R, Lakshminarayan R, Selby P, HampsonG, Chandra R, Ho S, Tobias J, Young Min S, McKenna M, Crowley R, Fraser WD, Tang J, Gennari L, Nuti R, Brandi M-L, del Pino-Montes J, Devogelaer J-P, Durnez A, Isaia G, Di Stefano, M,, Blanch J, Guanabens N, Seibel M, Walsh JP, Kotowicz M, Nicholson GC, Duncan EL, Major G, Horne A, Gilchrist N, Ralston SH. Characteristics of early Paget’s disease in SQSTM1 mutation carriers: baseline analysis of the ZiPP study cohort.  J Bone Miner Res 2020.

Link: Characteristics of Early Paget's Disease in SQSTM1 Mutation Carriers: Baseline Analysis of the ZiPP Study Cohort

[Methodology] Parker RA, Scott C, Inácio V et al. Using multiple agreement methods for continuous repeated measures data: a tutorial for practitioners. BMC Med Res Methodol 20, 154 (2020).

Link: Using multiple agreement methods for continuous repeated measures data: a tutorial for practitioners 

Stephen J, Weir CJ, Chin RF. Temporal trends in incidence of Rolandic epilepsy, prevalence of comorbidities and prescribing trends: birth cohort study. Archives of Disease in Childhood Published Online First: 14 January 2020. doi: 10.1136/archdischild-2019-318212

[FLAME] Anand A, Cudmore S, Robertson S, Stephen J, Haga K, Weir CJ, Murray SA, Boyd K, Gunn J, Iqbal J, Maclullich A, Shenkin SD, Fox KAA, Mills N, Denvir MA. (2020) Frailty assessment and risk prediction by GRACE score in older patients with acute myocardial infarction. BMC Geriatrics, 20:102.

[DelApp] Tieges Z, Stott DJ, Shaw R, Tang E, Rutter L-M, Nouzova E, Duncan N, Clarke C, Weir CJ, Assi V, Ensor H, Barnett JH, Evans J, Green S, Hendry K, Thomson M, McKeever J, Middleton DG, Parks S, Walsh T, Weir AJ, Wilson, E, Quasim T, MacLullich AMJ. (2020) A smartphone-based test for the assessment of attention deficits in delirium: A case-control diagnostic test accuracy study in older hospitalised patients. PLoS ONE, 15:e0227471.

[MS-SMART] Chataway J, De Angelis F, Connick P, Parker RA, Doshi A, John N, Barkhof F, Sharrack B, Weir CJ, Chandran S, MS-SMART Investigators. (2020) MS-SMART study: systematic sampling bias concerns – Authors' reply. The Lancet Neurology 19:479-480.

[MS-SMART] De Angelis F, Connick P, Parker R, Plantone D, Doshi A, John N, Stutters J, MacManus D, Prados F, Marshall I, Solanky B, Samson RS, Barkhof F, Ourselin S, Braisher M, Ross M, Cranswick G, Pavitt SH, Gnanapavan S, Giovannoni G, Wheeler-Kingshott CAG, Hawkins C, Sharrack B, Bastow R, Weir CJ, Stallard N, Chandran S, Chataway J. (2020) Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT. Efficacy Mech Eval 7(3) DOI:10.3310/eme07030

2019

(CHILD) Cunningham S, Graham C, McLean M, Aurora P, Ashworth M, et al. One year outcomes in a multi-centre cohort study of incident rare diffuse parenchymal lung disease in children (ChILD). Thorax 2019; doi:10.1136/thoraxjnl-2019-213217

(DIAMOND and PREFFIR sub-studies) Moss AJ, Doris MK, Andrews JPM, Bing R, Daghem M, van Beek EJR, Forsyth L, Shah ASV, Williams MC, Sellers S, Leipsic J, Dweck MR, Parker RA, Newby DE, Adamson PA. Molecular Coronary Plaque Imaging Using 18F-Fluoride. Circulation: Cardiovascular Imaging. 2019 Aug;12(8):e008574. DOI: 10.1161/CIRCIMAGING.118.008574

(DIAMOND) Moss AJ, Dweck MR, Doris MK, Andrews JPM, Bing R, Forsythe RO, Cartlidge TR, Pawade TA, Daghem M, Raftis JB, Williams MC, van Beek EJR, Forsyth L, Lewis SC, Lee RJ, Shah ASV, Mills NL, Newby DE, Adamson PD. Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque. J Am Coll Cardiol Img. 2019; DOI: 10.1016/j.jcmg.2019.05.023

(EVOLVED) Bing R, Everett R, Tuck C, Semple S, Lewis S, Harkess R, Mills NL, Treibel TA, Prasad S, Greenwood JP, McCann GP, Newby DE, Dweck MR. Rationale and design of the randomized, controlled Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial.  American Heart Journal 2019;212:91-100. DOI: 10.1016/j.ahj.2019.02.018.

(FaB) Duckworth AD, McQueen MM, Tuck CE, Tobias JH, Wilkinson JM, Biant LC, et al. Effect of Alendronic Acid on Fracture Healing: A Multicenter Randomized Placebo-Controlled Trial. Journal of Bone and Mineral Research [Internet]. 2019 Mar 7; 

Link: Effect of Alendronic Acid on Fracture Healing: A Multicenter Randomized Placebo‐Controlled Trial 

(LSA) McCrone A, Smith A, Hooper J, Parker RA, Peters A. The Life-Space Assessment Measure of Functional Mobility Has Utility in Community-Based Physical Therapist Practice in the United Kingdom. Physical Therapy, pzz131

Link: The Life-Space Assessment Measure of Functional Mobility Has Utility in Community-Based Physical Therapist Practice in the United Kingdom 

(MASK) Weir CJ, Assi V, Na L, Lewis SC, Murray GD, Langhorne P, Brady MC. Unreported summary statistics in trial publications and risk of bias in stroke rehabilitation systematic reviews: an international survey of review authors and examination of practical solutions. Journal of Stroke Medicine 2019;

Link: Unreported Summary Statistics in Trial Publications and Risk of Bias in Stroke Rehabilitation Systematic Reviews: An International Survey of Review Authors and Examination of Practical Solutions 

(POP) POP Trial Investigators, Dear J. Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial. Trials. 2019 Jan 8; 20:27.  doi: 10.1186/s13063-018-3134-1.

(POP) Morrison E, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W,.Lee RJ, Weir CJ, Henriksen D, Dear JW, On behalf of the POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019;46:423-430.  doi: 10.1016/j.ebiom.2019.07.013.

(RESTART) RESTART collaboration 2019, 'Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial' The Lancet.

Link: Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

(RESTART) RESTART collaboration 2019, 'Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial' Lancet Neurology.

Link: Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial 

(SOCLE). Brady MC, Stott DJ, Weir CJ, Chalmers C, Sweeney P, Barr J, Pollock A, Bowers N, Gray H, Bain BJ, Collins M, Keerie C, Langhorne P. A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards. Int J Stroke. 2019 Sep 30:1747493019871824. doi: 10.1177/1747493019871824.

(VICO) Hammersley V, Donaghy E, Parker R, McNeilly H, Atherton H, Bikker A, Campbell J, McKinstry B. Comparing the content and quality of video, telephone, and face-to-face consultations: a non-randomised, quasi-experimental, exploratory study in UK primary care. British Journal of General Practice 2019.

Link: Comparing the content and quality of video, telephone, and face-to-face consultations: a non-randomised, quasi-experimental, exploratory study in UK primary care 

(ZIPP) Cronin O, Forsyth L, Goodman K, Lewis S, Keerie C, Walker A, Porteous M, Cetnarskyj R, Ranganath L, Selby P, Hampson G, Chandra R, Ho S, Tobias J, Young-Min S, McKenna M, Crowley R, Fraser WD, Gennari L, Nuti R, Brandi ML, Del Pino-Montes J, Devogelaer JP, Durnez A, Isaia G, Di Stefano M, Nuria Guanabens M, Blanch J, Seibel M, Walsh J, Kotowicz MA, Nicholson GC, Duncan E, Major G, Horne A, Gilchrist N, Boers M, Murray G, Charnock K, Wilkinson D, Russell G, Ralston S. Zoledronate in the prevention of Paget’s (ZiPP): protocol for a randomised trial of genetic testing and targeted zoledronic acid therapy to prevent SQSTM1-mediated Paget’s disease of bone. BMJ Open 2019;9:e030689. doi: 10.1136/bmjopen-2019-030689

(4AT) MacLullich AM, Shenkin SD, Goodacre S, Godfrey M, Hanley J, Stíobhairt A, Lavender E, Boyd J, Stephen J, Weir C, MacRaild A, Steven J, Black P, Diernberger K, Hall P, Tieges Z, Fox C, Anand A, Young J, Siddiqi N, Gray A. The 4 'A's test for detecting delirium in acute medical patients: a diagnostic accuracy study. Health Technol Assess. 2019;23(40):1-194. doi: 10.3310/hta23400

(4AT) Shenkin SD, Fox C, Godfrey M, Siddiqi N, Goodacre S, Young J, Anand A, Gray A, Hanley J, MacRaild A, Steven J, Black PL, Tieges Z, Boyd J, Stephen J, Weir CJ, MacLullich AMJ. Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method. BMC Medicine (2019) 17:138.

Link: Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method  

(BRIDGE-IT) October 2019

Cameron ST, Baraitser P, Glasier A, McDaid L, Norrie J,Radley A, Stephenson J,

Trussell J, Battison C, Cameron S, Cowle K, Forrest M, Gilson R, Goulao B, Johnstone A,  McDonald A, Morelli A, Patterson S, Sally D, Stewart N, The Bridge-It Study Group Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol BMJ Open 2019;9:e029978. doi: 10.1136/bmjopen-2019-029978:

Link: Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol 

2018

(AFFIRM) Jane E Norman, Alexander E P Heazell, Aryelly Rodriguez, Christopher J Weir, Sarah J E Stock, Catherine J Calderwood, Sarah Cunningham Burley, J Frederik Frøen, Michael Geary, Fionnuala Breathnach, Alyson Hunter, Fionnuala M McAuliffe, Mary F Higgins, Edile Murdoch, Mary Ross-Davie, Janet Scott, Sonia Whyte. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. The Lancet, Volume 392, Issue 10158, 2018, Pages 1629-1638.

Link: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial  

(EPAT) Fallon M, Walker J, Colvin L, Rodriguez A, Murray G, Sharpe M for the EPAT study group. Pain management in cancer center inpatients: a cluster randomised trial to evaluate a systematic integrated approach - the Edinburgh Pain Assessment and Management Tool. J Clin Oncology 2018;doi 10.1200/JCO.2017.76.1825.

(ExPRES) Shankar-Hari M, Datta D, Wilson J, Assi V, Stephen J, Weir CJ, Rennie J, Antonelli J, Bateman A, Felton JM, Warner N, Judge K, Keenan J, Wang A, Burpee T, Brown AK, Lewis SM, Mare T, Roy AI,10, Wright J, Hulme G, Dimmick I, Gray A, Rossi AG, Simpson AJ, Conway Morris A, Walsh TS. Early PREdiction of Sepsis using leukocyte surface biomarkers: The ExPRES-Sepsis cohort study. Intensive Care Med. 2018;44(11):1836-1848. doi: 10.1007/s00134-018-5389-0.

(FOCUS) FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet 2018.

Link: Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

(HIGHSTEACS) Shah ASV, Anand A, Strachan FE, Ferry AV, Lee KK, Chapman AR, Sandeman D, Stables CL, Adamson PD, Andrews JPM, Anwar MS, Hung J, Moss AJ, O'Brien R, Berry C, Findlay I, Walker S, Cruickshank A, Reid A, Gray A, Collinson PO, Apple FS, McAllister DA, Maguire D, Fox KAA, Newby DE, Tuck C, Harkess R, Parker RA, Keerie C, Weir CJ, Mills NL, on behalf of the High-STEACS Investigators.  High-sensitivity troponin in the evaluation of patients with suspected acute coronary syndrome: a stepped-wedge, cluster-randomised controlled trial. Lancet 2018;392(10151):919-928.

(INFECT) Conway Morris A, Datta D, Shankar-Hari M, et al. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study. Intensive Care Medicine 2018.

(MASK) Weir CJ, Butcher I, Lewis SC, Murray GD, Langhorne P, Brady MC. Dealing with missing standard deviation and mean values in meta-analysis of continuous outcomes: a systematic review. BMC Research Methodology 2018;18:25

(Methodology) Keerie C, Tuck C, Milne G, Eldridge S, Wright N, Lewis SC. Data sharing in clinical trials - practical guidance on anonymising trial datasets. Trials 2018;19:25

(Methodology) Gray, E, Butler, HJ, Board, R, Brennan, PM, Chalmers, AJ, Dawson, T, Goodden, J, Hamilton, W, Hegarty, MG, James, A, Jenkinson, MD, Kernick, D, Lekka, E, Livermore, LJ, Mills, SJ, O'Neill, K, Palmer, DS, Vaqas, B & Baker, MJ 2018, 'Health economic evaluation of a serum-based blood test for brain tumour diagnosis: exploration of two clinical scenarios'. BMJ Open, vol. 8, no. 5, pp. e017593. DOI: 10.1136/bmjopen-2017-017593

(Methodology) Pallmann, P, Bedding, AW, Choodari-Oskooei, B, Dimairo, M, Flight, L, Hampson, LV, Holmes, J, Mander, A, Odondi, L, Sydes, MR, Villar, SS, Wason, J, Weir, C, Wheeler, GM, Yap, C & Jaki, T 2018, 'Adaptive designs in clinical trials: why use them, and how to run and report them'. BMC Medicine. DOI: 10.1186/s12916-018-1017-7

(MS-SMART) Connick P, De Angelis F, Parker RA, Plantone D, Doshi A, John N, Stutters J, MacManus D, Prados Carrasco F, Barkhof F, Ourselin S, Braisher M, Ross M, Cranswick G, Pavitt SH, Giovannoni G, Gandini Wheeler-Kingshott CA, Hawkins C, Sharrack B, Bastow R, Weir CJ, Stallard N, Chandran S, Chataway J.  Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART): a multiarm phase IIb randomised, double-blind, placebo-controlled clinical trial comparing the efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis. (study protocol) BMJ Open 2018.

Link: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART): a multiarm phase IIb randomised, double-blind, placebo-controlled clinical trial comparing the efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis 

(RESTART) Al-Shahi Salman R, Dennis MS, Murray GD, Innes K, Drever J, Dinsmore L, Williams C, White PM, Whiteley WN, Sandercock PAG, Sudlow CLM, Newby DE, Sprigg N, Werring DJ; RESTART collaborators. The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial. Trials. 2018 Mar 5;19(1):162. doi: 10.1186/s13063-018-2542-6.

(SCOT-Heart) Newby D, Lewis S et al. Coronary Computed Tomography Angiography in Patients with Stable Chest Pain and the Future Risk of Myocardial Infarction. NEJM 2018. DOI: 10.1056/NEJMoa1805971

(SNAP-ED) Reed MJ, McGrath M, Black PL, Lewis S, McCann C, Whiting S, O'Brien R, Grant ACM, Harrison B, Skyrme L, Odam M. Detection of physiological deterioration by the SNAP40 wearable device compared to standard monitoring devices in the Emergency Department: The SNAP40-ED study. Diagnostic and Prognostic Research 2018;2:18.

Link: Detection of physiological deterioration by the SNAP40 wearable device compared to standard monitoring devices in the emergency department: the SNAP40-ED study 

(4AT) Shenkin SD, Fox C, Godfrey M, Siddiqi N, Goodacre S, Young J, Anand A, Gray A, Smith J, Ryan T, Hanley J, MacRaild A, Steven J, Black PL, Boyd J, Weir CJ, MacLullich A. Protocol for validation of the 4AT, a rapid screening tool for delirium: a multicentre prospective diagnostic test accuracy study. BMJ Open 2018;8(2).

Link: Protocol for validation of the 4AT, a rapid screening tool for delirium: a multicentre prospective diagnostic test accuracy study 

Chin RFM, Stephen J, Weir CJ, et al Trends in epilepsy admissions in children, 1981–2013: population-based observational study using the Scottish national hospital discharge database Archives of Disease in Childhood Published Online First: 28 April 2018. doi: 10.1136/archdischild-2017-313944

Tsang STJ, McHugh MP, Guerendiain D, Gwynne P, Boyd J, Laurenson IF, Templeton KE, Lewis S, Simpson AHRW, Walsh TS. Evaluation of Staphylococcus aureus eradication therapy in orthopaedic surgery. Journal of Medical Microbiology 2018;67(6):893-901. doi: 10.1099/jmm.0.000731

2017

(AFFIRM) Heazell AEP, Weir CJ, Stock SJE, Calderwood CJ, Cunningham Burley S, Froen JF, Geary M, Hunter A, McAuliffe FM, Murdoch E, Rodriguez A, Ross-Davie M, Scott J, Whyte S, Norman JE. Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM). 2017

Link: Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM)  [protocol]

(Child-EU) Griese M, Seidl E, Hengst M, Reu S, Rock H, Anthony G, Kiper N, Emiralioğlu N, Snijders D, Goldbeck L, Leidl R, Ley-Zaporozhan J, Krüger-Stollfuss I, Kammer B, Wesselak T, Eismann C, Schams A, Neuner D, MacLean M, Nicholson AG, McCann L, Clement A, Epaud R, de Blic J, Ashworth M, Aurora P, Calder A, Wetzke M, Kappler M, Cunningham S, Schwerk N, Bush A. International management platform for children’s interstitial lung disease (chILD-EU). Thorax 2017; DOI 10.1136/thoraxjnl-2017-210519

(FOCUS) Graham C, Lewis S, Forbes J, Mead G, Hackett ML, Hankey GJ, Gommans J, Nguyen HT, Lundström E, Isaksson E, Näsman P, Rudberg AS, Dennis M. The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of Fluoxetine in patients with a recent stroke: a statistical and health economic analysis plan for three multicentre randomised controlled trials and a pre-planned individual patient data meta-analysis.  Trials 2017;18:627

(Methodology) Conroy EJ, Arch B, Harman NL, Lane, JA, Lewis SC, Norrie J, Sydes MR, Gamble C. A cohort examination to establish reporting of the Remit and Function of Trial Steering Committees in Randomised Controlled Trials. Trials 2017;18:590.

Link: A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials  

(Methodology) Gamble C, Krishan A, Stocken D, Lewis S, Juszczack E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Shanahan D, Barbachano Y, Loder E. Guidelines for the content of Statistical Analysis Plans in clinical trials. JAMA 2017;318(23):2337-43.

(COPD respiratory monitoring) Rubio N, Parker RA, Drost E, Pinnock H, Weir CJ, Hanley J, et al. Home monitoring of breathing rate in people with Chronic Obstructive Pulmonary Disease: observational study of feasibility, acceptability and change after exacerbation. International Journal of Chronic Obstructive Pulmonary Disease 2017;12:1221-1231. doi: 10.2147/COPD.S120706

(PRIME-RESTART) Maxwell AE, Dennis M, Rudd A, Weir CJ, Parker RA, Al-Shahi Salman R. Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART). Trials 2017, 18(1), 22.

(PRIME-RESTART) Parker RA, Weir CJ, Maxwell AE, Al-Shahi Salman R. Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART). Trials 2017, 18(1), 94.

2016

(COPD Resp) Parker R.A., Weir C.J., Rubio N., Rabinovich R., Pinnock H., Hanley J., et al. (2016). Application of Mixed Effects Limits of Agreement in the Presence of Multiple Sources of Variability: Exemplar from the Comparison of Several Devices to Measure Respiratory Rate in COPD Patients. PLoS ONE 11(12): e0168321. doi:10.1371/journal.pone.0168321

(COPD) Hunter LC, Lee RJ, Butcher I, Weir CJ, Fischbacher CM, McAllister D, Wild SH, Hewitt N, Hardie RM. Patient characteristics associated with risk of first hospital admission and readmission for acute exacerbation of chronic obstructive pulmonary disease (COPD) following primary care COPD diagnosis: a cohort study using linked electronic patient records. BMJ Open 2016;6(1):e009121. DOI: 10.1136/bmjopen-2015-009121

(DESIST) Walsh TS, Kalliopi K, Lee RJ, Everingham K, Antonelli J, Harkess RT, Cole S, Quasim T, Ruddy R, McDougall M, Davidson A, Rutherford J, Richards J, Weir CJ, for the Development and Evaluation of Strategies to Improve Sedation practice in inTensive care (DESIST) study investigators.  Development of process control methodology for tracking the quality and safety of pain, agitation, and sedation management in critical care units. Lancet Respiratory Med 2016; DOI 10.1016/S2213-2600(16)30178-3

(ExPRES-Sepsis) Datta D, Conway Morris A, Antonelli J, Warner N, Brown KA, Wright J, Simpson AJ, Rennie J, Hulme G, Lewis SM, Mare TA, Cookson S, Weir CJ, Dimmick I, Keenan J, Rossi AG, Shankar-Hari M, Walsh TS, for the ExPRES Sepsis Investigators. (2016) Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers. BMJ Open 6:e011335. doi:10.1136/bmjopen-2016-011335

(FLAME) Denvir MA, Cudmore S, Highet G, Robertson S, Donald L, Stephen J, Haga K, Hogg K, Weir CJ, Murray SA, Boyd K. Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease. Sci Rep. 2016 Apr 19;6:24619. doi: 10.1038/srep24619.

(GAPP) Lewis SC, Bhattacharya S, Wu O, Vincent K, Jack SA, Critchley HOD, Porter MA, Cranley D, Wilson JA, Horne AW. Gabapentin for the management of chronic pelvic pain in women (GaPP1): a pilot randomised controlled trial. PLOS One 2016.

Link: Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial

(INFECT) Conway Morris A, Datta D, Shankar-Hari M, Weir CJ, Rennie J, Antonelli J, Rossi AG, Warner N, Keenan J, Wang A, Brown KA, Lewis SM, Mare TA, Simpson AJ, Hulme G, Dimmick I, Walsh TS. (2016) Predictive value of cell surface markers in infections in critically ill patients:  protocol for an observational study (ImmuNe FailurE in Critical Therapy (INFECT) Study). BMJ Open 6:e011326. doi:10.1136/bmjopen-2016-011326

(Pregabalin) Fallon M, Hoskin PJ, Colvin LA, Fleetwood-Walker SM, Adamson D, Byrne A, Murray GD, Laird BJA. Randomized double-blind trial of pregabalin versus placebo in conjunction with palliative radiotherapy for cancer-induced bone pain.  Journal of Clinical Oncology 2016:550-556. DOI: 10.1200/JCO.2015.63.8221

(RAPID) Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Na L, Lewis SC, Thokala P, Newby DE. The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) — a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial.  Trials 2016;17:579. DOI: 10.1186/s13063-016-1717-2

(SALTIRE II) Pawade TA, Cartlidge TR, Jenkins WS, Adamson PD, Robson P, Lucatelli C, Van Beek EJ, Prendergast B, Denison AR, Forsyth L, Rudd JH, Fayad ZA, Fletcher A, Tuck S, Newby DE, Dweck MR. Optimization and Reproducibility of Aortic Valve 18F-Fluoride Positron Emission Tomography in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2016 Oct;9(10). pii: e005131

Link: Optimization and Reproducibility of Aortic Valve 18F-Fluoride Positron Emission Tomography in Patients With Aortic Stenosis.

(TELESCOT) Wild SH, Hanley J, Lewis SC, McKnight JA, McCloughan LB, Padfield PL, Parker RA, Paterson M, Pinnock H, Sheikh A, McKinstry B. Supported telemonitoring and glycemic control in people with type 2 diabetes pragmatic multicenter randomized controlled trial. PLoS Medicine 2016.

Link: Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial 

(TOPPIC) Mowat C, Arnott I, Cahill A, Smith M, Ahmad T, Subramanian S, Travis S, Morris J, Hamlin J, Dhar A, Nwokolo C, Edwards C, Creed T, Bloom S, Yousif M, Thomas L, Campbell S, Lewis SJ, Sebastian S, Sen S, Lal S, Hawkey C, Murray C, Cummings F, Goh J, Lindsay JO, Arebi N, Potts L, McKinley A, Thomson JM, Todd JA, Collie M, Dunlop MG, Mowat A, Gaya DR, Winter J, Naismith GD, Ennis H, Keerie C, Lewis S, Prescott RJ, Kennedy NA, Satsangi J, for the TOPPIC Study Group. Mercaptopurine versus placebo to prevent recurrence of Crohn’s disease after surgical resection (TOPPIC): a multicentre, double-blind, randomised controlled trial. Lancet Gastroenterology and Hepatology 2016.

Link: Mercaptopurine versus placebo to prevent recurrence of Crohn's disease after surgical resection (TOPPIC): a multicentre, double-blind, randomised controlled trial 

Denvir MA, Cudmore S, Highet G, Robertson S, Donald L, Stephen J, Haga K, Hogg K, Weir CJ, Murray SA, Boyd K. (2016)  Phase 2 randomised controlled trial and feasibility study of future care planning in patients with advanced heart disease. Scientific Reports 6:24619 | DOI: 10.1038/srep24619

Mukherjee M, Stoddart A, Gupta RP, Nwaru BI, Farr A, Heaven M, Fitzsimmons D, Bandyopadhyay A, Aftab C, Simpson CR, Lyons RA, Fischbacher C, Dibben C, Shields MD, Phillips CJ, Strachan DP, Davies GA, McKinstry B, Sheikh A. The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases.  BMC Med. 2016;14(1):113. doi: 10.1186/s12916-016-0657-8.

2015

(ABLE) Lacroix J, Hébert PC, Fergusson DA, Tinmouth A, Cook DJ, Marshall JC, Clayton L, McIntyre L, Callum J, Turgeon AF, Blajchman MA, Walsh TS, Stanworth SJ, Campbell H, Capellier G, Tiberghien P, Bardiaux L, van de Watering L, van der Meer NJ, Sabri E, Vo D,. (2015) ABLE Investigators and the Canadian Critical Care Trials G (2015) Age of Transfused Blood in Critically Ill Adults. The New England journal of medicine; 372:1410-1418; DOI: 10.1056/NEJMoa1500704 (published 9 April 2015)
 
(BIDS) Cunningham S, Rodriguez A, Adams T, Boyd KA, Butcher I, Enderby B, MacLean M, McCormick J, Paton JY, Wee F, Thomas H, Riding K, Turner SW, Williams C, McIntosh E, Lewis SC. Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial. Lancet 2015;386(9998):1041-8
 

(DexFEM/Methodology) Holm Hansen C, Warner P, Parker RA, Walker BR, Critchley HOD, Weir CJ. Development of a Bayesian response-adaptive trial design for the Dexamethasone for Excessive Menstruation (DexFEM) study. Statistical Methods in Medical Research, 2015. DOI: 10.1177/0962280215606155

(EMPIRE) Alam SR, Lewis SC, Zamvar V, Pessotto R, Dweck MR, Krishan A, Goodman K, Oatey K, Harkess R, Milne L, Thomas S, Mills NM, Moore C, Semple S, Wiedow O, Stirrat C Mirsadraee S, Newby DE, Henriksen PA. Perioperative Elafin for ischemia-reperfusion injury during coronary artery bypass graft surgery, a Randomized Controlled Trial. Heart 2015 doi:10.1136/heartjnl-2015-307745.

(EMPOWAR) Chiswick C, Reynolds RM, Denison F, Drake AJ, Forbes S, Newby DE, Walker BR, Quenby S, Wray S, Weeks A, Lashen H, Rodriguez A, Murray G, Whyte S, Norman JE. Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes and Endocrinology 2015;

Link: Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): a randomised, double-blind, placebo-controlled trial 

(EUROTHERM) Andrews PJD, Sinclair HL, Rodriguez A, Harris BA, Battison CG, Rhodes JKJ, Murray GD, Eurotherm3235 Trial Collaborators. Hypothermia for Intracranial Hypertension after Traumatic Brain Injury. New England Journal of Medicine 2015 DOI: 10.1056/NEJMoa1507581

(Methodology) Conroy EJ, Harman NL, Lane JA, Lewis SC, Murray G, Norrie J, Sydes MR, Gamble C. Trial Steering Committees in randomised controlled trials: a survey of registered clinical trials units to establish current practice and experiences. Clinical Trials 2015 DOI: 10.1177/1740774515589959

(Methodology) Harman NL, Conroy EJ, Lewis SC, Murray G, Norrie J, Sydes MR, Lane JA, Altman DG, Baigent C, Bliss JM, Campbell MK, Elbourne D, Evans S, Sandercock P, Gamble C. Exploring the role and function of Trial Steering Committees: Results of an expert panel meeting. Trials 2015,16:597. doi:10.1186/s13063-015-1125-z

(TELESCOT) Stoddart A, van der Pol M, Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, McKinstry B. Telemonitoring for chronic obstructive pulmonary disease: a cost and cost-utility analysis of a randomised controlled trial. J Telemed Telecare 2015;21(2):108-118, doi: 10.1177/1357633X14566574

(RECOVER) Walsh TS, Salisbury LG, Merriweather JL, Boyd JA, Griffith DM, Huby G, Kean S, Mackenzie SJ, Krishan A, Lewis SC, Murray GD, Forbes JF, Smith J, Rattray JE, Hull AM, Ramsay P for the RECOVER investigators. The effectiveness of increased physical rehabilitation and information provision following intensive care discharge: the RECOVER randomized controlled trial. JAMA Internal Medicine 2015.

2014

CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration. Effect of intermittent pneumatic compression on disability, living circumstances, quality of life, and hospital costs after stroke: secondary analyses from CLOTS 3, a randomised trial. Lancet Neurology 2014;13:1186-92

(PODOSA) Bhopal RS, Douglas A, Wallia S, Forbes JF, Lean MEJ, Gill JMR, McKnight JA, Sattar N, Sheikh A, Wild SH, Tuomilehto J, Sharma A, Bhopal R, Smith J, Butcher I, Murray GD. Effect of a lifestyle intervention on weight change in south Asian individuals in the UK at high risk of type 2 diabetes: a family-cluster randomised controlled trial. The Lancet Diabetes & Endocrinology 2014; 2(3): 218-227

(SNAP) Bateman N, Dear JW, Thanacoody R, Thomas SHL, Eddleston M, Sandilands EA, Coyle J, Cooper JG, Rodriguez A, Butcher I, Lewis SC, Vliegenthart AD, Veiraiah A, Webb DJ, Gray A. Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial. Lancet 2014; 383:697-704. DOI 10.1016/S0140-6736(13)62062-0

Hogg R, de Kok B, Netto G, Hanley J, Haycock-Stuart E. Supporting Pakistani and Chinese families with young children: perspectives of mothers and health visitors. Child: Health, Care and Development 2014; advance online publication doi:10.1111/cch.12154

Fairbrother P, Ure J, Hanley J, McCloughan L, Denvir M, Sheikh A, McKinstry B et al. Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study. J Clin Nurs 2014; 23(1-2):132-144.

McMillan TM, Weir CJ, Wainman-Lefley J. (2014) Mortality and morbidity 15 years after hospital admission with mild head injury: a prospective case-controlled population study. J Neurol Neurosurg Psychiatry, published online 12 March 2014 doi:10.1136/jnnp-2013-307279.

Milne H, van der Pol M, McCloughan L, Hanley J, Mead G, Starr J, McKinstry B et al. The use of global positional satellite location in dementia: a feasibility study for a randomised controlled trial. BMC Psychiatry 2014; 14(1):160.

Rolfe A, Cash-Gibson L, Car J, Sheikh A, McKinstry B. Interventions for improving patients' trust in doctors and groups of doctors. Cochrane Database Syst Rev 2014; 3:CD004134.

Pomeroy V, Ward NS, Johansen-Berg H, van Vliet P, Burridge J, Hunter SM, Lemon RN, Rothwell J, Weir CJ, Wing A, Walker AA, Kennedy N, Barton G, Greenwood RJ, for the FAST INdiCATE Investigators. (2014) FAST INdiCATE Trial protocol. Clinical efficacy of functional strength training for upper limb motor recovery early after stroke: neural correlates and prognostic indicators. International Journal of Stroke, 9:240-245.

Simpson H, Hamilton D, Beard D, Baker K, Wilton T, Hutchison J, Tuck C, Stoddart A, McFarlane G and Murray G. Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for randomised controlled trial. Trials 2014, 15:44

Ulugbek N, Siew L, Bright N, Mukherjee M, Grant L, Pagliari C: The effectiveness of mHealth interventions for maternal, newborn and child health in low and middle income countries: a systematic review and meta-analysis. Journal of Global Health, June 2014, Vol 4, no 1,

Link: Effectiveness of mHealth interventions for maternal, newborn and child health in low- and middle-income countries: Systematic review and meta-analysis

Wild S, Hanley J, Lewis S, McKnight J, McCloughan L, Padfield P, Paterson M, Pinnock H, McKinstry B. The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial. Trials 2013;14:198

CARC

(RECOVER study) Ramsay P, Salisbury LG, Merriweather JL, Huby G, Rattray JE, Hull AM, Brett SJ, Mackenzie SJ, Murray GD, Forbes JF et al.. (2014) A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial. Trials. 15(1):38.

2013

Burton C, McKinstry B, Szentagotai TA, et al. Activity monitoring in patients with depression: a systematic review. J Affect Disord 2013; 145(1):21-28.

Cameron EJ, Chaudhuri R, Mair F, McSharry C, Greenlaw N, Weir CJ, Jolly L, Donnelly I, Gallacher K, Morrison D, Spears M, Evans TJ, Anderson K, Thomson NC. (2013) Randomized controlled trial of azithromycin in smokers with asthma. European Respiratory Journal, in press.

CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. Lancet 2013;382(9891):516-24

Dolan M., Peters A. & Bulley, C. Postural Management in Multiple Sclerosis: The Results and Implications of a Survey and Stakeholder Event. (2013) Posture and Mobility, 30(1): 18-22

Davidson E, Simpson C, Demiris G, Sheikh A, McKinstry B: Integrating Telehealth Care-Generated Data With the Family Practice Electronic Medical Record: Qualitative Exploration of the Views of Primary Care Staff. DOI:10.2196/ijmr.2820. Interact J Med Res 2013 | vol. 2 | iss. 2 | e29.

Espie CA, Hames P, McKinstry B. Use of the Internet and Mobile Media for Delivery of Cognitive Behavioral Insomnia Therapy. Sleep Medicine Clinics 2013; 8(3):407-419

Fairbrother P, McKinstry B et al. Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study. J Clin Nurs 2013.

Fairbrother P, Pinnock H, Hanley J, McKinstry B et al. Exploring telemonitoring and self-management by patients with chronic obstructive pulmonary disease: A qualitative study embedded in a randomized controlled trial. Patient Educ Couns 2013; in press.

Fairbrother P, McCloughan L, Adam G, Brand R, Brown C, Watson M, Cotter N, Mackellaig J, McKinstry B: Involving patients in clinical research: the Telescot Patient Panel. Health Expectations, Sept 2013, DOI: 10.1111/hex.12132.

Gibbison B, Griggs K, Mukherjee M, Sheikh A. Ten years of asthma admissions to adult critical care units in England and Wales. BMJ Open 2013;3:e003420. doi:10.1136/bmjopen-2013-003420

Grant A, Ure J, Nicolson DJ, Hanley J, Sheikh A, McKinstry B et al. Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE). BMC Health Serv Res 2013; 13(1):422.

Hanley J, Ure J, Pagliari C, Sheikh A, McKinstry B. Experiences of patients and professionals participating in the HITS home blood pressure telemonitoring trial: a qualitative study. (2013). BMJ Open;3:e002671.

Hogg R, Ritchie D, Wood C, Huby G. (2013) Parenting support for families with young children - a public health, user focused study undertaken in a semi-rural area of Scotland. Journal of Clinical Nursing 22, 1140 - 1150.

Hogg R, Gray C, Kennedy C, Hanley J. (2013) Supporting the case for “progressive universalism” in health visiting: Scottish mothers and health visitors’ perspectives on targeting and rationing health visiting services, with a focus on the Lothian Child Concern Model. Journal of Clinical Nursing 22(1-2), 240-250.

Jaki T, Clive S, Weir CJ. Principles of dose finding studies in cancer: a comparison of trial designs. Cancer Chemotherapy and Pharmacology 2013; 71: 1107-1114

Legg L, Weir CJ, Langhorne P, Smith LN, Stott DJ. Is informal caregiving independently associated with poor health? A population-based study. Journal of Epidemiology and Community Health 2013; 67: 95-97

McArthur KS, Johnson PCD, Quinn TJ, Higgins P, Langhorne P, Walters MR, Weir CJ, Dawson J, Lees KR. (2013) Improving the efficiency of stroke trials: feasibility and efficacy of group adjudication of functional end points. Stroke, 44(12):3422-3428.

McKinstry B, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, Sheikh A, Krishan A, Stoddart A, Padfield P. Telemonitoring-based service redesign for the management of difficult-to-control hypertension (HITS): a multi-centre randomised controlled trial. BMJ 2013;346:f3030

McKinstry B, Sheikh A. The use of global positioning systems in promoting safer walking for people with dementia. J Telemed Telecare 2013; 19(5):288-292.

McKinstry B, Sheikh A. The use of global positioning systems in promoting safer walking for people with dementia. J Telemed Telecare July 2013 vol. 19 no. 5 288-292 doi: 10.1177/1357633X13495481

McKinstry B. Currently available smartphone apps for asthma have worrying deficiencies. Evid Based Med 2013; 18(5):e45

McKinstry B. The use of remote monitoring technologies in managing chronic obstructive pulmonary disease. Quarterly Journal of Medicine 2013. In press doi hct068 [pii];10.1093/qjmed/hct068 [doi]

McLean S, Sheikh A, Cresswell K, Nurmatov U, Mukherjee M, Hemmi A, Pagliari C The Impact of Telehealthcare on the Quality and Safety of Care: A Systematic Overview; PLoS One. 2013; 8(8): e71238.

McMillan TM, Weir CJ, Ireland A, Stewart E. The Glasgow Outcome at Discharge Scale: an inpatient assessment of disability after brain injury. Journal of Neurotrauma 2013; 30: 970-974

Morgan TC, Dawson J, Spengler D, Lees KR, Aldrich C, Mishra NK, Lane K, Quinn TJ, Diener-West M, Weir CJ, Higgins P, Rafferty M, Kinsley K, Ziai W, Awad I, Walters MR, Hanley D, the CLEAR and VISTA Investigators. The Modified Graeb Score: an enhanced tool for intraventricular haemorrhage measurement and prediction of functional outcome. Stroke 2013; 44: 635-641

Pagliari C, Wolters M, Burton C, McKinstry B, Szentafgotai A, Serrano Blanco A, Ferrini L, Albertini S, Castro JC, Estévez S: Psychosocial Implications of Avatar Use in Supporting Theraphy of Depression. Accepted: CYBER17-17th Annual CyberPsychology & CyberTherapy Conference, Brussels, Belgium.

Pagliari, C,. Burton, C, McKinstry, B, et al.Psychosocial implications of avatar use in supporting therapy for depression. Stud.Health Technol.Inform. 2013; 181:329-33

Pinnock H, Hanley J, McKinstry B et al. Impact of telemonitoring for chronic obstructive pulmonary disease (COPD) on hospitalisation: a randomised controlled trial. BMJ in press

Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, Lewis S, Stoddart A, Van der Pol M, MacNee W, Sheikh A, Pagliari C, McKinstry B. (2013) Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial. BMJ 2013; 347:f6070 doi: 10.1136/bmj.f6070

Spears M, McSharry C, Chaudhuri R, Weir CJ, de Wet C, Thomson NC. (2013) Smoking in asthma is associated with elevated levels of corticosteroid resistant sputum cytokines—an exploratory study. PLoS ONE, 8(8):e71460. doi:10.1371/journal.pone.0071460

Stoddart A, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, Sheikh A, Krishan A, Padfield P, McKinstry B. Telemonitoring-based service redesign for the management of difficult-to-control hypertension (HITS): A cost and cost-effectiveness analysis. BMJ Open 2013;3:e002681

Thanacoody HKR, Gray A, Dear JW, Coyle J, Sandilands EA, Webb DJ, Lewis S, Eddleston M, Thomas SHL, Bateman DN. Scottish and Newcastle Antiemetic Pre-treatment for Paracetamol Poisoning Study (SNAP). BMC Pharmacology and Toxicology 2013;14:20

Walsh TS, Boyd JA, Watson D, Hope D, Lewis S, Krishan A, Forbes JF, Ramsay P, Pearse R, Wallis C, Cairns C, Cole S, Wyncoll D; RELIEVE investigators. Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial. Critical Care Medicine 2013;41(10):2354-63.

Wardlaw J, Muir KW, MacLeod MJ, Weir C, McVerry F, Carpenter T, Shuler K, Thomas R, Acheampong P, Dani K, Murray A. Clinical relevance and practical implications for trials of perfusion and angiographic imaging in patients with acute ischaemic stroke: a multicentre cohort imaging study. Journal of Neurology, Neurosurgery and Psychiatry published online 3 May 2013

Wild S, Hanley J, McKinstry B et al. The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial. Trials 2013; 14 (1): 198.

CARC

RELINQUISH study Ramsay P, Huby G, Rattray J, Salisbury LG, Walsh TS, Kean S. (2013) A longitudinal qualitative exploration of healthcare and informal support needs among survivors of critical illness: the RELINQUISH protocol. BMJ open. 2(4)

Chandler A. Whittaker A. Williams N. McGorm K. Cunningham-Burley S. Matthews G. (in press) Mother’s little helper? Contrasting accounts of benzodiazepine and methadone use among drug-dependent parents in the UK, Drugs: Education, Prevention and Policy.

Chandler A. Whittaker A. Cunningham-Burley S. Williams N. McGorm K. Mathews G. (2013) Substance, stigma and structure: Parents in the UK accounting for opioid substitution therapy during the antenatal and postnatal periods, International Journal of Drug Policy, 24, 6, e35-42. 10.1016/j.drugpo.2013.04.004

Good practice guidance: Whittaker A. Templeton L, Mitchell F. Hill L. Neilson A. (in press) Practitioner Toolkit: Getting it right for children and families affected by parental problem alcohol and drug use, Edinburgh, NHS Lothian.